HICNet Medical News Digest Mon, 01 May 1995 Volume 08 : Issue 16 Today's Topics: 1995 FDA Consumer Articles +------------------------------------------------+ ! ! ! Health Info-Com Network ! ! Medical Newsletter ! +------------------------------------------------+ Editor: David Dodell, D.M.D. 10250 North 92nd Street, Suite 210, Scottsdale, Arizona 85258-4599 USA Telephone +1 (602) 860-1121 FAX +1 (602) 451-1165 Internet: mednews@stat.com Bitnet: ATW1H@ASUACAD Mosaic WWW *Asia/Pacific: http://biomed.nus.sg/MEDNEWS/welcome.html *Americas: http://cancer.med.upenn.edu:3000/ *Europe: http://www.dmu.ac.uk/ln/MEDNEWS/ Compilation Copyright 1995 by David Dodell, D.M.D. All rights Reserved. License is hereby granted to republish on electronic media for which no fees are charged, so long as the text of this copyright notice and license are attached intact to any and all republished portion or portions. The Health Info-Com Network Newsletter is distributed biweekly. Articles on a medical nature are welcomed. If you have an article, please contact the editor for information on how to submit it. If you are interested in joining the automated distribution system, please contact the editor. Associate Editors: E. Loren Buhle, Jr. Ph.D. Dept. of Radiation Oncology, Univ of Pennsylvania Tom Whalen, M.D., Robert Wood Johnson Medical School at Camden Douglas B. Hanson, Ph.D., Forsyth Dental Center, Boston, MA Lawrence Lee Miller, B.S. Biological Sciences, UCI Dr K C Lun, National University Hospital, Singapore W. Scott Erdley, MS, RN, SUNY@UB School of Nursing Jack E. Cross, B.S Health Care Admin, 882 Medical Trng Grp, USAF Albert Shar, Ph.D. CIO, Associate Prof, Univ of Penn School of Medicine Stephen Cristol, M.D. MPH, Dept of Ophthalmology, Emory Univ, Atlanta, GA Subscription Requests = mednews@stat.com anonymous ftp = vm1.nodak.edu; directory HICNEWS FAX Delivery = Contact Editor for information ---------------------------------------------------------------------- To: hicnews 0100000@orichalc.acsu.buffalo.edu> 1995 FDA CONSUMER ARTICLES OTC Options: Pain, Pain Go Away by Ruth Papazian Used to be, aspirin and other salicylates were the only medications available for nonprescription relief of minor ailments- -from headaches and fever to muscle strain and minor arthritis. Today, consumers looking for temporary relief from such garden- variety ills have their pick of what can be a bewildering array of "regular," "extra-strength," and "maximum pain relief" tablets, caplets and gel caps on the drugstore shelf. Though this cornucopia can seem confusing, the products' pain- relieving ingredients fall into just four categories: aspirin (and other salicylates), acetaminophen, ibuprofen, and naproxen sodium. For the most part, these over-the-counter (OTC) analgesic ingredients are equally effective. However, some may be more effective for certain types of ailments, and some people may prefer one type to another because of their varying side effects. "Knowing the pros and cons of each type of pain reliever will allow you to choose among them," says William T. Beaver, M.D., professor of pharmacology and anesthesia at Georgetown University School of Medicine in Washington, D.C. Old Faithful Americans have been reaching for aspirin for almost 100 years as an all-purpose pain reliever (see "Aspirin: A New Look at an Old Drug" in the January-February 1994 FDA Consumer). Aspirin (or acetylsalicylic acid) works in part by suppressing the production of prostaglandins, hormone-like substances that have wide-ranging roles throughout the body, such as stimulating uterine contractions, regulating body temperature and blood vessel constriction, and helping blood clotting. "Regular" strength aspirin contains 325 milligrams (mg) per tablet; "extra" or "maximum" strength, 500 mg per tablet. The usual adult (defined as 12 years and older) dosage is one to two 325-mg aspirin tablets every four hours. Some manufacturers add caffeine to aspirin. "There is no evidence that caffeine relieves pain, but it can enhance the effects of aspirin, possibly by lifting a person's mood," says Michael Weintraub, M.D., director of FDA's Office of OTC Drug Evaluation. Since a two-tablet dose provides roughly the same amount of caffeine as a cup of coffee, you can get the same effect by taking two plain aspirin with coffee. To minimize the stomach irritation aspirin can cause, some brands are "buffered" with calcium carbonate, magnesium oxide, and other antacids or coated so the pills don't dissolve until they reach the small intestine. Buffered formulas may offset aspirin's directly irritating effects on the stomach lining. They may be useful for people who get heartburn or stomach pain when they take aspirin, as well as for those with arthritis, who need to take as much as 4,000 mg every day. Aspirin also causes gastrointestinal (GI) upset indirectly (by inhibiting production of a prostaglandin that protects the stomach lining by stimulating mucus production); buffering does nothing to offset this effect. The downside of coated aspirin products is that they may take up to twice as long to provide pain relief as plain aspirin, according to Weintraub. Last September, an FDA advisory panel recommended that labels on products containing aspirin warn that heavy drinkers are especially vulnerable to developing GI bleeding. Aspirin should not be taken by people who have: ~ ulcers, because it can worsen symptoms ~ asthma, because it can trigger an attack in some asthmatics ~ uncontrolled high blood pressure, because of an increased risk of one type of stroke ~ liver or kidney disease, because it may worsen these conditions ~ bleeding disorders or who are taking anticoagulant medication, because it may cause bleeding. Continual high dosages of aspirin can cause hearing loss or tinnitis--a persistent ringing in the ears. FDA requires products containing aspirin and other salicylates to carry a label warning that children and teenagers should not use the medicine for chickenpox or flu symptoms because of its association with Reye syndrome, a rare disorder