FDA modifies diet supplement claims approach

The U.S. Court of Appeals ruled in 1999 that the Food and Drug Administration should consider allowing health claims on dietary supplements even though they are not widely recognized as valid by the scientific community.

This should be done if the evidence supporting the claim outweighs the evidence against the claim, and if the claim could be qualified by a disclaimer that would prevent consumers from being mislead. In the wake of the court’s decision, FDA modified its approach to processing the claims. If the claim meets the significant scientific standard (SSA) of evidence, the agency will publish a proposal or interim final rule authorizing the claim. If it doesn’t, FDA will “exercise enforcement discretion” for qualified health claims for dietary supplements provided: • the health claim petition meets FDA requirements for such petitions; • the scientific evidence supporting the claim outweighs the scientific evidence against it; • consumer health and safety are not threatened; • the claims meet the general requirements of a health claim. Even using the new approach, FDA denied two of the four health claims that were the basis for the lawsuit. It recently nixed a claim that stated 0.8 mg of folic acid in a dietary supplement was more effective in reducing the risk of neural tube defects than a lower amount in foods. There is also another claim in question about dietary fiber and reduced risk of colorectal cancer. The former claim could not be appropriately qualified without misleading consumers, FDA said, and the latter was not supported by sufficient scientific evidence. Studies consistently showed a lack of relationship between dietary fiber supplements and colorectal cancer. FDA said it would issue its decision on the other two claims shortly.

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