You may have read in the last few days that the FDA issued a Warning Letter to a nutrition supplement manufacturer for allegedly promoting its product as a drug by, among other things, using social media. The Warning Letter, seemingly for the first time, signaled the FDA’s view that “liking” a post on Facebook can constitute promotion. While this may be a new signal, more important is that we are still without a broad guidance document from the FDA on promotion over the internet or social media.
We’ve followed this issue for some time, posting on it here and here. That’s because FDA guidance is needed. For practical reasons, the industry’s use of the internet and social media to provide information to the users of its products will be limited until the FDA speaks with broad guidance. We saw this with print and broadcast promotion, which only increased substantially once the FDA issued its guidance. And we’re seeing it here.
Now, the FDA has issued intermittent signals as to promotion over the internet and social media. In late 2009, it held a “Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” It has also engaged in ad hoc regulation through Untitled Letters and Warning Letters that address promotion through product websites, sponsored internet links, online banners, and Facebook widgets. And the FDA did issue one draft guidance document, but it was limited, not broad, addressing only how the FDA believes that manufacturers should respond to off-label questions that come from, among other sources, the internet and social media. After all this time, however, the FDA has not issued a broad guidance document.
This latest Warning Letter, issued by the compliance branch in the FDA’s Los Angeles district, is more of the same. It states that AMARC, the manufacturer of a nutritional supplement called PolyMVA, improperly promoted the supplement as a drug on social media. It pointed to two actions on the manufacturer’s Facebook page:
We also note claims made on your Facebook account accessible at: https://www.facebook.com/poly.mva, which includes a link to your website at www.polymva.com. The following are examples of the claims:
In a March 10, 2011 post which was “liked” by “Poly MVA”:“
PolyMVA 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 AMARC”
In a May 5, 2010 post you provide a link to the blog post titled, “Children with Cancer Often Use Alternative Approaches” which can be found on your website at www.polymva.com/blog-news/218/children-with-cancer-often-use-alternative-approaches. At the end of the post is the following statement and a link to the website, www.facr.org:
“For information on how palladium lipoic complexes can nutritionally support the body during cancer and cancer therapy, visit the Foundation for Advancement in Cancer Research’s website.
”Your products are not generally recognized as safe and effective for the above referenced conditions
So, it appears from this excerpt that those people in the FDA’s Los Angeles office who issued this letter believed that the manufacturer promoted the supplement as a cancer drug by (1) “liking” a Facebook post in which a cancer patient said that the product kept her cancer at bay, and (2) posting a third-party article (from Reuters it appears) about the use of alternative cancer therapies while stating that the supplement can “support” the body during cancer therapy.
For purposes of this post, we express no opinion on these statements or the FDA’s comments about them. We see a bigger problem. What if anything is industry to take from this – that is, other than a general discomfort in using Facebook or social media? It seems that the letter creates uncertainty, not guidance. Raising questions isn’t regulating. Nor is discouraging manufacturers from providing information to the users of their products on forums where the users go to discuss the products and get information about them.
So here we still are – awaiting FDA guidance. As we told you last year, in July 2012, Congress gave the FDA two years to issue the type of regulatory guidance that’s needed – that is, guidance “regarding the promotion, using the Internet (including social media), of medical products.” If you do the math, this means that the FDA should have guidance in place by July 2014. That’s a long wait. But it gets shorter every day. 488 days, 487 . . .