that may cause seizures, brain damage, and death. The label also alerts pregnant women that use of aspirin in the last trimester may increase the risk of stillbirth and of maternal and fetal bleeding during delivery. One Aspirin Alternative Twenty years ago, FDA approved acetaminophen (Tylenol, and other brands and generics) in dosages of 325 mg and 500 mg for OTC use. "Nobody knows exactly how acetaminophen works, but one theory is that it acts on nerve endings to suppress pain," says Weintraub. Acetaminophen is as effective as aspirin in relieving mild-to- moderate pain and in reducing fever, but less so when it comes to soft tissue injuries, such as muscle strains and sprains, he adds. The usual adult dosage is two 325-mg tablets every four hours. Acetaminophen-based products to ease menstrual cramps often contain other ingredients, such as pamabrom (a diuretic) or pyrilamine maleate (an antihistamine used for its sedative effects). "While these ingredients are safe, they have not been proven effective against uterine cramps, although they may relieve other symptoms associated with menstrual pain," says Weintraub. Though acetaminophen is no better or faster at pain relief than aspirin, the drug is gentler on the stomach and reduces fever without the risk of Reye syndrome. However, even at moderate doses, acetaminophen can cause liver damage in heavy drinkers. At press time, FDA was planning to require a warning about this on the labels of OTC products containing the drug. >From Rx to OTC Like aspirin, ibuprofen and naproxen sodium inhibit prostaglandin production. However, they are more potent pain relievers, especially for menstrual cramps, toothaches, minor arthritis, and injuries accompanied by inflammation, such as tendinitis. FDA approved ibuprofen for OTC marketing in 1984 at a dosage level of 200 mg every 4 to 6 hours, and naproxen sodium in 1994 at a dosage level of 200 mg every 8 to 12 hours. "Ibuprofen and naproxen sodium were converted to OTC status after their manufacturers did the necessary studies to show that these pain relievers were effective at OTC dosages, which are lower than prescription dosages," explains Weintraub. The lowest dosage strength for prescription-strength ibuprofen (Motrin and others) is 300 mg per tablet, and 275 mg per tablet for the prescription version of naproxen sodium (Anaprox, for example). "In addition, the pharmaceutical companies had to show that these drugs were safe for use by a larger, more varied group of people [than would have received them by prescription only] and that the drugs were safe to use without medical supervision, as is the case with all nonprescription drugs." Taken at the recommended adult dosage, OTC ibuprofen (Advil and others) and naproxen sodium (Aleve) are somewhat gentler on the stomach than aspirin. However, people who have ulcers or who get GI upset when taking aspirin should avoid both. In addition, asthmatics and people who are allergic to aspirin should avoid ibuprofen and naproxen sodium. An FDA advisory panel has recommended labeling on ibuprofen products like that recommended for aspirin, warning heavy drinkers about increased risk of gastric bleeding and impaired liver function (products with naproxen sodium labels already include this information). Although ibuprofen and naproxen sodium interfere with blood clotting much less than aspirin does, they should not be used by people who have bleeding disorders or who are taking anticoagulants. Children under 12 should not be given either drug, except under a doctor's supervision, and people over 65 are advised to take no more than one naproxen sodium tablet every 12 hours. Choosing an OTC pain reliever involves balancing effectiveness for a particular ailment with side effects. Often this is a very individual choice, based in part on your health history and how the drug affects you. Regardless of which type of OTC pain reliever you choose, remember that it is intended to be used on a short-term basis, unless directed by a doctor, cautions Weintraub. The warning labels on these products include limitations on duration of use to ensure that chronic or serious illnesses are not masked. Typically, labels advise against taking the product for more than 10 days to relieve pain (for children, the upper limit is five days), or more than three days to reduce fever. If symptoms worsen, pain persists, or there is redness or swelling, medical attention should be sought. Ruth Papazian is a writer in New York City. ****************************************************************** HACCP: Patrolling for Food-Borne Illness by Paula Kurtzweil Like a cop on the beat, James Reed patrols his assigned food processing area daily for any wrongdoing. But instead of seeking out thugs on street corners, he's prowling for broken glass and other food hazards lurking inside automated food processing lines. Reed is a lead person in Heinz USA's Pittsburgh factory, where he oversees the filling and capping of 900 baby food jars a minute. Several times a day he fills in for other employees and stops the processing line, checks the machine for glass, documents findings via computer, and, if necessary, withdraws the affected food products for disposal. Reed's actions are part of a new food safety system that focuses on preventing food-borne hazards that can cause illness. The system is known as Hazard Analysis Critical Control Point, or HACCP (pronounced hassip), and Heinz is one of a number of U.S. food manufacturers that have adopted it within the last five years. The National Food Processors Association estimates that about half of its 300 member processors use some form of HACCP in their operations. More may soon join them. In August 1994, FDA announced in an advance notice of proposed rule-making that it was considering whether to make HACCP mandatory for much of the U.S. food supply. FDA already requires HACCP for the low-acid canned food industry and has proposed it for the seafood industry. Also, FDA incorporated HACCP into its 1994 Food Code. The Food Code is FDA's guidance and