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FDA Consumer magazine
VOL. 30 No. 2 MARCH 1996
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Features

Preventing Childhood Poisoning
Home can be a dangerous place when it comes to childhood poisoning. It's
not only prescription drugs that need to be kept out of little hands'
reach: Today the biggest concern is iron supplements.

Growing Older, Eating Better
Many older Americans, especially those who live alone, have been unable
to get proper nutrition due to problems that often accompany aging. But
food programs and other types of assistance are now helping elders to a
better diet.

Coping with Arthritis in Its Many Forms
One in seven Americans has some form of arthritis. Medications--some of
them nonprescription--and some kinds of exercise can provide relief. But
consumers need to avoid fraudulent products that seem to proliferate in
this profitable market.

Tea: A Story of Serendipity
Happy coincidence has played a part in making tea second only to water
in worldwide consumption. Americans drink their fair share--2.24 gallons
per person in 1994--much of it iced and most of it black rather than
green or oolong.

FDA, States Collaborate for Safety's Sake
FDA has formal cooperative programs with the states in four areas. The
public benefits from the expertise each partner brings to these
collaborations.


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Departments



Updates 

The latest information on FDA-related issues, gathered from FDA Press
Releases, Talk Papers, and other sources.



Notebook 

A potpourri of items of interest gathered from the Federal Register and
other sources.



Investigators' Reports 

Selected cases illustrating regulatory and administrative actions--such
as inspections, recalls, seizures, and court proceedings--by FDA's
regional and district offices across the country



Summaries of Court Actions 

Cases involving seizure, criminal and injunction proceedings.



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Preventing Childhood Poisoning

by Audrey T. Hingley

Most people regard their home as a safe haven, a calming oasis in an
often stormy world.

But home can be a dangerous place when it comes to accidental poisoning,
especially accidental poisoning of children. One tablet of some
medicines can wreak havoc in or kill a child.

Childhood poisonings caused by accidental overdoses of iron-containing
supplements are the biggest concern of poison control experts, consumer
protection groups, and health-care providers. Iron-containing
supplements are the leading cause of pediatric poisoning deaths for
children under 6 in the United States. According to the American
Association of Poison Control Centers, from 1986 to 1994, 38 children
between the ages of 9 months and 3 years died from accidentally
swallowing iron-containing products. The number of pills consumed by
these children varied from as few as five to as many as 98.

FDA is taking steps to protect children from iron poisoning by proposing
regulations that will make it harder for small children to gain access
to high-potency iron products (30 milligrams of iron or more per
tablet). FDA is also taking steps to ensure that health-care providers
and consumers are alerted to the dangers associated with accidental
overdoses of iron-containing products, including pediatric multivitamin
supplements that contain iron.

Although iron poisoning is the biggest concern when it comes to
childhood poisoning, there is also concern about other drugs.

"Over-the-counter diet pills have the potential to be lethal to
children, as do OTC stimulants used to keep you awake and decongestant
tablets," says George C. Rodgers, M.D., Ph.D., medical director of the
Kentucky Regional Poisoning Center. "Tofranil [imipramine], an
antidepressant drug also used for childhood bedwetting, and Catapres
[clonidine], a high blood pressure medicine, can be very hazardous
because it takes very little to produce life-threatening problems in
children. One tablet may do it.

"Antidepressant drugs have a high degree of toxicity," he continues.
"They are cardiac and central nervous system toxins, and it doesn't take
much of them to do harm, particularly in children. They are prescribed
fairly ubiquitously. One of the things we look at when we get kids'
poisonings is who had the medicine, and why."

Rodgers also urges extra caution when antidepressant drugs are
prescribed for teenage patients who may have behavioral or emotional
problems.

"Antidepressant drugs are commonly given to adolescents with behavioral
problems, and often a month or two-month supply is prescribed. Teens
should not be given more than a week's supply to begin with, and parents
need to monitor their usage," he says.

The marketing of pediatric vitamins is also a cause of concern for
Rodgers.

"Because they're marketed to look like candy or cartoon characters, it
looks like candy and doesn't seem like medicine," he explains.

In addition, children frequently mimic the behavior of their parents.
Children who watch their parents take pills may want to do it, too--with
potentially fatal results.

Poison-Proofing Your Home

Poison-proofing your home is the key to preventing childhood poisonings.
In the case of iron-containing pills or any medicine: 

 * Always close the container as soon as you've finished using it.
   Properly secure the child-resistant packaging, and put it away
   immediately in a place where children can't reach it.

 * Keep pills in their original container.

 * Keep iron-containing tablets, and all medicines, out of reach--and
   out of sight--of children.

 * Never keep medicines on a countertop or bedside table.

 * Follow medicine label directions carefully to avoid accidental
   overdoses or misdoses that could result in accidental poisoning.

For other substances, buy the least hazardous products that will serve
your purposes. When buying art supplies, for example, look for products
that are safe for children. For hazardous products such as gasoline,
kerosene, and paint thinners that are often kept on hand indefinitely,
buy only as much as you need and safely get rid of what you don't use.
Never transfer these substances to other containers. People often use
cups, soft-drink bottles, or milk cartons to store leftover paint
thinner or turpentine. This is a bad idea because children associate
cups and bottles with food and drink.

The kitchen and bathroom are the most likely unsafe areas. (Medicines
should never be stored in the bathroom for another reason: a bathroom's
warm, moist environment tends to cause changes or disintegration of the
product in these rooms.) Any cabinet containing a potentially poisonous
item should be locked.

"Bathrooms with medicines, kitchens with cleaning products, even
cigarette butts left out, can be toxic to kids," Rodgers explains. "And
remember that child-resistant caps are child-resistant, not childproof.
The legal definition is that it takes greater than five minutes for 80
percent of 5-year-olds to get into it: that means 20 percent can get in
in less time! Kids are inventive, and can often figure it out. And
leftover liquor in glasses on the counter after parties? Don't do it!" 

Alcohol can cause drunkenness as well as serious poisoning leading to
seizures, coma, and even death in young children. Children are more
sensitive to the toxic effects of alcohol than are adults, and it
doesn't take much alcohol to produce such effects. Alcohol-laced
products, such as some mouthwashes, aftershaves or colognes, can cause
the same problems.

Garages and utility rooms should also be checked for potential poison
hazards. Antifreeze, windshield washing fluid, and other products should
be stored out of children's reach in a locked cabinet. Childproof safety
latches can be purchased at your local hardware store.

In the living room or family room, know your plants' names and their
poison potential. Although most houseplants are not poisonous, some are.
To be on the safe side, keep houseplants out of the reach of young
children. Although much has been made of problems with poinsettias
(blamed for a death as early as 1919), recent studies indicate it is not
as highly toxic as was once believed. Although ingesting it may cause
some stomach irritation and burning in the mouth, it's unlikely to be
fatal.

"Plants are mostly a problem for children, since it's a natural response
for children to taste things. Few adults eat houseplants," Rodgers
points out. "Plants have a high capacity for making you sick, but they
are usually low-risk for producing life-threatening symptoms." After
poison-proofing your home, prepare for emergencies. Post the numbers of
your regional poison control center (which can be found on the inside
cover of the Yellow Pages or in the white pages of your phone directory)
and your doctor by the phone. Keep syrup of ipecac on hand--safely
locked away, of course. (See "Antidotes.") Never administer any antidote
without first checking with your doctor or poison control center.

Lead Poisoning

Although lead levels in food and drink are the lowest in history,
concern remains about lead leaching into food from ceramic ware.
Improperly fired or formulated glazes on ceramic ware can allow lead to
leach into food or drink.

Long recognized as a toxic substance, adverse health effects can result
from exposure to lead over months or years.

After a California family suffered acute lead poisoning in 1969 from
drinking orange juice stored in a pitcher bought in Mexico, FDA
established "action levels" for lead in ceramic ware used to serve food.
Over the years, these original action levels have been revised as
research has shown that exposure to even small amounts of lead can be
hazardous. The last revision for ceramic foodware was in 1991. On Jan.
12, 1994, FDA published a regulation for decorative ceramic ware not
intended for food use, requiring a permanently affixed label on
high-lead-leaching products.

"Most lead toxicity comes from multiple exposure and is a slow
accumulation over time," says Robert Mueller, a nurse and poison
information specialist at the Virginia Poison Center, headquartered at
The Medical College of Virginia Hospitals in Richmond. "Refusing to eat,
vomiting, convulsions, and malaise can all be symptoms of lead
poisoning." Because lead poisoning occurs over time, such symptoms may
not show up right away. A blood test is the surest way to determine that
your child has not been exposed to significant amounts of lead.

"In general, if a consumer purchases ceramic ware in the U.S.
marketplace today, it meets the new action levels," says Julia Hewgley,
public affairs specialist with FDA's Center for Food Safety and Applied
Nutrition. "But if you travel abroad and buy ceramic ware, be aware that
each country has its own safety regulations. Safety can be terribly
variable depending on the type of quality control and whether the piece
is made by a hobbyist." To guard against poisonings, Hewgley advises
that ceramic ware not be used to store foods. Acidic foods--such as
orange, tomato and other fruit juices, tomato sauces, vinegar, and
wine--stored in improperly glazed containers are potentially the most
dangerous. Frequently used products, like cups or pitchers, are also
potentially dangerous, especially when used to hold hot, acidic foods.

"Stop using any item if the glaze shows a dusty or chalky gray residue
after washing. Limit your use of antique or collectible housewares for
food and beverages," she says.

"Buy one of the quick lead tests available at hardware stores and do a
screening on inherited pieces."

Iron Poisoning

Iron-containing products remain the biggest problem by far when it comes
to childhood poisoning. In October 1994 FDA proposed regulations for
unit-dose packaging requirements for iron-containing products with 30
milligrams or more of iron per dosage unit. The agency also proposed
requiring warning labels about the adverse effects of high-dose iron
ingestion by children for all iron-containing products taken in solid
oral dosage forms. Because of the time and effort needed to open
unit-dose products, FDA believes unit-dose packaging will discourage a
youngster, or at least limit the number of tablets a child would
swallow, reducing the potential for serious illness or death.

FDA's proposed requirements would be in addition to existing U.S.
Consumer Product Safety Commission regulations, which require
child-resistant packaging for most iron-containing products. FDA issued
a supplementary proposed rule in February 1995. At press time, a final
rule regarding iron-containing products was expected soon.

Iron is an essential nutrient sometimes lacking in people's diets, which
is why iron is often recommended for people with conditions such as
iron-deficiency anemia. Taken as indicated, iron is safe. But when
tablets are taken beyond the proper dose in a short period, especially
by toddlers or infants, serious injury or death may result.

Children poisoned with iron face immediate and long-term problems.
Within minutes or hours of swallowing iron tablets, nausea, vomiting,
diarrhea, and gastrointestinal bleeding can occur. These problems can
progress to shock, coma, seizures, and death. Even if a child appears to
have no symptoms after accidentally swallowing iron, or appears to be
recovering, medical evaluation should still be sought since successful
treatment is difficult once iron is absorbed from the small intestine
into the bloodstream. And children who survive iron poisoning can
experience other problems, such as gastrointestinal obstruction and
liver damage, up to four weeks after the ingested poisoning.

FDA regulates iron-containing products as either drugs or foods,
depending on the product formulation and on intended use, as defined by
labeling and other information sources. Iron products are regulated as
drugs if they are intended to affect the structure or function of the
body, or are used in the diagnosis, cure, treatment, or prevention of
disease and are listed in the U.S. Pharmacopeia. All other products are
regulated as foods.

Some iron-containing products have been regulated as prescription drugs
because they included pharmacologic doses of folic acid and usually were
prescribed to meet high nutritional requirements during pregnancy.

Between June 1992 and January 1993, five toddlers died after eating iron
supplement tablets, according to the national Centers for Disease
Control and Prevention's Morbidity and Mortality Weekly Report of Feb.
19, 1993. All tablets involved in the reported deaths were prenatal iron
supplements. The incidents occurred in a variety of ways: Children ate
tablets from uncapped or loosely capped bottles, swallowed tablets found
spilled on the floor, and, in one case, a 2-year-old fed an 11-month-old
sibling tablets from a box found on the floor.

Iron is always included in prenatal vitamins prescribed for pregnant
women, and is sometimes included in multivitamin formulas. Often
available without prescription, iron supplements can be found in grocery
stores, drugstores, and health food stores in a wide variety of
potencies, ranging from 18 milligrams (mg) to 150 mg per pill. For a
small child, as little as 600 mg of iron can be fatal.

Because iron supplements are typically brightly colored and may look
like candy, they are particularly attractive to children. In 1993, the
Nonprescription Drug Manufacturers Association (NDMA), which
manufactures about 95 percent of nonprescription OTC medicines available
to Americans today, adopted formulation provisions for iron products
containing 30 mg or more of elemental iron per solid dosage form. These
provisions also stipulated that such products would not be made with
sweet coatings. That same year, NDMA manufacturers also independently
agreed to develop new voluntary warning labels for these products. The
voluntary labels read: "Warning: Close tightly and keep out of reach of
children. Contains iron, which can be harmful or fatal to children in
large doses. In case of accidental overdose, seek professional
assistance or contact a poison control center immediately."

Signs of Poisoning

How can you tell if your child has ingested something poisonous? "Most
poisons, with the exception of lead, work fairly quickly. A key is when
the child was otherwise well and in a space of hours develops unusual
symptoms: They can't follow you with their eyes, they're sleepy before
it's their nap time, their eyes go around in circles. Any unusual or new
symptoms should make you think of poisoning as a possibility," Rodgers
advises. "Poisonings typically affect the stomach and central nervous
system. If a child suddenly throws up, that can be more difficult to
diagnose."

Other signs of poison ingestion can be burns around the lips or mouth,
stains of the substance around the child's mouth, or the smell of a
child's breath. Suspect a possible poisoning if you find an opened or
spilled bottle of pills.

If you suspect poisoning, remain calm. For medicines, call the nearest
poison control center or your physician. For household chemical
ingestion, follow first-aid instructions on the label, and then call the
poison control center or your doctor. When you call, tell them your
child's age, height and weight, existing health conditions, as much as
you know about the substance involved, the exposure route (swallowed?
inhaled? splashed in the eyes?), and if your child has vomited. If you
know what substance the child has ingested, take the remaining solution
or bottle with you to the phone when you call. Follow the instructions
of the poison control center precisely.

