As previously reported here, in the prior administration, FDA had an unwritten and informal enforcement policy that that allowed a website selling dietary supplements to link to scientific literature discussing nutrients in those supplements and diseases, provided that the page containing the scientific literature was at least “two clicks” away from product pages in question.  The current administration appears to have no clear position on the matter.

One thing is clear, however.  A direct link (just one click between scientific information and product promotion) is insufficient.  In an April 24th warning letter to EuroPharma Co., Inc., FDA concluded that multiple products were drugs because the products’ pages linked directly to articles that contained disease claims.  For example, the company’s Calm Kids product page on its website linked to an article entitled, “Help Children with Attention Deficit-Hyperactivity Disorder (ADD OR ADHD),” and that article included claims like, “For ADD/ADHD focus look for a formula with these ingredients: [an ingredient list that is identical in both ingredients and amounts to what is provided on the Calm Kids page].”  Similarly, the company’s Curamin page contained a link to an article entitled “PAIN & INFLAMMATION Curcumin [an ingredient in Curamin]:  The All in One Solution,” which contained claims like, “[Curcumin . . .] can be used to treat almost every disease or illness, including: Cancer [. . .] Heart Disease [. . . ] Bronchitis and Asthma [. . .] Depression [. . .]”

This warning letter is typical of agency efforts to expand its scrutiny of dietary supplement labels, websites, and promotions.  FDA does not counsel parties on compliance, merely defines the violation and not the cure.  Its expansive application of the intended use doctrine, as witnessed by its decision to deem a company representative’s simple Facebook “like” to be an adoption of the therapeutic content of a customer’s claims, invites First Amendment challenges.  FDA appears to be undermining the court decision in Balanced Foods, Inc., which struck down an FDA attempt to deem vinegar and honey in a health food store an unapproved new drug because the health food store also had a library containing information on the therapeutic effects of vinegar and honey.  U.S. v. 24 Bottles “Sterling Vinegar & Honey, etc.” (Balanced Foods, Inc.),338 F.2d 157, 158 (2d Cir. 1964).



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