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This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENTS' DEFINITION AS "VITAMINS AND ESSENTIAL MINERALS" is the "critical first step" in the upcoming legislative debate on dietary supplements, FDA Deputy Commissioner for Policy Michael Taylor asserted in a March 31 speech. Speaking at the annual meeting of the Federation of American Societies for Experimental Biology (FASEB) in New Orleans, Taylor said that the term "dietary supplements" is "unfortunately being used without discrimination to refer to a very diverse spectrum of products that pose widely varying concerns and that may not all be subject appropriately to the same regulatory approach." Taylor's speech essentially lays out FDA's position on dietary supplements and attempts to frame the issue as the agency would like to see it addressed in the expected legislation from Rep. Bill Richardson (D-N.M.) and Sen. Orrin Hatch (R-Utah) ("The Tan Sheet" March 22, p. 12, and March 1, p. 5). Taylor suggested that the term "dietary supplement" has come to refer to "not only vitamins and minerals but also herbs" and amino acid supplements. Such "broad use" of the term, he maintained, "has confused the debate about supplement regulation because it lumps together with vitamins and essential minerals many products that have no recognized role in nutrition, that frequently bear express or implied disease claims, and that have been marketed for specific therapeutic purposes." Products outside of the vitamin/mineral realm are "more likely to raise public health concerns than vitamin and mineral supplements," Taylor asserted. For example, there are "many unanswered questions about the safety of amino acid supplements," he noted. The FDA official referred to a July 1992 FASEB report that concluded that "there is insufficient scientific evidence to establish safe upper levels of intake for any of the amino acid supplements on the market today." The report also recommended that, based on available data, women of childbearing age, smokers, the elderly and the young should not consume amino acid supplements unless they are under medical supervision. Based on the overall paucity of data on the safety of amino acid supplements, their patterns of use and adverse health effects, the FASEB report urged that a "systematic evaluation of certain biological effects of these substances" be undertaken. Specifically, "acute and chronic time course studies in both animals and humans of the consequences of supplemental amino acids ingestion" is necessary, the report suggested. The document also stated that "there is an immediate need to label [amino acid] products currently in the marketplace to provide accurate information on chemical composition and purity of ingredients, isomeric identity of the amino acid(s), shelf-life, suggested doses and contraindications for use." In response to the FASEB report, FDA is considering calling for data on the safety of amino acids in an upcoming Federal Register notice. The agency also met with companies that make amino acid and other supplements on March 8 to discuss the FASEB report and possible ways to address the document's recommendations. Taylor observed that the need to address the safety of amino acid supplements "is underscored by the fact that many of them are marketed to body builders and other athletes in ways that encourage high consumption." He added: "From FDA's perspective, high potency amino acid supplements are very different from the typical multivitamin supplement." Many "herbal and other botanical" products also are a cause for concern, Taylor maintained, because they are "more likely than nutritional products to be marketed or used for their perceived therapeutic or disease-prevention purposes." "It is a misnomer," Taylor argued, "to describe as dietary supplements herbal products marketed under such names as 'Immunotonic,' 'Immune Plus,' 'Arth-X Bone Joint and Ligament Nutritional Health Formula,' 'Blockaid 200 Cholesterol Control,' or 'Acnetonic.'" In addition, the FDAer said that the scientific literature indicates that some herbs are toxic, "especially those from pyrrolizidine alkaloid-containing plants." Herbs such as germander, comfrey, and chaparral all "have been linked with severe liver toxicity," he said, "despite the fact that their traditional use had not been thought to raise safety concerns." Earlier this year, for instance, FDA requested that chaparral be taken off the market following "at least five" reports of acute toxic hepatitis. Outlining FDA's regulatory goals for dietary supplements, Taylor remarked that they are "as straightforward as they are simple. They are to assure that the products are safe and properly labeled and that any disease- or health-related claims are scientifically supported." On the question of safety standards for nutritional supplements, the deputy commissioner framed the issue as a choice between either FDA pre-market review of supplements, or relying on the manufacturer's assertions of safety. He complained that "some believe Congress should take away FDA's authority to conduct premarket safety reviews for the entire spectrum of dietary supplement products" and "rely instead on the manufacturer's own substantiation of safety under a less rigorous safety standard, and with the burden on FDA to prove that safety has not been substantiated." Taylor added that "Congress will have to examine whether this approach would provide the level of safety assurance the public needs and expects," and decide "whether it makes sense to require" premarket approval for plant-derived products such as digitalis and cancer agent Taxol, "but to abandon it for all plant-derived products marketed as herbal supplements." He acknowledged, however, that "the big debate" on dietary supplements centers on FDA's regulatory goal of assuring "that disease-related health claims are scientifically supported in accordance with applicable legal standards." Taylor predicted that "some elements" of the dietary supplement industry will ask Congress to "abandon the principle of FDA review of health claims" because the agency's standards are "too strict and that the process unduly delays consumer access to information about the potential disease-related benefits of dietary supplements." If such a scenario is imposed, risk-benefit assessments for health-related claims will also be left to the manufacturer. "In light of market pressures to make claims, is this adequate to protect public health?" Taylor asked rhetorically. Taylor indirectly acknowledged the wide-scale, grass-roots opposition to the agency's position in concluding his speech. He asserted that FDA "understands and respects the view of many Americans that they should be free to choose nutritional supplements as they see fit . . . without government impediment." He said that FDA "agrees with this view, provided the products are safe and any claims of nutritional benefit are true." Most vitamin and mineral supplements are safe, Taylor stated, and the agency "wants to work with the nutritional supplement industry to document scientifically the safe upper limits on daily intake of vitamins and minerals." In addition to the Richardson/Hatch bill, Rep. Henry Waxman (D-Calif.) also reportedly is considering legislation to regulate dietary supplements. Unlike the Richardson/Hatch bill, however, the California congressman reportedly is favoring FDA regulation of certain supplements. Waxman staffers have already held discussions with members of the nutritional products industry, and Waxman's House Energy and Commerce/health subcommittee plans to hold a hearing on dietary supplements this spring. FDA said that it will provide "technical assistance" to all parties developing dietary supplement legislation.

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