WASHINGTON (FNS) -- President Bill Clinton signed into law a measure permitting 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. Clinton signed the bill Oct. 26, less than two weeks after it was approved by Congress.
"Manufacturers, experts in nutrition and legislators, acting in a conscientious alliance with consumers at the grass-roots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law," said Clinton in a statement.
A spokesman for the FDA, which opposed the bill, said the agency would continue to "do what we can to maintain safety of products."
Clinton made reference to attempts by the FDA to regulate some supplements as drugs, and the resulting consumer backlash that led to the new legislation.
"In recent years, the regulatory scheme designed to promote the interests of consumers and a healthful supply of good food has been used instead to complicate choices consumers have made to advance their nutritional and dietary goals," said Clinton. "With perhaps the best of intentions," he continued, "agencies of government charged with protecting the food supply and the rights of consumers have paradoxically limited the information to make healthful choices in an area that means a great deal to over 100 million people."
The law affects the sale and regulation of vitamins, minerals, herbs and other botanicals, amino acids and other substances used to supplement the diet, except for tobacco. Under the new law:
· Retailers are permitted to post literature on various supplements. Such literature, however, may not be posted adjacent to the products it is describing, cannot promote specific products or manufacturers and must be accurate.
· Dietary supplement manufacturers can continue to make statements about how their products affect the structure or function of the body, but must notify the FDA within 30 days of making the labeling claims. Supplement labels must also contain the following 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."
· The law states that dietary supplements cannot be regulated as either drugs or food additives. While the FDA retains its authority to act against unsafe products, the burden of proof is on the government to prove a product is unsafe.
· The bill establishes a new Office of Dietary Supplements at the National Institutes of Health and authorizes $5 million for it.
Congressional sponsors were Sen. Orrin Hatch, R.-Utah, whose state has 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 version adopted represents a "victory for consumers who want to lead healthy lifestyles." Hatch noted that during the two-year Congressional debate, representatives' offices had been flooded with mail and phone calls from constituents advocating passage of the bill.
Richardson said the bill ensures that the "FDA cannot rob consumers of their rights simply because some bureaucrat decides to do so."
