The U.S Food and Drug Administration regulates dietary supplements under the Dietary Supplement Health and Education Act, signed into law in 1994. Before this time, supplements were governed by the same regulations as foods. Unlike over-the-counter and prescription drugs, which must undergo clinical testing for effectiveness before entering the drug market, supplements require testing only if the supplement contains new ingredients.
Definition of New Ingredients
New dietary supplement ingredients include any vitamin, mineral, amino acid, herb, enzyme, extract, concentrate or metabolite sold in tablet, capsule, powder, softgel, gelcap or liquid form not sold before 1994 in the United States. New supplement ingredients do not include foods, drugs, antibiotics or biologics. Manufacturers of supplements that contain a new ingredient must submit proof of the supplement's safety. The FDA does not specify exactly what type of proof of safety it requires. This puts the burden on the manufacturer to provide adequate information by reviewing scientific literature and history of safe use of the supplement.
Ensuring Safety
The burden of proving a supplement's safety falls on the manufacturer rather than on the FDA. In addition, the FDA cannot remove a supplement from the market unless it can prove the supplement's lack of safety. Only supplements containing new ingredients must report information about the safety or effectiveness of a product to the FDA. In 2007, the FDA adopted Good Manufacturing Practices for regulating production, packaging, labeling and holding of supplements.
Health Claims
Supplements are considered foods, not drugs, and as such are not allowed to make claims that they can prevent or treat any type of disease. Manufacturers cannot claim any specific health benefit for their particular supplement on their labeling. General health claims that address a well-established health benefit, such as "calcium may reduce the risk of osteoporosis" are allowed, according to the FDA. However, the labeling must also state that the claims have not been substantiated by the FDA and that the supplement does not "diagnose, treat, cure or prevent any disease." The Federal Trade Commission, not the FDA, is responsible for ensuring that advertising claims are factual.
Verifying the Contents
The FDA does not test supplements to ensure that they contain the ingredients listed on the labeling in the amounts stated. The responsibility for ensuring that their products are safe and contain the ingredients listed falls on the manufacturers. The FDA does monitor some, but not all, of the supplements on the market for purity and accuracy. The FDA will not analyze the contents of a supplement if you send it to the agency, due to lack of time and funds for in-depth supplement testing.
Adverse Effects Reporting
You or your physician can report problems with a supplement to the FDA's MedWatch hotline. However, even with drugs, which are more stringently monitored, the FDA receives reports on only 1 percent of all adverse drug events and 10 percent of all serious ADEs, according to the American College of Physicians.
References
- U.S. Food and Drug Administration; Dietary Supplements; December 2010
- U.S. Food and Drug Administration; Overview of Dietary Supplements; October 2009
- U.S. Food and Drug Administration; New Dietary Ingredients in Dietary Supplements - Background for Industry; June 2009
- American College of Physicians; Improving FDA Regulation of Prescription Drugs; 2009
- Consumer Healthcare Products Association; Regulation of Dietary Supplements; 2010
- Bureau of Consumer Protection; Dietary Supplements: An Advertising Guide for Industry; April 2001
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