Progress Against Poisonings

The nation's first poison control center opened in Chicago in 1953,
after a study of accidental deaths in childhood reported a large number
were due to poisoning. Since that time, a combination of public
education, the use of child-resistant caps, help through poison control
centers, and increased sophistication in medical care have lowered
overall death rates.

Often, calling a poison center simply reassures parents that the product
ingested is not poisonous. In other cases, following phone instructions
prevents an emergency room trip.

Children are not the only victims of accidental poisonings: Older people
in particular are at risk because they generally take more medicines,
may have problems reading labels correctly, or may take a friend's or
spouse's medicine. 

In June 1995, the U.S. Consumer Product Safety Commission voted
unanimously to require that child-resistant caps be made so
adults--especially senior citizens--will have a less frustrating time
getting them off. Because many adults who had trouble with
child-resistant caps left them off, or transferred their contents to
less secure packaging that endangers children, officials say the new
caps will be safer for children.

"Childhood poisoning will always be a focus, because children are so
vulnerable, especially children under age 5," says Ken Giles, public
affairs spokesman for the Consumer Product Safety Commission. "The first
two or three years of a child's life are the highest-risk time for all
kinds of injuries, so there is a special need to educate new parents.
It's essential we keep raising these safety messages that medicines and
chemicals can be poisonous."

Audrey T. Hingley is a writer in Mechanicsville, Va.


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Protect Yourself Against Tampering

With FDA's new proposed regulations regarding packaging of high-dose,
iron-containing pills in mind, it's important to remember that no
packaging or warnings can protect without your involvement.
Nonprescription OTC drugs sold in the United States are among the most
safely packaged consumer products in the world, but "child-resistant"
and "tamper-resistant" do not mean "childproof" and "tamperproof."

FDA adopted "tamper-resistant" packaging requirements after seven people
in the Chicago area died from taking cyanide-laced Extra-Strength
Tylenol capsules in 1982. Although the product met all FDA requirements
at the time, it wasn't designed so tampering would leave visible
evidence. FDA swiftly enacted new regulations requiring most OTC drug
products to be packaged in "tamper-resistant" packaging, defined as
"packaging having an indicator or barrier to entry that could reasonably
be expected to provide visible evidence that tampering had occurred,"
and required OTC product labeling to alert consumers to tamper-resistant
packaging. In 1989, FDA regulations were amended to require two-piece
hard gelatin capsules to be packaged using at least two tamper-resistant
features unless sealed with a tamper-resistant technology.

"Consumer vigilance is part of the equation," says Lana Ragazinsky,
consumer safety officer with FDA's Center for Drug Evaluation and
Research, division of drug quality evaluation, office of compliance.
"The consumer is being led into a false sense of security because they
see 'tamper-resistant'... 'tamper evident' means you, the consumer, need
to look for evidence of tampering."

FDA has proposed changing the term "tamper-resistant" to
"tamper-evident" to underscore the fact that no package design is
tamperproof. The most important tool to detect tampering is you! Here
are a few tips to help protect against tampering: 


 * Read the label. OTC medicines with tamper-evident packages tell you
   what seals and features to look for.

 * Inspect the outer packaging before you buy.

 * Inspect the medicine when you open the package, and look again before
   you take it. If it looks suspicious: be suspicious.

 * Look for capsules or tablets different in any way from others in the
   package.

 * Don't use any medicine from a package with cuts, tears, slices, or
   other imperfections.

 * Never take medicine in the dark. Read the label and look at the
   medicine every time you take a dose.

--A.T.H.


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Antidotes

If you suspect childhood poisoning, call the nearest poison control
center or your physician first, and follow their instructions precisely.

To induce vomiting in case of accidental poisoning, experts recommend
keeping on hand syrup of ipecac--safely stored away from children, of
course! Syrup of ipecac induces vomiting, thus ridding the body of the
swallowed poison. It usually works within a half-hour of ingestion.

Some medical experts also recommend that parents keep activated charcoal
on hand as well: You may have to ask your druggist for it, because it
may not be on store shelves. Although some poison control experts
recommend having activated charcoal on hand, there is a difference of
opinion on its use by consumers. The U.S. Consumer Product Safety
Commission, for example, does not recommend that consumers use activated
charcoal because it is less palatable to young children.

Activated charcoal (or charcoal treated with substances that increase
its absorption abilities) absorbs poison, preventing it from spreading
throughout the body. One advantage of activated charcoal is that it can
be effective for a considerable time after the poison is swallowed. But
activated charcoal should never be used at the same time you administer
syrup of ipecac: The charcoal will absorb the ipecac.

For children ages 1 to 12, give one tablespoon of syrup of ipecac
followed by one or two glasses of water. Children ages 12 and over
should get two tablespoons, followed by one or two glasses of water.

Activated charcoal is usually found in drugstores in liquid form in
30-gram doses. For children under 5, give one gram per every two pounds
of body weight. Older children and adults may require much higher doses.

Both antidotes should only be used on conscious poison victims; an
unconscious victim should always be treated by professionals.

"Remember to call your local poison control center first before giving
your child any at-home antidote," says Robert Mueller, poison
information specialist at the Virginia Poison Center in Richmond, Va.

--A.T.H.

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Growing Older, Eating Better

by Paula Kurtzweil

When Bernadette Harkins, 89, of Rockville, Md., could no longer feed
herself properly, she moved to an assisted-living residence. Today, she
can enjoy three meals a day served to her and about 30 other people in
their home-like communal dining room.

When Harry, 85, of Moscow, Pa., could no longer feed himself properly,
he moved in with his daughter and her family. Today, with her guidance,
he's eating six times a day, snacking on high-calorie, high-protein
foods, and maintaining a near-normal weight.

Harry, who asked that his last name not be used, and Harkins typify many
of today's older generation. Living alone in most cases, they often are
unable to meet their dietary needs and are forced to make compromises.

Harry didn't know how to cook. He developed cancer, which made it even
more important that he eat a well-balanced diet. Harkins knew how to
cook but didn't take time to prepare adequate meals for herself.

"I would snack is what I'd do," she said. "I would think about getting a
meal and then just have a cup of tea and toast. I knew I wasn't doing
the right thing as far as nutrition was concerned."

Their eating problems stemmed from loneliness and lack of desire or
skill to cook. Other older people may eat poorly for other reasons,
ranging from financial difficulties to physical problems.

The solutions can be just as varied, from finding alternative living
arrangements to accepting home-delivered meals to using the food label
recently revised by the Food and Drug Administration and the U.S.
Department of Agriculture. Physical activity also is important in
maintaining a healthy lifestyle.

Why the Concern?

Nutrition remains important throughout life. Many chronic diseases that
develop late in life, such as osteoporosis, can be influenced by earlier
poor habits. Insufficient exercise and calcium intake, especially during
adolescence and early adulthood, can significantly increase the risk of
osteoporosis, a disease that causes bones to become brittle and crack or
break.

But good nutrition in the later years still can help lessen the effects
of diseases prevalent among older Americans or improve the quality of
life in people who have such diseases. They include osteoporosis,
obesity, high blood pressure, heart disease, certain cancers,
gastrointestinal problems, and chronic undernutrition.

Studies show that a good diet in later years helps both in reducing the
risk of these diseases and in managing the diseases' signs and symptoms.
This contributes to a higher quality of life, enabling older people to
maintain their independence by continuing to perform basic daily
activities, such as bathing, dressing and eating.

Poor nutrition, on the other hand, can prolong recovery from illnesses,
increase the costs and incidence of institutionalization, and lead to a
poorer quality of life.

The Single Life

Whether it happens at age 65 or 85, older people eventually face one or
more problems that interfere with their ability to eat well.

Social isolation is a common one. Older people who find themselves
single after many years of living with another person may find it
difficult to be alone, especially at mealtimes. They may become
depressed and lose interest in preparing or eating regular meals, or
they may eat only sparingly.

In a study published in the July 1993 Journals of Gerontology,
researchers found that newly widowed people, most of whom were women,
were less likely to say they enjoy mealtimes, less likely to report good
appetites, and less likely to report good eating behaviors than their
married counterparts. Nearly 85 percent of widowed subjects reported a
weight change during the two years following their spouse's death, as
compared with 30 percent of married subjects. The widowed group was more
likely to report an average weight loss of 7.6 pounds (17 kilograms).

According to the study, most of the women said they had enjoyed cooking
and eating when they were married, but, as widows, they found those
activities "a chore," especially since there was no one to appreciate
their cooking efforts.

For many widowed men who may have left the cooking to their wives, the
problem may extend even further: They may not know how to cook and
prepare foods. Instead, they may snack or eat out a lot, both of which
may lead people to eat too much fat and cholesterol and not get enough
vitamins and minerals.

Special Diets

At the same time, many older people, because of chronic medical
problems, may require special diets: for example, a low-fat,
low-cholesterol diet for heart disease, a low-sodium diet for high blood
pressure, or a low-calorie diet for weight reduction. Special diets
often require extra effort, but older people may instead settle for
foods that are quick and easy to prepare, such as frozen dinners, canned
foods, lunch meats, and others that may provide too many calories, or
contain too much fat and sodium for their needs.

On the other hand, Mona Sutnick, Ed.D., a registered dietitian in
private practice in Philadelphia, pointed out that some people may go
overboard on their special diets, overly restricting foods that may be
more beneficial than detrimental to their health.

"My advice for a 60-year-old person might be 'watch your fat' but for an
80-year-old who's underweight, I'd say, 'eat the fat, get the
calories,'" Sutnick said.

Physical Problems

Some older people may overly restrict foods important to good health
because of chewing difficulties and gastrointestinal disturbances, such
as constipation, diarrhea and heartburn. Because missing teeth and
poorly fitting dentures make it hard to chew, older people may forego
fresh fruits and vegetables, which are important sources of vitamins,
minerals and fiber. Or they may avoid dairy products, believing they
cause gas or constipation. By doing so, they miss out on important
sources of calcium, protein and some vitamins.

Adverse reactions from medications can cause older people to avoid
certain foods. Some medications alter the sense of taste, which can
adversely affect appetite. This adds to the problem of naturally
diminishing senses of taste and smell, common as people age.

Other medical problems, such as arthritis, stroke or Alzheimer's
disease, can interfere with good nutrition. It may be difficult, if not
impossible, for example, for people with arthritis or who have had a
stroke to cook, shop, or even lift a fork to eat. Dementia associated
with Alzheimer's and other diseases may cause them to eat poorly or
forget to eat altogether. 

Money Matters

Lack of money is a particular problem among older Americans who may have
no income other than Social Security. According to 1994 U.S. Census
Bureau data, nearly 12 percent of people 65 and over are below the
average poverty level for their age group. In 1994, the poverty level
for a person 65 and over was $7,108 a year.

According to the 1994 data, the mean annual income for people 65 and
over was $16,709, almost $10,000 less than what they earned on average
between ages 55 and 64.

Lack of money may lead older people to scrimp on important food
purchases--for example, perishable items like fresh fruits, vegetables
and meat--because of higher costs and fear of waste. They may avoid
cooking or baking foods like meats, stews and casseroles because recipes
for these foods usually yield large quantities.

Financial problems also may cause older people to delay medical and
dental treatments that could correct problems that interfere with good
nutrition.

Food Programs

Many older people may find help under the Older Americans Act, which
provides nutrition and other services that target older people who are
in greatest social and economic need, with particular attention on
low-income minorities. According to the U.S. Administration on Aging,
which administers the Older Americans Act, the nutrition programs were
set up to address the dietary inadequacy and social isolation among
older people.

Home-delivered meals and congregate nutrition services are the primary
nutrition programs. The congregate meal program allows seniors to gather
at a local site, often the local senior citizen center, school or other
public building or a restaurant, for a meal and other activities, such
as games and lectures on nutrition and other topics of interest to older
people.

Available since 1972, these programs, funded by the federal, state and
local governments, ensure that senior citizens get at least one
nutritious meal five to seven days a week. Under current standards, that
meal must comply with the Dietary Guidelines for Americans and provide
at least one-third of the Recommended Dietary Allowances for an older
person. Often, people receive foods that correspond with their special
dietary needs, such as no-added-salt foods for those who need to
restrict their sodium intake or ground meat for those who have trouble
chewing.

Other nutrition services provided under the Older Americans Act are
nutrition education, screening and counseling.

While these nutrition programs target poor people, they are available to
other older people regardless of income, according to Jean Lloyd, a
registered dietitian and nutrition officer with the Administration on
Aging. Although no one is charged for the meals, older people can
voluntarily and confidentially donate money, she said.

The meals provide not only good nutrition, but they also give older
people a chance to socialize--a key factor in preventing the adverse
nutritional effects of social isolation.

For those who qualify, food stamps are another aid for improving
nutrition. Under this program, a one-person household can receive up to
$115 a month in food stamps to buy most grocery items.

For the homebound, grocery-shopping assistance is available in many
areas. Usually provided by nongovernment organizations, this service
shops for and delivers groceries to people at their request. The
recipient pays for the groceries and sometimes a service fee.

In some communities, private organizations also sell home-delivered
meals.

Other Assistance

Family members and friends can help ensure that older people take
advantage of food programs by putting them in touch with the appropriate
agencies or organizations and helping them fill out the necessary forms.
Some other steps they can take include: 


 * looking in occasionally to ensure that the older person is eating
   adequately

 * preparing foods for and making them available to the older person

 * joining the older person for meals.

In some cases, they may help see that the older person is moved to an
environment, such as their home, an assisted-living facility, or a
nursing home, that can help ensure that the older person gets proper
nutrition. 

Whatever an older person's living situation, proper medical and dental
treatment is important for treating medical problems, such as
gastrointestinal distress and chewing difficulties, that interfere with
good nutrition. If a medication seems to ruin an older person's taste
and appetite, a switch to another drug may help.

A review of basic diet principles may help improve nutrition. Explaining
to older people the importance of good nutrition in the later years may
motivate them to make a greater effort to select nutritious foods.

Look to the Label

The food label can help older people select a good diet. Revamped in
1992, the label gives the nutritional content of most foods and enables
consumers to see how a food fits in with daily dietary recommendations.

Some of the information appears as claims describing the food's
nutritional benefits: for example, "low in cholesterol" or "high in
potassium." Under strict government rules, these claims can be used only
if the food meets certain criteria. This means that claims can be
trusted. For example, a "low-cholesterol" food can provide no more than
20 milligrams (mg) of cholesterol and no more than 2 grams of saturated
fat per serving. A high-potassium food must provide at least 700 mg of
potassium per serving.

Less common but also helpful are label claims linking a nutrient or food
to the risk of a disease or health-related condition. So far, FDA allows
only eight of these claims because they are the only ones supported by
scientific evidence. One claim links sodium, a nutrient found in salt
and used in many processed foods, to high blood pressure. On the food
label, this claim would read something like this:

"Diets low in sodium may reduce the risk of high blood pressure, a
disease associated with many factors."

More in-depth information is found on the "Nutrition Facts" panel on the
side or back of the food label. This information is required on almost
all food packages. Unlike before, this nutrition information is easier
to read because it appears in bigger type and is usually on a white or
other neutral contrasting background, when practical.

Some nutrition information also may be available for many raw meats,
poultry and fish and fresh fruits and vegetables at the point of
purchase. The information may appear in brochures or on posters or
placards.

Physical Activity

Besides diet, physical activity is part of a healthy lifestyle at any
age. It can help reduce and control weight by burning calories. Moderate
exercise that places weight on bones, such as walking, helps maintain
and possibly even increases bone strength in older people. A study
published in the Dec. 28, 1994, Journal of the American Medical
Association found that intensive strength training can help preserve
bone density and improve muscle mass, strength and balance in
postmenopausal women. In the study, subjects used weight machines for
strength training.

Also, scientists looking into the benefits of exercise for older people
agree that regular exercise can improve the functioning of the heart and
lungs, increase strength and flexibility, and contribute to a feeling of
well-being.

Any regular physical activity is good, from brisk walking to light
gardening. Common sense is the key. But, before a vigorous exercise
program is started or started after a long period of rest, a doctor
should be consulted.

Taking time out for exercise, using the food label to help pick
nutritious foods, taking advantage of the several assistance programs
available, and getting needed medical attention can go a long way in
helping older people avoid the nutritional pitfalls of aging and more
fully enjoy their senior years.

Paula Kurtzweil is a member of FDA's public affairs staff.


------------------------------------------------------------------------


For More Information

To learn more about the food label and nutrition for older people, write
for these publications: 

 * Using the New Food Label to Choose Healthier Foods. FDA,
   5600 Fishers Lane (HFE-88), Rockville, MD 20857.
   Ask for publication number (FDA) 94-2276.


 * Food Facts for Older Adults: Information on How to Use the Dietary
   Guidelines. Send check or money order for $4 payable to
   "Superintendent of Documents" to Consumer Information Center,
   Pueblo, CO 81009. Ask for Home and Garden Bulletin Number 251.

 * Healthy Eating for a Healthy Life. AARP (American Association of
   Retired Persons) Fulfillment, 601 E. St., N.W., Washington, DC 20049.
   Ask for publication by title and stock number D15565.

To learn about meal programs for senior citizens in your area, call the
Administration on Aging's Elder Care Locator, (1-800) 677-1116.

For information about food stamps, contact your county's food stamp
office listed in the blue pages of the telephone book.

To find a registered dietitian in your area, call the National Center
for Nutrition and Dietetics Consumer Nutrition Hotline, (1-800)
366-1655.

--P.K.

------------------------------------------------------------------------

Coping with Arthritis in Its Many Forms

by Carolyn J. Strange

It may begin as a slight morning stiffness. For the lucky person with
arthritis, that's as far as it goes. But for millions of others,
arthritis can become a disabling, even crippling, disease. Roman Emperor
Diocletian exempted citizens with severe arthritis from paying taxes, no
doubt realizing that the disease itself can be taxing enough.

One in seven Americans--nearly 40 million--have some form of arthritis.
That number will climb as the baby boomers age. By 2020, about 60
million Americans will have arthritis, according to The National
Arthritis Data Workgroup of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases. The disease is physical, but also
exacts a mental, emotional and economic toll.

"Chronic illness impacts a person's entire lifestyle--work, family and
recreation," says Gail Wright, Ph.D., a rehabilitation psychologist at
the University of Missouri, Columbia. To improve quality of life,
doctors and health educators increasingly advise combining drug
treatment with education, social support, and moderate forms of
exercise.

Arthritis means joint inflammation. In a normal joint, where two bones
meet, the ends are coated with cartilage, a smooth, slippery cushion
that protects the bone and reduces friction during movement. A tough
capsule lined with synovial membrane seals the joint and produces a
lubricating fluid. Ligaments surround and support each joint, connecting
the bones and preventing excessive movement. Muscles attach to bone by
tendons on each side of a joint. Inflammation can affect any of these
tissues.

Inflammation is a complex process that causes swelling, redness, warmth,
and pain. It's the body's natural response to injury and plays an
important role in healing and fighting infection. Joint injury can be
caused by trauma or by the wear and tear of aging. But in many forms of
arthritis, injury is caused by the uncontrolled inflammation of
autoimmune disease, in which the immune system attacks the body's own
tissues. In severe cases, all joint tissues, even bone, can be damaged.

The general term arthritis includes over 100 kinds of rheumatic
diseases, most of which last for life. Rheumatic diseases are those
affecting joints, muscle, and connective tissue, which makes up or
supports various structures of the body, including tendons, cartilage,
blood vessels, and internal organs. The Food and Drug Administration has
approved a wide variety of drugs to treat the many forms of arthritis.

The most common type of arthritis is osteoarthritis, affecting more than
16 million Americans. This degenerative joint disease is common in
people over 65, but may appear decades earlier. It begins when cartilage
breaks down, sometimes eroding entirely to leave a bone-on-bone joint in
extreme cases. Any joint can be affected, but the feet, knees, hips, and
fingers are most common. It may appear in one or two joints and spread
no further. Painful and knobby bone growths in the fingers are common,
but usually not crippling. The disease is often mild, but can be quite
severe.

Second most common is rheumatoid arthritis, which affects 2.5 million
Americans. It can strike at any age, but usually appears between ages 20
and 50. The hands are most commonly affected, but it can affect most
joints of the body. Inflammation begins in the synovial lining and can
spread to the entire joint. Highly variable and difficult to control,
the disease can severely deform joints. Some people become bedridden.
Others continue to run marathons.

An autoimmune disease affecting the whole body, rheumatoid arthritis can
also cause weakness, fatigue, loss of appetite, muscle pain, and weight
loss. Blood tests may reveal anemia and the presence of an antibody
called rheumatoid factor (RF). However, some people with RF never
develop rheumatoid arthritis, and some people with the disease never
have RF. In about one in six, the disease becomes severe and can shorten
life. Researchers hope to find ways to predict which patients should be
treated more aggressively.

Ups and Downs

With so many kinds of arthritis, which can appear and progress
unpredictably, diagnosis and treatment can be trying for both physician
and patient. Diagnosis depends on integrating a host of factors,
including the possibility that a person may have two forms of the
disease.

The normal ups and downs of chronic, painful disease further complicate
matters. "Just about any painful condition will wax and wane on its
own," says rheumatologist Dennis Boulware, M.D., University of Alabama,
Birmingham.

A worsening or reappearance of the disease is called a flare. Remissions
bring welcome relief, but can also obscure whether symptoms decreased on
their own or due to treatment.

Proper treatment depends on correct diagnosis of the specific disease,
and varies with severity and location, as well as from person to person.
But treatment need not wait for a final diagnosis because initial
treatment options, such as anti-inflammatory drugs and exercise, are
similar for many forms of the disease. Treatment should begin early to
reduce joint damage.

The drugs used for treating most types of arthritis are drawn from many
categories, but can be thought of in a few broad groups, such as
anti-inflammatory drugs and disease-modifying drugs. For treating gout,
there are also drugs that reduce the amount of uric acid in the blood.
More than one medication may be required for treating arthritis.

Anti-inflammatory agents generally work by slowing the body's production
of prostaglandins, substances that play a role in inflammation. Many
have an analgesic, or painkilling, effect at low doses. Usually, higher,
sustained doses are required to see sufficient anti-inflammatory
activity for treating arthritis. The most familiar anti-inflammatory
agent is aspirin, often a good arthritis treatment. Like aspirin,
nonsteroidal anti-inflammatory drugs (NSAIDs) fight pain and
inflammation. More than a dozen NSAIDs are available, most by
prescription only. At press time, FDA was considering whether labeling
changes to prescription-strength NSAIDs are necessary, due to
gastrointestinal side effects.

FDA has approved three NSAIDs for over-the-counter (OTC) marketing:
ibuprofen (marketed as Advil, Nuprin, Motrin, and others), naproxen
sodium (sold as Aleve), and ketoprofen (marketed as Actron and Orudis).
Although these drugs are available OTC, a doctor should be consulted
before taking any medication for arthritis symptoms.

"People shouldn't be mixing medications," says Linda Katz, M.D., of
FDA's pilot drug evaluation staff, and anyone regularly taking NSAIDs
should carefully read the labels of OTC products to make sure they don't
contain similar drugs. For example, many cough and cold preparations
contain analgesics such as aspirin, acetaminophen or ibuprofen.

The most potent anti-inflammatories are corticosteroids, synthetic
versions of the hormone cortisone. Like prednisone and dexamethasone,
the generic names often end in "-one." They're usually reserved for
short periods of use during intense flares or when other drugs don't
control unrelenting disease. Relief can be dramatic, but long-term use
causes side effects, such as weight gain, high blood pressure, and
thinning of bones and skin. Usually given orally, they can also be
injected directly into a joint to reduce side effects.

Disease modifiers slow the disease process in autoimmune diseases such
as rheumatoid arthritis or systemic lupus erythematosus. Patients taking
these drugs are closely monitored. It may take weeks or months to learn
if a drug works. During that wait, it's important to keep taking other
medications such as NSAIDs. Gold salts have been used to treat
rheumatoid arthritis for 60 years, although nobody knows why this
treatment works. Penicillamine, methotrexate, and antimalarials such as
hydroxychloroquine are also used. Doctors usually reserve other powerful
drugs that suppress the immune system for extremely serious disease.

Most people with arthritis never need surgery, but when all else fails,
it can dramatically improve independence and quality of life by reducing
pain and improving mobility. The surgeon may remove damaged or
chronically inflamed tissue, or replace the joint entirely. Artificial
replacements are available for all of the most commonly affected joints.

Use It or Lose It

In the past, doctors often advised arthritis patients to rest and avoid
exercise. Rest remains important, especially during flares. But doing
nothing results in weak muscles, stiff joints, reduced mobility, and
lost vitality. Now, rheumatologists routinely advise a balance of
physical activity and rest. Exercise offers physical and psychological
benefits that include improved overall fitness and well-being, increased
mobility, and better sleep.

For example, twice a week for three years, Elsie Sequeira, 81, of
Concord, Calif., has attended a water-based exercise class sponsored by
the Arthritis Foundation. "It's helped me a lot," she says. Sequeira has
rheumatoid arthritis in her shoulders and legs. She had also had a mild
stroke and got to her first classes with the help of a walker and an
attendant.

A few weeks passed before she saw any improvement, but within a few
months she no longer needed either the walker or the attendant. "The
warm water is very soothing and we can do things in the water that we
couldn't do on land," Sequeira says. She enjoys the social contact, and
feels better able to take care of herself. "I don't feel so hamstrung,"
she says.

Joints require motion to stay healthy. That's why doctors advise
arthritis patients to do range-of-motion, or flexibility, exercises
every day--even during flares. Painful or swollen joints should be moved
gently, however.

Strengthening and endurance activities are also recommended, but should
be limited or avoided during flares. Arthritis patients should consult
their doctors before starting an exercise program, and begin gradually.
Exercises must be individualized to work the right muscles while
avoiding overstressing affected joints. Doctors or physical therapists
can teach proper ways to move.

Muscle strength is especially important because strong muscles better
support and protect joints. "Several studies show that if you improve
muscle strength, you decrease pain," Boulware says. Joints will probably
hurt during exercise, but shouldn't still hurt several hours later.

"There's a fine line between doing too much and too little," says
rheumatologist William Ginsburg, M.D., of the Mayo Clinic, Jacksonville,
Fla. "Sometimes people have to be reminded to slow down and listen to
their disease."

Support groups and arthritis education can help people learn how to
listen to their disease, and cope with it. "The psychological aspects
are very important because that's what changes people's lives," Ginsburg
says.

Participants learn practical things, such as how to: get up off the
floor after a fall, protect joints with careful use and assistive
devices, drive a car, get comfortable sleep, use heat and cold
treatments, talk with their doctors, and cope with emotional aspects of
pain and disability. They may also learn to acquire and maintain what
health experts have long touted--a positive attitude.

Health education not only improves quality of life, but also lowers
health-care costs, and the benefits are lasting, according to studies at
Stanford University, Palo Alto, Calif. Four years after a short
Arthritis Self-Management Program, participants still reported
significantly less pain and made fewer physician visits, even though
disability increased. The benefits came, not from the specifics taught,
but from improved ability to cope with the consequences of arthritis--in
other words, confidence. "It's the same thing that any good coach tries
to instill," says Halsted R. Holman, M.D., Stanford University.

Avoiding Fraud

Learning to understand their disease can also help make people less
likely to fall victim to fraud. Because they have a painful, incurable
condition, people with arthritis are among the prime targets for fraud
and spend nearly a billion dollars annually on unproved remedies,
largely diets and supplements.

A claim describing the relationship between a nutrient or dietary
ingredient and a disease, such as arthritis, cannot be made on the label
or in labeling of a dietary supplement unless the claim is authorized by
FDA. In order for FDA to consider authorizing the use of a health claim,
there must be significant agreement among qualified experts that the
health claim is scientifically valid. Frequently, however, dietary
supplements are found on the market labeled in violation of these
requirements.

"If the claim sounds too good to be true, it probably is. Talk to your
doctor or other health professional," says Peggy Binzer, a consumer
safety officer in FDA's Center for Food Safety and Applied Nutrition.

Consumers who have questions or wish to report a company for falsely
labeling its products should call FDA's Office of Consumer Affairs at
(301) 443-3170 from 1 p.m. to 3:30 p.m. Eastern time. Consumers who have
suffered from a serious adverse effect associated with the use of a
dietary supplement should report the effect to their health-care
professional or to MedWatch at (1-800) FDA-1088.

Some remedies, such as vinegar and honey or copper bracelets, seem
harmless. But they can become harmful if they cause people to abandon
conventional therapy. Others, such as the solvent dimethyl sulfoxide
(DMSO), can be outright dangerous. (See "An FDA Guide to Choosing
Medical Treatments," FDA Consumer, June 1995.)

It's tempting to conclude that arthritis pain gets better or worse
because of what was added or eliminated from the diet the day or week
before. However, gout is the only rheumatic disease known to be helped
by avoiding certain foods. The unpredictable ups and downs of arthritis
make it hard to establish a relationship between diet and disease.
Scientists have only recently begun to study nutritional therapy for
arthritis, and the American College of Rheumatology (ACR) urges
continued research.

The ACR Position Statement on Diet and Arthritis advises, "Until more
data are available, patients should continue to follow balanced and
healthy diets, be skeptical of 'miraculous' claims and avoid elimination
diets and fad nutritional practices."

Research Under Way

New treatments are likely to stem from better understanding of the
underlying causes and destructive processes of the disease. Overuse,
injury and obesity are contributing factors in osteoarthritis, and
researchers have implicated a faulty gene in the breakdown of cartilage.
Heredity plays a role in other forms of arthritis, too, increasing
susceptibility in some people. Potential genetic therapy approaches are
still far off, however.

Increased knowledge of immunology and the inflammatory process offers
more immediate promise. Researchers have developed a drug that blocks
the effects of TNF-alpha, an inflammatory protein responsible for
reactions resulting in joint damage. In short-term preliminary trials,
the drug significantly reduced symptoms in rheumatoid arthritis
patients.

Such results are encouraging, but the ultimate goal is to understand
what starts the immune response in the first place. "Until you know the
real cause, you're not going to have the right drug," Ginsburg says.

That quest continues and offers hope. But short of a cure, enlightened
coping may be the most promising avenue to a less taxing life for people
with arthritis. Emperor Diocletian would be pleased.

Carolyn J. Strange is a science and medical writer in Saratoga, Calif.


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Common Types of Arthritis

Of more than 100 different kinds of arthritis, these are the most common: 

Osteoarthritis 

Also called degenerative arthritis. Occurs when the cushioning cartilage
in a joint breaks down. Commonly affects feet, knees, hips, and fingers.
Affects 16 million Americans, mostly 45 and older. About half of those
65 and older have this form.



Rheumatoid Arthritis 

Immune system attacks the lining, or synovial membrane, of the joints.
Joint damage can become severe and deforming. Involves the whole body,
and may also cause fatigue, weight loss and anemia, and affect the
lungs, heart and eyes. Affects about 2.1 million Americans, three times
more women than men.



Gout 

Causes sudden, severe attacks, usually in the big toe, but any joint can
be affected. A metabolic disorder in which uric acid builds up in the
blood and crystals form in joints and other places. Drugs and attention
to diet can control gout. Affects about 1 million Americans (70 to 80
percent men), with first attack starting between 40 and 50 years of age.
(See "Getting to Know Gout," FDA Consumer, March 1995.)



Ankylosing Spondylitis 

A chronic inflammatory disease of the spine that can result in fused
vertebrae and rigid spine. Often milder and harder to diagnose in women.
Most people with the disease also have a genetic marker known as
HLA-B27. Affects about 318,000 Americans, usually men between the ages
of 16 and 35.



Juvenile Arthritis 

The most common form is juvenile rheumatoid arthritis. Arthritis
diagnosis, treatment, and disease characteristics are different in
children and adults. Some children recover completely; others remain
affected throughout their lives. Affects about 200,000 Americans.



Psoriatic Arthritis 

Bone and other joint tissues become inflamed, and, like rheumatoid
arthritis, it can affect the whole body. Affects about 5 percent of
people with psoriasis, a chronic skin disease. Likely to affect fingers
or spine. Symptoms are mild in most people but can be quite severe.
Affects about 160,000 Americans.



Systemic Lupus Erythematosus 

Involves skin, joints, muscles, and sometimes internal organs. Symptoms
usually appear in women of childbearing age but can occur in anyone at
any age. Also called lupus or SLE, it can be mild or life threatening.
Affects at least 131,000 Americans, nine to ten times as many women as
men.



Other forms 

Arthritis can develop as a result of an infection. For example, bacteria
that cause gonorrhea or Lyme disease can cause arthritis. Infectious
arthritis can cause serious damage, but usually clears up completely
with antibiotics. Scleroderma is a systemic disease that involves the
skin, but may include problems with blood vessels, joints, and internal
organs. Fibromyalgia syndrome is a soft-tissue rheumatism that doesn't
lead to joint deformity, but affects an estimated 5 million Americans,
mostly women. 

--C.J.S.

------------------------------------------------------------------------


Tea: A Story of Serendipity

by Marian Segal

As legend has it, one day in 2737 B.C. the Chinese Emperor Shen Nung was
boiling drinking water over an open fire, believing that those who drank
boiled water were healthier. Some leaves from a nearby Camellia sinensis
plant floated into the pot. The emperor drank the mixture and declared
it gave one "vigor of body, contentment of mind, and determination of
purpose."

Perhaps as testament to the emperor's assessment, tea--the potion he
unwittingly brewed that day--today is second only to water in worldwide
consumption. The U.S. population is drinking its fair share of the brew;
in 1994, Americans drank 2.25 billion gallons of tea in one form or
another--hot, iced, spiced, flavored, with or without sugar, honey,
milk, cream, or lemon.

A serving of tea generally contains about 40 milligrams of caffeine
(less than half as much caffeine as in coffee), but the actual levels
vary depending on the specific blend and the strength of the brew.
Decaffeinated tea is also available.

Many tea drinkers find the beverage soothing, and folk medicine has long
valued it as a remedy for sore throats and unsettled stomachs. Recent
studies have shown that certain chemicals in tea called polyphenols may
help reduce the risk of far more serious illnesses, including
atherosclerosis and some cancers, although the data are not conclusive.
(See "Tonic in a Teapot?")

Black, Green and Oolong

Tea comes in black, green and oolong varieties, all produced from the
leaves of Camellia sinensis, a white-flowered evergreen. The method of
processing the leaf distinguishes the three types. (Herbal teas are made
from leaves of other plants. FDA requires that herbal tea labels carry
the name of the plant the product derives from, such as chamomile. For
more on herbal teas, see "Herbal Teas and Toxicity" in the May 1991 FDA
Consumer.)

The traditional method of producing black tea begins with withering. The
plucked leaves are placed on shelves called withering racks, where
excess moisture is removed. They are then rolled in special machines
that release the leaves' enzymes and juices, which give tea its aroma
and taste. Next, the leaves ferment in a room with controlled
temperature and humidity; finally they are dried in ovens. More recently
some processors have forsaken the traditional method to speed production
by using machines that finely chop the leaves, thereby cutting the time
for withering and fermenting.

Green tea is made by steaming or otherwise heating the leaves
immediately after plucking to prevent the fermentation that makes black
tea. Then the leaves are rolled and dried.

Oolong tea is fermented only partially--to a point between black and
green. While the leaves wilt naturally, enzymes begin to ferment them.
Processors interrupt the fermentation by stirring the leaves in heated
pans, then rolling and drying them.

Different varieties of Camellia sinensis grow in different geographic
areas and produce leaves that vary from a very small China leaf, perhaps
one-half to three-quarters of an inch long, to the Assam leaf, which may
be 3 or 4 inches long. Certain varieties are better suited than others
for a particular processing method. For example, the China leaf from
China and Formosa produces the best oolongs.

Scented and spiced teas are made from black tea. "Scented teas look just
like any other tea," says FDA chemist and tea expert Robert Dick,
"because the scent is more or less sprayed on. They're flavored with
just about anything--peach, vanilla, cherry. The spiced teas, on the
other hand, usually contain pieces of spices--cinnamon or nutmeg or
orange or lemon peel--so you can see there's something in there."

What about orange pekoe? Orange pekoe refers to the size of the tea
leaf. Processed tea leaves are sorted into sizes by passing them over
screens with different size holes. The largest leaves are orange pekoe,
pekoe, and pekoe souchong. The smaller or broken leaves are classified
as broken orange pekoe, broken pekoe souchong, broken orange pekoe
fannings, and fines (also called "dust").

In brewing, flavor and color come out of the larger leaves more slowly
than out of the broken and fine grades. The broken grades, which make up
about 80 percent of the total black tea crop, produce a stronger, darker
tea. The grades have nothing to do with the quality or flavor of tea;
they simply refer to leaf size.

"Technically, except for fannings and fines, the terms should apply only
to black, or fermented, tea," Dick says, "but nowadays I often see
oolongs labeled "orange pekoe," and even some green teas are labeled
pekoe or flowery pekoe."

Tea tastes vary, and one aficionado who squirts lemon in his cup may
cringe at the sight of another pouring milk or honey. But no matter how
the tea may be doctored, in the United States the odds are overwhelming
that it starts out black. Nearly 95 percent of all tea consumed here is
black, according to the New York City-based Tea Council of the U.S.A.; 4
percent is green, 1 percent oolong, and 1 percent flavored.

That wasn't always the case, and our proclivity for drinking black tea
over green or oolong may have been influenced by events in history.
Sixty years ago and more, the amount of black and green tea Americans
drank was split fairly evenly--each accounting for about 40 percent of
the market--with oolong constituting the rest. During World War II,
however, the major sources of green tea--China and Japan--were cut off
from the United States, leaving us with tea almost exclusively from
British-controlled India, which produces black tea. Americans came out
of the war drinking nearly 99 percent black tea.

With the Korean War in the 1950s, uncertainties about tea supplies
resurfaced, and the United States began to look for other suppliers.

"Argentina filled the bill," Dick says, "because tea could grow very
fast there. Although the country didn't produce an outstanding tea, it
produced a good average tea."

Today, most of our tea comes from Argentina, China (which got back into
the U.S. market in 1978), and Java. Thirty years ago most of it came
from India and Ceylon (now Sri Lanka). Argentine black tea is the kind
most used for iced tea, and that's another reason black tea dominates
the U.S. market.

Some Like It Cold

America is unique in its tea consumption habits, the Tea Council says,
in that approximately 40 billion of the 50 billion cups consumed here
each year are over ice.

Iced tea debuted in 1904 at the Louisiana State Purchase Exposition in
St. Louis, Mo. According to the Tea Council, "The temperature was
soaring and the staff in the Far East Tea House couldn't get any
fair-goers to even look their way, let alone sample their tea. So they
poured the hot tea over ice cubes and the drink quickly became the
exposition's most popular beverage."

The tea bag was born the same year as iced tea, and its arrival was
equally serendipitous. A Boston tea merchant began sending samples of
tea in small silk bags for customers to try. Eventually, the convenient
pre-measured sacks came to dominate the tea market. In 1994, according
to the Tea Council, approximately 60 percent of tea brewed in the United
States was prepared from tea bags; just over 1 percent was brewed from
loose tea. Iced tea mixes accounted for another 25 percent of prepared
tea, and the rest was made from instant tea.

These statistics attest to the importance of the "convenience factor" in
tea's growing popularity in this country. The demand for convenience
that led to the introduction of the tea bag and the creation of instant
tea and iced tea mixes led also to the more recent packaging of
ready-to-drink iced tea in cans, bottles, and plastic containers.
Ready-to-drink teas are the fastest-growing tea products and the
fastest-growing new product in the supermarket, according to the Tea
Council.

The Tea Council estimates total U.S. tea sales for 1994 at $3.75
billion, up from $1.8 billion in 1990. On any given day, the council
says, about half the population drinks tea, with the greatest
concentration of drinkers in the South and Northeast.

Keeping teacups full in the United States and around the world takes a
lot of tea. In 1993, 2,581,317 metric tons of tea were produced and
1,142,650 metric tons exported, according to the International Tea
Committee's 1994 Bulletin of Statistics. This billion dollar business
got its start centuries ago from a plant that once grew quietly
undisturbed in a far corner of the world. William H. Ukers, in his
comprehensive 1935 tome All About Tea, writes:

"Mother Nature's original tea garden was located in the monsoon district
of southeastern Asia. Many other plants now grow there, but specimens of
the original jungle, or wild, tea plant are still found in the forests
of the Shan states of northern Siam, eastern Burma, Yunnan, Upper
Indo-China, and British India. ... Before any thought was given to
dividing this land into separate states, it consisted of one primeval
tea garden where the conditions of soil, climate, and rainfall were
happily combined to promote the natural propagation of tea."

Marian Segal is a member of FDA's public affairs staff.


------------------------------------------------------------------------


Tonic in a Teapot?

The first documented reference to tea, according to the Tea Council of
the U.S.A., came in 350 A.D., when the Chinese scholar Kuo P'o described
"k'u t'u" as a medicinal beverage "made from the leaves by boiling."

In his book All About Tea, William H. Ukers cites other references from
China in the first millenium that ascribe to tea the healing powers of a
virtual wonder drug:

The seventh century medical book, Pen ts'ao, proclaims that tea quenches
thirst, lessens the desire for sleep, and "gladdens and cheers the
heart." Even today, no one would take great exception to that, but the
book goes on to pronounce the drink good for tumors or abscesses about
the head, ailments of the bladder, inflammation of the chest, and
dissipating heat caused by the phlegms. And the eighth century Ch'a
Ching, or Tea Classic, written by the Chinese scholar Lu Yu, contains
this prescription for children: "Bitter ch'a [tea] made with the
rootlets of onions can cure children who are frightened and tumble
without apparent causes."

Although these early claims have not been validated by 20th century
science, recent studies do show some evidence that
polyphenols--chemicals in tea with antioxidative and other biochemical
properties--may, in fact, have value in protecting against some serious
ailments.

Because they are processed differently, green and black tea have
slightly different chemical makeups. Both contain polyphenols, however,
and both have shown positive results in laboratory studies.

In a review article published in the July 7, 1993, issue of the Journal
of the National Cancer Institute, Chung S. Yang, M.D., of Rutgers
University in New Jersey reports that "many laboratory studies have
demonstrated inhibitory effects of tea preparations and tea polyphenols
against tumor formation and growth." The studies, though not conclusive,
are intriguing.

Yang describes studies in which laboratory animals fed green tea had
reduced formation or growth of skin tumors, esophageal tumors,
gastrointestinal tract tumors, and tumors of the liver, lung and
pancreas. Black tea also has shown activity against skin, lung, liver,
and esophageal tumors.

Results of epidemiological studies are murkier. Some indicate a
protective effect of tea against certain cancers, others show no
relationship, and still others show a higher incidence of some cancers,
particularly esophageal, in heavy tea drinkers.

Although higher rates of esophageal cancer are seen in some parts of
China, Iran and Japan, where tea consumption is high, it's not clear
why. According to FDA research chemist Joseph M. Betz, Ph.D., "It's been
bounced back and forth as to whether the high incidence is due to tea
polyphenols or to proliferation of esophageal cells in response to
physical damage to those cells cause by habitual consumption of a very
hot beverage, as has been proposed by Dr. Bruce Ames at the University
of California at Berkeley."

Yang reports that several case-control studies showed no association
between esophageal cancer and drinking tea at normal temperatures (35 to
47 degrees Celsius, or 95 to 117 degrees Fahrenheit), but that ingestion
of very hot tea (55 to 67 degrees Celsius, or 131 to 153 degrees
Fahrenheit) was associated with twofold to threefold increases in risk.

He concludes that tea may reduce cancer risk in certain populations,
adding that, "Depending on the etiology [cause] of the disease, the
protective effect may be observed in selected cancers in certain
populations but not in other situations." He advocates more studies on
the chemical properties and biologic activities of tea and tea
components--particularly of black tea, which is the major kind of tea
consumed in Western countries and whose properties, he says, are poorly
understood.

Polyphenols in tea are being looked at for a potential to lower heart
disease risk also. Biochemist Joe Vinson, Ph.D., at the University of
Scranton in Pennsylvania, found that hamsters fed green and black teas
had lowered blood cholesterol levels and reduced LDL cholesterol
oxidation. He also found that tea has an anti-clotting effect in rats,
which could help prevent or reduce the severity of a heart attack.

Vinson is cautious about translating the results of his studies to
humans, though, in part because the hamsters were given tea in amounts
equivalent to two quarts a day for humans. And although he is encouraged
by epidemiological studies in Japan and China that show less heart
disease in people who drink lots of tea, he stresses that "the tea story
has yet to be written as far as heart disease goes."

A. Richey Sharrett, M.D., Dr.P.H., at the National Heart, Lung, and
Blood Institute in Bethesda, Md., agrees. Sharrett considers tea
polyphenols potentially important in heart disease but is wary of
epidemiological studies.

"People don't just live on tea," he points out, "and if you compare
cultures, they differ in so many respects. To me, you have to fall back
on the biochemistry--you want to know if polyphenols are antioxidants,
if they are absorbed, and can you get direct evidence that they're
effective against coronary disease."

"The Food and Drug Administration has not done any reviews of possible
beneficial effects of tea," says John Vanderveen, Ph.D., director of
FDA's Office of Plant and Dairy Foods and Beverages. "If we were to do
it, it would be under the context of a health claim," he says, "and no
one has submitted a request for a health claim."

Whether or not tea will ultimately prove of value in combating cancer,
heart disease, or children's tumbling remains to be seen. In the
meantime, cuppa tea, anyone?

--M.S.


------------------------------------------------------------------------


Debugging the Dispenser

After a restaurant patron in Cincinnati complained last summer that his
iced tea smelled like sewage, the city's health department sampled iced
tea from several area restaurants. The study revealed high levels of
coliform bacteria (from fecal matter), prompting the state of Kentucky
to launch a similar survey of its restaurants. That study, too, found
contaminated tea in many restaurants. Although no illnesses were
reported, both jurisdictions last fall issued advisories to retail food
establishments on how to properly prepare brewed iced tea.

"There was a similar situation in Texas back in 1987," says Thomas L.
Schwarz, director of the division of cooperative programs in FDA's
Center for Food Safety and Applied Nutrition, "and the problem was the
same--the tea dispensers were not being properly cleaned and sanitized."

After the tea leaves are brewed, the hot tea is transferred from the
brewer to a reservoir-type unit with a spigot for dispensing the tea.
This unit has at its base a short section of tubing that goes from the
reservoir to the spigot.

"What was found in 1987 and again recently," Schwarz says, "is that the
dispenser is not being cleaned properly. Over time, the tubing and the
spigot build up a heavy bacteria-laden residue, accounting for the high
bacterial counts in some of the tea samples."

The solution to the problem is simple, Schwarz says. It requires
disassembling, cleaning and sanitizing the dispenser, hoses, spigot, and
other components. "If they dismantle the dispenser and clean and
sanitize it at least once a day, as is recommended by FDA for retail
food establishments, they shouldn't have any problems," he says, adding
that no extra precautions need to be taken for home-brewed iced tea.

--M.S.

------------------------------------------------------------------------

FDA, States Collaborate for Safety's Sake

by John Henkel

When Congress passed the Mammography Quality Standards Act in 1992
requiring federal certification of U.S. mammography facilities,
regulators faced the daunting task of inspecting and accrediting the
10,000 mammogram providers scattered across the country.

If the Food and Drug Administration--responsible for enforcing the
certification--had tried to tackle this alone, the task would have been
nearly impossible because of limited resources. The agency gets the job
done by drawing on a decades-long alliance with state departments.

Mammography facility inspection is part of a larger initiative to
protect the public against adverse health effects of radiation exposure.
It is one of four major FDA-state collaborations. Others involve retail
food protection, shellfish sanitation, and milk safety.

"FDA does not have primary responsibility to enforce compliance for the
commodities covered under the cooperative programs," says David Field,
state programs director for FDA's Northeast Region. "The states do that.
They have the police power."

In the case of mammography, FDA does enforce the law and does inspect
some facilities itself, such as those in the military and in states
without contracts with the agency. However, for thousands of other
inspections, FDA trains, audits, and provides technical expertise to
state inspectors under contract to FDA to do inspections.

The four FDA-state programs are unlike most others within the agency
because they run by authority of the Public Health Service (PHS) Act,
not the Federal Food, Drug, and Cosmetic Act, from which most of FDA's
regulatory authority comes.

The PHS Act directs FDA to "assist states ... in the prevention of
communicable diseases" and to advise states "on matters relating to
preservation and improvement of the public health."

More informal federal partnerships with states date back to the early
part of this century. In the 1920s, the Industrial Revolution changed
America's food habits. The shift away from an agricultural economy
meant, for example, that "many people no longer had a cow in their
backyard, so they were buying milk from the local store," says Field.
But because the industry lacked standards and controls, outbreaks of
food-borne disease occurred from milk that had been contaminated
somewhere along the processing route. Shellfish had similar tainting
problems. In 1925, several states asked the surgeon general for help in
stemming the rise of shellfish-related illnesses such as typhoid. In
response, the surgeon general held a conference that created the
framework for PHS programs that advise, train, and generally oversee
shellfish sanitation programs.

FDA-state alliances nowadays are governed by memoranda of understanding
with various national conferences, where federal and state officials,
along with industry representatives and others, meet either yearly or
biannually to review or revise procedures. 

"The states come to the table, they have voting authority, and they
examine ordinances, operational manuals, or pertinent issues to make
sure everyone is going to be playing the same tune," says Field.

FDA uses its six administrative regions--Northeast, Mid-Atlantic,
Southeast, Midwest, Southwest, and Pacific--as geographic sectors for
cooperative programs, with each region responsible for a cluster of
states. Working within these regions, state officials can readily
consult with FDA experts about technical problems. The proximity also
allows FDA regional personnel to audit state programs easily. And states
in each region can arrange easily to have FDA conduct training for state
inspectors.

Radiological Health

FDA's training role is crucial to the success of the cooperative
programs because in many cases state inspectors--such as those who
inspect mammography facilities--must be certified to perform a
regulatory function. The training, much of it available only from FDA,
is required for getting and maintaining certification.

Often, as in the radiological health program, states need a steady flow
of trained inspectors. "If you're a state radiation control director,
and you lose a seasoned member of the staff, it's tough," says Richard
Gross, associate director for liaison in FDA's Center for Devices and
Radiological Health. "You have to quickly bring someone else up to speed
to keep up with the workload. That's where FDA really helps by offering
the states specialized training [to individuals]."

Protecting the public from potentially harmful radiation effects is a
duty shared by at least five federal agencies, including the
Environmental Protection Agency, the Nuclear Regulatory Commission, the
Department of Labor, and the Centers for Disease Control and Prevention,
as well as FDA. But at the state level, these responsibilities typically
are focused into a single division. This allows a more comprehensive
approach to regulating local radiation sources, which include x-rays,
radioactive materials, microwave devices, lasers, and even
ultraviolet-source instruments.

The collaboration works well because federal agencies often have a
greater concentration of technical expertise and scientific resources.
But the states can respond to public health emergencies more quickly.
States also have personnel resources close to the sources of problems
and can act rapidly to resolve them.

The Conference of Radiation Control Program Directors guides FDA-state
programs in radiological health. One of the conference's main activities
is a yearly survey that gauges the quality of a specific x-ray--a dental
bite-wing exam, for instance--from a random sampling of facilities
nationwide. "The states voluntarily oversee data collection for these
surveys," says Gross, "while FDA lends technical expertise and helps
develop standard protocols [for gathering the data]."

The conference then distributes the data to trade groups (the American
Dental Association, for example) and state health departments as a
measure of radiological exposure nationwide to patients for the
particular test studied.

These data also show trends. A review of survey data on mammography
quality from 1985, 1988 and 1992 indicates a 34 percent improvement in
image quality and a 20 percent decrease in the "mean glandular dose" of
radiation required to produce a quality image. This, Gross says, is
consistent with the program's goal of reducing unnecessary public
radiation exposure.

Retail Food Protection

More than 3,000 state and local government agencies regulate the
country's retail food industry. They are responsible for over 1 million
food establishments--restaurants and grocery stores, as well as vending
machines, cafeterias, and other outlets in health-care facilities,
schools, and correctional facilities. FDA's regional food specialists
provide training, program evaluation, and technical assistance to these
agencies.

State health officials may request to be "standardized" in the Food Code
before they inspect food establishments. The Food Code is a model of
food safety standards FDA introduced in 1993 and updated in 1995. States
are encouraged to adopt this code as a sound technical and legal basis
for their own regulation of retail food establishments.

The standardization process, which tests an official's performance in
actual inspections, begins at FDA headquarters. A standardizing officer
from the agency's Center for Food Safety and Applied Nutrition and an
FDA regional food specialist inspect numerous food establishments
jointly, using a checklist that includes factors such as management
knowledge, food employee health, hand cleanliness, and time and
temperature management of potentially hazardous foods.

The regional specialist's ratings must agree with at least 80 percent of
the standardizing officer's ratings of items on the inspection form. The
regional standardized specialists then use the same method to
standardize state officials, who, in turn, can standardize county and
local inspectors.

FDA regional specialists also give the states technical assistance. For
example, state officials recently asked FDA for help in responding to
food-borne illness outbreaks, including incidents of contamination by
the bacterium E. coli O157:H7 in Missouri, Washington, Oregon, and
Texas, as well as a Texas botulism outbreak. Regional specialists
provided states with information on the relevance to the problem of food
additives, microbiology, ethnic foods, and plumbing.

In other instances, FDA regional specialists helped states ensure food
safety after disasters such as floods and earthquakes. They are
assisting with major food-service events such as the 1996 Olympics in
Atlanta and the 1996 Boy Scout Jamboree in rural Virginia.

As in the radiation health program, training is critical in the food
programs. Regional food specialists conduct many workshops for state
health departments. For example, in 1994, FDA began offering training to
familiarize state officials with the Food Code, and states now look to
FDA for guidance in interpreting and applying the code.

The Food Code includes standards for such things as cooking times and
temperatures, refrigeration temperatures, and storage requirements for
many kinds of foods. In 1994, Rhode Island was the first state to
implement the Food Code as law. But that was just a first step.

"After we got the code through, the high priority was training people on
what the code is," says Ernest Julian, Ph.D., chief of Rhode Island's
division of food protection. "FDA was of great assistance there, putting
together a Food Code course for us. And now if we have questions about
the code, we can go to FDA and have those answered."

Shellfish Sanitation

The shellfish program is governed by the Interstate Shellfish Sanitation
Conference, which was established in 1982 and meets each summer for
seven days. In April each year, conference members--FDA, states,
industry representatives, the Environmental Protection Agency, and the
National Marine Fisheries Service--submit ideas and issues for
consideration by the conference. One of three task forces, made up of
conference members, examines each issue and makes a recommendation to
the general assembly, which includes only state representatives who vote
on the issue.

In 1994, FDA offered the conference an option for controlling the
potentially hazardous Vibrio vulnificus bacterium in raw oysters. The
option suggested a ban on harvesting oysters for raw consumption from
Gulf of Mexico waters between April and October. The conference rejected
that option but agreed to a year-long study of time and temperature
factors that can reduce the risk of Vibrio infection in medically
compromised individuals. In early summer 1995, the states, with FDA's
input, offered another option based on oyster refrigeration when the
water reaches a certain temperature. For example, oysters taken from an
affected site during a month with an average monthly maximum water
temperature of more than 84 degrees F (29 degrees C) would have to be
chilled within six hours of harvesting. Oysters taken from cooler waters
could be kept unchilled longer. This time, the conference's voting
members approved the measure.

"Sometimes FDA is placed in a situation where it must compromise to get
an issue approved by the conference," says Stan Ratcliffe, team leader
for shellfish programs in FDA's Center for Food Safety and Applied
Nutrition. "Other times the agency might have to accept defeat of its
proposals."

Like the food safety program, FDA's Shellfish Sanitation Program has a
regional staff that interacts with state officials to help bolster
enforcement programs. These shellfish specialists audit state programs
to ensure compliance with laws, regulations and requirements of the
National Shellfish Sanitation Program (NSSP) and other criteria agreed
on by the Interstate Shellfish Sanitation Conference. Their goal is to
ensure that state officials comply with the NSSP in classifying
harvesting waters, controlling illegal harvesting, as well as overseeing
processing plant conditions and product labeling.

The shellfish program also provides states with training, technical
assistance, and results of scientific research. FDA shellfish
specialists use a process similar to that of food specialists for
standardizing state inspectors.

Milk Safety

FDA assists states in preventing disease transmitted through milk and
helps enforce state milk regulations. It promotes and helps ensure
compliance with the model Grade A Pasteurized Milk Ordinance, a document
similar to the Food Code. FDA's regional milk specialists offer seminars
to state officials to promote uniformity in interpreting the Pasteurized
Milk Ordinance, as well as on other issues such as laboratory analysis
methods.

The milk program has an auditing feature called check rating, which
doublechecks state evaluations of milk sources. FDA produces a quarterly
Interstate Milk Shippers list of ratings states have given to interstate
milk plants and farms. "We then go in and check rate, or justify, the
rating the state has given," says Field.

FDA regional milk specialists, like their counterparts in retail food
and shellfish programs, standardize state officials, after themselves
being standardized by FDA headquarters. Milk specialists also track
public health problems, such as those caused by bacterial contamination,
to assess the impact of state control programs and the effects of FDA's
activities on promoting public health.

The four FDA-state cooperative programs all have their own strategies,
but their methods of helping states are similar. "For a state compliance
officer with four or five programs to worry about, it can be difficult
to know who's on first," says FDA's Richard Gross. "That's why there's
been an effort to make these [cooperative] programs similar."

FDA officials also say the programs make good economic sense. Says FDA's
David Field: "For a small amount of resources, FDA is able to influence
and give good direction to four major industries across the country."

John Henkel is a staff writer for FDA Consumer.


------------------------------------------------------------------------


Battling AIDS Fraud

Recent years have seen a growth in fraudulent or scientifically unproven
treatments aimed at patients with AIDS who are desperate for any help
against this deadly disease.

FDA has joined with several states to form the AIDS Health Fraud Task
Force Network, a grassroots cooperative striving to curb AIDS fraud
through various information programs. So far, California, Colorado,
Florida, Georgia, Illinois, Louisiana, Michigan, Minnesota, Ohio, and
Texas have created task forces, each with its own programs tailored to
the state's needs.

"Our hope is that eventually all 50 states will come aboard the
program," says Richard Barnes, director of FDA's division of
federal-state relations. Task forces include federal, state and local
officials, along with members of AIDS service organizations, academia,
businesses, and AIDS medication "buyers' clubs." FDA funds the task
forces.

The 6-year-old task force network is not a law enforcement body, though
it sometimes refers suspected fraud cases to state or federal
regulators. Instead, the network seeks to abolish fraudulent activities
by sponsoring consumer education through telephone hot lines,
newsletters, public service announcements, exhibits, and videos. Because
they regard AIDS fraud as common and costly for people with AIDS or
infected with HIV (the virus that causes AIDS), task force members help
patients steer clear of fraudulent operations. Patients can report
suspected fraud to task forces (the phone numbers are listed in local
directories under state services). Task forces also help patients make
informed choices about legitimate treatments.

A clear advantage of the task forces is speed, says Lynne Isaacs, AIDS
coordinator in FDA's Florida district office. "If suspected fraud is
found, the task force can rapidly alert the news media, which gets the
message to the public."

One recent Florida case involved a hand lotion the distributor claimed
could block HIV and eliminate the need for health workers to wear
protective gloves. The task force quickly spread the word about this
unproven product, and FDA sent a warning letter to the company, which
resulted in the company canceling its advertising.

Collaborating with states makes good sense, Barnes says, because "FDA
cannot stop AIDS fraud alone. Fraud happens at the local level, and
that's where exposure of the fraud should take place."

Barnes emphasizes that AIDS fraud is not an isolated problem affecting a
small patient population. It is part of a much larger problem that has
negative consequences for the country's economy. "Let's face it," Barnes
says, "when someone is involved in health fraud, it ends up costing all
of us."

--J.H.

------------------------------------------------------------------------

Updates



Deadline for Supplement Comments

March 13, 1996, is the last day FDA will accept comments on its
proposals to standardize the labeling of dietary supplements. The
proposals appear in the Dec. 28, 1995, Federal Register.

The address for submitting comments is: FDA Dockets Management Branch
(HFA-305), Rockville, MD 20857-0001.

Under one proposal, labeling for dietary supplements would follow the
same format as that used in the labeling of packaged foods. It, too,
would give nutrition information about certain vitamins and minerals, as
well as other dietary ingredients. Instead of "Nutrition Facts," the
information would be presented under the heading "Supplement Facts."

Another proposal would set definitions for the terms "antioxidant" and
"high potency" as used in the labeling of dietary supplements.

The term "dietary supplements" refers to products containing vitamins,
minerals, herbs, amino acids, and other nutrients and ingredients
intended to supplement the diet.

The proposals would implement major provisions of the Dietary Supplement
Health and Education Act of 1994. Under that law, labeling rules for
dietary supplements must be final and in effect by Jan. 1, 1997.



New Regulations for Seafood

A revolutionary way of protecting the U.S. food supply from contaminants
could begin this year under new regulations for seafood safety that take
effect Dec. 18, 1997.

The regulations, announced by FDA last December, call for seafood
processors to adopt food safety practices based on the Hazard Analysis
Critical Control Point (HACCP) system. This system uses preventive
controls to keep unsafe foods off the market, instead of addressing
safety problems after the fact, which has been the approach since the
early 1900s.

FDA estimates its HACCP seafood safety regulations will prevent 20,000
to 60,000 seafood poisonings a year, which cost consumers as much as
$116 million annually.

Next year, the U.S. Department of Agriculture will issue HACCP rules for
meat and poultry, and in future years, FDA plans to issue regulations
covering other foods.

Under the seafood regulations, processors must identify hazards that,
without preventive controls, are reasonably likely to affect product
safety. Examples of food hazards are chemicals, toxins, bacteria,
parasites, and physical objects.

If a hazard is identified, the firm must implement an appropriate HACCP
plan. For example, a highly mechanized processing line would be checked
regularly for metal fragments in the food and records kept of those
checks. With the HACCP recordkeeping, FDA inspectors can monitor product
safety more closely and on a more continuous basis than with the older
"spot-checking" method.

The HACCP seafood regulations have special provisions for certain fish.
For example, processors of raw molluscan shellfish, such as oysters,
clams and mussels, must specify in their HACCP plans that they will
accept only molluscan shellfish harvested from approved waters. For
smoked fish, processors must implement procedures to ensure that the
product remains safe from Clostridium botulinum toxin through the shelf
life of the product.

The HACCP rules do not apply to fishing vessels and transporters.
However, processors must take responsibility for their seafood
materials, whether imported or domestic. The rules also do not apply to
retail seafood operations, which are regulated by state and local
authorities who have received training and other technical assistance
from FDA.

FDA published the rules in the Dec. 18, 1995, Federal Register.

(For more information, see "HACCP: Patrolling for Food Hazards" in the
January-February 1995 FDA Consumer.)



Device Reporting Rule Final

Beginning April 11, hospitals, nursing homes, and other health-care
facilities must report medical device-related deaths and serious
injuries or illnesses, according to an FDA final rule that also spells
out manufacturers' reporting requirements.

The rule requires that medical facilities: 


 * within 10 days, report deaths to FDA and to the manufacturer

 * within 10 days, report serious injuries or illnesses to the
   manufacturer, or to FDA if the firm's identity is not known

 * every six months, send FDA a summary of these reports.

The new criteria, published in the Dec. 11, 1995, Federal Register, are
part of a universal "alert system," required by the Safe Medical Devices
Act of 1990 and the Medical Device Amendments of 1992.

The rule requires that manufacturers: 

 * within five days, report to FDA any device-related incident requiring
   immediate action to protect the public health, as well as any incident
   for which the agency requests a report

 * within 30 days, report other device-related deaths, serious injuries,
   or illnesses, as well as device malfunctions likely to cause or
   contribute to death, serious injury, or illness

 * annually, submit a statement certifying the number of reports filed,
   or that no reports were filed during the previous 12 months

 * report incidents related even to products no longer marketed.

The rule helps lower costs by reducing paperwork. Reports can be
submitted on the same FDA Medwatch form used for reporting drug- and
biologics-related adverse events. Procedures are under way at FDA to
allow electronic filing of reports.


Doublechecking Pap Smears

Two new computer-based Pap smear screening systems will help increase
the detection of cervical cancer.

Laboratories can use the Autopap 300 QC System or the Papnet system to
doublecheck all or a selected portion of Pap smears initially found to
be normal.

Pap smears, samples of cervical cells quickly pressed on a glass slide
and "fixed" to prevent them from drying and changing appearance, can
detect cancer and precancerous cell changes in the cervix. About 50
million Pap smears are done annually in the United States.

Cytotechnologists, specially trained in identifying defective cells,
examine the slides under a microscope to look for signs of
abnormalities. Although cytotechnologists routinely rescreen 10 percent
of all negative (normal) smears, some abnormal smears may go undetected.
The error rate for Pap smears varies from lab to lab but is estimated to
be from 5 to 25 percent.

The Autopap system makes it possible to rescreen all normal Pap smears.
Using image processing and pattern recognition techniques, the device
picks out 10 to 20 percent of the most suspicious smears for a second
examination.

In the clinical studies conducted at seven laboratories in the United
States, the device screened 11,751 Pap smears initially thought to be
normal and found 297 that were actually abnormal.

The Papnet system also rescreens normal Pap smears. It selects the 128
most abnormal looking cells or cell clusters from each Pap smear. The
cells are recorded on a high-resolution color video monitor for a
cytotechnologist to evaluate.

In a clinical trial using Pap smears from 10 different labs, rescreening
with Papnet detected 464 abnormal smears out of 9,666 originally
diagnosed as normal.

Even with the Autopap and Papnet, however, false negatives may still
occur, due to reading errors, sampling and technical errors in handling
the smears, or rapidly progressing cancer that cannot be identified
during routine screening.

FDA approved the Autopap, manufactured by Neopath Inc. of Redmond,
Wash., on Sept. 29, 1995, and Papnet, manufactured by Neuromedical
Systems of Suffern, N.Y., on Nov. 8, 1995.

(For more about Pap smears, see "The Controversial Pap Test," in the
September 1989 FDA Consumer.)



Faster TB Test

A sputum test for tuberculosis recently approved by FDA gives results in
only four to five hours, instead of the one to eight weeks required by
conventional sputum culture tests. All tests must be done by qualified
laboratories.

The Amplified Mycobacterium TB Direct Test was approved last Dec. 18 for
use only on specimens of sputum that an acid fast stain has already
shown are likely to be positive for the TB bacteria. Because the new
test gives results more quickly, patients can receive antibiotic
treatment earlier, and isolation facilities can be used more
efficiently. In addition, others who have been in contact with the
patients can be tested earlier and given appropriate treatment if
necessary. However, a follow-up culture test must also be done to
confirm the presence of TB.

The manufacturer, Gen-Probe Inc., of San Diego, studied 6,079 specimens,
finding 198 likely to be positive by the acid fast stain and confirmed
with culture. The new test detected TB bacteria in 95.5 percent of
specimens that had the bacteria.



Recent Drug Approvals

Drugs to treat AIDS, a form of leukemia, Lou Gehrig's disease, and skin
damage were among those approved as 1995 drew to a close and this issue
of FDA Consumer was being prepared.

Invirase (saquinavir) and Epivir (lamivudine, or 3TC) were both approved
to treat HIV infection, including AIDS, under FDA's accelerated approval
process, which allows the agency to grant early marketing to products
while clinical studies continue.

Invirase is the first approved protease inhibitor, one of a new class of
drugs for the treatment of advanced HIV infection. Invirase is approved
for use in combination with drugs from the class known as nucleoside
analogs, to which five other drugs approved to treat AIDS, including
Retrovir (zidovudine, or AZT) and Epivir, belong. The agency approved
Invirase only three months after receiving its marketing application.
Clinical trials compared three drug combinations in more than 900
HIV-infected patients. Over 16 weeks of treatment, CD4 counts increased
an average of 30 to 40 cells in patients taking Invirase in combination
with Retrovir or Hivid (zalcitibine, or ddC), or with a combination of
Retrovir and Hivid. Invirase is manufactured by Roche Laboratories.

Epivir (lamivudine, or 3TC) is approved for use in combination with
Retrovir in treating AIDS and HIV infection. Trials show that patients
treated with the combination sustained higher increases of CD4 cells
than patients receiving Epivir or Retrovir alone, or Retrovir with
Hivid. Epivir and Retrovir are manufactured by Glaxo-Wellcome Inc.

Vesanoid (all trans retinoic acid, or ATRA) is approved to reverse the
progression of promyelocytic leukemia in patients who are resistant to
or cannot use standard cancer treatment. About 2,500 people in the
United States have promyelocytic leukemia, a life-threatening disease
associated with a genetic abnormality that causes excessive production
of white blood cells. In clinical studies sponsored by the National
Cancer Institute, 50 percent of patients who had relapsed following
standard chemotherapy had complete remission of the disease when treated
with the drug. Vesanoid is distributed by Hoffmann-La Roche.

Rilutek (riluzole) is the first drug shown to prolong the survival of
patients with amyotrophic lateral sclerosis (ALS), also known as Lou
Gehrig's disease. FDA approved the drug 5 1/2 months after receiving the
application for approval. ALS is a disease with no known cure that
causes progressive muscular weakness and paralysis. It is usually fatal
within five years after diagnosis. In clinical tests, Rilutek prolonged
the survival of ALS patients by about three months. The drug is
manufactured by Rhône-Poulenc Rorer Inc.

Renova (0.05% tretinoin emollient cream) is approved to assist in
treating certain kinds of skin damage, such as fine wrinkles, spotty
discoloration, and rough skin. Renova is to be used as part of a
comprehensive skin care and sun-avoidance program. In studies, after 24
weeks of treatment, about 30 percent of patients had moderate
improvement, 35 percent had slight improvement, and 35 percent had no
improvement. Renova does not eliminate wrinkles or repair sun damage
that can lead to skin cancer. Nor is there evidence that Renova treats
coarse skin, deep wrinkles, skin yellowing, or other skin problems.
Renova has not been studied in people 50 or older or in those with
moderately or darkly pigmented skin. Renova is related to the topical
acne medication Retin-A. Both medications are manufactured by Ortho
Pharmaceutical Corp.



Sensor Pad Helps Find Breast Lumps

A plastic pad that women, with proper training, can use to examine their
breasts for lumps was recently cleared for marketing by FDA.

The Sensor Pad will be available through health-care providers, clinics,
and other institutions where women can receive instructions for its use.
To ensure early detection of breast cancer, women should continue doing
bare hand self-examination and having exams by a doctor and yearly
mammograms.

The manufacturer, Inventive Products Inc., of Decatur, Ill., submitted
two clinical studies to FDA last November: a U.S. study of the impact of
different educational strategies on the skill and frequency of
self-exams, and a Japanese study that was part of a self-exam screening
program.

The Japanese study of the 832 women showed that women who had been
properly instructed in the pad's use detected their own breast lumps
almost as frequently as the lumps were found by trained nurses also
using the pad. Nurses were able to detect lumps in each of the 72 women
identified with breast cancer. Of the same 72, only one missed her
breast lump when self-examining with the pad.

FDA cleared the Sensor Pad for marketing last Dec. 22.



FDA Consumer Wins Four Awards

FDA Consumer won four awards in important publication competitions
recently. 

The magazine was awarded first place among magazines for general
audiences in the 1995 National Association of Government Communicators'
"Blue Pencil" Competition. NAGC also awarded the magazine second place
for visual design, and a second-place writing award for the feature
"Stalking the Wild Mushroom" by Marian Segal in the October 1994 issue. 

In addition, FDA Consumer received a Silver Award (second place) in the
1995 International Mercury Awards Competition, sponsored by MerComm
Inc., a New York-based organization. Magazines competing for the awards
include those from many sources, including industry and nonprofit
associations. 



Food Label Information Wins Prizes

Several of FDA's efforts to inform the public about the new food label
have garnered recent awards.

The video "The Food Label and You" received a gold award (first place)
in the 1995 International Mercury Awards Competition sponsored by
MerComm, Inc. Contestants in the competition include private, industry,
nonprofit, and government groups.

A high school teachers' guide, "The New Nutrition Label: There's
Something in It for Everyone," received The American Dietetic
Association Foundation's Presidents' Circle Award for Nutrition
Education last Oct. 31. The guide was a joint effort of FDA and the
International Food Information Council.

Two FDA public service announcements, "Check It Out" and the animated
"The Fat that Jack Eats," each received a third place award in the 1995
National Association of Government Communicators' "Gold Screen"
Competition. Both announcements give information about the new food
label.



Free Publications Available

Three backgrounders and three FDA Consumer reprints are now available
free from FDA. They are:

Olestra and Other Fat Substitutes (Revised) (BG 95-18) 

HACCP: A State-of-the-Art Approach to Food Safety (BG 95-19)

FDA Food Code (BG 96-1) (This replaces a January 1994 backgrounder.)

Not a Cure-All: Eye Surgery Helps Some See Better (FDA 96-1227)

On the Teen Scene: Food Label Makes Good Eating Easier (FDA 96-2294)

Prostate Cancer: New Tests Create Treatment Dilemmas (FDA 95-1220). 

To order single copies, write to FDA, HFE-88, Rockville, MD 20857. To
order 2 to 100 copies, write to FDA, HFI-40, at the same address, or fax
your order to (301) 443-9057. Include the publication number.


------------------------------------------------------------------------

Notebook


The Notebook: a potpourri of items of interest gathered from FDA news
releases, other news sources, and the Federal Register (designated FR,
with date of publication). The Federal Register is available in many
public libraries.



Oat bran and oatmeal products would be able to carry a heart disease
health claim under an FDA proposed rule. FDA has tentatively concluded
that diets high in oat bran and oatmeal and low in saturated fat and
cholesterol may reduce the risk of coronary heart disease. The public
may submit written comments on the proposed rule by April 3 to FDA,
Dockets Management Branch, HFA-305, Rockville, MD 20857. (FR Jan. 4)

Biotechnology medication regulations will be overhauled under measures
FDA has proposed to reduce costs for manufacturers, increase agency
efficiency, and continue to protect the public health. The measures were
published last November in the pamphlet "Reinventing the Regulation of
Drugs Made from Biotechnology." To date, FDA has published two Federal
Register notices: "FDA Guidance Document Concerning Use of Pilot
Manufacturing Facilities for the Development and Manufacture of
Biotechnology Products" (FR July 11) and "Interim Definition and
Elimination of Lot-by-Lot Release for Well-Characterized Therapeutic
Recombinant DNA-Derived and Monoclonal Antibody Biotechnology Products"
(FR Dec. 8). Those interested may comment on either document at any
time. For a free copy of the reinventing report, write to FDA, HFI-40,
Rockville, MD 20857; telephone (301) 443-3220.

User fee revenues and rates for fiscal year 1996 were set by FDA under
the Prescription Drug User Fee Act. The act authorizes FDA to collect
fees on drug and biological product applications, on establishments
where the products are made, and on the marketed products. The new fees
took effect Oct. 1, 1995. (FR Dec. 1)

A new antibiotic, cefpodoxime proxetil, was recently approved, according
to an FDA final rule effective last Dec. 27. In the rule, FDA published
standards for the drug and its use both as tablets and as granules for
oral suspension. (FR Nov. 27)

The first generic albuterol metered-dose inhaler (MDI) was approved by
FDA last Dec. 29. The albuterol MDI is used to prevent bronchospasm in
patients with asthma and was found equivalent to the brand-name product.
(FDA Talk Paper, Dec. 29)

Cadmium and lead contamination of pottery compliance policy guides have
been revised by FDA. For free single copies of "Pottery (Ceramics);
Imported and Domestic--Cadmium Contamination" and "Pottery (Ceramics);
Imported and Domestic--Lead Contamination," send two self-addressed
labels to FDA, Division of Compliance Policy, HFC-230, Rockville, MD
20857. Request Docket No. 95D-0370. (FR Dec. 12)

Animal drug and other veterinary information is now available through
FDA's Center for Veterinary Medicine World Wide Web home page. The site
includes general center information, some CVM guidelines, and
information on center research activities. The Internet address is
http://www.cvm.fda.gov/. (FDA Veterinarian, November-December 1995)

U.S. grade standards and other selected regulations have been lifted for
various agricultural products, according to an Agriculture Department
final rule effective last Dec. 4. Dairy products, tobacco, wool, mohair,
fresh and processed fruits and vegetables, livestock, meats and meat
products, eggs, and poultry and rabbit products will now be regulated
under voluntary standards set by USDA's Agricultural Marketing Service.
(FR Dec. 4)

Dietary fat and cancer will be the topic of the American Institute for
Cancer Research's annual conference at Loews L'Enfant Plaza Hotel in
Washington, D.C., Aug. 29 and 30. For more information, telephone AICR's
research department at (202) 328-7744 or (1-800) 843-8114; e-mail
jcohn@capcon.net.

------------------------------------------------------------------------

Investigators' Reports



Pharmaceutical Executives Convicted

by Isadora B. Stehlin

False statements to federal officials, false records, and unapproved
manufacturing procedures led to the conviction of two executives of a
Pennsylvania generic drug manufacturing firm. In addition, the firm
pleaded guilty to similar charges and was ordered to pay a $3,250,000
fine.

On March 31, a jury in the U.S. district court for the district of
Maryland found Suhas V. Sardesai guilty of seven felony counts of lying
to FDA and violating the Food, Drug, and Cosmetic Act. Sardesai was
senior vice president of operations for Mutual Pharmaceutical Co., Inc.,
Philadelphia. The jury also found Edmund J. Striefsky, director of
quality control for Mutual, guilty of six counts.

The charges included conspiracy to defraud FDA, preparing and
maintaining false production records that failed to reflect
reprocessing, batch number switches, intermingling of several batches,
failing to file supplemental new drug applications before making changes
in manufacturing processes, and false statements in annual reports to
FDA.

The illegal activities first came to the government's attention in May
1992, when a former production manager at Mutual contacted the U.S.
Attorney's Office in Baltimore. According to the informant, Mutual had
problems in manufacturing several of its generic drug products according
to the formulas and methods it had submitted to FDA in its abbreviated
new drug applications. The agency had approved the firm's applications,
and rather than seek supplemental approvals from FDA as required by law,
Mutual routinely reprocessed some products by illegally using unapproved
ingredients and manufacturing procedures. Mutual concealed these actions
from FDA by creating and maintaining false records, and by filing false
reports.

During an FDA inspection of the firm in July 1989, Sardesai told an
investigator that Mutual had never reprocessed any batches, and if the
firm decided to do so in the future, it would get FDA approval before
beginning.

FDA employees with the agency's generic drug task force began
interviewing current and former Mutual employees during the summer and
fall of 1992. All of those interviewed corroborated the original
informant's allegations.

According to these employees, Mutual routinely had problems with low
tablet hardness and with tablets splitting and sticking to the
equipment. At the direction of Sardesai and Striefsky, Mutual employees
returned these batches to the blending department for remilling and
remixing, and sometimes added extra lubricants such as magnesium
stearate. Remilling tablets or adding additional lubricant can affect
the bioavailability of a drug. The batch numbers of these reworked
batches were often switched with other batches of the same product in
order to maintain a sequential batch numbering system so that the
additional processing would not be detected by FDA.

Subsequently, the reworked batches would either be intermingled with
other batches of the same product, resulting in a loss of batch purity
and identity, or sent back to the tableting department for
recompression. Among the products Mutual reworked were acetazolamide
250-mg tablets, a prescription medication used to treat congestive heart
failure and glaucoma, and sulfasalazine 500-mg tablets, a prescription
antibiotic.

Some Mutual production employees gave the task force handwritten notes
of the reworking and intermingling of drug batches, and photocopies of
internal Mutual records, which also corroborated the allegations.

In September 1993, FDA asked the Justice Department to initiate a grand
jury investigation. In April 1994, the grand jury for the District of
Maryland indicted four of the firm's executives.

Mutual pleaded guilty to seven counts of criminal violations involving
interstate shipments of adulterated prescription medications on July 22,
1994. At that point, the court imposed the fine.

On March 31, 1995, after a seven-week trial, a jury convicted Sardesai
and Striefsky. At press time, sentencing had not been scheduled. 

Production employee Sunil C. Shah was found not guilty on all counts.
The jury convicted quality assurance manager Kirit R. Patel on one
count, but was not able to reach a verdict on the other counts. The
government has not decided whether to retry Patel on those counts.

Isadora B. Stehlin is a member of FDA's public affairs staff.


------------------------------------------------------------------------


Correction

In the July-August 1995 issue of FDA Consumer, an article about the
criminal prosecution of New England Shrimp Company and Robert Randazzo
contained errors. In April 1994, when that issue went to press, Randazzo
had not gone to jail. His three-year sentence was stayed by the district
court judge pending his appeal to the U.S. Court of Appeals for the
First Circuit. The statement in the article that an employee of the
company had been "fired because he failed to go along with New England
Shrimp's illegal activities" should have been attributed to the
employee.

Finally, the statement that "because STP was used in levels exceeding
the limits allowed under good manufacturing practices the product was
regarded as unsafe for human consumption" was also incorrect. Although
Randazzo was convicted of using STP in shrimp products in which STP was
prohibited, there is no evidence that New England Shrimp Company's
product was unsafe due to the use of STP. Rather, the harm caused by the
STP abuse was economic fraud.


------------------------------------------------------------------------


Hair Relaxers Destroyed After Consumers Complain

Two types of hair relaxers, valued at almost $2 million, were destroyed
last fall after thousands of consumers reported problems with them. It
was the largest number of complaints FDA had ever received about a
cosmetic product.

The destruction was one of several measures the hair products'
distributor, World Rio Corp. of Los Angeles, agreed to take in a consent
decree entered in the U.S. District Court for the Central District of
California on Sept. 1, 1995. The company also agreed not to sell another
product like the two destroyed and to use FDA's Cosmetic Product
Experience Report to report to the agency any adverse reactions from any
hair straighteners it markets.

In 1994 and early 1995, more than 3,000 people reported to FDA that
their scalp itched or burned and that their hair broke off or fell
out--and, in some cases, turned green--after using the hair relaxers Rio
Hair Naturalizer System and Rio Hair Naturalizer System with Color
Enhancer.

Based on the complaints and an FDA investigation, the agency alleged
that the hair products were being illegally sold in the United States
because:

Adverse effects experienced by consumers were consistent with those seen
with harmful substances.

Their labeling was false. The products' labeling listed an acid pH level
of 3.4, but FDA analysis revealed that the pH was significantly less
than 3.0. In addition, FDA alleged the labeling falsely described the
products as "chemical free," even though the ingredient labels listed
substances commonly recognized as chemicals.

Ingredients, such as mineral salts, were not listed by their common or
usual name, as required.

The products were destroyed in Nevada in June 1995 and in California in
October 1995. 

FDA and state government offices around the country began receiving
complaints about the Rio hair products in mid-1994. Many complainants
said they had bought the hair relaxers by mail after viewing a 30-minute
TV infomercial targeted to African Americans.

Some complainants reported that their hair began falling out immediately
after applying the products, while others said they had problems after
multiple applications. Some said they had seen doctors for treatment of
scalp irritation. Many women said they had to cut their hair short to
deal with bald spots.

FDA collected samples of the hair relaxers on Nov. 6 and 8, 1994, at a
Los Angeles-based affiliate, Pantron I Corp., of World Rio. Most of the
products, which were imported from Brazil, were in the possession of
Product Packaging West, also known as Pic 'N' Pac West, of North
Hollywood, Calif.

On Nov. 23, the California Department of Health embargoed the products
held in Los Angeles and North Hollywood, essentially blocking their sale
in the United States. On Dec. 21, FDA issued a talk paper advising
against use of the products after laboratory findings identified the low
pH and the number of consumer complaints indicated that the hair
relaxers were causing adverse reactions.

About the same time, World Rio stated it would stop all sales of the
products. But, FDA received reports from consumers that the company may
still have been taking orders and billing customers through a mail-order
company, Addressing and Mailing Inc., in North Las Vegas, Nev.

On Jan. 23, 1995, at FDA's request, U.S. marshals seized the entire lot
of products at Product Packaging West in California.

On Jan. 24, an investigator with FDA's San Francisco district office
went to Addressing and Mailing to inspect the firm and found more than
8,000 cases of the Rio hair relaxers, worth about $500,000 in retail
value. FDA notified the State of Nevada Division of Health, which, in
turn, embargoed the products, thus preventing their sale.

On June 14, World Rio voluntarily destroyed the 8,000 cases of Rio hair
relaxers held at Addressing and Mailing in Nevada.

Under the terms of the consent decree between the United States and
World Rio, the company agreed to destroy the product kits seized at
Product Packaging West, although it was allowed to retain some of the
kits for use in product liability litigation and for laboratory
analysis. These kits must be held by a custodian and be destroyed at the
end of the litigation. The company faces about 200 individual lawsuits.

Under the consent decree, World Rio agreed, among other things, not to
sell a reformulated hair relaxer or similar product until the product is
tested for safety, the results of those tests are shared with FDA, and
World Rio notifies FDA of the date on which it will begin marketing the
new product.

--Paula Kurtzweil


------------------------------------------------------------------------


Dairy Farm Enjoined for Illegal Drug Residues

An Oregon dairy farmer signed that state's first consent decree of
permanent injunction involving illegal drug residues found in animal
tissues. The order enjoined him from selling calves intended to be
slaughtered for food until he established a system of identifying
drug-treated animals and keeping treatment records on them. 

David L. Hogan, owner and operator of Hogan's Misty Meadow Dairy in
Tillamook, Ore., signed the order July 5, 1995, in the U.S. District
Court for the District of Oregon after an FDA investigation documented
illegal drug residues in calves he sold at market. 

A follow-up inspection by FDA Aug. 17 found the dairy to be in
compliance with the terms of the injunction.

Hogan's dairy is primarily a milk farm. At the time of the
investigation, it had a milk-producing herd of 700 cows out of a total
herd of 850 adult animals. It also had about 850 replacement calves in
different stages of growth, and it sold approximately 450 bull calves
each year for veal.

A calf that is given a drug or that has nursed from a drug-treated cow
must be withheld from the market until the drug withdrawal time is
complete. Residues in animals sold for food can present public health
risks both directly from the meat (for example, to someone who is
allergic to the drug) and by contributing to the development of
resistance to antibiotics. 

"To keep cows milking, they have to be impregnated periodically,"
explains FDA Seattle district compliance officer Tom Piekarski. "They
dry up eventually, but when they deliver a calf, the milk starts flowing
again. Female calves are kept as replacements. Bull calves go straight
to market, within hours to days of birth," he says.

When calves go to market, the U.S. Department of Agriculture samples
portions of tissue--the liver, kidney, and sometimes muscle--from
virtually every calf right at the slaughterhouse, Piekarski says. If
illegal drug residues are found, the carcass is condemned and USDA
notifies the producer and FDA. FDA then inspects the producer.

An FDA inspection of Hogan's dairy on Aug. 17, 1994, found that a calf
that had tested positive for drug residues in USDA's sampling program
had been slaughtered at Hogan's dairy June 15. The USDA analysis showed
illegal residues of the antibiotic neomycin in the calf's kidney. This
was not the first violative residue found in calves from Hogan's dairy.
FDA inspections and USDA sampling dating from March 1990 documented 16
illegal residues of streptomycin, neomycin, gentamicin, and
oxytetracycline in his animals.

"Tissue residues in calves can come either from treatment right around
birth or from the mother if the cow was treated," Piekarski says, "so
that records must be maintained on both the adult animals and the
calves." Hogan admitted he fed calves milk from treated cows and did not
keep medication or treatment records. Despite the lack of records,
investigators located at the dairy sources of the residues found in the
animals: gentamicin and a stress formula containing neo-terramycin.

FDA had issued a warning letter to Hogan March 27, 1992, regarding the
violations, but he continued to ship calves with residues. After USDA
notified the agency of the most recent violation, FDA inspected again in
June and August 1994. Because the violations persisted, in November FDA
asked the Department of Justice to file a complaint for injunction,
which it did July 20, 1995, after negotiating with Hogan. The resulting
consent decree prohibited Hogan from selling veal calves for slaughter
until he complied with the terms of the decree, which include the
following:

Medicated bulls and cows must have a band affixed with the date of
banding or the date of medication, whichever is later.

Medication for the bulls and calves must be used in accordance with the
labeling, and tissues from these animals cannot be sold until the
withdrawal period for the medication is passed.

Calves intended for sale must be segregated in separate pens from those
not intended for sale.

If a calf is medicated or fed milk from a medicated cow, the medication
for the calf or cow must be used in accordance with its labeling; the
calf must be marked for identification; and written records must be kept
showing the identity and date of medication, the amount and method of
administration, the withdrawal period for the medication, the date the
withdrawal period expires, the date the calf was sold, and the name and
address of the purchaser.

Such a calf cannot be sold until the withdrawal period has lapsed.

--Marian Segal


------------------------------------------------------------------------


Summaries of Court Actions


Summaries of Court Actions are given pursuant to Section 705 of the
Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions report
cases involving seizure proceedings, criminal proceedings, and
injunction proceedings. Seizure proceedings are civil actions taken
against goods alleged to be in violation, and criminal and injunction
proceedings are against firms or individuals charged to be responsible
for violations. The cases generally involve foods, drugs, devices, or
cosmetics alleged to be adulterated or misbranded or otherwise violative
of the law when introduced into and while in interstate commerce.

Summaries of Court Actions are prepared by Food and Drug Division,
Office of the General Counsel, HHS, and are published by direction of
the Secretary of Health and Human Services.




SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Betel Nuts, dried and sliced, at Chicago, Ill. (N.D.Ill.);
Civil No. 95-C-4903.

CHARGED 8-25-95: While held for sale after shipment in interstate
commerce at Lien Hoa Food Corp., in Chicago, Ill., the articles were
adulterated in that they contained a poisonous and deleterious
substance--402(a)(1).

DISPOSITION: A default decree of condemnation, forfeiture and
destruction ordered the articles destroyed. (F.D.C. No. 67100; S. No.
95-741-549; S.J. No. 1)


PRODUCT: Lobster Tails, frozen, at Miami, Fla. (S.D.Fla.); Civil No.
95-616-CIV-Ungaro-Benages.

CHARGED 3-27-95: While held for sale after shipment in interstate
commerce at Preferred Freezer Services, Inc., in Miami, Fla., the
articles were adulterated in that they consisted of decomposed lobster
tails--402(a)(3).

DISPOSITION: A consent decree for reexport authorized the release of the
goods for reexportation. (F.D.C. No. 67075; S. No. 95-711-238; S.J. No.2)


PRODUCT: Mushrooms, canned, at Jacksonville, Fla. (M.D.Fla.); Civil No.
95-106-CIV-J-20.

CHARGED 2-3-95: While held for sale after shipment in interstate
commerce at Grimes Distribution Services, in Jacksonville, Fla., the
articles were misbranded in that their labeling falsely represented that
the articles were packed and grown in Taiwan--403(a)(1).

DISPOSITION: A default decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 67042; S. No. 93-682-700; S.J. No.3)


PRODUCT: Prune Culls, at Cheektowaga, N.Y. (W.D.N.Y.); Civil No.
94-CV-0144.

CHARGED 2-25-94: While held for sale after shipment in interstate
commerce at Allied Frozen Storage, Inc., in Cheektowaga, N.Y., the
articles were adulterated in that they consisted of insects, insect
parts, insect pupae, insect larvae, insect webbing, and insect
excreta--402(a)(3).

DISPOSITION: A consent decree of condemnation, forfeiture and
destruction ordered the articles destroyed. (F.D.C. No. 66908; S. No.
93-673-113; S.J. No. 4)


PRODUCT: Scallops, at Gretna, La. (E.D.La.); Civil No. 95-0604 Sect.
SMAG.5.

CHARGED 2-21-95: While held for sale after shipment in interstate
commerce at Gulf Atlantic Cold Storage, Inc., in Gretna, La., the
articles were adulterated in that they consisted of a decomposed
substance--402(a)(3).

DISPOSITION: A default decree ordered the articles destroyed. (F.D.C.
No. 67065; S. No. 95-745-218; S.J. No. 5)


Drugs/Human Use

PRODUCT: Oxygen USP, at Tulsa, Okla. (N.D.Okla.); Civil No. 93-C 840B.

CHARGED 9-16-93: While held for sale after shipment in interstate
commerce at American Respiratory, Inc., in Tulsa, Okla., the article was
adulterated in that the methods used in, and the facilities and controls
used for, its manufacture, processing, packing, and holding did not
conform to and were not operated and administered in conformity with
current good manufacturing practice requirements--501(a)(2)(B). The
article was misbranded in that its labeling failed to bear the name and
place of business of the manufacturer, packer or distributor--502(b)(1).
The article was also misbranded in that its labeling failed to contain a
statement of the quantity of contents and adequate directions for its
intended use--502(b)(2) and 502(f)(1).

DISPOSITION: A consent decree of condemnation and reconditioning was
filed. The articles were reconditioned and brought into compliance.
(F.D.C. No. 66758; S. No. 93-687-401; S.J. No. 6) 


Medical Devices

PRODUCT: Bandages, conforming stretch gauze, at Mundelein, Ill.
(N.D.Ill.); Civil No. 94C-4505.

CHARGED 7-25-95: While held for sale after shipment in interstate
commerce at Medline Industries, Inc., in Mundelein, Ill., the articles
were adulterated in that they were contaminated with mold, yeast and
bacteria--501(c). The articles were misbranded in that their labeling
falsely represented them as sterile--502(a).

DISPOSITION: A consent decree of condemnation was filed. The articles
were reexported to Germany under agency supervision. (F.D.C. No. 66999;
S. No. 94-710-913; S.J. No. 7)


PRODUCT: Eye Cleaners and Disinfectants, at San Jose, Calif.
(N.D.Calif.); Civil No. C-94-20711.

CHARGED 10-7-94: While held for sale after shipment in interstate
commerce at Lobob Laboratories, in San Jose, Calif., the articles were
adulterated in that the methods used in, and the facilities and controls
used for, their manufacturing, packing and storage were not in
conformity with current good manufacturing practice
requirements--501(h).

DISPOSITION: A default decree of condemnation, forfeiture and
destruction ordered the articles destroyed. (F.D.C. No. 67008; S. No.
94-705-815; S.J. No. 8)


PRODUCT: Frequency Generators and Cosmic and Magnetic Polarizers, at San
Diego, Calif. (S.D.Calif.); Civil No. 93-0230S.

CHARGED 2-12-93: While held for sale after shipment in interstate
commerce at Crane Foundation, in San Diego, Calif., the articles were
adulterated in that they were class III devices without an application
for premarket approval--501(f)(1)(B). The articles were misbranded in
that their labeling represented the articles as effective for treating
cancer, AIDS, heart disease, arthritis, diabetes, infections, burns, and
pain--502(a). The articles were also misbranded in that their labeling
failed to bear adequate directions for use, and they were not
manufactured in a duly registered establishment--502(f)(1) and 502(o).

DISPOSITION: An order of summary judgment, condemnation and destruction
was filed, and the articles were destroyed. (F.D.C. No. 66496; S. No.
92-641-318; S.J. No. 9)



CRIMINAL ACTIONS

DEFENDANT: John Bushow, at St. Croix, U.S. Virgin Islands (D.Md.);
Criminal No. HAR-91-0330.

CHARGED 9-6-91: The defendant, with the intent to mislead, failed to
establish and maintain accurate batch production records--301(e). The
defendant also failed to comply with current good manufacturing practice
requirements in that he directed employees to manufacture a drug product
following production procedures different from the process approved by
FDA--301(e). He also directed employees to prepare and maintain
production batch records which falsely stated that the approved mixing
procedures were utilized--333(a)(2).

DISPOSITION: Guilty plea; sentenced to four months of prison, four
months of parole, and ordered to pay a $50 special assessment. (F.D.C.
No. 66528; S.J. No. 10)


DEFENDANT: Steve Colton, at Springfield, N.Y. (D.Md.); Criminal No.
HAR-91-0125-R.

CHARGED 4-24-91: Counts 1-3: The defendant knowingly made a false
statement to FDA in that he filed a bioequivalency study claiming it
compared a generic drug product to the innovator product when the
generic drug product was disguised as the innovator product--18 U.S.C.
sections 2 and 1001.

DISPOSITION: Guilty plea; sentenced to 27 months of prison, fined $150,
and debarred from providing any services in any capacity to a person
with an approved or pending drug product application. (F.D.C. No. 66529;
S.J. No. 11)


DEFENDANTS: Cypress Seafood Processors and Bethel Dyson, at Abbeville,
La. (W.D.La.); Criminal No. CR-95-60017-01-02.

CHARGED 4-10-95: Counts 1-3: The defendants introduced adulterated food
into interstate commerce--402(a)(4). The food was adulterated in that it
was prepared, packed and held under insanitary conditions whereby it
might have been contaminated with filth or rendered injurious to
health--301(a) and 402(a)(4).

DISPOSITION: Cypress Seafood Processors, Inc., was sentenced to three
years of probation and fined $2,500. Bethel Dyson, president of Cypress
Seafood Processors, Inc., was sentenced to three years of probation and
fined $3,000. (F.D.C. No. 66824; S.J. No. 12)



INJUNCTION ACTIONS

DEFENDANT: Frank Lampley, at Glenmoore, Pa. (E.D.Pa.); Civil No.
91-8023.

CHARGED 12-31-91: The defendant distributed adulterated and misbranded
animal drugs in interstate commerce--301(a). The animal drugs were
adulterated in that they were new drugs without an approved new drug
application--501(a)(5). Some of the animal drugs were misbranded in that
their labels did not contain a list of active ingredients--501(e)(1)(A).

DISPOSITION: A permanent injunction was filed and granted. The defendant
appealed the decision to the U.S. Court of Appeals for the Third
Circuit, which affirmed the district court's decision. (Inj. No. 1274;
S. No. 90-611-703/704; S.J. No. 13)



MISCELLANEOUS ACTIONS

ACTION: U.S. v. Floyd E. Weston, at Sacramento, Calif. (E.D.Calif.);
Civil Action No. CR-S 93-517 GGH.

CHARGED 3-22-94: The defendant pleaded guilty to a misdemeanor count for
introducing unapproved medical devices into interstate commerce. The
plea agreement required the defendant to agree to a permanent injunction
barring him from selling the device or homeopathic remedies--301(a).

DISPOSITION: A consent decree of permanent injunction was filed. (Misc.
No. 1073; S.J. No. 14) 

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FDA Consumer magazine (March 1996)