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New Quality Control Regulations Not Enough to Ensure Safety of Dietary Supplements

Statement of CSPI Staff Attorney Ilene Heller

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We’re glad the FDA has finally issued long-delayed quality-control regulations known as Good Manufacturing Practice Regulations (GMPs) for dietary supplements. However, these regulations will not ensure that supplements are safe and effective. Nor will the GMPs address whether the products carry adequate directions for use and appropriate warnings.

Outside of requiring manufacturers to test that an ingredient is properly identified, FDA leaves it up to companies to determine appropriate quality control measures. Robert Brackett, director of the FDA’s Center for Food Safety and Applied Nutrition, explained that the regulations are not as stringent as those for infant formula and low-acid canned foods. Congress, however, is so concerned about the safety of dietary supplements that it recently required manufacturers to report serious adverse reactions to the FDA. Although all manufacturers will have to retain adverse reaction reports, FDA will only be inspecting high-risk companies. Given FDA's limited resources, that may be as infrequently as once every five or ten years.

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Contact Jeff Cronin (jcronin[at]cspinet.org) or Ariana Stone (astone[at]cspinet.org).