Late last summer while visiting the Alaska State Museum in Juneau, a postcard with a photo of a decorated canoe caught my eye. On the front it said, “Genuine Alaskan Native Art” and on the back was a blurb about the Federal Trade Commission (FTC) and FTC information on Alaskan Native Art. There are specific guidelines on when terms such as ‘Alaska native’ can be used.
The FTC has recently gotten the attention of the food and dietary supplement industries by requiring two clinical trials for support of structure-function claims. Nowhere in FDA regulations is this required. Companies must have data supporting the claims they make as discussed in this FDA guidance but there is no stipulation that 2 clinical trials are required. FDA Law Blog has written very good pieces about the conflict between POM Wonderful and the FTC.
Today FDA published an announcement in the Federal Register that the Office of Management and Budget had approved the agency’s request to collect information from industry on substantiation of structure-function claims. It will be important for the industry to respond with realistic information about the time and effort proper vetting of claims takes.
We can review your claims and supporting data to help you determine if you have proper substantiation.