FDA CONSUMER (436210) is the official magazine of the Food and Drug Administration, Rock- ville, Md. 20857, and is published monthly, ex- cept for combined issues for July-August and December-January. Subscriptions should be ordered from and made payable to SUPERIN- TENDENT OF DOCUMENTS, Government Printing Office, Washington, D.C. 20402, at $12.00 a year ($15.00 foreign mailing). Second- class postage paid at Washington, D.C., and additional mailing offices. POSTMASTER: Send address change to FDA CONSUMER/HFI-20, 5600 Fishers Lane, Rockville, Md. 20857. Text of articles published in FDA CONSUMER may be republished without permission. Credit to FDA CONSUMER as the source is appreciated. Use of funds for printing this publication ap- (a) The Secretary shall cause to be published from time to time reports summarizing all judgments, decrees, and court orders which have been rendered under this Act, including the nature of charge and the disposition (b) The Secretary may also cause to be dis- seminated information regarding food, drugs, devices, or cosmetics in situations involving, in the opinion of the Secretary, imminent danger to health, or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, report- Update Letterwriters Take Vitamins In March of this year, FDA published a report of an expert advisory committee on the use of vitamins and minerals as over-the-counter drugs. The panel said that nine vitamins and three minerals were safe and effective to treat and/or prevent deficiency diseases, but that they should be used "when the need for such therapy has been determined by a physician." What else the panel said was reported in Vitamins Over the Counter: Take Only When Needed, in the April 1979 FDA CONSUMER. Here's an update. If anyone wants to set off a letterwriting campaign, the most effective way, apparently, is to use the words "regulate vitamins and minerals." Publication of the report and recommendations of the panel on vitamins and minerals in the March 16 FEDERAL REGISTER unleashed a flood of mail to FDA. An OTC Drug Evaluation Division spokesman estimates that approximately 5,700 letters have come in expressing fears that the panel report will lead eventually to the regulation of those vitamins and minerals sold as dietary supplements. The bulk of these letters have been addressed to the hearing clerk, but hundreds have been answered by the OTC Drug Evaluation Division. All will become part of the official public record on the panel's report. Those who write directly to the Division receive a clarification statement assuring them that the report "does not affect the consumer's ability to purchase vitamins and minerals for use as dietary supplements." The panel report also sparked the introduction of legislation to limit the authority of the Secretary of Health, Education, and Welfare to regulate vitamin and mineral drug products for over-thecounter human use. Introduced by Congressman Lawrence McDonald, the bill would prohibit the Secretary from promulgating the proposed rule applicable to vitamin and mineral products or any other rule or regulation or any other action that would have the same effect as the proposed rule. The bill has been referred to the Subcommittee on Health and Environment of the House Committee on Interstate and Foreign Commerce. PREVENTION, a monthly magazine aimed at health food advocates, calls the panel report "A new antivitamin effort by FDA." In a question and answer column in the September issue, the magazine suggests that if the proposed rule, which is attributed to FDA, is passed it could mean that a prescription would be needed to buy vitamins and minerals in drugstores. Readers were urged by the magazine to write to Congressman Henry Waxman, chairman of the Health and Environment Subcommittee, to request that hearings be held on the McDonald bill. Certification Ended for U-80 Insulin The many steps FDA goes through to insure the purity and potency of insulin was the subject of an article, in the April 1977 FDA CONSUMER, titled: Insulin Standards: Precision With a Purpose. Here's an update. As of March 24, 1980, FDA will no longer certify 80 unit (U-80) insulin products. This action is being taken to reduce the potential for patient error that results from having insulin available in two different high concentrations. After that date U-100 insulin will be the only high concentration product to be certified. However, any batches of U-80 insulin certified before March 24 will be allowed to stay on the market until they become outdated. The proposal to discontinue certification of U-80 insulin was first made in the FEDERAL REGISTER of July 28, 1978. The proposal also invited