The FDA Is Studying Influencers Who Endorse Healthcare Products

The Food and Drug Administration (FDA) is probing the world of influencers who endorse healthcare products.

In a proposal published Jan. 28, the agency said it’s already conducted two related studies. One concluded that more people buy drugs and products endorsed by physicians, pharmacists, and other consumers than drugs endorsed by celebrities. The other found that consumers think expert endorsers are more credible than celebrities, but pay the same amount of attention to ads from both.

Now, the FDA is proposing two additional studies. These will zero in on how different kinds of disclosures (such as the popular #ad and #sponcon tags) affect viewers’ perception of sponsored content and opinion of the items being marketed.

Influencers properly disclosing when they’re connected to brands or are compensated by brands to promote products has long been a focus of the FDA and the Federal Trade Commission. They’ve had their eye on healthcare endorsements for years, as influencers on platforms like Instagram and YouTube increasingly hawk products like diet shakes/teas/smoothies, hair pills, and waist trimmers. These promotions can be big business for both creators and brands. Example: The Fashion Law points out that in 2015, Kim Kardashian was reportedly paid $500,000 for one Instagram post about morning sickness med Diclegis. Following her endorsement, Diclegis sales jumped 21% and brought total estimated revenues of $41.7 million that year.

In case you’re not sure what the FDA and FTC require for disclosures, they recently came together to issue updated, more explicit rules, as well as their first official guide for creators. They clarified that vague tags like #spon or #collab don’t count as disclosure–but #ad or #sponsored do–and that influencers need to include a disclosure when they are compensated by a brand in any way, not just financially. Getting free products? Disclosure. Getting stock in a company or a cut of sales traffic coming from their post? Disclosure. Overall, the rules say a disclosure is neccessary when an influencer has a “personal, family, or employment or a financial relationship” with a brand.

Jeffrey A. Greenbaum, an influencer marketing expert and partner attorney at law firm Frankfurt Kurnit Klein & Selz, told MediaPost that the FTC “has issued very specific guidance and very specific opinions about what they believe will be effective” when it comes to endorsement disclosures. However, he said, “One of the things that has been starkly missing from the FTC’s guidance is empirical evidence.”

It appears the FDA is now attempting to gather that empirical evidence.

What exactly is the FDA researching?

The first proposed study will look at how consumers respond to posts clearly marked with endorsement disclosures versus posts with no endorsement disclosures at all. 654 people will be presented with print ads featuring endorsement (one from a celebrity influencer, one from a physician, and one from a patient) for a fake acne product. Some people will see ads with no disclosure. Others will get ads printed with what the FDA calls “direct” endorsement language–something like “[Endorser] has been paid to appear in this ad for Drug X.”

All 654 participants must report familiarity with the celebrity influencer to be included in the study.

The second study will pit endorsement specifically from a digital influencer against endorsement from a patient. 698 participants will look at Instagram posts from either the influencer or the patient, all advertising a fake endometriosis-related product. Some posts will involve direct endorsement disclosure, some will involve “indirect” disclosure (a vague hashtag like #sp), and, again, some will have no disclosure.

For this study, the FDA plans to pull all 698 participants from the pool of one prominent digital influencer’s 500,000+ Instagram followers. It says it won’t share the influencer’s identity “to maintain the integrity of the study.”

“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 agency wrote in its proposal. It added that its mission “is to protect the public health by helping to ensure that prescription drug promotional material is truthful, balanced, and accurately communicated, so that patients and healthcare providers can make informed decisions about treatment options.”

The FDA published notice of its intent to conduct these studies on Jan. 28. Per regulation, the general public now has 60 days from that date to submit comments to the FDA about the studies that will be considered before they’re officially approved. Comments can be submitted here.