Drug Criteria & Outcomes-Dietary supplement claims revised in new FDA rule

Supplements to undergo label changes

The U.S. Food and Drug Administration has published its final rule defining the types of statements that can be made concerning the effects of dietary supplements on the structure and/or function of the body, based on the Dietary Supplement Health and Education Act of 1994 (DSHEA).

According to DSHEA, dietary supplements may make structure/function claims without FDA review (such as, "helps you relax"), but not disease claims (such as, "prevents osteoporosis"). That is, they may claim to affect various structures or functions of the body, but they may not claim to alter disease.

In response to comments that earlier definitions of disease were too broad for supplements, the final rule more precisely defines the differences between structure/function and disease claims. It is expected that several dietary supplements will undergo labeling changes, resulting in more structure/function claims.

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Dietary supplement manufacturers already are required to have on file data to substantiate any structure/function claims made. In addition, their labels must indicate that the supplements are not "drugs" and that they do not have FDA approval. They also must notify the FDA of any claims they are making within 30 days of marketing the supplements with those claims.

The FDA has advised dietary supplement manufacturers not to make any pregnancy-related claims on their products based on the ruling. The FDA plans to issue further guidance regarding pregnancy claims in the near future.

In the meantime, pregnant women are advised to seek the counsel of their health care providers before taking any kind of dietary supplement or medication.

(For additional information, visit these Web sites: http://vm.cfsan.fda.gov/~lrd/tpdsclm.html and http://vm.cfsan.fda.gov/~lrd/hhssupp3. html. Consumer questions can be directed to (888) INFO-FDA.)