Social Media

3 Ridiculous Ways the FDA Is Policing Social Media

In the FDA's world, Facebook likes are advertising and honey is a "new drug" that must be regulated.

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I'm not sure if the Food and Drug Administration (FDA) is especially good at empire-building or it's just that I pay more attention to this federal agency than others. But the FDA seems to spend a significant amount of its time trying to extend its reach.

Recently it has taken a manifest destiny mindset toward the digital landscape, attempting to broaden its regulatory jurisdiction to include Twitter, Facebook, message boards, blog comments, and more. Here are three absurd (and possibly unconstitutional) ways that the FDA is now policing food, drug, and other companies online.

Facebook Micromanagement

On June 27, the FDA sent a warning later to Zarbee's Naturals, a line of cough syrup, sleep aids, and seasonal-allergy remedies. Zarbee's products rely on active ingredients such as buckwheat honey, Butterbur leaf extract, and the sleep hormone melatonin. The FDA scolded Zarbee's for saying its products treat conditions such as coughs and congestion, as treating these conditions would "cause the products to be drugs." That's right—if your all-natural product does the same thing as a drug, that makes the product a "new drug" to the FDA.

"New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA," the agency warned Zarbee's. FDA drug approval is a lengthy and expensive process, of course (and no real guarantee of a drug's safety at all).

As examples of Zarbee's illegal promotion of its "new drugs", the FDA cited several Facebook posts from the company as well as personal testimonials that customers had posted to its Facebook page. Zarbee's "liking" these comments was considered "endorsing or promoting" them. From the FDA warning letter:

Zarbees "liked" the following comment made on February 4, 2014: "…I received your…Zarbee's Naturals Children's Sleep Product. I have a daughter…born with cerebral palsy and she suffers from Complex Regional Pain Syndrome… [s]he took the samples you sent and slept through the night…best sleep she has had in years…"

On February 4, 2014: Zarbees commented "Mary, Thank you for writing this!!! We love to hear that we have helped people…" on this claim.

Zarbees "liked" the following comment made on January 7, 2014: "I've been battling either bronchitis or pneumonia for the last 18 days and have tried everything…your Children's Cough Syrup and mucus relief got rid of…my hoarsness [sic]…[m]y throat and chest are beginning to feel so much better…"

Zarbees "liked" the following comment made on October 30, 2013: "Love Zarbee's this is the only medicine we use for our 2 year old. Colds and congestion clear up in 2 days."

Zarbees "liked" the following comment made on October 15, 2013: "Received the sample for allergy relief and my husband had a terrible problem with allergies…he was very impressed on how well it worked for him…"

Good thing the FDA is going to step in and pull this dangerous product off the market until it gets a permission slip, or at least stop Zarbee's from making honest, accurate, non-FDA approved claims. These customers may think Zarbee's cold remedies are working for them and their children, but clearly that's only because they've been duped by the company's manipulative advertising (like this February tweet the FDA cites: "Try @Zarbees #naturalremedies for Cold and Cough Season").

The FDA must step in to break this false consciousness brought on by lived experience and not an external authority—for the ignorant masses' own good!, obviously. Coughs and colds, after all, "are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners," the FDA states. "Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes."

(h/t Tristyn Bloom/The Daily Caller)

Tweet Police

Zarbee's Naturals was also cited for several tweets. It's not the first company to come under FDA scrutiny on Twitter, and it certainly won't be the last: Draft guidelines released by the agency in June instructed drug companies that any pro-pharmaceutical tweet would also have to list product risks and side effects.

Because Twitter users only have 140 characters to convey a message, this would effectively make tweeting about prescription drugs (and perhaps honey) illegal. And this may be what the FDA intends: "If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message," the agency states.

If the FDA's attitude toward Facebook liking is any indication, companies may also want to reconsider what they retweet and "favorite" on Twitter, too, lest that be considered a form of criminal endorsement. (It's a good thing the FDA doesn't regulate beer—Tecate recently favorited an Instagram photo of my kitten getting curious about a can, thereby tacitly endorsing my unscientifically-tested caption, "even kittens love Tecate".)

"It's been very challenging for companies to use Twitter in a way that the FDA prescribes," Jeffrey K. Francer, vice president and senior counsel with Pharmaceutical Research and Manufacturers of America (PhRMA), told biotechnology publication GEN.

"If the FDA is going to require the same type of fine print that you see in a magazine ad to be in a tweet, then the FDA is essentially taking that tool away from patients who may want to hear from companies as well as healthcare professionals."

Francer said PhRMA has proposed in the past that companies be allowed to use graphic symbols to indicate risk, with a short statement about what the drug does, and a link to more detailed risk-benefit information. Such character-limited messages would be along the lines of the FDA's (new drug approval tweets), which include links with the details about risks and benefits rather than embedding info within the tweets.

