I wasn’t sure this was even possible, but my attorney assured me it was. Early this morning, I received an email and follow up fax from the FDA that contained a warning letter (download the actual letter here). Yes, that kind of warning letter. I thought that they could only issue them to pharma and medical device manufacturers and distributors, but apparently not. They referenced Section OU812 of the Federal Food, Drug, and Cosmetic Act. Apparently, they aren’t too happy with some of my recent posts including:

• FDA Uses Social Media, But You Can’t
• How to Avoid FDA Regulations Using Mobile Marketing
• The FDA Is Already Creating Digital Promotion Rules
• FDA Isn’t Ready for Us…Stop All E-Marketing

The critical part of the letter was as follows:

“As you are not a manufacturer, distributor, or seller of pharmaceutical products, we have limited jurisdiction over what you post. However, in cases like these, the Act allows us to assume executive powers as indicated under Section OU812 of the Act. These powers can only be assumed when FDA has determined that any marketing (as quoted from the Section in the Act) “makes it appear as though FDA is not a subject matter expert” or “infers that FDA is not in touch with the realities of the marketplace.” Your blog posts violate both of these clauses.” 

There’s quite a bit more detail in the letter including some potential penalties, so check out the actual warning letter for more details. 

They’ve given me 15 days to stop writing and/or remove all the FDA related content from the blog. I’m not sure what I’ll do now, but I’m not really up for a massive fine at this point. While I’m deciding, I thought we could start something of a petition. So, if you believe that this is inappropriate harrassment by the FDA, then please leave a comment with your thoughts. Maybe that will sway them a bit, but I doubt it. Alternatively, you can write directly to the Director at the FDA who sent this letter, Trevor Manfranginsindin, Esq., Director, Office of Compliance.

So, if you haven’t read my posts about the FDA, now’s the time, they might not be there for long. Thank you for your support in this difficult time. 

UPDATE: April 8

All right. Enough of you have emailed, called, twittered, or otherwise tracked me down to ask if this is real and if the FDA really can do this. No, they can’t, but anything’s possible on April 1. We’ll leave it at that.

Possibly related posts (auto-generated):

1. Is the FDA Already Creating Digital Promotion Rules?
2. Dose of Digital: The Year So Far
3. No, Pharma’s Digital Future Isn’t All Social Media