In the agency’s first enforcement action based on social media activity, the Food and Drug Administration published a warning letter sent to dietary supplement maker AMARC Enterprises for “liking” a consumer testimonial about one of its products and for marketing other products as a drug.
The letter – which was sent in December 2012 but just made public – addressed the Poly-MVA products that were marketed on Web sites, in information packets that accompany purchase of the product, and through social media. According to the FDA, the human and animal dietary supplements were promoted as a drug within the meaning of the Food, Drug, and Cosmetic Act.
In one example, the FDA noted a consumer testimonial that read, “I want everyone to know that I am now 3 years clear of lung cancer!! When I was told I had a mass in my lung, the first thing I did when I returned home was to call AMARC Enterprises – the PolyMVA people. PolyMVA helped save my life. . . .Thank you again and again for the support that PolyMVA gave my body in my fight against cancer!”
“The claims in the literature and on your websites establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease,” the agency wrote. “The marketing of your product with these claims violates the Act.”
But the agency went one step further, criticizing the company for “liking” a March 10, 2011, comment on the AMARC Facebook page for Poly-MVA. The comment read, “[Product] has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation. . . .Thank you [Company.]” In response, AMARC “liked” the comment.
By liking the post, the company made an impermissible drug claim that the product at issue was intended for use in the diagnosis, cure, mitigation, treatment, or prevention of a disease, the FDA said. “Your products are not generally recognized as safe and effective for the above referenced conditions and therefore…[are] “new drugs,” the marketing of which must be preapproved by the FDA. The agency further stated that, [the] products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended uses,” making them misbranded under the FDA Act.
AMARC was given 15 days to respond to the agency’s letter or face regulatory action.
To read the FDA’s warning letter, click here.
Why it matters: While drug companies have sought guidance on marketing their products in the context of Web 2.0, the agency has not provided any direction. Although the FDA has said the regulation of social media is under consideration (for example, how to fit all the required drug warnings in a 140-character tweet), for the present, the drug industry must use care when engaging with consumers online. The warning letter serves notice that the FDA will treat the “liking” of a consumer comment as marketing or promotional activity and that it will scrutinize all forms of social media activity in the future.