The Federal Trade Commission in conjunction with the Food and Drug Administration has announced that they have issued warning letters to several companies who are making claims regarding omega 3 fatty acids and brain and vision function. The agencies are seeking information regarding the substantiation of these claims.
Recently, Northwest Natural Products successfully responded to a similar warning letter with the result that FTC issued a closeout letter stating that no enforcement action would be taken. In the letter, the FTC stated,
“Upon careful review of the matter, including non-public information submitted to staff, we have determined not to recommend enforcement action at this time. The factors we considered in making this determination include the very limited duration of the print advertising campaign containing the claims at issue and NNP's swift and voluntary action to modify all marketing materials for these products, including product packaging and labeling, to ensure compliance with the FTC Act. Specifically, we understand that NNP has destroyed all remaining product labels containing the claims at issue and is in the process of distributing new labels”
The letter further stated that the FTC staff “appreciates NNP' s significant cooperation in the prompt resolution of this matter.” This example clearly shows how having appropriate documentation of all claims as well as displaying good faith by being cooperative and working to address any regulatory issues can prevent enforcement actions that could result in product seizure and severe disruptions in business.
At Bioscience Translation & Application, we often provide our clients with information as to what risks various claims may pose. We also remind our clients that all claims must be truthful, not misleading and substantiated by scientific data. We at Bioscience Translation & Application are ready to evaluate your product claims and to help you gather the information required to substantiate your product claims to ensure your success We also stand ready to help you respond to FDA letters and actions, should the need ever arise. Visit us at www.BioTransApp.com
For further information on this topic, you may view the FTC news release at http://www.ftc.gov/opa/2010/02/omega.shtm and a discussion of it at http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2010/02/ftc-hones-in-on-omega3-claims-among-others.html
See the Northwest Natural Products closeout letter at http://www.ftc.gov/os/closings/091030northwestclosingletter.pdf
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