"The companies want to provide information that's useful to physicians and that's useful to patients, and they should be able to use all the different media that the government uses itself," Francer said. "I assume that the FDA believes that its own tweets are truthful and not misleading. If they believe that, then why couldn't a company use Twitter in the same way that the FDA is using Twitter?"

Francer said it raised First Amendment concerns that the government is restricting the speech of a particular group while engaging in that same type of speech itself. In a January 2014 letter to the FDA, PhRMA said the agency's proposed rules for drug companies on social media, podcasts, and blogs "could chill truthful and nonmisleading communication protected by the First Amendment."

And as we see with Zarbee's Naturals, it's not just pharmaceutical companies who should worry about FDA oversight on social media. Any company marketing a remedy for something that could also be treated with drugs is apparently on notice.

All Your Social Medias Are Belong to Us

Under the FDA's new draft guidelines, pharmaceutical companies must submit monthly reports to the agency listing "all non-restricted sites for which it is responsible or in which it remains an active participant" if these sites involve real-time communications. In other words, every company must keep the FDA abreast of any and all of its social media accounts, and resubmit this information on an ongoing basis.

"Firms need not submit screenshots or other visual representations of the actual interactive or real-time communications with the monthly updates" if the site is public, the FDA oh-so-generously offers. Just let it know where you are online and the FDA is more than capable of monitoring your every comment and like, thanks.

Brittany La Couture, a health policy analyst with the American Action Forum, nicely sums up the damage these kind of FDA policies can do. "With each additional regulation limiting free speech in marketing, producers are under more pressure to refrain from any advertising at all for fear of harsh repercussions for inadvertently crossing an invisible line," writes La Couture. "When drug and device manufacturers are afraid to use the latest and most popular technologies to market their products, companies and patients both pay the price."

Here are the relevant FDA draft guidelines:

January 2014: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

June 2014: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

June 2014: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

NEXT: See a Kid in a Car? Get Out Your Crowbar and Start Smashing, Says New Law

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  1. FDA: Federal Agency who’s headquarters are in greatest need of a suitcase nuke?

    Fuck, now I’m on a list…

    1. Like you weren’t already.

      1. Now he’s on TWO lists.

        1. Just by coming to this site you got on a list.

  2. The FDA scolded Zarbee’s for saying its products treat conditions such as coughs and congestion, as treating these conditions would “cause the products to be drugs.”

    Just a doggone minute. The *same* FDA that slaps a “This product is not intended to diagnose, treat, cure, or prevent any disease” label on every ad for products explicitly proclaiming exactly those intentions?

    *Kindly* tell me again exactly what service the FDA provides.

    1. Killing off people who want to try experimental treatments mostly. Because they’re scary risk takers!!!!

    2. *Kindly* tell me again exactly what service the FDA provides

      They provide a steady income to people who would otherwise be occupying cardboard boxes?

      1. They provide busywork for people who would otherwise be meddling with something more important, like that Nation’s energy grid. Wish we could get the EPA in a swivit about honey……

    3. Good fodder for outraged bloggers?

      1. SO MUCH THIS!!

      2. And a lot of stress for marketers.

      3. Who provides good fodder for outraged commenters.

        It’s the fodder chain!

        1. The FDA’s in the pocket of Big Fodder.

          1. +1 Sileage

    4. They are a disservice to the US citizens. They along products that should be allowed on the market. We are far from many other countries who have clear regulations against harmful products to its citizens.

  3. Question:

    Can a President dismantle all regulatory agencies with an executive order?

    Congress has delegated its authority to the Executive branch. Can the President simply fire everyone working in that agency and then not hire replacements? Sure, Congress can continue to fund it at current levels. Fine, when we don’t spend the money, you give it back.

    Can a President “effectively” cut government within his own branch?

    1. Reagan fired the air traffic controllers Santa’s elves.
      http://www.thecomicstrips.com/…..?iid=78462

      1. So a principled President Paul could gut all regulatory agencies and force lawmaking back to the publicly accountable legislature. Cut them to almost nothing. Cut them back so far that the next administration would need to dedicate ALL of it’s energy rebuilding them.

        1. It’s theoretically possible, assuming their union contracts were up. Then someone would kill him and his replacement would hire everyone back.

          1. No, serious cuts. Bare bones, absolute essentials (whatever that is) only. At least 50% and close the doors for shit like DOE.

            If you did it early in the term, these people would be in the streets for over four years. They will be forced to get real jobs. They will scatter to the winds and the next administration won’t be able to rehire them. Would you come back after finding a new job and knowing the same thing could happen again?

            1. No, seriously, someone would kill him. Within weeks. Then everyone would be hired back, and nothing else would happen.

