FDA – The Slacker Agency Speaks

Thanks to my friend Dan Lally for sending this blog post today.  Dan asked for my POV.  So here goes.  The post talks about a “regulatory gray area” at the FDA.  And as a result, two companies find themselves the subject of unwanted attention.  The FDA recently delivered two interesting  warning letters.  The  first went to a company called AMARC Enterprises.  The FDA was concerned that AMARC “liked” a post that a customer made on its Facebook page. The customer comment suggested that a  product made by AMARC allowed him “to keep cancer at back without the use of chemo and radiation.”  In the second warning letter, the FDA expressed concern with a Web site maintained by M.D.R. Fitness Corp. Apparently when visitors typed in words like “cancer” or “diabetes” into a search field, the Web site would return a list of the company’s dietary supplements.  According to the FDA, in doing so, M.D.R. was creating the implication that its products are “intended for use in the diagnosis, cure, mitigation, treatment or prevention of such diseases.”  So here are my thoughts: 

 1.  In my experience, there is almost nothing worse than a “regulatory gray area.”  The only thing that comes to mind immediately is the Pete Rose reality TV show.  

 2.  I think the FDA is being a little picky on the “liking” thing.  It reminds me a little of some state bar association ethics opinions that take a dim view of lawyers and judges being “friends” on Facebook.   The term “friend” for purposes of Facebook in my view refers to a relationship that is less intimate than what we traditionally thought. In the same way, the FDA seems to be giving a little more weight to “liking” something than that term deserves.  Of course AMARC “likes” a positive review of its product.  To interpret that as endorsing the consumer’s conclusion seems like a bit of a stretch to me.  I would be more interested in whether the consumer’s post is totally on the up and up, and I can see room for a lot of mischief here.  But as I say, it seems kind of unfortunate that a company can’t show it’s appreciation for a positive review.  I wonder if the FTC would take an equally expansive view.  Imagine a consumer who says “Morton’s has the freshest steaks!”  and Morton’s “likes” it.   Is that deceptive advertising?   I hope not.

3. For some reason, I’m not as troubled by the warning letter on the computer generated search results.  This seems to be a bit more nefarious in terms of creating an association between a dietary supplement and a particular condition.  It seems to me it’s fair to ask why the term “cancer” causes that particular supplement or supplements to pop up.  I wonder if a disclaimer of some sort would solve the problem.   

 4.  Given that the SEC and FTC have already provided guidance on the issue, it seems to me fair to conclude that the FDA is the slacker of federal agencies. 

But if you are regulated by the FDA, or any other agency for that matter, the lesson here is how easy it is to run afoul of the regulators’ whims.  Better think hard before posting.