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Posted October 5, 2012

Illegal Claims on Weight Loss, Immune System Dietary Supplements, and Few Backed by Clinical Data

On October 3, 2012, the U.S. Department of Health and Human Services issued a report warning that dozens of weight loss and immune system supplements have illegal claims of curing or treating disease on their labels and/or lack the scientific evidence to support such label claims.

The investigation found 20% of the 127 weight loss and immune system supplements purchased online and in retail stores made illegal label claims. Additionally, nine supplements lacked the FDA disclaimer required on supplement labels that with structure/function claims.

Supplement manufacturers are limited as to what kinds of statements they can put on a label and in advertising. Disease claims - statements that imply a dietary product can prevent, treat, mitigate cure or diagnose any disease - are illegal, although specific health claims are permitted for certain ingredients, such as “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.”

Manufacturers can make statements called structure/function claims, which describe the role of a dietary supplement in the structure and function of human bodies. An example of an acceptable structure/function claim given in the report is the statement “supports immunity.” If mention of a disease were to be added to the statement, such as “boosts the immune system against cold and flu,” this would then become an illegal disease claim.

If a manufacturer does make a structure/function claim, they are required to notify the FDA in a Notification Letter within thirty days of marketing the product. They are also required to maintain documents of scientific support for the claim, although they do not have to submit this with their notification. Dietary supplement labels with a structure/function claim are also required to have a disclaimer that lets consumers know the statement has not been evaluated by the FDA.

The Department of Human Health’s report found that the products examined had a median of 3 structure/function claims each. However, out of the 127 supplements, only 21 had structure/function claim Notification Letters on file, and 17 of these letters were lacking required information.

When manufacturers were asked as part of the investigation to submit their documents citing scientific support for their claims, most of the evidence was not from human studies (recommended by FDA guidelines). Moreover, of the 34 percent of scientific documentation that was from human studies, none met all of the FDA’s recommendations for competent and reliable evidence. “Overall,” the report states, “substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable information.”

As part of its product testing and reviews, checks labels to make sure they comply with FDA guidelines, and published label claim violations in its reports.

To read the complete report from the Department of Human Services, use the link below.