recommendations to state and territorial agencies that license and inspect retail food establishments in the United States and can serve as a model for them. Many restaurants and retail food establishments already follow HACCP principles, some because their local regulators mandate it. (See "New Food Code: A Menu of Modern Safety Standards" in the April 1994 FDA Consumer.) And, the U.S. Department of Agriculture has announced it will propose HACCP for the meat and poultry industry. (USDA regulates meat and poultry; FDA all other foods.) "This system--though it is simple and based on common sense-- signals one of the broadest food safety policy shifts in the last 50 years," said FDA Commissioner David A. Kessler, M.D. Old vs. New Traditionally, industry and regulators have depended on spot- checks of manufacturing conditions and random sampling of final products to ensure safe food. This system is seen as more reactive than preventive because it finds problems after they have occurred rather than as the food is being prepared. HACCP, on the other hand, focuses on problem prevention. Companies analyze their food production processes and determine the "critical control points." These are points in a food's production- -from its raw state through processing and shipping to consumption by the consumer--at which hazards can be prevented, controlled or eliminated. At Heinz USA in Pittsburgh, for example, there are several critical control points on the "capper," the machine that places caps on baby food jars. One potential hazard is broken glass. Even though the machine can automatically detect the presence of broken glass, employees stop the line and inspect the machine every half hour for broken glass. This checking is a preventive measure. It helps ensure that glass does not get into the baby food. Cooking, chilling, sanitizing, preventing cross contamination, and employee hygiene are other examples of critical control points. What HACCP doesn't do is replace basic sanitation and good manufacturing practices that are a part of today's food safety system, noted Jeffery Rhodehamel, a microbiologist in FDA's division of HACCP programs. "HACCP works in concert with them," he said. HACCP Close Up As it does at Heinz, a HACCP program typically involves seven steps: ~ Analyze hazards. Potential hazards associated with food are identified. The hazard could be biological (such as a microbe), chemical (such as mercury), or physical (such as broken glass or metal). Also, establish preventive measures to control identified hazards. ~ Identify critical control points. ~ Establish critical limits for each preventive measure associated with a critical control point. An example for cooked food might include setting the minimum cooking temperature and time required to ensure a safe product. The temperature and time are the critical limits. ~ Establish procedures to monitor the control points. Such procedures might include determining how and by whom cooking time and temperature should be monitored. ~ Establish corrective actions to be taken when monitoring shows that a critical limit has not been met. Examples are reprocessing or disposing of food if the minimum cooking temperature is not met. ~ Establish effective record keeping to document the HACCP system. At Heinz USA in Pittsburgh, record keeping is computerized. ~ Establish procedures to verify the system is working consistently--for example, auditing records to confirm that all critical limits have been met during a production run. Each of these steps has to be based on sound scientific and technical knowledge, such as published microbiological studies. Why HACCP? A number of national and international organizations have endorsed HACCP, including the National Advisory Committee on Microbiological Criteria for Foods, which includes government and non-government food safety experts, and the Codex Alimentarius Commission, an international food standard-setting organization. HACCP is viewed favorably because of its potential to help the United States and other countries cope with new food safety challenges. Among the challenges most often cited is an increase in the number of human disease outbreaks due to food-borne microbial pathogens. For example, between 1973 and 1988, bacteria not previously recognized as important causes of food-borne illness in the United States--such as Escherichia coli O157:H7, Listeria monocytogenes, and Salmonella enteritidis--became more widespread. "Fifty years ago, we were dealing with only a limited number of food-borne pathogens," said FDA's Rhodehamel, referring to Clostridium botulinum, Staphylococcus aureus, Salmonella, and the parasite Trichinella spiralis. "Today, the list of known food-borne pathogens is much more extensive." There also is increasing concern about chemical contamination, such as the effects of lead on the nervous system. Another problem is that processing and packaging systems designed to prolong shelf life may introduce new food safety risks. Also of interest is the increasing size of the U.S. food industry--both in the amount of domestic food manufactured and the number and kinds of foods imported. FDA now lists over 30,000 food manufacturers and processors and more than 20,000 food warehouses in its inventory, and in 1992 alone dealt with more than 1 million imported food items. At the same time, FDA and state and local agencies face severe resource constraints that make it increasingly difficult to ensure food safety. Advantages Advocates of HACCP believe that it offers a number of advantages to help deal with these challenges. Most importantly, HACCP: ~ focuses on preventing hazards from contaminating food ~ is based on sound science úÿ ~ places responsibility for ensuring food safety on the food manufacturer or distributor. Under a HACCP-based inspection system, the food company develops the HACCP plan, and government's role is to verify that the company is carrying out its plan. Government monitoring would ensure that preventive controls are in place and working properly. ~ permits more efficient