FDA announces science-based approach to protecting Americans from unsafe dietary supplements

Speaking before the American Society for Pharmacology and Experimental Therapeutics (ASPET) and the American Society for Nutritional Sciences, Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA), today outlined the agency's science-based approach to protecting American consumers from unsafe dietary supplements.

Dr. Crawford said the agency would soon provide further details about its plan to ensure that the consumer protection provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA) are used effectively and appropriately. Through DSHEA, which sets up a distinct regulatory framework for dietary supplement products, Congress attempted to strike a balance between providing consumers access to dietary supplements and giving FDA regulatory authority to act against supplements or supplement ingredients that present safety problems, are marketed with false or misleading claims, or are otherwise adulterated or misbranded.

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Dr. Crawford. "Unlike most foods, some dietary supplements are pharmacologically active. And we have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."

In the last 6 months, FDA has inspected 180 domestic dietary supplement manufacturers; sent 119 warning letters to dietary supplement distributors; refused entry to 1,171 foreign shipments of dietary supplements; and seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products. "We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Crawford said.

In March FDA requested that 23 companies cease distributing dietary supplements containing androstenedione, which are marketed to stimulate testosterone and muscle growth but have anabolic steroid effects in the body.

Over the next several months FDA will provide additional information to explain and implement the tools available to the agency under DSHEA to act against unsafe supplements and false or misleading supplement labeling claims.

FDA is also developing regulations for industry on good manufacturing practices (GMPs). When finalized, this rule, proposed last spring, will help protect consumers from dietary supplements that contain impurities or contaminants as a result of how they are manufactured or handled.

FDA is, in addition, putting dietary supplement labeling under closer scrutiny. Dietary supplement labels cannot claim the supplement will treat or cure a disease, and since December 2002 FDA has worked with the Federal Trade Commission to challenge false claims of supplement effectiveness for treating a range of diseases.

To support its consumer protection actions, the agency is developing approaches to systematically review the evidence about the safety of individual dietary supplements. FDA expects to evaluate the available pharmacology, published literature (including animal, in vitro, epidemiological and clinical trial data) evidence-based reviews, and adverse event information -- the approach that formed the scientific foundation for FDA's recent rulemaking on ephedra.

Supplement labels can make claims about the impact of a supplement on the structure or function of the body, but the claims must be truthful and not misleading. Two weeks ago, FDA sent warning letters to 16 firms to stop making false claims for weight loss. The FDA plans, in addition, to issue guidance on what data would substantiate such claims.

FDA's rulemaking on dietary supplements containing ephedrine alkaloids became effective on April 12, 2003. Last week the federal district court supported the agency's rule by declining to issue a temporary restraining order sought by the industry.

When DSHEA was passed a decade ago, there were about 4,000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals. Congress determined that these products were more like foods than drugs, which cannot be put on the market unless a high threshold of evidence about their safety and efficacy is met, and that, like foods, such dietary supplements should in general be given the benefit of the doubt as to safety.

A recent Institute of Medicine report, sponsored by FDA, estimated that American consumers spend $18 billion annually on dietary supplements and that there are about 29,000 such products on the market, with another 1,000 new products introduced each year.