FDA Takes Action on Supplement Safety

Standards Proposed for Labeling, Manufacturing of Dietary Supplements

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March 7, 2003 -- For years, the only advice federal officials could give consumers buying herbal and other dietary supplements was "buyer beware." But a new proposal released today by the FDA marks the first step toward establishing labeling and manufacturing standards that would help ensure that people get what they pay for when buying dietary supplements.

Although the proposed rule would reduce fraud and contamination of dietary supplements, the move does not address the safety of the products, nor address claims about their effectiveness. A 1994 law exempts supplement makers from such oversight.

Instead, the FDA is aiming at quality control. The proposed rule would -- for the first time -- establish standards to ensure that the supplements do not contain contaminants or impurities and are labeled to accurately reflect what they active ingredients they contain.

"Too often, consumers purchase dietary supplements based on inaccurate or incomplete information on what they are getting," said FDA commissioner Mark B. McClellan, MD, PhD, in a news release announcing the proposal.


FDA officials say the proposed regulation would help eliminate some of the guesswork when it comes to finding high-quality dietary supplements.

Independent studies by private laboratories have shown that a large number of dietary supplement products do not contain the amounts of active ingredients that would be expected based on their labels. In addition, the FDA has found many products that are not accurately labeled contain ingredients that might be harmful or should not be found in such a product.

According to the FDA, recent examples include:

  • Five of 18 soy and/or red clover-containing products were found to contain only 50% to 80% of the declared amount of isoflavones (the active ingredient claimed).
  • One firm recalled dietary supplements because they contained excessive amounts of lead, which may pose a health risk especially to children and women of childbearing age.
  • Another company recalled its folic acid dietary supplement, which is often taken by pregnant women to reduce the risk of birth defects, after it was discovered that the product contained only 35% of the amount of folic acid claimed on the label.


"Americans must have confidence that the dietary supplements they purchase are not contaminated and that they contain the dietary ingredients and the amounts claimed on the labels," said health and human services secretary Tommy G. Thompson, in a news release. "Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products they're paying for."

The new rule would require manufacturers of dietary supplement products to follow current good manufacturing practices, including meeting requirements for designing and constructing plants and establishing quality control procedures. The proposal also has requirements for manufacturers to maintain records and for handling consumer complaints.

The manufacturers would also be required to evaluate the purity, identity, quality, strength, and composition of their dietary ingredients and supplements.

Researchers say the FDA's action will also foster more research on dietary supplements to determine their safety and effectiveness. Current research on dietary supplements is often hampered by the wide variability of the products.


Final rules are expected next year.

SOURCE: FDA. News release, FDA.

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