and effective government oversight, primarily because the record keeping allows government investigators to see how well a firm is complying with food safety laws over time rather than how well it is doing on any given day. Under the proposal FDA envisions, the agency would have access to critical control point records. ~ helps food companies compete more effectively in the world market. Members of the European Union and other countries, such as Canada, will soon require imported foods and foods made within their borders to be processed under HACCP requirements. At the Heinz plant in Pittsburgh, company officials have discovered another advantage: a potential savings to the company. According to Ed Sonnet, technical operations consultant for Heinz USA, the HACCP system seems to have led to a drop in the number of stock cases held at the company's Pittsburgh plant. These are cases of food that are withheld from the market because of poor quality or safety concerns. "We have a very strong feeling in our minds that HACCP is doing a good job for us," he said. "We think we'll be able to quantify it a lot better when we go into our other plants." Sonnett said HACCP will be implemented in the company's four other U.S. manufacturing facilities by April 1995. What's Ahead FDA has begun reviewing comments it received in response to its August 1994 advance notice of proposed rule-making. At press time, in late 1994, the agency was planning to begin a pilot HACCP program with about six food manufacturing companies. FDA will use information from this program to help decide whether to propose a HACCP system for industry, and, if so, to what extent. If FDA decides to implement HACCP for the seafood industry, it expects to issue final regulations this year. This program, along with HACCP programs already in use, will likely lay the groundwork for future food safety in the United States and the world. Paula Kurtzweil is a member of FDA's public affairs staff. ******************************************************************** Plasma Center Owner Sentenced The owner of a Cincinnati plasma center has been sentenced for illegally shipping source plasma used in manufacturing in vitro reagents for testing blood groups. Victor Torbeck, owner of Cincinnati-based Worldwide Biologicals, Inc., was sentenced Sept. 23, 1994, in the U.S. District Court for the Southern District of Ohio, Western Division, to six months home confinement and three years supervised probation. He was also fined $5,500 and assessed a $200 court fee. Torbeck pleaded guilty April 29 to two counts of introducing into interstate commerce a misbranded medical device with the intent to defraud and mislead, one count of misbranding a medical device after receipt from interstate commerce and while held for sale, and one count of making a false representation to FDA. As part of his plea agreement, Torbeck surrendered the United States license for his plasma center and is barred for life from working in the blood or plasma business. In vitro reagents are considered medical devices under the Food, Drug, and Cosmetic Act. Source plasma centers that ship their products in interstate commerce are required to be licensed by FDA. A routine inspection of Torbeck's Cincinnati laboratory July 18, 1991, by FDA's Cincinnati district revealed violations of the agency's good manufacturing practice (GMP) regulations. Investigators found that the laboratory was not adequately testing blood products it received from all four of Torbeck's collection centers--two in Cincinnati, including the firm's corporate headquarters, one in Fayetteville, N.C., and one in Nashville, Tenn. As a result of the GMP violations, FDA suspended the license of the Cincinnati laboratory on Oct. 1. "We asked that [Torbeck] select another lab, which FDA had to approve, to test the materials that he collected," said compliance officer Eric Batchelor. Concurrently, FDA investigators in Raleigh, N.C., found that the Fayetteville Center also had GMP violations and its license was also suspended Oct. 1. The following month, FDA allowed the Fayetteville Center to resume collecting plasma for purposes of a reinspection. In March 1992, the center was permitted to ship the products collected in Fayetteville to Torbeck's corporate headquarters solely for storage. However, he was not permitted to sell any plasma that had been collected at the Fayetteville Center. On July 15, 1992, FDA learned from a confidential informant that Torbeck had illegally sold and shipped from the center in Cincinnati plasma that had been collected in Fayetteville. On Sept. 20, 1992, FDA investigators, along with U.S. marshals, seized the records from Torbeck's Cincinnati corporate headquarters facility. From records, investigators learned that Torbeck had received from his Fayetteville center 12 bottles of plasma containing the valuable antibody to the red blood cell Rh antigen E, which is the primary component of Anti-E blood grouping reagent. They found that on May 11, 1992, Torbeck illegally shipped to Frankfurt, Germany, three bottles of plasma containing Anti-E and on May 22, he shipped one bottle of misbranded plasma containing Anti-E to Conroe, Texas. Torbeck had no license to make either of these shipments. Agency investigators also learned that Torbeck falsely labeled bottles of plasma as containing Anti-E to hide the fact that he had illegally shipped the four bottles of plasma drawn from the Fayetteville center. During an FDA inspection on June 26, Torbeck told agency investigators that 12 bottles of plasma contained Anti-E, as the labels stated, and were drawn from his Fayetteville center. The investigators knew these statements were false. In November 1992, FDA asked the district court to issue subpoenas to major U.S. manufacturers of medical devices using blood products, requesting shipping and receiving information concerning blood products received from Worldwide Biologicals. During the next 16 months, agency investigator Marianne Allen evaluated the manufacturers' records to try to determine when and