A recent warning letter suggests that FDA, in regulating user generated content (“UGC”) on social media pages, will likely treat all companies the same. Earlier this year, FDA released two guidance documents for drug and medical device companies on social media. Those documents provided the following stance on UGC: “[A] firm generally is not responsible for UGC that is truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular).” For this stance, FDA cited Section 230 of the Communications Decency Act, which has been interpreted as protecting websites owners from liability, in many areas, for the posts of others. Section 230 applies equally to drug and device companies, as well as dietary supplement, food, and other types of companies. Thus, FDA presumably should treat UGC on companies’ social media pages the same no matter what kind of product is being promoted. Not all past FDA warning letters, though, have appeared consistent with Section 230. See, e.g., Origin BioMed warning letter.
The FDA’s recent warning letter, however, is consistent with Section 230 and may signal that FDA offices are adopting a uniform approach to UGC. The recent letter was addressed to a company that sells cough syrups and sleep remedies as foods. FDA alleged that certain claims for the products were disease claims and, thus, converted the products into unapproved drugs. FDA pointed to Facebook and Twitter comments by consumers on the company’s social media pages, but only if the company had either “liked” or otherwise endorsed the comments through responses (e.g., “Mary, thank you for writing this!!! We love to hear that we have helped people”). It appears that by virtue of the “likes” and responses, FDA no longer considered the consumer comments truly independent. It remains to be seen whether FDA will stay the course and remain consistent in its future enforcement efforts against products other than drugs or medical devices.