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DIETARY SUPPLEMENT HEALTH CLAIMS WOULD NOT BE SUBJECT TO FDA PRECLEARANCE

This article was originally published in The Tan Sheet

Executive Summary

DIETARY SUPPLEMENT HEALTH CLAIMS WOULD NOT BE SUBJECT TO FDA PRECLEARANCE under bills introduced by Rep. Bill Richardson (D- N.M.) and Sen. Orrin Hatch (R-Utah) on April 7. Both called the Dietary Supplement Health and Education Act of 1993, the two bills would prevent FDA from establishing a requirement that health claims be approved by the agency "before the claim may be used," according to the language of the Hatch bill. Instead, HR 1709 and S 784 would allow dietary supplement labeling to "characterize the relationship between the supplement and a disease or other health-related condition" if the claim has been authorized by FDA based on scientific evidence, or if the claim "accurately represents" current scientific evidence on the relationship between the supplement and the health condition. The provision does not "prohibit the inclusion" of "truthful and nonmisleading information concerning the vitamin, mineral or other dietary properties of the supplement," the bills add. Richardson's bill contains a provision that dietary supplement manufacturers must provide notification to FDA that a health claim will be made in product labeling at least 30 days before the product's market introduction. Documentation supporting the claim also may be provided with the notification, HR 1709 stipulates, stressing that FDA "may not impose any additional premarket requirement, including . . . requests for further documentation." Although the Hatch bill does not require FDA notification, it would establish a new dietary supplements office within the National Institutes of Health (see following story) that, among its responsibilities, will be required to conduct a study on the "desirability of a notification requirement relating to new claims about dietary supplements." According to the bill, the study should examine the need and feasibility of requiring dietary supplement marketers to notify FDA before making health claims, and evaluate the "effect of such a requirement on the marketing of dietary supplements and on the ability of consumers to purchase dietary supplements." The study would be scheduled for completion within three years of the bill's passage. Among other regulatory provisions, the bills explicitly exclude dietary supplements from FD&C Act consideration as "food additives" and the Hatch bill specifies that dietary supplements cannot be considered "drugs." Both measures also propose to extend Rogers-Proxmire Amendments' protections to other dietary supplements besides vitamins and minerals. FDA also is prohibited: from establishing "maximum limits on the potency of any dietary supplement"; from classifying a dietary supplement "as a drug solely because it exceeds the level of potency" that FDA has determined is "nutritionally rational or useful"; and from limiting the combination or number of ingredients in a dietary supplement. In lieu of food additive authority, the House and Senate bills outline criteria that would deem a dietary supplement adulterated, including if it contains an ingredient FDA said presents a "substantial and unreasonable risk of illness or injury," or if the manufacturer has not provided a "history of safe use" for the product. The Richardson bill also deems dietary supplements adulterated if FDA is not notified of "significant changes in manufacturing practices" that "have been shown to present adverse safety consequences" in the product. HR 1709 requires FDA to establish regulations within 18 months that mandate notification of manufacturing practices changes or "potential problems of safety or contamination arising from any such changes." In a provision not found in the House measure, Hatch's S 784 requires the NIH dietary supplements office to conduct a study on "significant changes in the manufacturing practices of manufacturers of raw materials utilized in dietary supplements." The study, which must be submitted to Congress within three years after the bill's enactment along with recommendations for legislative reform, should include an analysis of the "extent to which such changes pose a risk to public safety," the bill says. Both S 784 and HR 1709 give dietary supplement firms who receive FDA warning letters or other agency notifications that their products are in violation of the law the option of requesting a hearing on the FDA action within 60 days. Both the Richardson and Hatch bills broadly define dietary supplements to include vitamins, minerals, herbs, amino acids, or other ingredients used to supplement the diet, including a "concentrate or extract." The bills' wide definition is contrary to how FDA would like to see dietary supplements defined. For example, at a recent Federation of American Societies for Experimental Biology meeting, FDA Deputy Commissioner for Policy Michael Taylor maintained that narrowly defining dietary supplements to include only "vitamins and essential minerals" was the "critical first step" in crafting legislation for supplements ("The Tan Sheet" April 5, p. 1). Taylor contended that amino acids and certain herbal products are more likely to raise public health concerns than vitamins and minerals. In addition, both bills direct HHS to establish by regulation "daily value" recommendations for each nutrient in lieu of Recommended Daily Allowances (RDAs) that will "be no less than" the RDAs for groups "most at risk of nutritional deficiencies of any particular nutrient." According to the legislation, the daily value "shall reflect the daily intake of each such nutrient that will promote optimal health and minimize the risk of disease or other health-related conditions." Dietary supplement labeling should also list the name and quantity of each ingredient, with the exception of quantitative listing of proprietary combinations. Supplement products would be considered misbranded under the bills if they fail to have the identity and strength indicated on the label or if they do not meet quality standards they claim to meet. Hatch's bill contains a "findings" section outlining the rationale for the legislation. "Consumers should be empowered to make choices about preventative health care programs based on data from scientific studies of health benefits related to particular dietary supplements," the bill maintains. S 784 adds that "recent national surveys have revealed that almost 50% of the 260 mil. Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition." The legislation also asserts that "nearly all consumers indicate that dietary supplements should not be regulated as drugs." The Hatch bill estimates that the "600 dietary supplements manufacturers in the U.S. produce approximately 3,400 products, with total annual sales of such products . . . reaching $ 4 bil." The industry, according to the bill, "consistently projects a positive trade balance." To date, S 784 has three cosponsors -- Sens. Harry Reid (D- Nev.), Frank Murkowski (R-Ark.) and Malcolm Wallop (R-Wyo.). In introducing the bill, Sen. Hatch also noted that his legislation has the support of organizations such as the Council for Responsible Nutrition, the National Nutritional Foods Association, the Nutritional Health Alliance and Shaklee. HR 1709 has 13 cosponsors so far, including eight Democrats and five Republicans. Other organizations have opposed the Richardson/Hatch legislation during its development, including the Food and Nutrition Labeling Group, an organization comprised of the Center for Science in the Public Interest, the American Association of Retired Persons, the Society for Nutrition Education and the American Heart Association, among others. In a March letter to Rep. Richardson, FNLG complained that a draft of HR 1709 made it "more difficult for FDA to take action against a dietary supplement product of questionable safety by reversing the burden of proof and weakening the safety standard" in the FD&C Act. FNLG also opposed the provision to exempt dietary supplements from the "food additive" definition, "thereby preventing the FDA from invoking this authority when it may be appropriate." S 784 is essentially a reprise of a bill Hatch introduced last year (S 2835), which would have prevented FDA from regulating dietary supplements on the basis of their potency or because labeling or advertising for the products made claims about their potency or health benefits ("The Tan Sheet" March 1, p. 5). Like S 784, last year's legislation would have barred FDA from regulating supplements as food additives.
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