For some it’s hard to remember life before the internet. Having access to endless amounts of “resources” and knowledge, instant “friends” with those thousands of miles away, and the ability to always be in-step with those you “follow”- all have revolutionized the modern day world. Recent warning letters issued by FDA urge the industry to take cautionary steps when navigating this new World Wide Web frontier.
Last month FDA issued a warning letter to a company which FDA claims to have “therapeutic claims on website establish that products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.” The company’s website has a product search field and when keywords like “cancer” or “diabetes” were entered certain products appeared as a result. The problem is that the products that were generated were “new drugs” and not recognized as safe and effective.
Does this warrant the title of “implying” that the products are meant for treatment for the disease? Is the company guilty of misbranding?
A recent posting on RAPS included a humorous heading of “FDA Does Not ‘Like’ This Post” - in reference to a different company who recently ‘liked’ an unapproved claim about its product on Facebook. According to an FDA Warning Letter to the company, by ‘liking’ testimonials on Facebook the firm is promoting products as having “intended for use in the cure, mitigation, treatment, or prevention of disease” when the product is still unapproved.
The article in RAPS also notes that “it has long been a matter of speculation in the social media world of whether a "like"—or on Twitter, a "re-tweet"—represents an endorsement of the content, or just a passive-but-friendly recognition of that content.”
Until FDA issues a formal social media policy it looks like industry should be weary of whom it “follows” and “likes”. Similarly, perhaps company’s need to be more aware of their metadata and search engine optimization techniques which might have unfavorable results.
Is this an overextension of FDA’s reach? Do you believe these are just causes for FDA to issue a warning letter? Share your thoughts below.
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