FDA issues dietary supplements final rule

July 2, 2007

The FDA announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements.

The FDA announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. FDA commissioner Andrew C. von Eschenbach, M.D., stated, "This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label. In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary-supplement-related adverse events to the FDA." The final rule is effective on Aug. 24. The final rule has a three-year phase-in for small businesses.

Consumers Union said the guidelines are a good step toward consistency in the ingredients that go into supplements, but it still does nothing to ensure that supplements are safe or effective before they go on the market. "This new rule requires dietary supplement makers follow procedures to ensure that their products contain the type and amount of ingredients on the label. However, consumers still have no idea if a given product works, or whether it is dangerous," said Janell Mayo Duncan, senior counsel for Consumers Union, publisher of Consumer Reports. The Natural Products Association said, "We think the final regulation is strong, but more reasonable than the proposed version. It offers a more flexible framework in meeting standards, such as testing and facility design. This will help smaller companies control costs—costs that would have been passed along to the consumer—while still maintaining quality standards."

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