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DIET SUPPLEMENTS COULD NOT BE REGULATED AS DRUGS ON BASIS OF HIGH POTENCY

Executive Summary

DIET SUPPLEMENTS COULD NOT BE REGULATED AS DRUGS ON BASIS OF HIGH POTENCY or because labeling or advertising for a supplement product makes claims about potency or health benefits, under legislation (S 2035) introduced by Sen. Hatch (R-Utah) June 11. Hatch said consumers should be able to purchase foods, including supplements, without restriction provided that labeling and advertising are truthful and there is "reasonable scientific evidence for product claims." Hatch had noted his concern about dietary supplements in a Senate Labor & Human Resources Committee hearing earlier that week on FDA's food labeling rules. "In our free society, consumers should be able to purchase any food they want -- whether it is an egg, ice cream, a steak, coffee, potato chips, or a dietary supplement -- regardless of whether someone in the federal bureaucracy approves," Hatch declared in a June 11 Senate floor statement. "Unfortunately, however, some people in the government, including some people at the FDA, appear to have unfairly treated dietary supplements and have tried to establish unreasonable regulatory burdens on such products." Hatch did not cite any specific allegedly burdensome regulations but said he has heard from consumers and manufacturers in his home state who are concerned about access to dietary supplements. The provision that a supplement could not be regulated as a drug due solely to its potency extends a principle of the current FD&C Act "already established for vitamins and minerals, i.e. that FDA may not classify a food substance as a drug solely because it exceeds the level of potency that FDA believes is nutritionally rational or useful," Hatch said. Hatch's legislation would also prohibit FDA from regulating a food substance provided by a dietary supplement as a food additive, providing the food substance is identified on the product labeling. "This is not just a theoretical concern," the senator asserted. For example, he said that FDA has defined chromium compounds as "unapproved said that FDA has defined chromium compounds as "unapproved food additives' and thus illegal when added to dietary supplements even through it is clear that chromium is an essential mineral that is extremely safe...and is not present in optimum amounts in all American diets." He noted that chromium is contained in many multivitamin supplements as well as products sold in health food stores. Hatch said his legislation would not remove FDA's current authority to bar a food, including a dietary supplement, from containing a substance the agency can show is "poisonous or deleterious" and may render the product "injurious to health." The bill also would define a dietary supplement as an item that "includes, and is intended to supplement the diet with, a vitamin, a mineral, an herb, or another similar nutritional substance, including a concentrate or an extract of such a substance."
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