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:
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