to whom Torbeck had shipped plasma. Based on FDA's evidence, Torbeck pleaded guilty to all counts on April 29, 1994, rather than proceed with a grand jury indictment. As a result, Torbeck transferred ownership of his Cincinnati corporate headquarters to his son. The three remaining collection centers, in Cincinnati, Nashville and Fayetteville, have all since closed. --Kevin L. Ropp Sorry, Wrong Label As a result of reporting to FDA a tomato can labeled "rejected due to rust," a consumer in Lindhurst, N.Y., received an apology and gift certificate from the California manufacturer who mistakenly left the test label under a regular label after reconditioning the can. The consumer discovered the test label while preparing cans for recycling last spring and was concerned that food was possibly being marketed in rusty cans. Fortunately, this was not the case, and the manufacturer promised FDA it would try to keep its employees "on their toes." Consumer safety officer Rochelle Globus, of FDA's Long Island resident post, in the New York district, investigated the complaint on June 21, 1994. Globus collected copies of the label and reported the incident to FDA's San Francisco district office, which has jurisdiction over the manufacturer, Tri-Valley Growers plant no. 7, in Modesto, Calif. On July 20, Robert Howell, of the San Francisco district's Stockton resident post, visited the plant and showed George Bishop, the plant's distribution quality control manager, photocopies of both labels. Bishop identified the can as having been manufactured at his plant in 1991. Howell learned that Tri-Valley destroyed badly rusted cans, but that it was not uncommon for the firm to recondition cans with only minor rust. As interpreted by Bishop, the coding on the test label indicated the can had undergone such reconditioning, completing the process May 4, 1992. "Bishop insisted that before redistributing the products, can integrity and appearance is always checked," Howell says. "He said he would use my visit and the example to reinforce standing policy and insure test labels would be removed. He said that while these types of slip-ups are uncommon, they do happen, and that he would try to keep his people on their toes." --Dixie Farley ****************************************************************** Huge Cache of Frozen Foods Destroyed Eleven vendors storing 58 tons of frozen vegetables and seafood in a Washington state warehouse voluntarily destroyed the food after a ruptured refrigerant line severely contaminated the goods with ammonia gas. Seattle-based Olympic Cold Storage Service Inc., which has since gone out of business, had housed the foods in its 90-year-old facility. The disposed goods were worth "several hundred thousand dollars," according to FDA documents. On Feb. 24, 1994, a forklift operator ran the lift into an ammonia line on the third floor of the four-story facility. Ammonia gas seeped from the damaged line into the third-floor storage area and penetrated the packaging of frozen foods stored there, says Tom Piekarski, compliance officer in FDA's Seattle district. "The company repaired the leak and tried to vent the gas with fans," Piekarski says. "But from what we could determine, the damage had already been done." Only food stored on the third floor was contaminated. In mid-March, during a routine inspection of the facility, a U.S. Department of Agriculture official noticed a strong ammonia smell and notified FDA, which sent an investigator and an analyst to inspect the warehouse March 22. On site, the FDA investigator was nearly overcome by the strong ammonia odor. He choked and his eyes burned, yet he was able to collect several food samples for testing. The analyst stayed outside the facility. That same day, a Washington state inspector placed a 30-day embargo on food stored on the facility's third floor. An FDA laboratory analysis of the samples confirmed that ammonia contamination had rendered the goods unfit for human consumption. When the state's embargo expired, the 11 owners of the damaged food agreed voluntarily not to distribute the goods. Meanwhile, FDA began the process of filing for seizure of the food. But by mid-May, Olympic Cold Storage had decided to go out of business. With no storage space and with the possibility of seizure, the food owners agreed to destroy all the contaminated goods. From May 25 to 31, the food was taken to a local transfer station for final transport to a waste management facility in Arlington, Ore., where it was buried in a landfill. By not having to seize, store and dispose of the goods, the federal government saved "thousands of dollars," Piekarski says. --John Henkel ******************************************************************* Orange Juice Scheme Gone Sour by Paula Kurtzweil A scheme to produce and sell bogus orange juice concentrate via secret rooms, hidden pipes, and deceptive record keeping has left two Kentuckians with prison terms of more than six years each. These are the longest sentences ever imposed for adulteration of orange juice. Four other people also were sentenced, and two still await sentencing. On Oct. 12, 1994, Judge John G. Heyburn of the U.S. District Court in Louisville, Ky., sentenced Patsy J. Mays, former owner, director, and secretary-treasurer of Sun Up Foods Inc. of Benton, Ky., to six years and eight months in prison and imposed a $100,000 fine. Her brother-in-law, Samuel W. Mays, former Sun Up vice president and operations manager, received the same prison sentence. He was not fined. At press time, James V. Mays--Patsy Mays' husband and the acknowledged ringleader of the hoax--awaited sentencing scheduled for Dec. 6, 1994. He is a former owner, director and president of Sun Up. The previous May 6, James Mays, Patsy Mays and Samuel Mays were convicted on one count of conspiracy and 20 counts of violating the Federal Food, Drug, and Cosmetic Act. James Mays and Patsy Mays also were found guilty of seven and five counts of mail fraud respectively. The company had been substituting an inexpensive liquid beet sugar