Wednesday, February 04, 2009

FDA Supplement Warning Letters: 2008 Year in Review

Ivan Wasserman and Svetlana Walker have published the useful FDA supplement warning letters: 2008 year in review in (27-Jan-2009). Wasserman and Walker analyzed the 44 warning letters issued by the US Food and Drug Administration (FDA) to supplement marketers last year. This type of analysis can provide insight into the types of claims and other issues that are at the top of FDA’s list for enforcement.

FDA’s emphasis on cancer claims made on internet web sites is no surprise as this has long been a red flag to the agency. All 44 of the warning letters involved some type of concern regarding disease claims (36 mentioned cancer claims). Website claims were mentioned in 41 of the letters. By comparison, only three warning letters were sent following facility inspections.

The amount of letters triggered by website reviews highlights the importance of diligence when it comes to creating website content. FDA may consider any statement that appears on a company’s web pages to be a labeling claim. Consumer testimonials, even when truthful can still be misleading, and when used in a company’s marketing, FDA will consider these testimonials to be the same as direct claims.

In addition, FDA considers metatags (hidden tags used direct search engines) to also be part of a product’s claims. For instance, “gout” as a metatag for a dietary supplement webpage would drive customers seeking gout information to that website. Almost half of the 2008 FDA Warning Letters sent to dietary supplement marketers identified the use of disease terms in metatags.

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