WASHINGTON (FNS) -- Congress has passed a bill that would permit all dietary supplements on the market by Oct. 15, 1994, to remain on store shelves unless the Food and Drug Administration proves they are unsafe. The measure was ushered through Congress before adjournment for the Nov. 8 elections and has been sent to President Clinton to be signed into law.
If signed, the measure would have several ramifications for the sale and regulation of dietary supplements, which include vitamins, minerals, herbs and other botanicals, amino acids and other substances, except tobacco:
· Retailers would be permitted to post literature on various supplements, but such information cannot be adjacent to the products being described, cannot promote any specific products or manufacturers and must be accurate.
· Dietary supplement manufacturers could continue to make statements about how their products affect the structure or function of the body, but they must notify the FDA within 30 days of making such claims on labels. All labels must carry this disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
· Dietary supplements could not be regulated as either drugs or food additives, but the bill would enhance the FDA's powers to act against products that pose a health risk. The burden of truth would be on the government.
· A new Office of Dietary Supplements at the National Institutes of Health would be established, funded by $5 million.
The legislation stemmed from a move by the FDA to regulate most amino acid supplements and herbal products by classifying them as drugs. The bill's passage ended a bitter debate in Congress over what health claims manufacturers of vitamins and other nutritional supplements can make. The measure was opposed by the FDA, and a spokesman said the agency would continue to "do what we can to maintain safety of products."
The bill was sponsored by Sen. Orrin Hatch, R-Utah, whose state is home to almost $1 billion in dietary supplement manufacturing, and Rep. Bill Richardson. D-N.M., whose district includes a national center for complementary and alternative health care. Hatch said in a statement that the compromise bill passed represents a "victory for consumers who want to lead healthy lifestyles." Hatch noted that during the two-year debate, congressional offices were flooded with mail and phone calls from constituents advocating passage of the bill.
Richardson said the bill ensures the "FDA cannot rob consumers of their rights simply because some bureaucrat decides to do so."
A study by the Center for Science in the Public Interest showed that the dietary-supplement industry had spent more than $2.5 million since January 1993 lobbying Congress for passage of the bill. CSPI legal director Bruce Silverglade had criticized the measure because it would permit manufacturers and retailers to import unapproved drugs and sell them as dietary supplements, make it more difficult for the FDA to remove illegal products from the marketplace, and facilitate the promotion of products on the basis of frivolous nutritional claims. He said he was heartened that the legislation preserved the FDA's authority over health claims and its ability to remove hazardous products from the market.