comments on the need for retaining a low-potency insulin product on the market. Comments on this proposal are still being evaluated and will be discussed in a future FEDERAL REGISTER notice if FDA decides some action is needed. The final rule on U-80 products was published in the September 25, 1979, FEDERAL REGISTER. Hair Dye Label Warning Regulation An article, Hair Dyes, a Look at Safety and Regulation, in the June 1978 issue of FDA CONSUMER, noted a scientific finding by the National Cancer Institute, in 1977, that an ingredient used in many permanent "coal-tar" hair dyes caused cancer in laboratory test animals. The article reported FDA's regulatory proposal to require manufacturers who produce hair dyes containing the ingredient, 4-methoxy-m-phenylenediamine (4MMPD) or its sulfate, 4MMPD sulfate, to place a warning statement on the label. Here's an update. Permanent hair dye products that contain the ingredient 4-methoxy-m-phenylenediamine (4MMPD) or its sulfate, 4MMPD sulfate, must, if shipped after April 16, 1980, include a warning on the label of the product's cancer-causing potential. The new FDA regulation, published in the FEDeral Register, on October 16, 1979, requires this label warning: "Warning-Contains an ingredient that can penetrate your skin and has been determined to cause cancer in laboratory animals." The chemicals are also known as 2,4 diaminoanisole (2,4 DAA) and 2,4 diaminoanisole sulfate (2,4 DAA sulfate). Many hair dye makers began discontinuing use of the ingredient in their products after FDA proposed the warning label in January 1978, but a few continue to use these chemicals. Meanwhile, FDA is evaluating similar National Cancer Institute data covering several other ingredients in coal-tar hair dyes, including 4amino-2-nitrophenol, 2-nitro-p-phenylenediamine, 4-chloro-m-phenylenediamine, and toluene 2,4 diamine. If FDA concludes that any of these may cause cancer in humans, the Agency may require products containing them to bear similar warning labels. Coal-tar hair dyes were exempted from the adulteration section of the Food, Drug, and Cosmetic Act of 1938. Manufacturers may market these products as long as they warn consumers on the label of possible skin irritation and to avoid use around the area of the eyes. FDA is on record urging repeal of this exemption. Some permanent hair dye products in shades of black and brown may still contain high levels of 4MMPD and 4MMPD sulfate and some products in vivid warm shades, such as reddish or golden blond, may contain lower concentrations. These chemicals are never used in temporary tints or rinses or in semi-permanent hair dyes. FDA withdrew its proposal to require warning posters in establishments that dye hair, noting the difficulty of enforcing such a regulatory requirement because the Agency does not inspect these establishments. FDA said customers can ask such establishments to show them the labels of dye products to be used and that publicity about the label warning regulation will serve to alert many consumers who have their hair dyed in these places. Microbe Some microbes belong in our food supply, others definitely do not. Scientists at the Minneapolis Center for Microbiological Investigations, a unique FDA field laboratory, help assure that not only food, but also drugs, cosmetics, and medical devices, are free of harmful microorganisms. by Annabel Hecht microbe, according to Webster, is a very minute organism. Some microbes are natural inhabitants of food and are essential for the creation of such delectables as cheese and yogurt. Others are distinctly undesirable and their presence is a clue that a food product has been contaminated. Analyzing various foods to determine how many microbes exist, and to set standards for how many can be safely allowed, is one of the major tasks of the Minneapolis Center for Microbiological Investigations, a oneof-a-kind FDA field laboratory situated in the heart of that Minnesota city. Each year, FDA surveys a group of products in its continuing program to assure a safe food supply. Of particular concern are those with the greatest potential for harm, such as foods that do not have to be cooked, and eggs and egg products. Samples for testing at the Minneapolis lab are collected at various stages during processing, starting with the raw material and ending The granular appearance in the lower section of this petri dish (below) is a clue to the exact identity of a Salmonella organism, the "bug" that causes some types of food poisoning. This clumping of cells occurs only when a Salmonella culture is mixed with antiserum containing the antigens to which a particular type of Salmonella will react. |