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.
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."
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: