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FDA Consumer magazine
VOL. 29 No. 8 OCTOBER 1995


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Features

Getting SMART: Drug Review in the Computer Age
FDA is beginning to launch its drug review process into cyberspace. This
electronic transformation is expected to speed review of new drug
applications.

More People Trying Vegetarian Diets
The desire to reap the benefits of a high-fiber, low-fat diet is just
one of the reasons more people are turning to various types of
vegetarian diets. 

Can Your Kitchen Pass the Food Safety Test?
It takes more than spotless counters and gleaming sinks to make a clean
kitchen. How well do you score on knowing what else is necessary to safe
food preparation?

Breast-Feeding Best Bet for Babies
Breast milk is nutritionally the best food for babies. It also confers
other benefits, such as protecting babies from some illnesses,
strengthening the jaw, and encouraging the growth of straight, healthy
teeth.

Recalls: FDA, Industry Cooperate to Protect Consumers
When a marketed product is found to violate the law, more often than not
it's the company that removes it from the market--or recalls it, in FDA
lingo. This helps the companies, taxpayers and consumers. 


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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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Getting SMART: Drug Review in the Computer Age

by Ken Flieger 

The Food and Drug Administration is in the early stages of launching its
drug review and approval system into cyberspace. This will transform a
process that has traditionally involved laborious hands-on scrutiny of
mountains of paper into a computerized system able to accomplish in an
instant what now might take hours or days or weeks of tedious checking
and rechecking. 

And the system will work not just faster, but better. Electronic data
handling will let agency reviewers of drugs and biological products spot
problems, such as unexpected side effects or subtle variations in drug
metabolism, that might be buried in the millions of bits of information
that tell whether a drug merits approval or rejection. It will allow
rapid comparison of a new investigational drug with other drugs of the
same type or other drugs used to treat the same health problem. The
result: more complete understanding of how a new drug or biological
product works, its benefits, and potential role in health care. 

This electronic transformation in the making is called SMART, Submission
Management and Review Tracking. Full SMART implementation is several
years away, but elements of the plan are already in place and more will
be added in coming months. Some of the foundation blocks for SMART were
in fact laid down more than a decade ago. 

The Paper Chase 

It helps to have a general understanding of how FDA's drug review and
approval process works to grasp what SMART is and what it promises. (See
"From Test Tube to Patient: New Drug Development in the United States,"
an FDA Consumer Special Report published in January 1995.) 

To seek FDA marketing approval for a new drug, the drug's sponsor,
usually a pharmaceutical company, submits a new drug application (NDA)
consisting of voluminous, detailed reports on the drug's properties,
development, manufacture, and testing results. Similar applications are
required for biological products, animal drugs, certain medical devices,
and food additives. 

The drug sponsor provides a summary of this mass of data, but FDA
requires that its reviewing scientists have access to the primary
information on which the NDA is based. Consequently, an NDA comprises
tens of thousands of pages of text, charts, tables, graphs, case
reports, and clinical notes--the complete history of a drug from
discovery and the first studies in animals to advanced clinical testing,
from how it will be manufactured and packaged to how it will be
described and promoted to health professionals and the public. 

This means that paper NDAs don't arrive at FDA in envelopes; they come
in trucks. But over the last decade or so, NDAs have begun to arrive at
FDA on computer tapes and disks. With the agency's encouragement, drug
sponsors now furnish some or all of the information contained in an NDA
in a format that can be read and processed by computer. The companies
also often lend FDA the computer hardware that agency scientists need to
process these computer-assisted new drug applications (CANDAs). At the
end of the review, FDA keeps the computer disks and the sponsor takes
back the hardware. 

CANDAs, and computer-assisted product licensing applications submitted
for vaccines and other biological products, shorten review time by
reducing the need to sift through reams of paper to get the answers to
reviewers' questions. Ordinarily, if a medical reviewer has a question
about a specific patient in a drug trial, the reviewer sends a written
request for the patient's record to the central document room where NDA
files are kept. It could take a day or more to get the information.
Moreover, reviewing scientists often go back to the drug sponsor for
clarification or reworking of statistical data, which can delay the
process for days or weeks. CANDAs eliminate some of this delay. 

Between 1991 and 1994, CANDAs were approved about six months faster than
traditional paper applications--in an average 18.4 months compared with
about 24.6 months. FDA hopes that by the end of this year all new drug
applications will contain data that can be processed by computer. 

The Leap into Cyberspace 

But CANDAs are a far cry from state-of-the-art information technology.
For one thing, each CANDA is a one-of-a-kind production. The sponsor
assembles NDA information, organizes it on computer disks, and literally
wheels the hardware and software into the FDA reviewer's office.
Electronic information handling speeds the review for that specific
drug, but not for any other. The next CANDA to arrive may use a totally
different data processing system employing different hardware and
software. 

It's not unusual in fact for a drug reviewer's office to house several
computer systems, each devoted exclusively to a separate new drug under
review. Until fairly recently, each member of the team reviewing a
computerized application--typically as many as four people--would get a
stand-alone computer system with identical information and specialized
software tailored to work with that specific CANDA. But now local area
computer networks in FDA's Center for Drug Evaluation and Research allow
CANDAs to be stored centrally and shared by all team members. 

Though an exciting step forward, networking--and indeed CANDAs
themselves--barely hint at what will be possible when the drug review
and approval process is reengineered to take full advantage of advanced
information technology. 

When SMART is fully up and running, all marketing applications will be
reviewed using a single, unified data processing system. Agency
reviewers will be able to access the system, retrieve information in
response to specific inquiries, perform statistical and other kinds of
analyses, confer with other reviewers, communicate with drug
sponsors--in short, carry out all the tasks involved in the review
process with greater speed and accuracy than is possible without the aid
of a fully integrated electronic data processing system. 

Drug sponsors won't have to redesign their information systems, some of
which are considered valuable trade secrets by the companies that use
them. Instead, FDA will receive an electronic NDA submission from the
sponsor, ensure its compatibility with SMART, verify that no errors have
occurred in the electronic acceptance, and electronically file the NDA,
allowing agency scientists to begin the review. 

Although details of the system remain to be worked out, it's likely that
each reviewer's desktop computer will have a set of "tools"--computer
programs that allow the reviewer to carry out data searches, create and
manipulate spreadsheets, produce tables and graphs, and even display
pictures of clinical effects, such as wound healing. (See accompanying
article.) 

Eventually, as more and more information about investigational and
approved drugs enters the system, reviewers will be able to compare the
information in a pending NDA with data on other drugs, an enormously
time-consuming task when an NDA consists of scores or hundreds of bound
volumes that can only be cross-checked by hand. 

FDA estimates that reviewers working on paper NDA submissions currently
spend much of their time doing routine clerical work, which lessens the
amount of time they can devote to their primary task--assessing drug
safety and effectiveness. SMART will completely change this pattern,
making much better use of the time and skills of reviewing physicians,
pharmacologists, chemists, microbiologists, statisticians, and other
highly trained scientists. The time saving is, in fact, one of the
primary goals of SMART. 

A Commitment to Do Better 

In 1992 when Congress passed the Prescription Drug User Fee Act, FDA
committed itself to completing action on "standard" drug applications in
12 months and on "priority" applications in six months. Applications for
drugs similar to products already on the market are termed standard;
priority applications are those for drugs believed to offer significant
advances over existing treatments. 

User fees paid by drug and biological product companies help cover the
cost of reviewing new drug and biologic submissions and inspecting
sponsors' testing and manufacturing facilities. Expected to total more
than $325 million by September 1997, user fees enable FDA to speed the
review process by hiring more reviewing scientists and physicians. But
agency managers are also counting on the computerization initiative to
further reduce review times 

A second force driving the SMART program is the trend toward
international harmonization of drug development and regulation. Because
almost all major drug companies operate on a global scale, they
generally support efforts to adopt regulatory systems compatible among
many nations. 

SMART supports a basic framework for information systems standards
usable by regulatory authorities in Japan, Europe, the Western
Hemisphere, and elsewhere. Regulatory requirements will almost certainly
differ from one country to the next, but drug industry officials say
they welcome progress toward a single package of marketing approval
information that would meet the varying needs of multiple regulatory
systems. 

Technical Challenges 

Much of what is needed to bring FDA's product review process fully into
the computer age is already in place--both within and outside the
agency. For example, FDA's drug reviewers are now using personal
computers linked both to local area networks and to the Internet. This
allows them to exchange information with colleagues and use databases
and other computer systems throughout the world. 

At the same time, physicians carrying out clinical trials of
investigational drugs are increasingly recording data, case notes, and
related information via electronic systems linked electronically with
the drug sponsor's computers. Not only does this make data transfer
virtually instantaneous, it also sharply reduces the risk of errors in
writing down and copying patient information. 

SMART is being developed in collaboration with representatives of the
pharmaceutical and other industries and with officials from foreign
regulatory agencies. High on the list of technical challenges is
security of the information. One industry official noted that while
CANDAs don't represent a problem in terms of protecting confidential,
proprietary information about new drugs, the concept of computerized NDA
information moving over telephone lines is cause for concern. There are
ways of ensuring security--encryption programs and dedicated phone
lines, for example--but precisely how this issue will be handled remains
to be decided. 

By the same token, any system for moving massive amounts of data
electronically has to have built-in, highly reliable means to make sure
that the data received is identical to the data sent--that there haven't
been any inadvertent electronic "typos" along the way. FDA planners are
now exploring numerous error-checking systems to determine which will
best meet SMART requirements. 

Finally and perhaps most important, any scheme for assembling,
transmitting and processing product approval submissions to FDA must
ensure patient privacy and anonymity. Individuals who consent to take
part in studies of experimental drugs, biologics, and medical devices
have a right to know that their identity and health records will be kept
in strict confidence. SMART is being designed to do that. 

When fully operational, SMART will save substantial amounts of time and
effort in the product review and approval process. It also promises to
maintain, and very likely elevate, FDA's high standards for gauging
safety and efficacy and for monitoring product performance. Thus, the
ultimate beneficiaries of SMART are the people who rely on the
health-care products FDA regulates. 

Ken Flieger is a writer in Washington, D.C. 
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Think of a Giant Spreadsheet

"When you talk about major areas of review in the center, in almost all
of them you're talking about giant spreadsheets," says Roger Williams,
M.D., associate director of FDA's Center for Drug Evaluation and
Research. As an example, he describes what a spreadsheet on safety data
contained in a new drug application might look like. 

"First you might have a patient's number. Then you would want to have
demographic information about that patient--weight, height, age, sex,
etc. That takes up the first ten columns of the spreadsheet. 

"What's in the next ten columns? Well it might be things like drug dose,
duration of dose, change in dose, cumulative dose, and so forth. Next
you might want to see all the clinical laboratory tests for that
patient--blood count, urinalysis, biochemical assays, etc." After that,
he says, the spreadsheet might show adverse events and other findings
and observations about that patient's experience with the drug. "Pretty
soon you might have a spreadsheet that has a thousand columns in it." 

But, Williams points out, the spreadsheet couldn't have just one row per
patient. "A patient may come in for a hundred visits during the clinical
investigation. So now you've got a hundred rows each having a thousand
columns, a hundred thousand cells of information to describe one
patient." 

It's not unusual for an investigational drug to be studied in 3,000
patients, which means that a single NDA may have 300 million cells of
information on safety data alone. There could be equally big data sets
for efficacy, pharmacology, preclinical studies, chemistry,
manufacturing--all the elements that make up a typical new drug
application. 

"That sounds overwhelming, and I think it is," says Williams. "But
that's where the wonders of computers come in. They give us a way to get
a handle on these massive data sets. The computer is an incredible
tool," he says, for the staggering job FDA has to do to decide whether
or not a new drug belongs on the American market. 

--K.F.

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More People Trying Vegetarian Diets

by Dixie Farley 

Perceiving plant foods as beneficial because they are high in dietary
fiber and, generally, lower in saturated fat than animal foods, many
people turn to vegetarian diets. 

Grain products, for instance, form the base of the U.S. Department of
Agriculture and Department of Health and Human Services' Food Guide
Pyramid, which recommends 6 to 11 daily servings of bread, cereal, rice,
and pasta. Daily intakes advised for other foods are: 3 to 5 servings of
vegetables; 2 to 4 servings of fruits; 2 to 3 servings of milk, yogurt
and cheese; and 2 to 3 servings of meat, poultry, fish, dry beans, eggs,
and nuts. The guide advises using fats, oils and sweets sparingly. 

And, who hasn't seen signs in their grocer's produce section urging
consumers to eat "5 a day for better health"? This slogan reflects a
major government-industry campaign to help people eat more fruits and
vegetables as part of a high-fiber, low-fat diet that emphasizes
variety. 

The campaign is consistent with the USDA-DHHS Dietary Guidelines for
Americans, which states: "Many American diets have too many calories and
too much fat (especially saturated fat), cholesterol, and sodium. They
also have too little complex carbohydrates and fiber. Such diets are one
cause of America's high rates of obesity and of certain diseases--heart
disease, high blood pressure, stroke, diabetes, and some forms of
cancer." 

But health benefits are not the only reason vegetarian diets attract
followers. 

Certain people, such as Seventh-Day Adventists, choose a vegetarian diet
because of religious beliefs. Others give up meat because they feel
eating animals is unethical. Some believe it's a better use of the
Earth's resources to eat low on the food chain--that is, to eat plant
foods, rather than the animals that eat the plant foods. And many people
eat plant foods simply because they are less expensive than animal
foods. 

It's wise to take precautions, however, when adopting a diet that
entirely excludes animal flesh and dairy products, called a vegan diet.
(See "Vegetarian Varieties.") 

"The more you restrict your diet, the more difficult it is to get the
nutrients you need," says John Vanderveen, Ph.D., director of the Food
and Drug Administration's Office of Plant and Dairy Foods and Beverages.
"To be healthful, vegetarian diets require very careful, proper
planning. Nutrition counseling can help you get started on a diet that
is nutritionally adequate." 

If appropriately planned, vegan diets, though restrictive, can provide
adequate nutrition even for children, according to the American Dietetic
Association and the Institute of Food Technologists. 

Plant Food Benefits 

Registered dietitian Johanna Dwyer, of Tufts University Medical School
and the New England Medical Center Hospital, Boston, summarizes these
plant food benefits: 

"Data are strong that vegetarians are at lesser risk for obesity, atonic
[reduced muscle tone] constipation, lung cancer, and alcoholism.
Evidence is good that risks for hypertension, coronary artery disease,
type II diabetes, and gallstones are lower. Data are only fair to poor
that risks of breast cancer, diverticular disease of the colon, colonic
cancer, calcium kidney stones, osteoporosis, dental erosion, and dental
caries are lower among vegetarians." 

According to Dwyer, vegetarians' longevity is similar to or greater than
that of non-vegetarians, but is influenced in Western countries by
vegetarians' "adoption of many healthy lifestyle habits in addition to
diet, such as not smoking, abstinence or moderation in the use of
alcohol, being physically active, resting adequately, seeking ongoing
health surveillance, and seeking guidance when health problems arise." 

Can Veggies Prevent Cancer? 

The National Cancer Institute, in its booklet Diet, Nutrition, & Cancer
Prevention: A Guide to Food Choices, states that 35 percent of cancer
deaths may be related to diet. The booklet states: 

 * Diets rich in beta-carotene (the plant form of vitamin A) and vitamin C
   may reduce the risk of certain cancers.
 * Reducing fat in the diet may
   reduce cancer risk and, in helping weight control, may reduce the risk
   of heart attacks and strokes.
 * Diets high in fiber-rich foods may reduce
   the risk of cancers of the colon and rectum.
 * Vegetables from thecabbage family (cruciferous vegetables) may reduce
   the risk of colon cancer.

FDA, in fact, authorized several health claims on food labels relating
low-fat diets high in some plant-derived foods with a possibly reduced
risk of cancer. 

While FDA acknowledges that high intakes of fruits and vegetables rich
in beta-carotene or vitamin C have been associated with reduced cancer
risk, it believes the data are not sufficiently convincing that either
nutrient by itself is responsible for the association. Nevertheless,
since most fruits and vegetables are low-fat foods and may contain
vitamin A (as beta-carotene) and vitamin C, the agency authorized a
health claim relating diets low in fat and rich in these foods to a
possibly reduced risk of some cancers. 

Another claim may relate low-fat diets high in fiber-containing
vegetables, fruits and grains to a possible reduction in cancer risk.
(The National Cancer Institute recommends 20 to 30 grams of fiber a
day.) Although the exact role of total dietary fiber, fiber components,
and other nutrients and substances in these foods is not fully
understood, many studies have shown such diets to be associated with
reduced risk of some cancers. 

Lowering Heart Disease Risk 

FDA also notes that diets high in saturated fats and cholesterol
increase blood levels of total cholesterol and LDL cholesterol, and thus
the risk for coronary heart disease. (The National Cholesterol Education
Program recommends a diet with no more than 30 percent fat, of which no
more than 10 percent comes from saturated fat.) For this reason, the
agency authorized a health claim relating diets low in saturated fat and
cholesterol to a possibly reduced risk of coronary heart disease. 

Another claim may relate diets low in fat and high in fruits,
vegetables, and grain products that contain fiber, particularly soluble
fiber, to a possibly reduced risk of coronary heart disease. However,
the agency recognizes that it is impossible to adequately distinguish
the effects of fiber, including soluble fiber, from those of other food
components. 

With respect to increasing fiber in the diet, Joanne Slavin, Ph.D.,
R.D., of the University of Minnesota, in 1990 in Nutrition Today, gives
this advice: "The current interest in dietary fiber has allowed
recommendations for fiber supplementation to outdistance the scientific
research base. Until we have a better understanding of how fiber works
its magic, we should recommend to American consumers only a gradual
increase in dietary fiber from a variety of sources." 

Precautions 

The American Dietetic Association's position paper on vegetarian diets
states, "Because vegan diets tend to be high in bulk, care should be
taken to ensure that caloric intakes are sufficient to meet energy
needs, particularly in infancy and during weaning." Dwyer and Suzanne
Havala, also a registered dietitian, updated the paper in the 1993 issue
of the association's journal. 

It's generally agreed that to avoid intestinal discomfort from increased
bulk, a person shouldn't switch to foods with large amounts of fiber all
at once. A sensible approach is to slowly increase consumption of
grains, legumes, seeds, and nuts. "Some may choose to eliminate red meat
but continue to eat fish and poultry occasionally, and such a diet is
also to be encouraged," Jack Zeev Yetiv, M.D., Ph.D., in his book
Popular Nutritional Practices: A Scientific Appraisal. 

As with any diet, it's important for the vegetarian diet to include many
different foods, since no one food contains all the nutrients required
for good health. "The wider the variety, the greater the chance of
getting the nutrients you need," says FDA's Vanderveen. 

In its position paper on vegetarian diets, the American Dietetic
Association states that, with a plant-based daily diet, eating a variety
of foods and sufficient calories for energy needs will help ensure
adequate intakes of calcium, iron and zinc. (See "Replacing Animal
Sources of Nutrients.") 

The mixture of proteins from grains, legumes, seeds, nuts, and
vegetables provides a complement of amino acids so that deficits in one
food are made up by another. Not all types of plant foods need to be
eaten at the same meal, since the amino acids are combined in the body's
protein pool. 

"Soy protein," the paper states, "has been shown to be nutritionally
equivalent in protein value to proteins of animal origin and, thus, can
serve as the sole source of protein intake if desired." 

The Institute of Food Technologists also recommends careful diet
planning for vegetarians. This is especially important when the diet
excludes dairy foods, to ensure adequate intake of calcium, iron,
riboflavin, and vitamin D. For these vegetarians, the institute
recommends calcium supplements during pregnancy, when breast-feeding,
and for infants and children. 

The institute and the American Dietetic Association say a vitamin D
supplement may be needed if sunlight exposure is limited. (Sunlight
activates a substance in the skin and converts it into vitamin D.) 

They also point out that vegan diets should include a reliable source of
vitamin B12 (see "Replacing Animal Sources of Nutrients"), because this
nutrient occurs only in animal foods. Vitamin B12 deficiency can result
in irreversible nerve deterioration. 

The need for vitamin B12 increases during pregnancy, breast-feeding, and
periods of growth, Dwyer says. In a recent issue of Annual Review of
Public Health, she writes that elderly people also should be especially
cautious about adopting vegetarian diets because their bodies may absorb
vitamin B12 poorly. 

Unless advised otherwise by a doctor, those taking dietary supplements
should limit the dose to 100 percent of the U.S. Recommended Daily
Allowances. 

With the array of fruits, vegetables, grains, and spices available in
U.S. grocery stores and the availability of vegetarian cookbooks, it's
easy to devise tasty vegetarian dishes that even non-vegetarians can
enjoy. 

However, the key to any healthful diet--vegetarian or non-vegetarian--is
adherence to sound nutrition principles. 

Dixie Farley is a staff writer for FDA Consumer.
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Vegetarian Varieties

The American Dietetic Association describes three types of vegetarians.
They are listed here by the extent to which the diet includes animal
foods: 


 * lacto-ovo-vegetarian--dairy foods and eggs
 * lacto-vegetarian--dairy foods, but no eggs
 * vegan--no animal foods of any type


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Replacing Animal Sources of Nutrients

Vegetarians who eat no animal products need to be more aware of nutrient
sources. Nutrients most likely to be lacking and some non-animal sources
are: 


 * vitamin B12--fortified soy beverages and cereals

 * vitamin D--fortified soy beverages and sunshine

 * calcium--tofu processed with calcium, broccoli, seeds, nuts, kale,
   bok choy, legumes (peas and beans), greens, lime-processed tortillas,
   and soy beverages, grain products, and orange juice enriched with
   calcium

 * iron--legumes, tofu, green leafy vegetables, dried fruit, whole
   grains, and iron-fortified cereals and breads, especially whole-wheat.
   (Absorption is improved by vitamin C, found in citrus fruits and
   juices, tomatoes, strawberries, broccoli, peppers, dark-green leafy
   vegetables, and potatoes with skins.)

 * zinc--whole grains (especially the germ and bran), whole-wheat bread,
   legumes, nuts, and tofu

 * protein--tofu and other soy-based products, legumes, seeds, nuts,
   grains, and vegetables



--D.F. 
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American Dietetic Association Recommendations

For people who follow vegetarian diets, the American Dietetic
Association has these recommendations: 


 * Consult a registered dietitian or other qualified nutrition
   professional, especially during periods of growth, breast-feeding,
   pregnancy, or recovery from illness.

 * Minimize intake of less nutritious foods such as sweets and fatty foods.

 * Choose whole or unrefined grain products instead of refined products.

 * Choose a variety of nuts, seeds, legumes, fruits, and vegetables,
   including good sources of vitamin C to improve iron absorption.

 * Choose low-fat or nonfat varieties of dairy products, if they are
   included in the diet.

 * Avoid excessive cholesterol intake by limiting eggs, if they are
   included in the diet, to three or four egg yolks per week.

 * For infants, children and teenagers, ensure adequate intakes of
   calories, vitamin D, calcium, iron, and zinc. (Intakes of vitamin D,
   calcium, iron, and zinc are usually adequate when a variety of foods and
   sufficient calories are consumed.)

 * If exclusively breast-feeding premature infants or babies beyond 4 to
   6 months of age, give vitamin and iron supplements to the child from
   birth or at least by 4 to 6 months, as your doctor suggests.

 * Usually, take iron and folate (folic acid) supplements during pregnancy.

 In addition, for vegans:

 * Use properly fortified food sources of vitamin B12, such as fortified
   soy beverages or cereals, or take a supplement.

 * If sunlight is inadequate, take a vitamin D supplement during
   pregnancy or while breast-feeding.

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


Can Your Kitchen Pass the Food Safety Test?

by Paula Kurtzweil

What comes to mind when you think of a clean kitchen? Shiny waxed
floors? Gleaming stainless steel sinks? Spotless counters and neatly
arranged cupboards?

They can help, but a truly "clean" kitchen--that is, one that ensures
safe food--relies on more than just looks: It also depends on safe food
practices.

In the home, food safety concerns revolve around three main functions:
food storage, food handling, and cooking. To see how well you're doing
in each, take this quiz, and then read on to learn how you can make the
meals and snacks from your kitchen the safest possible.



Quiz

Choose the answer that best describes the practice in your household,
whether or not you are the primary food handler.

1. The temperature of the refrigerator in my home is:

a. 50 degrees Fahrenheit (10 degrees Celsius)
b. 40 F (4 C)
c. I don't know; I've never measured it.

2. The last time we had leftover cooked stew or other food with meat,
chicken or fish, the food was:

a. cooled to room temperature, then put in the refrigerator
b. put in the refrigerator immediately after the food was served
c. left at room temperature overnight or longer 

3. The last time the kitchen sink drain, disposal and connecting pipe in
my home were sanitized was:

a. last night
b. several weeks ago
c. can't remember

4. If a cutting board is used in my home to cut raw meat, poultry or
fish and it is going to be used to chop another food, the board is:

a. reused as is
b. wiped with a damp cloth
c. washed with soap and hot water and sanitized with a mild chlorine
   bleach solution

5. The last time we had hamburgers in my home, I ate mine:

a. rare
b. medium
c. well-done

6. The last time there was cookie dough in my home, the dough was:

a. made with raw eggs, and I sampled some of it
b. store-bought, and I sampled some of it
c. not sampled until baked

7. I clean my kitchen counters and other surfaces that come in contact
with food with:

a. water 
b. hot water and soap
c. hot water and soap, then bleach solution
d. hot water and soap, then commercial sanitizing agent

8. When dishes are washed in my home, they are:

a. cleaned by an automatic dishwasher and then air-dried
b. left to soak in the sink for several hours and then washed with soap
   in the same water
c. washed right away with hot water and soap in the sink and then air-dried
d. washed right away with hot water and soap in the sink and immediately
   towel-dried

9. The last time I handled raw meat, poultry or fish, I cleaned my hands
afterwards by:

a. wiping them on a towel
b. rinsing them under hot, cold or warm tap water
c. washing with soap and warm water

10. Meat, poultry and fish products are defrosted in my home by:
a. setting them on the counter 
b. placing them in the refrigerator
c. microwaving


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Answers

1. Refrigerators should stay at 40 F (4 C) or less, so if you chose
answer B, give yourself two points. If you didn't, you're not alone.
According to Joseph Madden, Ph.D., strategic manager for microbiology in
the Food and Drug Administration's Center for Food Safety and Applied
Nutrition, many people overlook the importance of maintaining an
appropriate refrigerator temperature.

"According to surveys, in many households, the refrigerator temperature
is above 50 degrees (10 C)," he said.

His advice: Measure the temperature with a thermometer and, if needed,
adjust the refrigerator's temperature control dial.

A temperature of 40 F (4 C) or less is important because it slows the
growth of most bacteria. The temperature won't kill the bacteria, but it
will keep them from multiplying, and the fewer there are, the less
likely you are to get sick from them. 

Freezing at zero F (minus 18 C) or less stops bacterial growth (although
it won't kill bacteria already present).

2. Answer B is the best practice; give yourself two points if you picked
it.

Hot foods should be refrigerated as soon as possible within two hours
after cooking. But don't keep the food if it's been standing out for
more than two hours. Don't taste test it, either. Even a small amount of
contaminated food can cause illness.

Date leftovers so they can be used within a safe time. Generally, they
remain safe when refrigerated for three to five days. If in doubt, throw
it out, says FDA microbiologist Jeffery Rhodehamel. "It's not worth a
food-borne illness for the small amount of food usually involved."

3. If answer A best describes your household's practice, give yourself
two points. Give yourself one point if you chose B. 

According to FDA's Madden, the kitchen sink drain, disposal and
connecting pipe are often overlooked, but they should be sanitized
periodically by pouring down the sink a solution of 1 teaspoon (5
milliliters) of chlorine bleach in 1 quart (about 1 liter) of water or a
solution of commercial kitchen cleaning agent made according to product
directions. Food particles get trapped in the drain and disposal and,
along with the moistness, create an ideal environment for bacterial
growth.

4. If answer C best describes your household's practice, give yourself
two points. Washing with soap and hot water and then sanitizing with a
mild bleach solution is the safest practice, said Dhirendra Shah, Ph.D.,
director of the division of microbiological studies in FDA's Center for
Food Safety and Applied Nutrition.

If you picked A, you're violating an important food safety rule: Never
allow raw meat, poultry and fish to come in contact with other foods.
Answer B isn't good, either. Improper washing, such as with a damp
cloth, will not remove bacteria.

5. Give yourself two points if you picked answer C.

The safest way to eat hamburgers is to cook them until they are no
longer red in the middle and the juices run clear. That doesn't happen
with rare-cooked meats, and it may not happen with medium-cooked ones.
Cooking food, including ground meat patties, to an internal temperature
of at least 160 F (71 C) usually protects against food-borne illness.
Well-done meats reach that temperature.

To be on the safe side, check cooked meat, fish and poultry with a meat
thermometer to ensure that they have reached a safe internal
temperature.

For microwaved food, follow directions, including the standing time,
either in or out of the microwave, after cooking. Microwave cooking
creates pockets of heat in the food, but allowing the food to stand
before eating allows the heat to spread to the rest of the food.

6. If you answered A, you may be putting yourself at risk for infection
with Salmonella enteritidis, a bacterium that can get into shell eggs.
Cooking the egg or egg-containing food product to at least 140 F (60 C)
kills the bacteria. So answer C--eating the baked product--will earn you
two points.

You'll get two points for answer B, also. Foods containing raw eggs,
such as homemade ice cream, cake batter, mayonnaise, and eggnog, carry a
Salmonella risk, but their commercial counterparts don't. Commercial
products are made with pasteurized eggs; that is, eggs that have been
heated sufficiently to kill bacteria, and also may contain an acidifying
agent that kills the bacteria. Commercial preparations of cookie dough
are not a food hazard. 

If you want to sample homemade dough or batter or eat other foods with
raw-egg-containing products, consider substituting pasteurized eggs for
raw eggs. Pasteurized eggs are usually sold in the grocer's refrigerated
dairy case.

7. Answers C or D will earn you two points each; answer B, one point.
According to FDA's Madden, bleach and commercial kitchen cleaning agents
are the best sanitizers--provided they're diluted according to product
directions. They're the most effective at getting rid of bacteria. Hot
water and soap does a good job, too, but may not kill all strains of
bacteria. Water may get rid of visible dirt, but not bacteria.

Also, be sure to keep dishcloths and sponges clean because, when wet,
these materials harbor bacteria and may promote their growth.

8. Answers A and C are worth two points each. There are potential
problems with B and D. When you let dishes sit in water for a long time,
it "creates a soup," FDA's Madden said. "The food left on the dish
contributes nutrients for bacteria, so the bacteria will multiply." When
washing dishes by hand, he said, it's best to wash them all within two
hours. Also, it's best to air-dry them so you don't handle them while
they're wet.

9. The only correct practice is answer C. Give yourself two points if
you picked it.

Wash hands with warm water and soap for at least 20 seconds before and
after handling food, especially raw meat, poultry and fish. If you have
an infection or cut on your hands, wear rubber or plastic gloves. Wash
gloved hands just as often as bare hands because the gloves can pick up
bacteria. (However, when washing gloved hands, you don't need to take
off your gloves and wash your bare hands, too.)

10. Give yourself two points if you picked B or C. Food safety experts
recommend thawing foods in the refrigerator or the microwave oven or
putting the package in a water-tight plastic bag submerged in cold water
and changing the water every 30 minutes. Changing the water ensures that
the food is kept cold, an important factor for slowing bacterial growth
that may occur on the outer thawed portions while the inner areas are
still thawing.

When microwaving, follow package directions. Leave about 2 inches (about
5 centimeters) between the food and the inside surface of the microwave
to allow heat to circulate. Smaller items will defrost more evenly than
larger pieces of food. Foods defrosted in the microwave oven should be
cooked immediately after thawing.

Do not thaw meat, poultry and fish products on the counter or in the
sink without cold water; bacteria can multiply rapidly at room
temperature.



Rating Your Home's Food Practices

20 points: Feel confident about the safety of foods served in your home.



12 to 19 points: Reexamine food safety practices in your home. Some key
rules are being violated.



11 points or below: Take steps immediately to correct food handling,
storage and cooking techniques used in your home. Current practices are
putting you and other members of your household in danger of food-borne
illness.

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


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


Home-Based Food-Borne Illness

When several members of a household come down with sudden, severe
diarrhea and vomiting, intestinal flu is often considered the likely
culprit. But food poisoning may be another consideration.

A true diagnosis is often never made because the ill people recover
without having to see a doctor.

Health experts believe this is a common situation in households across
the country, and because a doctor is often not seen for this kind of
illness, the incidence of food-borne illness is not really known.

A task force of the Council for Agricultural Science and Technology, a
private organization of food science groups, estimated in 1994 that 6.5
million to 33 million cases of food-borne illness occur in the United
States each year. While many reported cases stem from food prepared by
commercial or institutional establishments, sporadic cases and small
outbreaks in homes are considered to be far more common, according to
the April 1995 issue of Food Technology.

Cases of home-based food-borne illness may become a bigger problem, some
food safety experts say, partly because today's busy family may not be
as familiar with food safety issues as more home-focused families of
past generations.

A 1993 FDA survey found that men respondents tended to be less safe
about food practices than women respondents and that respondents younger
than 40 tended to be less safe than those over 40.

For example, when asked if they believed that cooked food left at room
temperature overnight is safe to eat without reheating--a very unsafe
practice--12 percent of the men respondents (but only 5 percent of the
women respondents) said yes.

And, in looking at age differences, the survey found that nearly 40
percent of respondents younger than 40 indicated they did not adequately
wash cutting boards, while only 25 percent of those 60 and over
indicated the same.

The increased use of convenience foods, which often are preserved with
special chemicals and processes, also complicates today's home food
safety practices, said Joseph Madden, Ph.D., strategic manager for
microbiology in FDA's Center for Food Safety and Applied Nutrition.
These foods, such as TV dinners, which are specially preserved, give
consumers a false idea that equivalent home-cooked foods are equally
safe, he said. 

To curb the problem, food safety experts recommend food safety education
that emphasizes the principles of HACCP (Hazard Analysis Critical
Control Point), a new food safety procedure that many food companies are
now incorporating into their manufacturing processes. Unlike past
practices, HACCP focuses on preventing food-borne hazards, such as
microbial contamination, by identifying points at which hazardous
materials can be introduced into the food and then monitoring these
potential problem areas. (See HACCP: Patrolling for Food Hazards in the
January-February 1995 FDA Consumer.) 

"It's mainly taking a common-sense approach towards food safety in the
home," said FDA microbiologist Jeffery Rhodehamel. 

"Basically, consumers need to make sure they're not defeating the system
by contaminating the product."

--P.K.
------------------------------------------------------------------------


More Information

FDA's Office of Consumer Affairs
HFE-88
Rockville, MD 20857


FDA Seafood Hotline
(1-800) FDA-4010
(202) 205-4314 in the Washington, D.C., area
24 hours a day


USDA's Meat and Poultry Hotline
(1-800) 535-4555
(202) 720-3333 in the Washington, D.C., area
Recorded messages available 24 hours a day. Home economists and registered dietitians available 10 a.m. to 4 p.m. Eastern time, Monday through Friday.


Also check with:

 * your supermarket or its consumer affairs department
 * your local county extension home economist
 * local health departments
 * food manufacturers


Food safety educators may contact:

Foodborne Illness Education Information Center
Food and Nutrition Information Center
National Agricultural Library/USDA
Beltsville, MD 20705-2351
Facsimile (301) 504-6409
E-mail: croberts@nalusda.gov
World Wide Web site: http://www.nalusda.gov/fnic.html


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


Other Kitchen Contaminants


Lead

Lead leached from some types of ceramic dinnerware into foods and
beverages is often consumers' biggest source of dietary lead, says John
Jones, Ph.D., strategic manager for pesticides and chemical contaminants
in FDA's Center for Food Safety and Applied Nutrition. (See "Lead Threat
Lessens, But Mugs Pose Problem" in the April 1993 FDA Consumer and "An
Unwanted Souvenir: Lead in Ceramic Ware" in the December 1989-January
1990 FDA Consumer.) Here are some tips to reduce your exposure:

 * Don't store acidic foods, such as fruit juices, in ceramic containers.

 * Avoid or limit to special occasions the use of antique or collectible
   housewares for food and beverages.

 * Follow label directions on ornamental ceramic products labeled "Not
   for Food Use--May Poison Food" or "For Decorative Purposes Only," and
   don't use these items for preparing or storing food.

Also, don't store beverages in lead crystal containers for extended
periods.


Microwave Packaging

High temperature use of some microwave food packaging material may cause
packaging components, such as paper, adhesives and polymers, to migrate
into food at excessive levels. For that reason, choose only
microwave-safe cooking containers. Never use packaging cartons for
cooking unless the package directs you to do so. (See "Keeping Up with
the Microwave Revolution" in the March 1990 FDA Consumer.)


Aluminum

According to FDA's Jones, there has been speculation linking aluminum to
Alzheimer's disease. The link has never been proved, he said, but if
consumers are concerned, they should avoid cooking acidic foods, such as
tomato sauce, in aluminum pans. For other uses, well-maintained aluminum
pans--as well as stainless steel, copper and iron pots and pans--present
no apparent hazards.


Insect and Rodent Droppings, and Dirt

 * Avoid storing food in cabinets that are under the sink or have water,
   drain and heating pipes passing through them. Food stored here can
   attract insects and rodents through openings that are difficult to seal
   adequately.

 * Wash the tops of cans with soap and water before opening.

--P.K

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

Breast-Feeding Best Bet for Babies

by Rebecca D. Williams

New parents want to give their babies the very best. When it comes to
nutrition, the best first food for babies is breast milk.

More than two decades of research have established that breast milk is
perfectly suited to nourish infants and protect them from illness.
Breast-fed infants have lower rates of hospital admissions, ear
infections, diarrhea, rashes, allergies, and other medical problems than
bottle-fed babies.

"There are 4,000 species of mammals, and they all make a different milk.
Human milk is made for human infants and it meets all their specific
nutrient needs," says Ruth Lawrence, M.D., professor of pediatrics and
obstetrics at the University of Rochester School of Medicine in
Rochester, N.Y., and spokeswoman for the American Academy of Pediatrics.

The academy recommends that babies be breast-fed for six to 12 months.
The only acceptable alternative to breast milk is infant formula. Solid
foods can be introduced when the baby is 4 to 6 months old, but a baby
should drink breast milk or formula, not cow's milk, for a full year.

"There aren't any rules about when to stop breast-feeding," says
Lawrence. "As long as the baby is eating age-appropriate solid foods, a
mother may nurse a couple of years if she wishes. A baby needs breast
milk for the first year of life, and then as long as desired after
that." 

In 1993, 55.9 percent of American mothers breast-fed their babies in the
hospital. Only 19 percent were still breast-feeding when their babies
were 6 months old. Government and private health experts are working to
raise those numbers. 

The U.S. Food and Drug Administration is conducting a study on infant
feeding practices as part of its ongoing goal to improve nutrition in
the United States. The study is looking at how long mothers breast-feed
and how they introduce formula or other foods. 

Health experts say increased breast-feeding rates would save consumers
money, spent both on infant formula and in health-care dollars. It could
save lives as well.

"We've known for years that the death rates in Third World countries are
lower among breast-fed babies," says Lawrence. "Breast-fed babies are
healthier and have fewer infections than formula-fed babies."

Human Milk for Human Infants 

The primary benefit of breast milk is nutritional. Human milk contains
just the right amount of fatty acids, lactose, water, and amino acids
for human digestion, brain development, and growth. 

Cow's milk contains a different type of protein than breast milk. This
is good for calves, but human infants can have difficulty digesting it.
Bottle-fed infants tend to be fatter than breast-fed infants, but not
necessarily healthier.

Breast-fed babies have fewer illnesses because human milk transfers to
the infant a mother's antibodies to disease. About 80 percent of the
cells in breast milk are macrophages, cells that kill bacteria, fungi
and viruses. Breast-fed babies are protected, in varying degrees, from a
number of illnesses, including pneumonia, botulism, bronchitis,
staphylococcal infections, influenza, ear infections, and German
measles. Furthermore, mothers produce antibodies to whatever disease is
present in their environment, making their milk custom-designed to fight
the diseases their babies are exposed to as well.

A breast-fed baby's digestive tract contains large amounts of
Lactobacillus bifidus, beneficial bacteria that prevent the growth of
harmful organisms. Human milk straight from the breast is always
sterile, never contaminated by polluted water or dirty bottles, which
can also lead to diarrhea in the infant. 

Human milk contains at least 100 ingredients not found in formula. No
babies are allergic to their mother's milk, although they may have a
reaction to something the mother eats. If she eliminates it from her
diet, the problem resolves itself.

Sucking at the breast promotes good jaw development as well. It's harder
work to get milk out of a breast than a bottle, and the exercise
strengthens the jaws and encourages the growth of straight, healthy
teeth. The baby at the breast also can control the flow of milk by
sucking and stopping. With a bottle, the baby must constantly suck or
react to the pressure of the nipple placed in the mouth.

Nursing may have psychological benefits for the infant as well, creating
an early attachment between mother and child. At birth, infants see only
12 to 15 inches, the distance between a nursing baby and its mother's
face. Studies have found that infants as young as 1 week prefer the
smell of their own mother's milk. When nursing pads soaked with breast
milk are placed in their cribs, they turn their faces toward the one
that smells familiar. 

Many psychologists believe the nursing baby enjoys a sense of security
from the warmth and presence of the mother, especially when there's
skin-to-skin contact during feeding. Parents of bottle-fed babies may be
tempted to prop bottles in the baby's mouth, with no human contact
during feeding. But a nursing mother must cuddle her infant closely many
times during the day. Nursing becomes more than a way to feed a baby;
it's a source of warmth and comfort. 

Benefits to Mothers

Breast-feeding is good for new mothers as well as for their babies.
There are no bottles to sterilize and no formula to buy, measure and
mix. It may be easier for a nursing mother to lose the pounds of
pregnancy as well, since nursing uses up extra calories. Lactation also
stimulates the uterus to contract back to its original size. 

A nursing mother is forced to get needed rest. She must sit down, put
her feet up,and relax every few hours to nurse. Nursing at night is easy
as well. No one has to stumble to the refrigerator for a bottle and warm
it while the baby cries. If she's lying down, a mother can doze while
she nurses. 

Nursing is also nature's contraceptive--although not a very reliable
one. Frequent nursing suppresses ovulation, making it less likely for a
nursing mother to menstruate, ovulate, or get pregnant. There are no
guarantees, however. Mothers who don't want more children right away
should use contraception even while nursing. Hormone injections and
implants are safe during nursing, as are all barrier methods of birth
control. The labeling on birth control pills says if possible another
form of contraception should be used until the baby is weaned. 

Breast-feeding is economical also. Even though a nursing mother works up
a big appetite and consumes extra calories, the extra food for her is
less expensive than buying formula for the baby. Nursing saves money
while providing the best nourishment possible.

When Formula's Necessary 

There are very few medical reasons why a mother shouldn't breast-feed,
according to Lawrence. 

Most common illnesses, such as colds, flu, skin infections, or diarrhea,
cannot be passed through breast milk. In fact, if a mother has an
illness, her breast milk will contain antibodies to it that will help
protect her baby from those same illnesses.

A few viruses can pass through breast milk, however. HIV, the virus that
causes AIDS, is one of them. Women who are HIV positive should not
breast-feed. 

A few other illnesses--such as herpes, hepatitis, and beta streptococcus
infections--can also be transmitted through breast milk. But that
doesn't always mean a mother with those diseases shouldn't breast-feed,
Lawrence says.

"Each case must be evaluated on an individual basis with the woman's
doctor," she says. 

Breast cancer is not passed through breast milk. Women who have had
breast cancer can usually breast-feed from the unaffected breast. There
is some concern that the hormones produced during pregnancy and
lactation may trigger a recurrence of cancer, but so far this has not
been proven. Studies have shown, however, that breast-feeding a child
reduces a woman's chance of developing breast cancer later.

Silicone breast implants usually do not interfere with a woman's ability
to nurse, but if the implants leak, there is some concern that the
silicone may harm the baby. Some small studies have suggested a link
between breast-feeding with implants and later development of problems
with the child's esophagus. Further studies are needed in this area. But
if a woman with implants wants to breast-feed, she should first discuss
the potential benefits and risks with her child's doctor.

Possible Problems

For all its health benefits, breast-feeding does have some
disadvantages. In the early weeks, it can be painful. A woman's nipples
may become sore or cracked. She may experience engorgement more than a
bottle-feeding mother, when the breasts become so full of milk they're
hard and painful. Some nursing women also develop clogged milk ducts,
which can lead to mastitis, a painful infection of the breast. While
most nursing problems can be solved with home remedies, mastitis
requires prompt medical care (see accompanying article).

Another possible disadvantage of nursing is that it affects a woman's
entire lifestyle. A nursing mother with baby-in-tow must wear clothes
that enable her to nurse anywhere, or she'll have to find a private
place to undress. She should eat a balanced diet and she might need to
avoid foods that irritate the baby. She also shouldn't smoke, which can
cause vomiting, diarrhea and restlessness in the baby, as well as
decreased milk production. 

Women who plan to go back to work soon after birth will have to plan
carefully if they want to breast-feed. If her job allows, a new mother
can pump her breast milk several times during the day and refrigerate or
freeze it for the baby to take in a bottle later. Or, some women
alternate nursing at night and on weekends with daytime bottles of
formula. 

In either case, a nursing mother is physically tied to her baby more
than a bottle-feeding mother. The baby needs her for nourishment, and
she needs to nurse regularly to avoid getting uncomfortably full
breasts. But instead of feeling it's a chore, nursing mothers often cite
this close relationship as one of the greatest joys of nursing. Besides,
nursing mothers can get away between feedings if they need a break. 

Finally, some women just don't feel comfortable with the idea of
nursing. They don't want to handle their breasts, or they want to think
of them as sexual, not functional. They may be concerned about modesty
and the possibility of having to nurse in public. They may want a break
from child care to let someone else feed the baby, especially in the wee
hours of the morning. 

If a woman is unsure whether she wants to nurse, she can try it for a
few weeks and switch if she doesn't like it. It's very difficult to
switch to breast-feeding after bottle-feeding is begun.

If she plans to breast-feed, a new mother should learn as much as
possible about it before the baby is born. Obstetricians, pediatricians,
childbirth instructors, nurses, and midwives can all offer information
about nursing. But perhaps the best ongoing support for a nursing mother
is someone who has successfully nursed a baby. 

La Leche League, a national support organization for nursing mothers,
has chapters in many cities that meet regularly to discuss
breast-feeding problems and offer support. 

"We encourage mothers to come to La Leche League before their babies are
born," says Mary Lofton, a league spokeswoman. "On-the-job training is
hard to do. It's so important to learn how to breast-feed beforehand to
avoid problems." 

Most La Leche League chapters allow women to come to a few meetings
without charge. League leaders offer advice by phone as well. To find a
convenient La Leche League chapter, call (1-800) LA-LECHE.

Rebecca D. Williams is a writer in Oak Ridge, Tenn.


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


Tips for Breast-Feeding Success

It's helpful for a woman who wants to breast-feed to learn as much about
it as possible before delivery, while she is not exhausted from caring
for an infant around-the-clock. The following tips can help foster
successful nursing: 

 * Get an early start: Nursing should begin within an hour after
   delivery if possible, when an infant is awake and the sucking
   instinct is strong. Even though the mother won't be producing milk
   yet, her breasts contain colostrum, a thin fluid that contains
   antibodies to disease.

 * Proper positioning: The baby's mouth should be wide open, with the
   nipple as far back into his or her mouth as possible. This minimizes
   soreness for the mother. A nurse, midwife, or other knowledgeable
   person can help her find a comfortable nursing position.

 * Nurse on demand: Newborns need to nurse frequently, at least every
   two hours, and not on any strict schedule. This will stimulate the
   mother's breasts to produce plenty of milk. Later, the baby can
   settle into a more predictable routine. But because breast milk is
   more easily digested than formula, breast-fed babies often eat more
   frequently than bottle-fed babies.

 * No supplements: Nursing babies don't need sugar water or formula
   supplements. These may interfere with their appetite for nursing,
   which can lead to a diminished milk supply. The more the baby nurses,
   the more milk the mother will produce.

 * Delay artificial nipples: It's best to wait a week or two before
   introducing a pacifier, so that the baby doesn't get confused.
   Artificial nipples require a different sucking action than real ones.
   Sucking at a bottle could also confuse some babies in the early days.
   They, too, are learning how to breast-feed.

 * Air dry: In the early postpartum period or until her nipples toughen,
   the mother should air dry them after each nursing to prevent them
   from cracking, which can lead to infection. If her nipples do crack,
   the mother can coat them with breast milk or other natural
   moisturizers to help them heal. Vitamin E oil and lanolin are
   commonly used, although some babies may have allergic reactions to
   them. Proper positioning at the breast can help prevent sore nipples.
   If the mother's very sore, the baby may not have the nipple far
   enough back in his or her mouth.

 * Watch for infection: Symptoms of breast infection include fever and
   painful lumps and redness in the breast. These require immediate
   medical attention.

 * Expect engorgement: A new mother usually produces lots of milk,
   making her breasts big, hard and painful for a few days. To relieve
   this engorgement, she should feed the baby frequently and on demand
   until her body adjusts and produces only what the baby needs. In the
   meantime, the mother can take over-the-counter pain relievers, apply
   warm, wet compresses to her breasts, and take warm baths to relieve
   the pain.

 * Eat right, get rest: To produce plenty of good milk, the nursing
   mother needs a balanced diet that includes 500 extra calories a day
   and six to eight glasses of fluid. She should also rest as much as
   possible to prevent breast infections, which are aggravated by fatigue.


--R.D.W.


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


Medicines and Nursing Mothers

Most medications have not been tested in nursing women, so no one knows
exactly how a given drug will affect a breast-fed child. Since very few
problems have been reported, however, most over-the-counter and
prescription drugs, taken in moderation and only when necessary, are
considered safe. 

Even mothers who must take daily medication for conditions such as
epilepsy, diabetes, or high blood pressure can usually breast-feed. They
should first check with the child's pediatrician, however. To minimize
the baby's exposure, the mother can take the drug just after nursing or
before the child sleeps. In the January 1994 issue of Pediatrics, the
American Academy of Pediatrics included the following in a list of drugs
that are usually compatible with breast-feeding:

 * acetaminophen
 * many antibiotics
 * antiepileptics (although one, Primidone, should be given with caution)
 * most antihistamines
 * alcohol in moderation (large amounts of alcohol can cause drowsiness,
   weakness, and abnormal weight gain in an infant)
 * most antihypertensives
 * aspirin (should be used with caution)
 * caffeine (moderate amounts in drinks or food)
 * codeine
 * decongestants
 * ibuprofen
 * insulin
 * quinine
 * thyroid medications


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


Drugs That Are NOT Safe While Nursing

Some drugs can be taken by a nursing mother if she stops breast-feeding
for a few days or weeks. She can pump her milk and discard it during
this time to keep up her supply, while the baby drinks previously frozen
milk or formula.

Radioactive drugs used for some diagnostic tests like Gallium-69,
Iodine-125, Iodine-131, or Technetium-99m can be taken if the woman
stops nursing temporarily.

Drugs that should never be taken while breast-feeding include:

Bromocriptine (Parlodel): A drug for Parkinson's disease, it also
decreases a woman's milk supply.

Most Chemotherapy Drugs for Cancer: Since they kill cells in the
mother's body, they may harm the baby as well.

Ergotamine (for migraine headaches): Causes vomiting, diarrhea,
convulsions in infants.

Lithium (for manic-depressive illness): Excreted in human milk.

Methotrexate (for arthritis): Can suppress the baby's immune system.

Drugs of Abuse: Some drugs, such as cocaine and PCP, can intoxicate the
baby. Others, such as amphetamines, heroin and marijuana, can cause a
variety of symptoms, including irritability, poor sleeping patterns,
tremors, and vomiting. Babies become addicted to these drugs.

Tobacco Smoke: Nursing mothers should avoid smoking. Nicotine can cause
vomiting, diarrhea and restlessness for the baby, as well as decreased
milk production for the mother. Maternal smoking or passive smoke may
increase the risk of sudden infant death syndrome (SIDS) and may
increase respiratory and ear infections.

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

Recalls: FDA, Industry Cooperate to Protect Consumers

by Tamar Nordenberg

The Phoenix New Fiber chocolate chip cookies were promoted as aids in
weight control and as cures for colon cancer and other diseases. In
1990, the Food and Drug Administration got the skinny on the "weight
control" cookies--they had twice the calories, half the fiber, and five
times the fat declared in the products' labeling. The cookies could be
dangerous to diabetics, who often need to control their food intake, and
to people with other ailments, who might rely on the unsupported disease
claims and forego effective therapy. 

But FDA didn't take the company to court to get the cookies off the
market. The agency didn't have to because the distributor voluntarily
recalled the goods. 

A recall is a firm's removal or correction of a marketed product when
that product violates the laws enforced by FDA. Unlike FDA's other tools
for achieving compliance, such as seizures and injunctions, recalls are
almost always voluntary. FDA can't order a company to recall a product,
except in some cases involving infant formulas, biological products, and
devices that present a serious hazard to health.

Before taking a company to court, FDA usually notifies the responsible
person of the violation and provides an opportunity to correct the
problem. In most situations, a violation results from a mistake by the
company rather than from an intentional disregard for the law. 

"Recall is by far a better choice than seizure to protect the public,
particularly when the product has been widely distributed," says Willie
Bryant, emergency operations coordinator in FDA's division of emergency
and epidemiological operations (DEEO). Recall is far less costly and
time-consuming than a court procedure, and it gets defective products
off the market more quickly.

Without Phoenix's cooperation, it would have been difficult to track
down and retrieve the hundreds of thousands of cases of Phoenix cookies
that had been distributed to 55,000 weight-loss counselors nationwide. 

In Phoenix's case, the goods were returned to the firm for correction.
But in some cases, a correction is made in the field, where the product
is being used.

"There are many factors that come into play in deciding whether to
remove the product from the market or correct the problem in the field,"
Bryant says. "It depends on the type of product, the problem, and how
the company intends to correct the problem." 

Many recalled devices are not returned to the manufacturer or
distributor. An x-ray or dialysis machine, for example, is so large that
it is usually more practical to correct the problem on-site. Foods and
drugs are almost always returned, but even then some problems may be
corrected at the wholesale or retail site. For example, a labeling
violation can sometimes be corrected by simply sticking a new label on
the product. 

Avoiding a Court Action

There are several incentives for a company to recall a product,
including the moral duty to protect its customers from harm and the
desire to avoid private lawsuits if injuries occur. In addition, the
alternatives to recall are seizures, injunctions, or criminal actions.
These are often accompanied by adverse publicity, which can damage a
firm's reputation.

A company recall does not guarantee that FDA will not take a company to
court. If a recall is ineffective and the public remains at risk, FDA
may seize the defective products or obtain an injunction against the
manufacturer or distributor. A few years ago, FDA seized from an
uncooperative recalling firm numerous packets of "Sober-Up-Time," an
unapproved new drug that supposedly minimized the effects of alcohol.
The firm had refused to provide documentation of its notification to
distributors. 

If the firm's recall had met FDA's consumer protection goals, there
would have been no need for further regulatory action. "For the most
part, companies do the recalls in an effective and timely manner," says
Cecilia Wolyniak, emergency operations coordinator in DEEO. To help
firms conduct recalls, FDA has published guidelines in the Code of
Federal Regulations setting forth the agency's preferred recall
procedures.

The recalling firm is always responsible for conducting the actual
recall by contacting its purchasers by telegram, mailgram, or
first-class letters with information including:

 * the product being recalled
 * identifying information such as lot numbers and serial numbers
 * the reason for the recall and any hazard involved
 * instructions to stop distributing the product and what to do with it.

FDA monitors the recall, assessing the firm's efforts.

Initiating a Recall 

A firm can recall a product at any time. Firms usually are under no
legal obligation to even notify FDA that they are recalling a defective
product, but they are encouraged to notify the agency, and most firms
seek FDA's guidance. FDA may request a recall of a defective product,
but it does so only when agency action is essential to protect the
public health. 

"If we request a recall, we are prepared to seize the product and go to
the press," says W. Remle Grove, chief of DEEO's emergency operations
branch. In the last five years, there have been only about a dozen
FDA-requested recalls, according to Grove.

When a firm undertakes a recall, the FDA district office in the area
immediately sends a "24 Hour Alert to Recall Situation" notifying the
relevant FDA center (responsible for foods and cosmetics, drugs,
devices, biologics, or veterinary medicine) and DEEO of the product,
recalling firm, and reason for the recall. FDA also informs state
officials of the product problem, but for routine recalls, the state
does not become actively involved. 

After inspecting the firm and determining whether there have been
reports of injuries, illness, or other complaints to either the company
or to FDA, the district documents its findings in a recall
recommendation ("RR") and sends it to the appropriate center's recall
coordinator. The RR contains the results of FDA's investigation,
including copies of the product labeling, FDA laboratory worksheets, the
firm's relevant quality control records, and, when possible, a product
sample to demonstrate the defect and the potential hazard. The RR also
contains the firm's proposed recall strategy. 

The Strategy

FDA reviews the firm's recall strategy (or, in the rare cases of
FDA-requested recalls, drafts the strategy), which includes three
things: the depth of recall, the extent of public warnings, and
effectiveness check levels. 

The depth of recall is the distribution chain level at which the recall
will be aimed. If a product is not hazardous, a recall aimed only at
wholesale purchasers may suffice. For more serious defects, a firm will
conduct a recall to the retail level. And if the public health is
seriously jeopardized, the recall may be designed to reach the
individual consumer, often through a press release. 

But most defects don't present a grave danger. Most recalls are not
publicized beyond their listing in the weekly Enforcement Report
published by FDA's press office. The Enforcement Report lists the
product being recalled, the degree of hazard (called "classification"),
whether the recall was requested by FDA or initiated by the firm, and
the specific action taken by the recalling firm.

A firm is responsible for conducting "effectiveness checks" to
verify--by personal visits, by telephone, or with letters--that everyone
at the chosen recall depth has been notified and has taken the necessary
action. An effectiveness check level of "A" (check of 100 percent of
people that should have been notified) through "E" (no effectiveness
check) is specified in the recall strategy, based on the seriousness of
the product defect. 

"If a recall involves a serious health hazard, we usually require 100
percent effectiveness checks at all levels of distribution, including
the points of final retail sale," says Ron Joyce, recall coordinator for
the Center for Food Safety and Applied Nutrition. "If it's a very minor
violation that does not pose a hazard to health, it may not be worth
using any more resources to conduct a check."

The Health Hazard Evaluation

When the center receives the RR from the district office, it evaluates
the health hazard presented by the product and categorizes it as a class
I, II, or III. The classification is determined by an ad hoc "Health
Hazard Evaluation Committee" made up of FDA scientists chosen for their
expertise. Classification is done on a case-by-case basis, considering
the potential consequences of a violation.

A class I recall involves a strong likelihood that a product will cause
serious adverse health consequences or death. A very small percentage of
recalls are class I. Recently, a Colorado manufacturer of cardiac
pacemaker leads--J-shaped electric cables that connect the pacemakers to
the heart--conducted a class I recall of two models because the wires
inside the cable were breaking through the outer coating and in some
cases puncturing the heart. Two patients died as a result. Other recent
class I recalls involved Schwan's ice cream contaminated with Salmonella
bacteria (see Investigators' Reports section in the June 1995 FDA
Consumer) and Alaska King Seafoods' Seafood Spread, contaminated with
Listeria monocytogenes bacteria. 

A class II recall is one in which use of the product may cause temporary
or medically reversible adverse health consequences, or in which the
probability of serious adverse health consequences is remote. When 408
boxes of Keebler's Graham Crackers were recalled earlier this year due
to contamination with glass pieces, the recall was categorized as a
class II because injury from swallowing the glass was unlikely. Boxes of
corn flakes cereal also recently underwent a class II recall due to
glass pieces. 

A class III recall involves a product not likely to cause adverse health
consequences. When 2,500 bottles of Diet Lemon Nestea were mistakenly
labeled as regular Lemon Nestea earlier this year, FDA concluded there
was no health hazard. But because the bottles were misbranded, they were
recalled by the manufacturer, Coca-Cola USA. 

"Many people think a hazard must be involved in a recall," says FDA's
Philadelphia district recall coordinator Mary Rosenhagen. "Actually,
what you must have is a violative product. The label, for example, may
have something missing and then, even though it may not be hazardous,
the product shouldn't be on the market." 

For class I and II, and infrequently for class III, FDA conducts audit
checks to ensure that all customers have been notified and are taking
appropriate action. The agency does this by personal visits or telephone
calls. "The recall is mainly the firm's responsibility," Grove says.
"We're just performing an audit function to protect the public
interest."

A recall is classified as "completed" when all reasonable efforts have
been made to remove or correct the product. The district notifies a firm
when FDA considers its recall completed.

Planning Ahead

FDA recommends that firms maintain plans for emergency situations
requiring recalls. Companies can minimize the disruption caused by the
discovery of a faulty product if they imprint the date and place of
manufacture on their products and keep accurate and complete
distribution records.

A recall is often the best tack for protecting the public. "Ultimately,
FDA's goal is consumer protection," says New York district recall
coordinator Maria Caride. "We're out there to make sure no one gets
hurt." 

Tamar Nordenberg is a lawyer with the Office of the Director in FDA's
Center for Drug Evaluation and Research.


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


When Is a 'Recall' Not a Recall?

On Oct. 4, 1982, Johnson & Johnson announced a nationwide recall of 31
million bottles of Tylenol after seven people died from taking
cyanide-laced Extra-Strength Tylenol capsules. The company destroyed all
31 million bottles of the largest-selling over-the-counter medicine in
the country.

"We set as the number one priority the safety of the consumer," said J &
J general counsel George Frazza at an August 1983 American Bar
Association meeting. "We took immediate steps to find out as quickly as
possible what caused the tragedy, then to do all within our power to
contain it, regardless of whether the product was found to be blameless
or at fault," Frazza said. 

The product was not at fault; a criminal tamperer was. The company
stated that it was "recalling" the product from the market. Although the
action was a recall according to the common usage of the term, FDA did
not consider the action a recall, but a market withdrawal.

A "market withdrawal" is a firm's removal or correction of a distributed
product that involves no violation of the law by the manufacturer. A
product removed from the market due to tampering, without evidence of
manufacturing or distribution problems, is one example of a market
withdrawal. 

A stock recovery is another action that may be confused with a recall. A
stock recovery is a firm's removal or correction of a product that has
not yet been distributed.

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


Updates


Public Can Comment on Proposal to Curb Teen Smoking

The Clinton administration is proposing comprehensive measures to
significantly reduce the number of children and adolescents who become
addicted to nicotine in cigarettes and smokeless tobacco (snuff and
chewing tobacco). Children are becoming addicted to these products, with
more than 80 percent of smokers beginning to smoke by age 18. 

The public has until Nov. 9 to comment on the proposal, published by FDA
in the Aug. 11, 1995, Federal Register. Written comments may be sent to:
FDA Dockets Management Branch, HFA-305, Rockville, MD 20857. 

Experts consistently recommend that the keys to reducing children's
smoking are: reducing access and limiting the appeal for children. Under
the new proposal, measures to achieve these goals include: 

Reducing Easy Access by Children 


 * Require age verification and face-to-face sale.
 * Eliminate mail-order sales, vending machines, free samples,
   self-service displays, and sale of single cigarettes ("loosies") and
   packages with fewer than 20 cigarettes ("kiddie packs").


Reducing Appeal to Children 

 * Ban outdoor advertising within 1,000 feet of schools and playgrounds.
   Permit black-and-white-text-only advertising for all other outdoor
   advertising, including billboards, signs inside and outside of buses,
   and point-of-sale advertising.

 * Permit black-and-white-text-only advertising in publications with
   significant youth readership (under 18). (Significant readership
   means more than 15 percent, or more than 2 million.)

 * Prohibit sale or giveaway of products like caps or gym bags that
   carry cigarette or smokeless tobacco product brand names or logos.
   Prohibit exchange of non-tobacco products for proof of purchase of
   tobacco products.

 * Prohibit brand-name sponsorship of sporting or entertainment events,
   but permit it in the corporate name.

 * Require industry to fund ($150 million annually) a public education
   campaign to prevent kids from smoking.


The proposal maintains the legal status of cigarettes and smokeless
tobacco products for adults. 


Smoking: Leading Cause of Avoidable, Premature Death

Tobacco products are responsible for more than 400,000 deaths annually
due to cancer, respiratory illness, heart disease, and other health
problems. Cigarettes kill more Americans each year than AIDS, alcohol,
car accidents, murders, suicides, illegal drugs, and fires combined.
Smokers who die as a result of smoking would have lived, on average, 12
to 15 years longer if they had not smoked. 

The national Centers for Disease Control and Prevention estimated the
health-care costs associated with smoking in 1993 to be $50 billion:
$26.9 billion for hospital costs, $15.5 billion for doctors, $4.9
billion in nursing home costs, $1.8 billion for prescription drugs, and
$900 million for home health-care expenditures. 

The Office of Technology Assessment calculated the social costs
attributable to smoking in 1990 to be $68 billion: $20.8 billion in
direct health-care costs, $6.9 billion in lost productivity from
disabilities, and $40.3 billion in lost productivity from premature
deaths. 

Preventing children from smoking is key to reducing the deadly toll of
smoking. The Clinton administration's proposal is intended to reduce
smoking by people under 18 by half. The proposal builds on previous
actions taken by Congress and others, such as the ban on television
advertising and state laws prohibiting the sale or use of tobacco by
children. It follows recommendations by the American Medical Association
and the Institute of Medicine. 



A Closer Look at Easy Access

Despite state laws prohibiting the sale of tobacco to minors, children
can easily buy these products. One study estimated that teenagers
annually consume 516 million packs of cigarettes and 26 million
containers of chewing tobacco. A review of 13 studies of
over-the-counter sales found that on average, children and adolescents
could successfully buy tobacco products 67 percent of the time. 

Vending machines are a primary source of tobacco products for young
smokers. A study by the vending machine industry found that 22 percent
of 13-year-old smokers use vending machines, compared with 2 percent of
17-year-old smokers. The 1994 Surgeon General's Report found that young
people could buy cigarettes in vending machines an average of 88 percent
of the time. 

Mail-order sales provide no sure way of verifying age. Current industry
practice only asks the consumer to provide a birth date or check box to
verify age. 

Self-service displays allow children to easily obtain tobacco products.
The Institute of Medicine, in its landmark 1994 report "Growing Up
Tobacco Free," concluded that placing tobacco products "out of reach
reinforces the message that tobacco products are not in the same class
as candy or potato chips." 

Free samples are obtained by children, including those in elementary
school, despite industry code prohibiting distribution to anyone under
21. Free samples are distributed on street corners, in shopping malls,
and at sporting events. A New Jersey survey found that one-third of high
school students who were smokers or ex-smokers reported receiving free
samples before age 16. 



Appealing to Children


Advertising and promotional activities can greatly influence a young
person's decision to smoke or use smokeless tobacco products. Awareness
of tobacco products and messages is very high among even the youngest
children. Studies show that 30 percent of 3-year-olds and 91 percent of
6-year-olds could identify "Joe Camel" as a symbol for smoking. 

CDC recently reported that 86 percent of underage smokers who purchase
their own cigarettes purchase one of the three most heavily advertised
brands: Marlboro, Camel and Newport. 

Tobacco products are among the most heavily advertised products in the
United States. In 1993, the tobacco industry spent $6.2 billion on
advertising and promoting cigarettes and smokeless tobacco. Tobacco
advertising expenditures have increased more than 1,500 percent between
1970 (the year before television and radio advertising was banned) and
1992. 

Promotion of tobacco products is reaching children through non-tobacco
items such as T-shirts, hats, and gym bags and through sponsorship of
events. 

A 1992 Gallup Survey found that half of adolescent smokers and
one-quarter of adolescents who do not smoke owned at least one tobacco
promotional item, such as a T-shirt, cap, sports item, or lighter.
Another report found that one out of four 12-and 13-year-olds owned one
of these items. Used or worn by young people, these become "walking
billboards," promoting the products in schools and other locations where
tobacco advertising is usually prohibited. 

Sponsorship of events such as tennis tournaments, car races, and rodeos
associate tobacco products with excitement and glamour, and provide a
way for tobacco brands to be advertised on television despite the
broadcast advertising ban. 


A Pediatric Disease

Children are becoming addicted to nicotine. The average teenage smoker
starts at 14 1/2 years old and becomes a daily smoker before age 18.
More than 80 percent of all adult smokers had tried smoking by their
18th birthday, and more than half of them had already become regular
smokers by that age. Studies show that if people do not begin to smoke
as teenagers or children, it is unlikely they will ever do so. 

Each and every day, another 3,000 young people become regular smokers,
and nearly 1,000 of them will eventually die as a result of their
smoking. Currently, more than 3 million children and adolescents smoke
cigarettes, and 1 million adolescent boys use smokeless tobacco. 

Smoking by young people is rising sharply. Between 1991 and 1994, the
percentage of eighth-graders who smoke increased 30 percent, and the
percentage of tenth-graders who smoke increased 22 percent. 

Children tend to vastly underestimate the likelihood that they will
become addicted to these products. Although only 5 percent of daily
smokers surveyed in high school said they would definitely be smoking
five years later, close to 75 percent were smoking seven to nine years
later. A survey conducted in 1992 found that about two-thirds of
adolescents who smoked said they wanted to quit, and 70 percent said
they would not start smoking if they could make that choice again.
------------------------------------------------------------------------


Public Hearing on Autologous Transplantation of Living Human Cells

A public hearing on emerging products and services involving living
human cells for autologous transplantation will be held Nov. 16 and 17
at the Gaithersburg Hilton in Gaithersburg, Md. 

FDA will hear information from scientists, clinical investigators,
professional groups, trade groups, commercial enterprises, and consumers
about living human cells intended for structural repair or
reconstruction. This includes cells implanted at the site where cells or
tissues were removed or at another site in or on the patient, and
includes products such as cartilage, fat and skin that are used for
cosmetic reconstruction and augmentation. 

Not included for discussion are gene therapy products and autologous
cell products intended for functional repair or reconstruction--such as
autologous pancreatic cells to produce insulin following total removal
of the pancreas, stem cells for functional replacement of muscle, and
lymphocytes activated to induce immune function. 

Further details regarding the public hearing will be announced in the
Federal Register. 

Living human cell and gene therapies must undergo the standard FDA
application processes for investigational use and licensing of
biologicals, which are described in the Oct. 14, 1993, Federal Register. 

OTC Bronchodilator Drugs

Over-the-counter bronchodilator drugs containing theophylline can no
longer be sold in the United States, and those containing ephedrine may
soon follow suit. 

In July, FDA banned the sale of OTC theophylline-containing combination
bronchodilators because evidence failed to show that the products are
safe and effective. These products had been on the market for decades. 

The agency cited data showing that the therapeutic dose for these drugs
may be toxic to some people, causing life-threatening events and death.
Studies also show no evidence that the ingredients in these OTC products
contribute to the claimed therapeutic effects or that the dosage of each
component is safe and effective for a significant number of patients. 

The ban does not include theophylline-containing OTC inhalers. 

At the same time, FDA proposed banning OTC bronchodilators containing
ephedrine, ephedrine hydrochloride, ephedrine sulfate, and racephedrine
hydrochloride because of abuse and misuse. According to the U.S. Drug
Enforcement Administration, ephedrine is being used to make illegal
drugs. And, FDA has found that some drug manufacturers promote ephedrine
for unapproved uses, such as weight control and muscle enhancing. 

People with asthma who have been using ephedrine will have several OTC
alternatives containing other drugs, including epinephrine, epinephrine
bitartrate, and racepinephrine hydrochloride. These are sold as
metered-dose inhalers. Prescription options exist, as well. 

Impotence Treatment Approved

A self-injectable treatment for impotence, shown in studies to be
effective for as many as 80 percent of patients, has received FDA
approval. 

FDA approved Coverject Sterile Powder (alprostadil, or prostaglandin E-1
hormone) for treatment of erectile dysfunction due to neurologic,
vascular, psychological, or mixed causes, and to supplement other tests
in diagnosing erectile dysfunction. 

The patient injects the drug into the side of the base of the penis. It
usually induces an erection within 5 to 20 minutes by relaxing smooth
muscle and dilating the major blood artery in the penis. 

Impotence support organizations estimate that 30 million men in the
United States are impotent. One in three men over age 60 is affected. 

Dosage is determined in the doctor's office, where patients must be
properly instructed and trained in injection techniques. Most men will
achieve optimal results with doses of 20 micrograms or less, and dosage
should not exceed 60 micrograms. The drug should be used no more than
three times a week and no more than once in 24 hours. 

Potential side effects are mild to moderate pain at the injection site,
local formation of excessive fibrous tissue, and an abnormally prolonged
erection, or priapism. If erection persists longer than six hours,
patients should immediately call their doctors or seek other emergency
medical assistance. 

Patients with sickle cell anemia or trait, multiple myeloma, leukemia,
anatomical deformation of the penis, or penile implants should not use
Coverject Sterile Powder. Also, underlying treatable medical causes of
impotence should be diagnosed and treated before beginning this
treatment. 

Coverject Sterile Powder is manufactured by Upjohn Corporation,
Kalamazoo, Mich. 

(For more about impotence treatment, see "Inflatable Penile Implants
Under Scrutiny" in the January-February 1994 FDA Consumer.) 

New Indication for Cholesterol-Lowering Drug

The approved cholesterol-lowering drug Zocor (simvastatin) was recently
approved by FDA for a new use--reducing deaths and preventing heart
attacks in people with heart disease and high cholesterol. It is the
first cholesterol-lowering drug approved for this use. 

Marketing with the new use was approved by FDA last June. Zocor was
first approved in 1988 as an adjunct to diet to reduce elevated total
and low-density lipoprotein cholesterol in patients with high
cholesterol. Other drugs in its class include Lescol (fluvastatin),
Mevacor (lovastatin), and Pravachol (provastatin). 

Approval of the new use was based on results of the Scandinavian
Simvastatin Survival Study, also known as the 4S study. The study
assessed 4,444 patients with coronary heart disease and cholesterol
levels of 212 to 309 milligrams per deciliter of blood over an average
of 5.4 years. Zocor reduced overall deaths by 30 percent. Specifically,
the drug reduced coronary heart disease deaths by 42 percent and reduced
the occurrence of hospital-verified, nonfatal heart attacks by 37
percent. 

Side effects associated with Zocor were generally mild and included:
headache, abdominal pain, constipation, flatulence, and diarrhea. 

Zocor is manufactured by Merck & Co. Inc., Whitehouse Station, N.J. 

(For more information on cholesterol, see "Lowering Cholesterol," in the
March 1994 FDA Consumer.) 

Sweat Test for Drugs of Abuse

The first sweat patch test system for amphetamines, cocaine and opiates
has received FDA marketing clearance for use by trained drug abuse
testing professionals in clinical and rehabilitation centers. 

The test system consists of a patch applied to the skin to collect sweat
and an assay to detect drugs. The Sudormed Sweat Specimen Container is
manufactured by Sudormed, of Santa Anna, Calif. The SolarCare
Technologies Corporation EIA Micro-Place Assay is made by SolarCare
Technologies Corporation, Bethlehem, Pa. 

The patch is a waterproof, adhesive pad about the size of a playing
card. It can be worn up to seven days on the back, upper arm, or lower
chest and will collect drugs of abuse used during that time. A
tamper-proof feature restricts it to a single application, so that it
cannot be removed and reapplied later. 

Currently, most drug abuse screening programs use urine tests, which
only detect drug use up to 36 hours before the urine collection. 

FDA cleared the patch test for marketing July 14. The agency based this
decision on its review of Sudormed's clinical studies on effectiveness,
its consideration of the scientific, medical and social issues
concerning drug abuse testing, and the recommendation last April of the
Medical Devices Advisory Committee's Clinical Chemistry and Clinical
Toxicology Panel. 

Implant News

Updated information on saline-filled breast implants and
polyurethane-coated silicone gel-filled implants has been announced by
FDA. 

Results of a study show that women with polyurethane-coated breast
implants are at negligible risk for cancer. In 1991, an FDA analysis
showed that polyurethane could break down under human body conditions
and form a chemical called TDA, which can cause cancer in animals. The
manufacturer, Surgitek, a former subsidiary of Bristol Myers Squibb Co.
of New York, immediately stopped selling the implants. 

The study, designed by FDA and Bristol-Myers Squibb, showed the risk of
cancer from exposure to TDA in women with these implants is only one in
a million over a lifetime. About 110,000 women have the
polyurethane-coated implants. FDA does not recommend removing the
implants, as the agency considers the health risk connected with
surgical explantation to be far greater than the risk of developing
cancer. 

Information that doctors must give to women considering saline breast
implants has been revised. Saline implants are the only type still on
the market for general use. These devices are composed of a saline (salt
water)-filled solid silicone envelope. The most common risks of the
devices are deflation or rupture, interference with mammography, and
capsular contracture (formation and hardening of scar tissue around the
implant). FDA advises women considering the implants to read all the
information before surgery and discuss the possible benefits and risks
with their doctors. 

The revised information was reviewed by consumer groups, health
professionals, and industry. It was published in the June 28 Federal
Register. 

Program to Track Food-Borne Illness

Federal and state health agencies are expected to begin a program this
month to identify more closely the incidence of food-borne bacterial
infections, especially those caused by E. coli and Salmonella. This
follows a three-month trial of the program. 

FDA, the U.S. Department of Agriculture's Food Safety and Inspection
Service, and the national Centers for Disease Control and Prevention,
working with state health departments, will collect data from five
locations around the country to learn more about risk factors for
transmission of E. coli, Salmonella, and other harmful bacteria in food.
The data will be used to help track the effectiveness of new federal
food safety programs and regulations. 


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


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.


Saline-filled breast implant information is available free from FDA.
"Information for Women Considering Saline-filled Breast Implants"
provides prospective patients with information about the possible risks
involved. To order a copy, send two self-addressed labels to the
agency's Center for Devices and Radiological Health, Division of Small
Manufacturers Assistance (HFZ-220), Rockville, MD 20850; facsimile (301)
443-8818. Request Docket No. 95N-0007. (FR June 28) 

Lead solder will be prohibited in manufacturing cans for packaging
foods, according to an FDA rule effective Dec. 27, 1995. The agency
found that lead solder in food cans may be harmful, especially to
fetuses, infants and children. (FR June 27) 

Child-resistant packaging for naproxen products containing 250
milligrams or more of the drug will be required beginning Feb. 6, 1996,
according to a Consumer Product Safety Commission rule. Naproxen is used
to treat various forms of arthritis, mild to moderate pain, and
menstrual pain. Child-resistant packaging will help protect children
under 5 from serious injury and illness that may result from their
ingesting naproxen. (FR July 28) 

Revised guidelines for blood establishment quality assurance are
available from FDA's Center for Biologics Evaluation and Research. For a
free copy of "Guideline for Quality Assurance in Blood Establishments,"
send two self-addressed labels to Congressional and Consumer Affairs
Branch (HFM-12), CBER, Rockville, MD 20852-1448; telephone (301)
594-1800; or E-mail gde-qa@a1.cber.fda.gov. (FR July 14) 

New research integrity regulations became effective Oct. 1, under a
Public Health Service rule. The regulations are intended to ensure that
the design, conduct or reporting of research funded by PHS grants,
cooperative agreements, or contracts is not biased by conflicting
financial interests of the investigators responsible for the research.
(FR July 11) 

Nine medical devices that are generic types of class I (low-risk)
devices are now exempt from FDA premarket notification requirements,
according to an agency rule effective Aug. 28. The exempted devices
range from anesthetic warmers to root canal posts. (FR July 28) 

Behavioral and relaxation approaches to treating chronic pain and
insomnia will be discussed at a National Institutes of Health technology
assessment conference Oct. 16-18 at the Natcher Conference Center,
Bethesda, Md. For more information or to register for the conference,
write to the Conference Registrar, Technical Resources International,
Inc., 3202 Tower Oaks Blvd., Rockville, MD 20852; telephone (301)
770-0610; facsimile (301) 468-2245. 

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


Investigators' Reports


Food Broker Sentenced in Export Diversion Scheme

by Marian Segal

A New Jersey businessman has been sentenced to four months in prison and
another four months of home detention for participating in false export
diversion schemes. His activities cost nearly 40 American manufacturers
of drugs, foods, and health and beauty aids as much as $20 million.

Judge John C. Lifland sentenced 42-year-old Steven LaSala in the U.S.
District Court for the District of New Jersey on Jan. 12, 1995. The
judge also ordered LaSala to pay $1.9 million in fines, forfeitures and
restitution from a Swiss bank account he maintained.

U.S. manufacturers often export products for sale overseas at discounts
of up to 50 percent below U.S. prices to open new markets and expand
worldwide sales. They also may offer discounts for goods that are to be
donated to poor people in impoverished countries, or because the
manufacturer's overhead costs may be lower for some products it sells
overseas.

"LaSala would buy products from the manufacturers at the discounted
prices, claiming they were for foreign export," says Dave Carman,
special agent in FDA's Office of Criminal Investigations. "Then he'd
sell the products for distribution in the United States and pocket the
difference between the domestic and export wholesale prices." 

LaSala's sentence followed a guilty plea in April 1994 in which he
admitted to 39 schemes involving wire fraud, customs fraud, and causing
a drug company to maintain false drug distribution records. 

According to the New Jersey U.S. Attorney's Office, LaSala used several
methods to mask the diversion schemes. In some cases, he would ship the
goods overseas to a port in Belgium or Holland, for example, but return
them immediately to the United States as "American Goods Returned,"
which enter the country duty-free. He and others working with him
created false invoices for U.S. Customs that made it appear the goods
were returned because they could not be sold overseas.

In other cases, LaSala would have others issue false bills of lading or
other shipping documents that purported to show a product had been
shipped overseas when it hadn't.

"Diversion of these products caused the manufacturers to unknowingly
violate FDA record-keeping requirements," Carman says, "and the false
records would hamper their ability to recall a product if that became
necessary." 

"For instance," he explains, "if I tried to track a drug for recall and
the manufacturer told me it was shipped to Belgium, I would alert the
State Department officer covering that part of Europe to inform his
counterpart in Belgium of a problem with the product. What I wouldn't
know is that I should have been talking to someone in the health
department in Arkansas or Kentucky or wherever it was that the product
was actually sold."

The Office of Criminal Investigations entered the case in the winter of
1993, when the Newark U.S. Attorney's Office asked FDA to assist U.S.
Customs Service in Newark in its investigation of a Bogota, N.J., firm
called Christopher Trading, operated by LaSala. A Customs office in the
Midwest had identified the company as a possible participant in illegal
export diversion schemes.

Carman and Anthony Merinda, a U.S. Customs agent, interviewed employees,
clients and manufacturers across the country to unravel the details of
the operation.

"We served several hundred subpoenas, executed search warrants,
conducted surveillances, and used several grand juries in the case over
a year's time," Carman says. "In reviewing records, we uncovered
evidence such as duplicate invoices for the same material, indicating it
was sold and shipped to two different locations on the same date. We
found shipments indicated on ships that didn't dock at the port listed."

Also because of LaSala's ruses, companies unknowingly used false
shipping documents to obtain monetary and subsidy benefits from U.S.
Customs and the U.S. Department of Agriculture programs designed to
promote exports of U.S. finished products.

For example, Nestle U.S.A. of Glendale, Calif., was able to buy sugar
from USDA at subsidized prices below the U.S. market price based on
false bills of lading issued to mask a diversion scheme in which LaSala
participated. LaSala also caused Bock Pharmacal Company of St. Louis,
Mo., to maintain false records of drug distributions by falsely
representing that goods bought by LaSala would be sold in Nigeria when,
in fact, LaSala sold them for distribution in the United States.

Among the 39 companies defrauded in LaSala's schemes were Nestle,
American Cyanamid/Lederle, Redmond, General Mills, Ralston Purina, Alpo
Pet Foods, Van Camp/Hormel, Forest Pharmaceuticals, ICN Pharmaceuticals,
Fissons Pharmaceuticals, Schwarz Pharmacal, Elder Pharmaceuticals, CIBA
Pharmaceuticals, Fujisawa Pharmaceuticals, Golden Grains Company,
Tsumora Medical, Hunt/Wesson, and Procter and Gamble.

LaSala is cooperating with government authorities in ongoing
investigations of export scams. 

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


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


Feed Mills Correct GMP Violations

After receiving separate injunctions in federal court, three animal feed
plants in Puerto Rico have corrected a series of manufacturing
violations, which included producing medicated feed with the wrong drugs
or no drugs added. 

The three plants--two run by Molinos de Puerto Rico Inc., and one
operated by To-Ricos Inc.--passed FDA inspections last April after
executing a remedial plan. The companies had a three-year history of
violating good manufacturing practice (GMP) provisions of food and drug
law.

Both firms are owned by Omaha, Nebraska-based ConAgra Inc. They
manufactured feeds--with and without drugs added--that were marketed for
a variety of animals. Before the December 1994 injunction, the three
mills supplied about half of Puerto Rico's medicated-feed stock. The
injunction cited the firms for product adulteration and misbranding.

The injunction permitted shutting down medicated feed production at all
three plants. However, FDA agreed to allow the Molinos plant located in
Catano and the To-Ricos plant in Las Piedras to keep producing medicated
feed after plant officials demonstrated a good-faith effort to correct
violations. The Molinos plant in Hatillo permanently stopped making
medicated feed but continued to supply nonmedicated feed. Further
infractions at the Catano or Las Piedras plants will subject them to
immediate shutdown of medicated feed production.

FDA first discovered GMP infractions during a routine inspection of the
Las Piedras plant in January 1992. Besides pigeons in the plant,
investigators' findings included deficiencies in record keeping and
failure to maintain a daily drug inventory. When FDA sent a warning
letter the same month, the company promised to come into compliance. 

New problems surfaced in September 1993, when FDA inspected the Catano
plant and found major GMP deviations, including batch records showing
the wrong drugs had been added to feed, failure to follow adequate
equipment clean-up procedures, and failure to stop selling feed that had
drug concentrations below what was stated on the label. An inspection of
the Hatillo plant two months later uncovered similar deviations. 

"Some employees and lower-level managers seemed unaware that to make
medicated feeds, you have to keep accurate records," says Philip
Lindeman, compliance officer in FDA's San Juan district office. "They
didn't seem to have any knowledge of federal regulations."

Investigators observed that the plants failed to flush equipment and
working surfaces between batches, setting the stage for contamination. 

"Some employees would make up feed for chickens that contained the drug
monensin, which is toxic to horses," Lindeman says. "Then they'd make
horse feed with the same equipment, which, of course, could be
contaminated with monensin." 

Another recurring problem was selling feed containing less than the
stated drug amounts. "The firms' own records show that about 30 percent
of samples showed subpotent drug concentrations," says Lindeman. "Also
in their records were a few examples with zero potency."

In October and December 1993, FDA sent warning letters to managers of
both plants detailing the inadequacies. Again, company officials assured
FDA the problems would be corrected.

But the following February, FDA inspected all three facilities and found
little had changed, especially at the Catano plant. FDA's San Juan
district office recommended that both companies, along with ConAgra, be
enjoined. At that point, the firms entered a period of negotiation with
FDA. 

A July 1994 inspection of all three facilities revealed that the plants,
though making some progress, still had substantial problems. The
following month, FDA forwarded the case to the Department of Justice,
which proceeded with an injunction. More negotiations followed, and,
Lindeman says, by October 1994, the plants were showing improvement.

The injunction was signed in the U.S. District Court for the District of
Puerto Rico in December, but FDA waived closing down medicated feed
production at the plants when the agency determined that the Catano and
Las Piedras plants were addressing remaining problems. All three plants
reorganized, improved record keeping, and upgraded equipment.

Last April, FDA inspected the three plants and found them in compliance.

--John Henkel


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


Unapproved Devices Destroyed

The 9th U.S. Circuit Court of Appeals, based in San Francisco, upheld
FDA's right to seize a medical device illegally promoted as a cure for
cancer, AIDS, and other diseases. The decision came after a three-year
legal battle in which the device maker countersued FDA and others for
more than $4 million in damages. The court ruled in favor of the
government Nov. 11, 1994. U.S. marshals destroyed the devices the
preceding August.

Called the Bio-Ionic System, the device operated like a transcutaneous
electrical nerve stimulation, or TENS, unit, which FDA has approved only
for treating pain. A TENS device transmits electrical impulses through
electrodes placed on the skin.

The Bio-Ionic System was one of several medical devices that were the
focus of a 1992 congressional hearing, "Recent Trends in Dubious and
Quack Medical Devices." At the hearing, the daughter of a deceased
54-year-old breast cancer patient testified about her mother's treatment
with the Bio-Ionic System by Evans Rapsomanikis, the device's maker. She
said he declared her mother free of cancer after the treatment, yet the
mother died of cancer six weeks later. 

Rapsomanikis was owner of Paradise Pain Clinic and Kyttaron Energy
Corp., both in Las Vegas, Nev. Kyttaron manufactured the devices, 11 of
which were used at the clinic to treat patients.

FDA believes that Rapsomanikis fled the country, possibly with some of
his devices, in 1991, and that he may have set up practice in London.
FDA has informed British health officials about Rapsomanikis' activities
in this country.

The Paradise Pain Clinic came to FDA's attention in spring 1991, when
the Nevada State Board of Medical Examiners contacted FDA's San
Francisco district office about a complaint it had received from Jean
Harris of Pleasant Hill, Ore. Harris, whose son is paralyzed from the
neck down, told the board that she believed Rapsomanikis misrepresented
himself as a medical doctor because he had indicated to another family
member that he could cure quadriplegia. Harris took her son to Paradise
Pain Clinic for therapy, but when the treatments failed, they returned
to Oregon, refusing to pay Rapsomanikis' fee of $150 to $200 a
treatment.

The Nevada board investigated but found no evidence that Rapsomanikis
referred to himself as a physician, and the case was dropped.

In summer 1991, Las Vegas TV station KVBC aired a two-part news report
on Rapsomanikis' clinic. The report included interviews with two KVBC
employees who posed as cancer patients. Both reported that Rapsomanikis
told them he could cure their cancer. In an interview, Rapsomanikis told
the reporter his treatment had an 80 percent success rate for cancer.

In August 1991, an anonymous caller to FDA's Las Vegas resident post
told investigators the general location of where the devices were made.
FDA traced the exact site to a Las Vegas office building, where space
had been leased under the name Paradise Pain Clinic.

In September, an investigator with FDA's San Francisco district office,
posing as a breast cancer patient, and an investigator with the Las
Vegas district attorney's office, posing as her brother, went to
Paradise Pain Clinic. They met with Rapsomanikis, who told them he could
cure her cancer after three weeks of treatment with the Bio-Ionic
System. He also said he had treated numerous women with breast cancer
and they all were fine.

The investigators were given promotional videotapes and a packet of
testimonials allegedly written by former patients who claimed
Rapsomanikis' medical device had cured them of Guillain BarrŽ syndrome,
chronic fatigue syndrome, Epstein-Barr virus, arthritis, and other
diseases.

The next day, the investigator posing as the patient went to a Las Vegas
chiropractor to whom Rapsomanikis had referred her. The chiropractor
examined her and told her she had two lumps "the size of grapes" in her
left breast. That same day, the investigator went to a medical doctor
for a mammogram and breast ultrasound. Both tests revealed no lumps or
cancerous growths in either breast.

The investigator returned to Paradise Pain that same day, but according
to the investigators, for unknown reasons, Rapsomanikis apparently had
become suspicious of both investigators and refused to treat the one
posing as the patient. He said that because she had no pain, she was
ineligible for treatment at the pain clinic. In October, FDA obtained
warrants to inspect the Paradise Pain and Kyttaron sites. Rapsomanikis
was not present at either site.

At the clinic, FDA investigators interviewed the office manager and
Rapsomanikis' assistant. At times, the employees refused to cooperate,
denying the investigators access to patient records and trying to
prevent them from taking photographs.

According to the office manager, Rapsomanikis saw an average of 14
patients a day, with treatments generally lasting three hours a day for
two to three weeks.

The investigators detained 11 Bio-Ionic devices for 30 days by taping
and tagging them with warnings about using the devices during the
detention period.

Meanwhile, at Kyttaron, two other FDA investigators detained two
completely assembled Bio-Ionic devices and various parts of partially
assembled units, including 24 overstuffed chairs, 63 empty cabinets, and
several batteries and battery chargers. At this time, the investigators
also discovered that the company did not keep production records, as
required by federal law.

Rapsomanikis, through his attorney, scheduled a meeting in November 1991
with FDA officials to discuss the devices' detention. The day before the
meeting was scheduled, however, Rapsomanikis canceled it. That Nov. 13,
he sued FDA, individual FDA investigators, KVBC-TV reporters, and the
Harrises, who had filed the initial complaint against him. His lawsuit
kept the case open until last fall.

U.S. marshals seized a semitruckload of the detained items on Nov. 29,
1991, at Kyttaron. When the marshals arrived at Paradise Pain Clinic
that same day to seize the devices there, they found the facility empty
of all but two incomplete devices. An informant later told FDA that
Rapsomanikis had moved the devices and promotional literature to another
location the night before the seizure. Investigators never located the
missing devices.

--Paula Kurtzweil


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


Contaminated Tea Destroyed

After an investigation by FDA and the New York City Health Department of
belladonna poisoning from drinking contaminated Paraguay Tea, the city
embargoed--and later destroyed--21 pounds of the imported dried herb.
Two victims with severe symptoms were given antidote to the poison and
recovered. Five victims with milder symptoms recovered without
treatment.

Belladonna poisoning typically causes fever, dilated pupils, rapid
heartbeat, flushed skin, agitation, and disorientation. It can be fatal
to older people, children, or heart patients.

The NYC Health Department found belladonna in the tea, and speculated it
may have come from jimson weed, a plant of the nightshade family, which
often grows alongside tea plants. Within a day of being notified of the
poisonings, FDA's Northeast Regional Laboratory, in independent testing,
also identified belladonna in the tea.

A report on the poisonings in the national Centers for Disease Control
and Prevention's March 24, 1995, Morbidity and Mortality Weekly Report
stated: "This report underscores the need for persons who use herbal
products to report any adverse reactions immediately to health
authorities. .... The public should be aware that all herbal products
have the potential to be misidentified when collected, mislabeled,
contaminated, or adulterated."

The first poisoning occurred March 20, 1994. Within a half-hour of
drinking Paraguay Tea, a couple and their 10-month-old baby developed
belladonna poisoning symptoms. The wife and baby were only mildly ill
and didn't require treatment. Because the husband's symptoms were
severe, he was given two doses of the antidote, physostigmine, derived
from another plant.

The next day, a 20-year-old woman was treated in a hospital emergency
room about an hour after drinking a cup of the tea. Her symptoms
included impaired thinking that progressed to stupor. Her stomach was
pumped, and she was given a laxative and also activated charcoal to
prevent absorption of the poison. Ten hours later, she was discharged.

On March 24, a 10-year-old boy became unusually agitated and restless an
hour after drinking the tea. His parents took him to an emergency room,
where he was given two doses of antidote. The parents and another son,
18 years old, also drank the tea. Both parents were diagnosed with
belladonna poisoning but required no treatment. The older son had left
for school immediately after drinking his tea.

The treating doctors reported their cases to the New York City Poison
Control Center and obtained samples of packaged tea from each family for
analysis. The day of the last case, the health department alerted FDA
and issued a news release on the hazard.

FDA's New York district office sent Gregson Joseph of the district to
investigate immediately with city health officials. His first stop was
the poison control center.

"Doctors at the center told me the 18-year-old's family didn't know
where he was," Joseph says. "The school reported he didn't show up."

While at the center, Joseph took samples from an opened bag of the tea
consumed by the family (also sampled and tested by the city), and from
an intact bag the family had given the center.

Next, Joseph, William Meggs, M.D., of the center, and a health
department sanitarian went to Maspeth, N.Y., to inspect Bonita Foods,
the firm listed on the tea label.

They learned that Ecuadorean Tropical Products, Inc., doing business as
Bonita, had imported the tea from Ecuador. "Robert Burgos, the firm's
president, said Bonita had imported only a few pounds," Joseph says,
"but he'd left the import records at his home, so he wasn't sure."

Bonita repacked the tea in half-ounce bags, and sold it to Casa America,
a local store owned by Burgos' father and managed by his brother. Burgos
gave Joseph copies of invoices showing sales to Casa America of four
cases, 24 bags per case, on March 17, 1994, and one case on March 23.
None was left at Bonita, Joseph was told. 

The investigators then went to Casa America. They found that, by order
of the police, the manager earlier that day had removed the tea from the
shelf. Only 24 bags had been sold. Joseph took a sample, and Meggs and
the sanitarian embargoed the rest. The manager agreed to put a notice in
the store telling customers who might have bought the tea not to consume
it, but to return it to the store.

Joseph delivered his samples to FDA's Northeast Regional Laboratory for
testing. From the poison control center, he learned the 18-year-old
victim had returned home, but was disoriented and couldn't account for
his whereabouts all day.

On March 25, Joseph returned to Bonita. Burgos had brought in the import
records, which showed importation of a 25-pound bag of Paraguay Tea,
listing it as "Aromatic Dry Leaves." He told Joseph that his father had
bought the tea during a trip to Ecuador in February.

Joseph notified the health department, which sent two sanitarians to
Bonita. Joseph collected a sample, as did the sanitarians, who then
embargoed the remaining tea.

That same day, FDA's regional laboratory provided Joseph with
preliminary results. Analysts Samuel Walker and Samuel Matthew had
identified atropine, scopolamine, and hyoscyamine belladonna alkaloids
in the tea by HPLC analysis, and the laboratory's mass spectroscopist,
Thomas Barry, confirmed the findings with more sophisticated testing.

The health department issued a second press release reporting some
results of the investigation.

On March 30, Joseph returned to Bonita. Burgos' father told him he had
purchased this Paraguay Tea in Guayaquil.

On April 4, FDA issued an import alert to increase sampling of imported
dried plant materials to be used in spices, teas, or other foods.

On Nov. 2, Joseph watched as health department sanitarian Compton Tucker
destroyed with antifreeze and ammonia or bleach all the embargoed tea,
valued at about $1,300.

--Dixie Farley

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


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: Pure Maple Syrup and Bear Mountain Honey, at Marysville and
Arlington, Wash. (W.D.Wash.); Civil No. C94-1587Z.

CHARGED 10-24-94: While held for sale after shipment in interstate
commerce at Eagle Creek Farms in Marysville and Arlington, respectively,
the articles were adulterated in that a sweetener resembling corn syrup
was substituted for maple syrup, honey, and sorghum syrup--402(b)(2).
The articles were misbranded in that their labeling falsely represented
that the articles consisted entirely of maple syrup, honey, and sorghum
syrup--403(a)(1); and the articles were offered for sale under the name
of another food--403(b). Furthermore, the maple and sorghum syrups
failed to conform to their definitions; instead, they consisted of
sweetener resembling corn syrup--403(g)(1).

DISPOSITION: A consent decree of condemnation and constructive
destruction ordered the articles delivered to a charitable institution.
(F.D.C. No. 67022; S. No. 94-736-103; S.J. No. 1)



PRODUCT: Scallops, at Middleboro, Mass. (D.Mass.); Civil No. 91-13102C.

CHARGED 11-26-91: While held for sale after shipment in interstate
commerce at Northeast Refrigerated Terminals, Inc., in Middleboro,
Mass., the articles were adulterated in that they consisted of
decomposed scallops--402(a)(3).

DISPOSITION: A consent decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 66320; S. No. 91-638-329; S.J. No.
2) 



PRODUCT: Scallops, at Chicago, Ill. (N.D.Ill.); Civil No. 95-C-1767.

CHARGED 3-22-95: While held for sale after shipment in interstate
commerce at Continental Freezer in Chicago, Ill., the articles were
adulterated in that they consisted of decomposed scallops--402(a)(3).

DISPOSITION: A consent decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 67074; S. No. 95-710-318; S.J. No.
3) 



Drugs/Human Use


PRODUCT: Helium and Oxygen, at Carol Stream, Ill. (N.D.Ill.); Civil No.
94-C-1948.

CHARGED 3-31-94: While held for sale after shipment of one or more of
their components in interstate commerce at BOC Airco Gases in Carol
Stream, Ill., the articles were adulterated in that the methods used in,
and the facilities and controls used for, their manufacture, processing,
packing, and holding did not conform to current good manufacturing
practice requirements--501(a)(2)(B).

DISPOSITION: A consent decree of partial condemnation and a final
consent decree of condemnation were filed. The articles were
reconditioned by the manufacturer. (F.D.C. No. 66937, S. No.
94-710-343/344; S.J. No. 4) 



PRODUCT: Liquid Oxygen, at Peoria, Ill. (C.D.Ill.); Civil No. 94-1217.

CHARGED 5-11-94: While held for sale after shipment of one or more of
its components in interstate commerce at Homedco, Inc., in Peoria, Ill.,
the article of drug 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).

DISPOSITION: A consent decree of condemnation was filed, and the article
was reconditioned. (F.D.C. No. 66593; S. No. 94-610-670; S.J. No. 5) 



PRODUCT: Oxygen USP, at Louisville, Ky. (W.D.Ky.); Civil No.
94-0466-L(M).

CHARGED 7-26-94: While held for sale after shipment of one or more of
its components in interstate commerce at Welding and Therapy, Inc.,
d/b/a Industrial Oxygen Co., in Louisville, Ky., 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).

DISPOSITION: A consent decree of condemnation was filed, and the article
was reconditioned by the manufacturer. (F.D.C. No. 66944; S. No.
94-671-704; S.J. No. 5) 



Drugs/Veterinary


PRODUCT: Gentamicin Sulfate, at Des Plaines, Ill. (N.D.Ill.); Civil No.
93-C-703.

CHARGED 2-3-93: While held for sale after shipment in interstate
commerce at British Airways Cargo Terminal in Des Plaines, Ill., the
article was misbranded in that its label failed to bear adequate
directions for use--502(f)(1).

DISPOSITION: A consent order was filed permanently enjoining the
claimant from importing, selling or distributing the article and four
other drugs. Furthermore, the consent order provided for the destruction
of the article and another animal drug, dimetridazole, that was found in
the claimant's possession. The articles were destroyed. (F.D.C. No.
66674; S. No. 93-661-157; S.J. No. 7) 



Medical Devices

PRODUCT: K6-I Diagnostic Systems and Physiotech 4000 Systems, at
Seattle, Wash. (D.Wash.); Civil No. C93-1045C.

CHARGED 8-6-93: While held at Myo-Tronics, Inc., in Seattle, Wash., the
articles were adulterated in that they were Class III devices without an
application for premarket approval--501(f)(1)(B).

DISPOSITION: A consent decree of condemnation and forfeiture was filed,
and the devices were brought into compliance. (F.D.C. No. 66619; S. No.
92-668-946; S.J. No. 8) 



PRODUCT: Micro-Swab, at Sudbury, Mass. (D.Mass.); Civil No. 92-10910MA.

CHARGED 5-12-92: While held for sale after shipment in interstate
commerce at Dutton Company d/b/a St. Germain Management Co., in Sudbury,
Mass., the article was adulterated in that it was a Class III device
that did not have an application for premarket approval--501(f)(1)(B).

DISPOSITION: A default decree of condemnation and destruction ordered
FDA to constructively destroy the condemned article by releasing it to
the district office for further regulatory use consistent with the Food,
Drug, and Cosmetic Act. (F.D.C. No. 66402; S. Nos. 92-648-890 and
92-648-886; S.J. No. 9) 



PRODUCT: Sterile Latex Surgical Gloves, at Monmouth, Ill. (C.D.Ill.);
Civil No. 93-4085.

CHARGED 10-4-93: While held at American Pro Latex in Monmouth, Ill., the
articles were adulterated in that the methods used in, and the
facilities and controls used for, their manufacture, packing and storage
did not conform to current good manufacturing practice
requirements--501(h).

DISPOSITION: A default decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 66766; S. No. 93-610-624; S.J. No.
10) 



PRODUCT: Ultrasonic Tips, at Long Beach, Calif. (C.D.Calif.); Civil No.
95-0219 MRP (JGX).

CHARGED 1-11-95: While held for sale after shipment in interstate
commerce at Sherburne Manufacturing Co., in Long Beach, Calif., the
articles were adulterated in that they were Class III devices that did
not have an application for premarket approval--501(f)(1)(B). The
methods used in, and the facilities and controls used for, their
manufacture, packing and storage did not conform to current good
manufacturing practice requirements--501(h).

DISPOSITION: A consent decree of condemnation was filed, and the
articles were brought into compliance. (F.D.C. No. 66722; S. No.
93-683-659; S.J. No. 11) 





CRIMINAL ACTIONS



DEFENDANT: American Therapeutics, Inc., at Bohemia, N.Y. (D.Md.);
Criminal No. HAR-90-077.

CHARGED 10-6-91: Count 1: The defendant, with intent to defraud and
mislead, caused the drug erythromycin to be adulterated, in that the
company manufactured the drug on nonvalidated, off-site equipment and
intentionally failed to prepare and maintain accurate batch production
and control records--301(k), 303(b), and 501(a)(2)(B). Count 2: The
defendant knowingly and willfully made and gave to FDA false batch
records for the generic drug sulindac that described the personnel and
manufacturing equipment used and identified the dates of certain
in-processing testing--18 U.S.C. Section 1001. Count 3: The defendant
concealed from FDA investigators various crumbled and discolored reserve
samples of the drug clorazepate dipotassium, and replaced the drug with
tablets that had been manufactured at a different time and had different
lot numbers and expiration dates--18 U.S.C. Section 1505.

DISPOSITION: Guilty plea; ordered to pay concurrently a $1 million fine,
a $500,000 fine, and a $600 penalty. Ranju Vegesna, CEO of American
Therapeutics, Inc., was also indicted and pleaded guilty to counts 1 and
2. He was ordered to pay a $50,000 fine and sentenced to three years'
probation and 1,000 hours of community service. (F.D.C. No. 65716; S.
No. 89-601-461; S.J. No. 12)



DEFENDANT: Henry J. Moore, at Bayou La Batre, Ala. (S.D.Ala.); Criminal
No. 95-00002-AH.

CHARGED 1-11-95: Counts 1-4: The defendant, d/b/a Fish Market Inc.,
adulterated claw crab meat, cocktail claw finger crab meat, and backfin
crab meat, which consisted of a filthy substance, and the articles were
packed, produced, prepared, and held under insanitary
conditions--402(a)(3) and 402(a)(4).

Counts 5-6: The defendant, d/b/a Crab Company, Inc., adulterated claw
crab meat and lump crab meat, which consisted of a filthy substance, and
the products were prepared, packed and held under insanitary
conditions--402(a)(3) and 402(a)(4). DISPOSITION: Guilty plea; ordered
to pay a $50 special assessment for counts 1 and 5; sentenced to three
years' probation and four months' home confinement. (F.D.C. No. 66584;
S. No. 91-575-076; S.J. No. 13)





INJUNCTION ACTIONS


DEFENDANT: Carter Wallace, Inc., at Cranbury, N.J. (D.NJ); Civil No.
94-3085.

CHARGED 6-29-94: While held for sale after shipment of one or more of
their components in interstate commerce at Carter Wallace, Inc., in
Cranbury, N.J., the drugs were adulterated in that they were unapproved
new drugs distributed in interstate commerce--301(d). The drugs were
misbranded in that they failed to bear adequate directions for use when
introduced into interstate commerce--301(d) and 301(k). 

DISPOSITION: A consent decree of permanent injunction was filed, and the
drugs were destroyed. (Inj. No. 1366; S. No. 94-648-183; S.J. No. 14) 



DEFENDANTS: Molinos de Puerto Rico, To-Ricos, Inc., and ConAgra Inc., at
Guaynabo, Hatillo, and Las Piedras, Puerto Rico (D.Puerto Rico); Civil
No. 94-2478(CC).

CHARGED 11-1-94: While held for sale after shipment of one or more of
their components in interstate commerce at the respective feed mills in
Guaynabo, Hatillo, and Las Piedras, Puerto Rico, the articles of
medicated and nonmedicated animal feed were adulterated in that the
methods used in, and the facilities used for, their manufacture,
processing, packing, or holding did not conform to good manufacturing
practice requirements--501(a)(2)(B).

DISPOSITION: A consent decree of permanent injunction was filed, and the
articles were brought into compliance with the decree. (Inj. No. 1359;
S. No. 94-637-448; S.J. No. 15) 


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


FDA Consumer is the official magazine of the U.S. Food and Drug
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for the general public on FDA-related health issues. The magazine also
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to show how the agency protects the public from unsafe or worthless
products.

FDA Consumer is published monthly, except for combined issues for
July-August and January-February. Subscriptions are available for $15
per year by writing:

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Government Printing Office
Washington, DC 20402-9371.

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