The Food and Drug Administration wants
to examine the effectiveness of disclaimers on social media ads for pharmaceuticals, the agency said this week.
The FDA, along with the Federal Trade Commission, has attempted to crack down on
online influencer marketing that lacked disclaimers in recent years.
But the FDA’s new proposal, unveiled this week, signals that regulators want to generate the kind of evidence that could
buttress new guidance, according to advertising lawyer Jeffrey A. Greenbaum, a partner in the law firm Frankfurt Kurnit Klein & Selz.
“The FTC has been struggling with this
issue for years,” he says, referring to disclaimers in influencer marketing. “The FTC has issued very specific guidance and very specific opinions about what they believe will be
effective. But one of the things that has been starkly missing form the FTC’s guidance is empirical evidence.”
The FDA is specifically proposing to conduct two related studies.
For the first, consumers would be shown an endorsement by either a celebrity, physician or patient, for an acne drug. The ad would either have no disclaimer at all, a disclaimer such as
“#sp” — which the agency characterizes as “indirect” — or a “direct” statement like “paid ad.”
The second study would examine how nearly 700 web users respond to
different disclaimer language in a post by someone described as “an influencer who maintains an Instagram page with more than 500,000 followers and has posted about endometriosis.”
“In both studies, we are interested in the role of endorsement and payment status on participants’ recall, benefit and risk perceptions, and behavioral intentions,” the FDA writes.
Greenbaum predicts that the evidence from the experiments will inform regulators’ approach to
social media. “It could be extremely influential,” he says.
At the same time, the FDA’s proposal doesn’t address key details about the disclaimers it plans to test, including their
placement on the page, or the context in which they will appear.
Without that kind of information, the proposal “raises more questions than it answers,” Greenbaum says.
FDA is currently accepting public comments on the proposed studies.
The FDA has demonstrated concern about social media ads since at least 2015, when the agency warned pharmaceutical company
Duchesnay about an Instagram ad by Kim Kardashian for the morning sickness drug Diclegis.
The FDA said at the time that the post wrongly omitted information about the drug’s potential risks and
Kardashian also said in the original post that she was “partnering” with Duchesnay — but didn’t explicitly state that she had been paid to advertise the drug.
revised the ad after hearing from the agency.
Last summer, the FDA and FTC sent joint warning letters to makers of flavored e-cigarettes over their social marketing campaigns, including
The letters alleged that the ads didn’t warn consumers that the products contain nicotine, and reminded the companies that the FTC requires social media influencers to disclose
when they are paid for posts.