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Dose of Digital Blog Issued FDA Warning Letter

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:

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 and have a wonderful April.

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About The Author


Jonathan Richman

Jonathan Richman

Jonathan is the creator of Dose of Digital. You can find him on Twitter and here's his official Google+ profile.


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  • http://alikuru.com/ Ali Kuru

    Really sorry to hear this. I wonder what would they do if someone out of the states posted those ideas on his/her blog?

    Ali Kuru’s last blog post..Opera Mobile 9.7 will have Flash and support Google Gears

  • http://alikuru.com Ali Kuru

    Really sorry to hear this. I wonder what would they do if someone out of the states posted those ideas on his/her blog?

    Ali Kuru’s last blog post..Opera Mobile 9.7 will have Flash and support Google Gears

  • MSilver

    Ridiculous but not unbelieveable. I do hope you find some way to keep the content up.

    Too bad there isnt any onus on the FDA to prove that they are actually SMEs and “in touch with the realities of the marketplace.”

  • MSilver

    Ridiculous but not unbelieveable. I do hope you find some way to keep the content up.

    Too bad there isnt any onus on the FDA to prove that they are actually SMEs and “in touch with the realities of the marketplace.”

  • MCasey

    This is so ridiculous that it must be April 1st.

  • MCasey

    This is so ridiculous that it must be April 1st.

  • PhillyCooke

    Cute.

  • PhillyCooke

    Cute.

  • Noah

    April Fools, eh? Nice bit about Pharmalot hidden amidst the legalese.

  • Noah

    April Fools, eh? Nice bit about Pharmalot hidden amidst the legalese.

  • Jeff

    This feels like a complete disregard for your free speech rights. The wording in the act feels like the decree of a dictator. I thought an individual citizen has the right to publish their thoughts regarding any government agency.

    On a side note: I thought this was an April Fools joke at first given the section number they reference is also a bad Van Halen album.

  • Jeff

    This feels like a complete disregard for your free speech rights. The wording in the act feels like the decree of a dictator. I thought an individual citizen has the right to publish their thoughts regarding any government agency.

    On a side note: I thought this was an April Fools joke at first given the section number they reference is also a bad Van Halen album.

  • Guest

    Wow. Today is April Fool’s Day. I totally forgot.

  • Jonathan Richman

    Wow. Today is April Fool’s Day. I totally forgot.

  • Michelle

    you got me!!! you’ll pay sucker!

  • Michelle

    you got me!!! you’ll pay sucker!

  • http://alikuru.com/ Ali Kuru

    Got me too, fine one :)

    Ali Kuru’s last blog post..Opera Mobile 9.7 will have Flash and support Google Gears

  • http://alikuru.com Ali Kuru

    Got me too, fine one :)

    Ali Kuru’s last blog post..Opera Mobile 9.7 will have Flash and support Google Gears

  • http://www.mommycast.com/ Paul Vogelzang

    Oh, you totally got me! I live in DC, home of the practical joke on 4/1, and I began showing this around, until someone looked at me and said: “Oh you ate one, too!”

    Paul Vogelzang’s last blog post..Pampers & Unicef

  • http://www.mommycast.com Paul Vogelzang

    Oh, you totally got me! I live in DC, home of the practical joke on 4/1, and I began showing this around, until someone looked at me and said: “Oh you ate one, too!”

    Paul Vogelzang’s last blog post..Pampers & Unicef

  • Donna

    If this is an April Fool’s joke, it is in poor taste. A bogus government agency threat to our First Amendment right is not a laughing matter on any day of the year. As an American, I trust you agree.

  • Donna

    If this is an April Fool’s joke, it is in poor taste. A bogus government agency threat to our First Amendment right is not a laughing matter on any day of the year. As an American, I trust you agree.

  • http://www.stevewoodruff.com Steve Woodruff

    Not only is this a horrible joke to play on well-meaning Americans, but it has been recycled as a 2010 joke as well. Fortunately, Dose of Digital has been de-funded in the healthcare overhaul of 2010, so you’re history anyway!

    • http://www.doseofdigital.com/ Jonathan Richman

      Thank goodness. This blog is a lot of work. Maybe I’ll get some free time now.

  • Sam Walmsley

    ha ha ha!
    Spent 10mins ranting about how the FDA had no right to do this! Good one Jon, this is the first one thats got me today :D

    • http://www.doseofdigital.com/ Jonathan Richman

      Please tell me that I didn’t get you on this one last year also when I published it the first time.

  • http://www.stevewoodruff.com Steve Woodruff

    Not only is this a horrible joke to play on well-meaning Americans, but it has been recycled as a 2010 joke as well. Fortunately, Dose of Digital has been de-funded in the healthcare overhaul of 2010, so you’re history anyway!

    • http://www.doseofdigital.com Jonathan Richman

      Thank goodness. This blog is a lot of work. Maybe I’ll get some free time now.

  • Sam Walmsley

    ha ha ha!
    Spent 10mins ranting about how the FDA had no right to do this! Good one Jon, this is the first one thats got me today :D

    • http://www.doseofdigital.com Jonathan Richman

      Please tell me that I didn’t get you on this one last year also when I published it the first time.

  • http://www.wyckaert.info/simon Simon Wyckaert

    A very nice one, indeed

  • http://www.wyckaert.info/simon Simon Wyckaert

    A very nice one, indeed

  • Tthor

    Oh geezzz. No I didn’t see this last year and I totally fell for it. Good one!!!

  • Anonymous

    Well done. You sure got me!

  • http://twitter.com/GlenGilmore Glen Gilmore, Esq.

    Jonathan, thanks for having the courage to blog about the FDA’s edict that you stop blogging about them. Unfortunately, their letter seems to have at its core intimidating a critic rather than safeguarding the integrity of the industry or the safety of the public. I hope that rather than having a chilling effect on other bloggers, it inflames them. No regulatory agency should be permitted to use its regulatory authority as a bludgeon. I hope that you continue to share your passion and expertise!

  • Mike

    This is a problem of oversight. If you have challenged the specialist acumen of the FDA, whoever has oversight of the agency should be the ones demanding that you put up or shut up, while challenging the FDA to prove the allegations incorrect. However, a requirement to keep agencies like the FDA independant, at arm’s length from politics, means that oversight is necessarily virtually non-existant. A problem without a simple solution. Add to that the implied need of agencies of this nature to retain a degree of public confidence and you have the recipe for an overreaction that will only make matters worse if/when the media escelate the story.

  • http://twitter.com/LeighFazzina Leigh Fazzina

    Wowzers Jonathan.