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DIETARY SUPPLEMENT SAFETY REVIEW BY FDA WOULD BE CONDUCTED

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT SAFETY REVIEW BY FDA WOULD BE CONDUCTED under proposed legislation being floated by the Center for Science in the Public Interest. Under the CSPI proposal, FDA would be required to "review the safety of all dietary ingredients currently in use" during which time the ingredients could be marketed unless FDA found that a particular ingredient was "not generally recognized as safe." A summary of the proposed bill defines dietary supplements as either a vitamin, mineral, herb, amino acid or "other similar nutritional substance." Under the legislative proposal, dietary ingredients in use as of March 1, 1993 would be "deemed safe, provided manufacturers can adequately demonstrate through either scientific procedures or experience based on common usage, that the ingredient is safe under the conditions of its intended use." CSPI offered two other possible mechanisms to establish the safety of dietary supplement ingredients: (1) FDA could require that a dietary ingredient "comply with a regulation prescribing conditions under which it may be safely used"; or (2) a dietary ingredient could be deemed safe if it is "generally recognized among experts as having been adequately shown through scientific procedures to be safe under the conditions of its intended use," according to the summary. The proposed legislation also includes a requirement that companies give FDA advanced notice of plans to market new dietary ingredient products that are already generally recognized as safe (GRAS). According to CSPI, the provision would "allow FDA to monitor dietary ingredients that are being introduced into the market and to raise timely objections if there are concerns about an ingredient's safety." CSPI developed the dietary supplement legislative proposal in response to legislation introduced by Rep. Bill Richardson (D- N.M.) and Sen. Orrin Hatch (R-Utah) on April 7 ("The Tan Sheet" April 12, p. 6). In a prepared statement, CSPI calls the Richardson/Hatch measures "anti-consumer" and instead has urged support for its own proposal, which it calls the Dietary Supplement Consumer Protection Act. CSPI asserted that the Richardson (HR 1709) and Hatch (S 784) bills "would make it difficult for the FDA to stop fraudulent, misleading and unsubstantiated health claims by manufacturers of dietary supplements" and "deprive the FDA of the authority to protect consumers from potentially unsafe products." CSPI further argued that the dietary supplement industry, through grassroots lobbying efforts, is "garnering support for this flawed legislation by issuing false, extremist warnings" that FDA regs implementing the 1990 Nutrition Labeling and Education Act "will lead to a federal ban on supplements." The Richardson/Hatch bills would "in truth . . . repeal portions of the NLEA, a landmark consumer protection law that prohibits unscrupulous manufacturers from making misleading, unsubstantiated and deceptive health claims about their products," CSPI maintained. Neither HR 1709 nor S 784 would subject dietary supplement health claims to FDA preclearance. Apart from mapping out potential dietary supplement safety mechanisms, the CSPI legislative proposal calls for FDA to regulate "health claims for dietary supplements and conventional foods in the same manner" under NLEA. The proposal also would require supplement labels to disclose information regarding potential adverse effects as well as expiration dates. CSPI noted, for example, that "iron tablets might specifically be required to disclose the symptoms of iron overdose and its impact on children." In February, the Public Health Service issued a statement urging parents to keep iron supplements beyond the reach of children to avoid accidental iron overdoses ("The Tan Sheet" March 1, In Brief). Other provisions of the CSPI proposal include: establishing an FDA dietary supplement advisory committee to examine issues such as health claims and safety concerns; allocating $ 5 mil. to fund "expanded research and better coordination of existing research on the health benefits and risks of dietary supplements" by the National Institutes of Health; and mandating that supplements meet good manufacturing practices and "quality factor requirements," such as disintegration standards and potency standards, which would be established by regulation. CSPI also is disseminating its message to dietary supplement consumers via an "open letter" sent to health-related magazines on April 14. The letter explains various NLEA provisions and underscores that the NLEA does not ban the use of dietary supplements. If FDA is not allowed to review health claims for dietary supplements, "it will be nearly impossible to prevent unscrupulous individuals . . . from defrauding the public by marketing supplements deceptively," the consumer group maintained. CSPI concludes its letter by asking consumers to urge their congressional representatives to support its legislative proposal. In addition to Richardson and Hatch, Rep. Henry Waxman (D-Calif.) also has expressed interest in the regulation of dietary supplements, and is considering convening a hearing on the issue in the near future.
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