for some of the more expensive orange juice concentrate, labeling the product unsweetened orange juice concentrate, and selling it to manufacturers and dairies for making juice for retail sales. According to documents obtained by FDA, the scheme allowed Sun Up to increase its sales from almost nothing in 1984--its second year of operation--to more than $57 million in 1989. The extent of the conspiracy was discovered in an FDA investigation that included more than 250 interviews with at least 150 former employees, suppliers, builders, customers, and others who did business with Sun Up. Investigators also reviewed an estimated 1 million paper and computer documents seized by U.S. marshals with help from FDA. The marshals also seized several objects, including an electric control panel that had disguised an entryway, as evidence of Sun Up's efforts to carry out the fraud in secrecy. Also sentenced Oct. 12 were: ~ James Timothy Mays--son of James and Patsy Mays--Sun Up's vice president of sales and marketing. He pleaded guilty to one count of conspiracy and was sentenced to 20 months in prison. ~ Elizabeth Mays Murphy--the Mays' daughter--who, with her husband, Stephen Murphy, owned Candy Base Co., a Sun Up sugar supplier. They pleaded guilty to nine counts of Food, Drug, and Cosmetic Act violations and were placed on probation for two years. ~ John Donald Langness, Sun Up's production and plant manager. He pleaded guilty to one count of conspiracy and was placed on probation for four years. Frank Farmer, another Sun Up sugar supplier, pleaded guilty to one count of adulteration of orange juice with intent to mislead and defraud. He was fined $50 and sentenced to three years probation. As part of the plea agreements, these five testified against James, Samuel and Patsy Mays during a three-week trial. Sun Up filed for bankruptcy in September 1990, under Chapter 11 of the Federal Bankruptcy Act. It shut down in May 1992. The plant is now under new ownership. FDA first learned of possible illegal activities at Sun Up in the late 1980s, when employees of Sun Up and other companies anonymously reported to FDA that Sun Up was substituting sugar for orange juice concentrate and marketing the product as an unsweetened orange juice product. At that time, Sun Up operated a plant in Louisville, Ky. FDA inspections of the plant found no evidence to support the complaints. In late 1989, Sun Up moved its operations to a new facility in Benton, Ky. In spring 1990, an East Coast customer of Sun Up recalled an entire shipment of the product it had bought after laboratory analysis showed contamination with beet sugar. FDA later learned that because of the resulting publicity, Sun Up lost about 90 percent of its business in the first 60 days following the recall. As a result, the company had to lay off employees and reduce salaries by almost half. In December 1990, Leonard Farr, a compliance officer in FDA's Cincinnati district office, attended a Florida Citrus Commission interview of a former Sun Up employee. In an affidavit, the employee indicated that at both its facilities, the company had bought large amounts of sugar and had set up secret rooms to hold tanks of liquid beet sugar. The employee also provided copies of purchase records and names of people who would talk about Sun Up's activities. FDA immediately got a search warrant for the Benton facility. During the search on Dec. 21, 1991, records were seized; however, FDA investigators could not locate the secret room described by the informant. During the next four months, FDA investigators conducted interviews and, at one of them, learned the location of the secret room. After obtaining a second search warrant on May 8, 1991, and accompanied by U.S. marshals, FDA investigators again searched the facility. This time, they found the hidden room. At FDA's request, U.S. marshals seized a 4-by-2 1/2-foot steel electric control panel, which disguised the only entry to the room. Investigators also located stainless steel pipes hidden in the walls. The pipeline was linked to the main processing area. During searches in May and July 1991, FDA investigators identified a similar setup in the abandoned plant. They had to rebuild the pipe system to see if some discarded pipes found on the plant's property fit into the secret setup. They did. "I never saw anything as sophisticated as this," Farr said. "These pipes were really well-hidden." Farr said the pipes were set up to look like part of the sewage system, and during a government inspection, the line carrying the sugar could be shut off and the outside pipe closed to conceal the sugar line inside. Additional evidence showed that Sun Up: ~ ran its illegal activities from at least 1985 to late 1990 ~ secretly received under cover of night up to 20 million pounds of beet sugar ~ used Candy Base Co., of Louisville, Ky., and Murray, Ky., and Frank Farmer, in Jackson, Tenn., as fronts for buying sugar. Both billed Sun Up to make it look like they bought "orange concentrate" instead of sugar. ~ cheated consumers out of $10 million to $20 million in fake orange juice. FDA received no reports of deaths or illness from the "sugar- sweetened" juice concentrate. Paula Kurtzweil is a member of FDAs public affairs staff. ****************************************************************** The New Food Label Better Information for Special Diets by Paula Kurtzweil (This is the fifth and last in a series of articles telling how to use the new food label to meet specific dietary needs.) The right diet is important for everyone, but for Tony Robinson of Orlando, Fla., it truly is his lifeblood. Robinson has end-stage renal disease. Three times a week, he goes to a local medical center, where a dialysis machine does what his kidneys no longer can: purify his blood. Between treatments, he's careful about what he eats because some nutrients can cause harmful--sometimes deadly--levels of substances to build up in his blood. He eats a diet low in protein, sodium and potassium to keep those dangerous substances minimal, and high in