              1. Even if he didn’t get killed, getting anything else done would be effectively impossible.

                Taking paychecks from thousands and thousands of government employees and giving them 40 hours of freedom every week would go a long way to hampering your other agendas.

                “We have a rule…we never free a mind once it reaches a certain age. It’s dangerous, and the mind has trouble letting go.”

                1. +5 EMP

            2. I like Rand Paul. But I doubt this will happen. The president is not more powerful or obstinate than the institution over which he provides. The leviathan will not be felled by one principled person in power, only by the greater moral understanding of the people who may otherwise support it’s continued existence.

    2. Sure, one who wants a JFK buzz cut…

      Government serves the interests of those within it, and then the cronies outside of it who pay for their continued installation. It’s the primary reason that it should be maximally contained. Of course, with the 55% of my labor already taxed, regulated, mandated, prohibited, and debased away into the government wasteland, the slope has been more than tipped in their favor. That’s why it’s not going to end pretty, and no POTUS is going to do a damn thing about it until everything explodes. I don’t see Americans waiting around for 70 more years until the thing implodes.

      Just some of the happy thoughts I have throughout the day…

      1. Americans have been, and will continue to be, down right saturnalian in their celebration of the nation state.

        Liberty is incompatible with getting goosebumps with flyovers.

    3. I’ve actually been thinking about this for a while. Short answer: I don’t see why not. These agencies are part of the executive branch. So the president should be able to fire all of them, and freeze all new hires. Also, some agencies were created by executive order. Can they also be eliminated by executive order?

    4. It depends. There are some parts of the regulatory structure that were put into place by statutory laws. Those would be harder to cut.

      1. All the major details are established by acts of Congress. In the present case, for instance, POTUS would be close to powerless to countermand such legislative mandates as “the secretary shall…”.

        So the short answer is “no”. Trying deliberately to not carry out what Congress had enacted would be ground for removal from office.

    5. Legally? No. But I think that ship has sailed.

    6. That’s my second favorite Rand Paul fantasy!

  4. If we allow them to claim a mixture of natural ingredients can help an ailment without first spending hundreds of millions of dollars going through FDA trials, we’ll be no better than Somalia.

  5. The tweet police, they’re in my Internet
    The tweet police, they’ll get me yet
    The tweet police, police, police

  6. Looks like someone could’ve used Ralph Fucetola’s services:

    http://vitaminlawyer.com

  7. Ironic that liberals have been PUSHING FDA for more action and the hand of government now turns on them.

    I am frankly for ALL medications being available over the counter, and support alterantive/free choice in medicine, but Zarbees is in CLEAR and OBVIOUS violation of the current regs. Sorry ENB, but “natural” is irrelevant to the argument.

    I’d love to see the nature is god food crowd promote local MEDICINE.

    1. Not saying the FDA is right. Not even saying that I find no worth in “alternative medicine”. But I do notice that somehow “Traditional Chinese Medicine” is considered a fountain of wisdom when it is using accupuncture or herbs, and the hand of the devil when it is using rhino horn……

      1. Saiga horn is better, because the liberals told them so. Now the saiga is almost extinct. It’s also closer to China.

        1. Just replace the rhino or saiga horn with ground fingernail. Equally effective.

  8. I brought up that the FDA is basically useless and should be greatly reduced or removed. You would have thought I ate a live kitten covered in dolphin sauce. But then people will just sell us poison! I’ll start a business selling poison and I can’t be stopped!

    People believe humans will become retarded without uncle sugar taking care of them.

  9. The FDA must step in to break this false consciousness brought on by lived experience and not an external authority?for the ignorant masses’ own good!

    That’s some good snark. Sadly, that’s probably how the FDA’s bureatards see themselves: noble defenders of the ignorant serfs against their own lying eyes and the EVULS of advertising.

    1. I mean, yeah, I think that’s pretty apparent from their quote about how a COLD IS A SERIOUS MEDICAL AILMENT us plebes can’t possibly diagnose and treat without a doctor’s visit and an FDA approved med.

      1. The key point is this: if the rules for what constitutes an OTC med are “bad” then let’s change for all; not just “natural” and “feel good” remedies. True freedom means that ALL companies should be treated equally.

  10. OT: Is Tecate any good? When I’m craving a cerveza, it’s usually a Dos Equis amber, but I’m open to trying new things.

    1. Considering they sell gobs of it some people must think so. Yet not everyone drinks it.

      Were you hoping to be asking those who think so, or those who think not ?

  11. I don’t see why Zarbee’s Naturals would be regulated as drugs rather than supplements. Supplements are allowed to make “truthful” claims, without going through the FDA drug-approval process. (Of course, it’s still the FDA that gets to decide what’s “truthful”–)

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