FDA today published its final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Under DSHEA, dietary supplements may bear “structure/function” claims — claims that the products affect the structure or function of the body — without prior FDA review. They may not, without prior FDA review, bear a claim that they can prevent, treat, cure, mitigate or diagnose disease (a disease claim).
This final rule describes how FDA will distinguish disease claims from structure/function claims. While this rule should not affect the availability of dietary supplement products or consumer access to them, it may affect whether certain claims can be made under DSHEA and therefore may result in some labeling changes for these products.
The final rule precludes express disease claims (“prevent osteoporosis”) and implied disease claims (“prevents bone fragility in post-menopausal women”) without prior FDA review. The final rule clarifies that such express and implied disease claims can be made through the name of a product (“Carpaltum,” “CircuCure”), through a statement about the formulation of a product (contains aspirin), or through the use of pictures, vignettes, or symbols (electrocardiogram tracings). The rule permits claims that do not relate to disease. These include health maintenance claims (“maintains a healthy circulatory system”), other non-disease claims (“for muscle enhancement,” “helps you relax,”), and claims for common, minor symptoms associated with life stages (“for common symptoms of PMS,” “for hot flashes”).
In response to comments from industry and consumers, FDA made several significant changes in the final rule. These changes, which have the effect of expanding the number of acceptable structure/function claims, include revising the definition of “disease” in response to comments that it was too broad and permitting structure/function claims about certain common conditions associated with aging, pregnancy, menopause, and adolescence. Serious conditions associated with aging, pregnancy, menopause, and adolescence, such as toxemia of pregnancy, and osteoporosis, will continue to be treated as diseases.
Under DSHEA and existing regulations, dietary supplement manufacturers are already required to have, in their files, substantiation of any structure/function claims they make. They must also include a disclaimer on their labels that the dietary supplements are not drugs and receive no FDA pre-market approval. Finally, they must notify FDA of the claims they are making within 30 days of marketing a given dietary supplement.
FDA believes that this rule, which clarifies appropriate structure/function claims, will ultimately provide consumers with better information on dietary supplement labeling that will help them select appropriate products. The issuance of this rule is an important part of FDA’s overall dietary supplement strategy, which was announced this past week, and which is aimed at providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplements.
The rule publishes in the Jan. 6, 2000 Federal Register and will become effective 30 days after the date of publication. Any product that is marketed for the first time after the date of publication and any new claims made for an existing product for the first time after publication will be expected to comply with the rule beginning 30 days after publication. Small businesses that marketed a product as of the publication date will have an additional 17 months to bring existing claims into compliance and all other products that were on the market as of the publication date will have an additional 11 months to bring existing claims into compliance.
Source: FDA TALK PAPER, January 5, 2000. FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.