calories to maintain his weight. Until recently, he and his wife, who does most of the cooking, kept mainly to foods listed in a brochure of "foods to eat" and "foods to avoid" for people with end-stage renal disease. But now they're using the new food label as another source of information. "The new label adds to what we already know," Robinson said. "And mandatory nutrition labeling gives us the information we need to choose from a wider range of food products." Label Benefits Under the Nutrition Labeling and Education Act of 1990 and regulations from the Food and Drug Administration and the U.S. Department of Agriculture, virtually all food labels must now give information about a food's nutritional content. That wasn't always the case. Until 1994, nutrition information úÿ was voluntary. Manufacturers had to provide it only when a food contained added nutrients or when nutrition claims appeared on the label. Nearly 40 percent of products didn't carry nutrition information. "Just to have the information on the label is a big plus for consumers on therapeutic diets," said Camille Brewer, a registered dietitian and nutritionist in FDA's Office of Food Labeling. Another group the regulations help is people with food sensitivities. Every product with two or more ingredients must now list the ingredients on the label. That includes standardized foods, such as peanut butter, and some baked goods. These foods previously were exempt from ingredient labeling because at one time, most Americans were familiar with the recipes since they were foods routinely prepared at home. Also, the source of some ingredients (for example, hydrolyzed soy protein) must now be identified. Get the Nutrition Facts Consumers looking for nutrition information about a food should first look at "Nutrition Facts," usually on the side or back of the package. For many people on special diets, the amount of the nutrient in grams or milligrams is most important because their diets are based on a set amount of one or more nutrients a day specific to their needs--for example, 60 grams (g) of protein, 2,000 milligrams (mg) of sodium a day. Special dieters can find the amount by weight of nutrients listed in the top part of the Nutrition Facts panel. Some important points about the Nutrition Facts panel: The values listed for total carbohydrate include all carbohydrates, including dietary fiber and sugars listed below it. The sugars include naturally present sugars, such as lactose in milk and fructose in fruits, as well as those added to the food, such as table sugar, corn syrup, and dextrose. The label can claim "no sugar added" but still have naturally occurring sugar. An example is fruit juice. Also, potassium may be listed voluntarily with the nutrients listed on the top part of the panel, just below sodium. Its % Daily Value is based on a recommended intake of 3,500 mg a day. Other vitamins and minerals may be listed on the Nutrition Facts panel, along with vitamins A and C, iron, and calcium. Amounts of vitamins and minerals are only presented as percentages of the Daily Value. Calorie information appears at the top of the Nutrition Facts panel, following serving size information. This information is important for those needing to increase or decrease their calories. Serving Size The serving size information gives the amount of food to which all the other numbers on the Nutrition Facts panel apply. Now serving sizes are more uniform among similar products and are designed to reflect the amounts people actually eat. Also, serving sizes must be about the same for the same types of products--for example, different brands of frozen yogurt--and for similar products within a food category--for example, ice cream, ice milk, and sherbet within the category frozen dairy-type desserts. Having more uniform serving sizes makes it easier to compare the nutritional values of related foods. People who follow special diets should be aware that the serving size on the label may not be the same as that recommended for their specific needs. For example, the label serving size for cooked fish is 3 ounces (84 g). A person following a 60-gram protein diet may be allowed only 1 ounce (28 g) of fish at a meal. So, in this case, the nutrient values would have to be divided by 3 to determine the nutritional content of the 1-ounce portion eaten. Ingredients The ingredient list is a source of information especially useful for people with food sensitivities. (See Ingredient Labeling: What's in a Food?" in the April 1993 FDA Consumer.) Some new requirements that provide more information in the list are: ~ Listing protein hydrolysates by source--instead of "hydrolyzed vegetable protein," the list must state the type of vegetable (for example, "hydrolyzed corn protein"). ~ Stating FDA food-certified color additives by name--for example, "FD&C Blue No. 1 and FD&C Yellow No. 6. Before, they could be listed simply as "colorings." ~ Declaring caseinate as a milk derivative in foods that claim to be non-dairy, such as coffee whiteners. On some labels, the ingredient list may state the source of sweeteners, too, although this is voluntary. For example, instead of "dextrose" or "dextrose monohydrate," the ingredient may be listed as "corn sugar monohydrate." Nutrient Claims Elsewhere on the label, consumers may find claims about the food's nutrient content. Often, these claims appear on the front of the package, where shoppers can readily see them. These claims signal that the food contains desirable levels of certain nutrients. Some claims, such as "low-sodium" "high in calcium," or "good source of fiber," describe nutrient levels. (See "A Little 'Lite' Reading," in the June 1993 FDA Consumer.) Some, but not all, highlight foods containing beneficial amounts of nutrients for some people with special dietary needs. The same claim may warn other consumers, for whom the nutrient is detrimental, to avoid the product. For example, a product claiming to be an "excellent source of potassium" is not a wise buy for a person following a low- potassium diet. (See "Nutrient Claims Guide for Individual Foods.") Health Claims Health claims describe a relationship between a nutrient or food and a disease or health-related condition. FDA has authorized eight such claims; they are the only ones that can be used in a label. The claims may show a link between: ~ calcium and a lower risk of osteoporosis ~ fat and a greater risk of cancer ~ saturated fat and cholesterol and a greater risk of coronary heart disease ~ fiber-containing grain products, fruits and vegetables and a reduced risk of cancer ~ fruits, vegetables and grain products that contain fiber and a reduced risk of coronary heart disease ~ sodium and a greater risk of high blood pressure ~ fruits and vegetables and a reduced risk of cancer ~ folic acid and a decreased risk of neural tube defect-affected pregnancy. Nutrient and health claims can be used only under certain circumstances, such as when the food contains appropriate levels of the stated nutrients. The intent of the new food label is not just to ensure that label information is truthful but to provide more complete and useful nutrition and ingredient information for consumers' use. People with special dietary needs will likely find the labeling changes a welcome bonus. n Paula Kurtzweil is a member of FDA's public affairs staff. Special Diets Label information can help individuals select foods appropriate for their special dietary needs, determined by a physician, registered dietitian, or nutritionist. Some medical conditions that require special attention to diet are: ~ Kidney disease For many people whose kidneys have failed or are failing, protein, potassium and sodium are restricted. The nutrient phosphorus also may be restricted. People undergoing dialysis may be encouraged to eat 20 to 25 grams (g) of fiber daily because fluid restrictions, lack of exercise, and some kidney medications can cause constipation. The Daily Value for fiber, which is based on a 2,000-calorie diet, is 25 g. Daily Values are reference numbers based on recommended dietary intakes to help consumers use label information to plan a healthy diet. (See "'Daily Values' Encourage Healthy Diet" in the May 1993 FDA Consumer.) ~ Liver disorders People with hepatitis, cirrhosis, and other liver diseases often need a high-calorie, low-protein diet to help rejuvenate the damaged liver and maintain adequate nutrition. They also may need to increase their intake of vitamins--particularly folic acid, vitamin B12, and thiamin--and minerals. ~ Food sensitivities According to the Food Allergy Network (a national nonprofit organization) common food allergens are milk, eggs, wheat, peanuts and other nuts, and soy. The treatment: avoiding the food or foods containing them. ~ Celiac disease This is a genetic disorder in which the body cannot tolerate gliadin, the protein component of the gluten in wheat, barley, rye, and oats. So, people with celiac disease must avoid all products containing these grains--even foods that may contain only small amounts of the protein, such as vinegar, bouillon, and alcohol- containing flavorings. The intolerance leads to malabsorption--not only of the offending food but virtually all nutrients. ~ Cancer Because weight loss is common during cancer treatment, many cancer patients need to increase their calories and protein intake. In the case of bowel obstruction--either from surgery, radiation or the tumor--cancer patients may need to eat less fiber. But, they may need more if they become constipated. To help reduce their risk of developing cancer again, following treatment, patients may want to choose foods and nutrients whose role in reducing cancer risk has been borne out by significant scientific evidence. (See "Look for 'Legit' Health Claims on Foods" in the May 1993 FDA Consumer.) ~ Bowel Disease Increased fiber is often recommended for people with chronic constipation, irritable bowel syndrome, and diverticulosis. Low- fiber diets may be called for during flare-ups of these and other bowel diseases, such as Crohn's disease and ulcerative colitis. ~ Osteoporosis In osteoporosis, bone mass decreases, causing bones to become brittle and easily broken, especially in later life. A low-calcium intake throughout life is thought to be a major risk factor. The Daily Value for calcium, based on calcium needs for all ages, is 1,000 milligrams. Vitamin D also is important because it aids calcium absorption. The Daily Value for vitamin D is 400 International Units. n --P.K. Nutrient Claims Guide For Individual Foods Fiber High-fiber: 5 grams (g) or more per serving Good source of fiber: at least 2.5 g per serving More or added fiber: at least 2.5 g more per serving than the reference food. (Label will say 10 percent more of the Daily Value for fiber.) Protein High-protein: 10 g or more of high-quality protein per serving Good source of protein: at least 5 g of high-quality protein per serving More protein: at least 5 g more of high-quality protein per serving than reference food. (Label will say 10 percent more of the Daily Value for protein.) Calcium High-calcium: 200 milligrams (mg) or more per serving Good source of calcium: at least 100 mg per serving More calcium: at least 100 mg more than reference food. (Label will say 10 percent more of the Daily Value for calcium.) Vitamin D High in vitamin D: 80 International Units (IU) or more per serving Good source of vitamin D: at least 40 IU per serving More or fortified with vitamin D: at least 40 IU more than reference food. (Label will say 10 percent more of the Daily Value for vitamin D.) Special Report Articles cited in this story are among those included in the in-depth and easy-to-understand FDA Consumer special report, Focus on Food Labeling. Copies cost $5 each. To order, write to: Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250- 7954. Ask for stock number S/N 017-012-00360-5. ------------------------------ End of HICNet Medical News Digest V08 Issue #16 ********************************************* --- Editor, HICNet Medical Newsletter Internet: david@stat.com FAX: +1 (602) 451-6135