5. These claims might include statements such as “maintains a healthy circulatory system” or “helps you relax.” Supplements may not make express or implied disease claims (those that claim the product can prevent, treat, cure, mitigate or diagnose disease) without prior review by the agency. FDA said these prohibited disease claims can be made through the product name, through a statement about the formulation of the product, or through the use of pictures, vignettes or symbols. Labels also must in-clude a disclaimer that the dietary supplements are not drugs and receive no FDA pre-market approval.
This final rule, which takes effect Feb. 5, was much more lenient as to acceptable structure/function claims than the earlier proposed rule.
Critics of the proposed rule said FDA had included too broad a definition of “disease” and would have severely limited manufacturers’ ability to make structure/function claims. The GMA applauded FDA’s final rule, saying it performs a great public service by allowing more information to be given to consumers. Not everyone was happy. The consumer advocacy group Center for Science in the Public Interest predicted the market would be flooded with products claiming to treat a wide variety of ailments. For the average consumer, it means “buyer beware,” said CSPI.
