IN THIS ARTICLE, WE EXPLAIN HOW THE FDA AND THE FTC REGULATE SOCIAL MEDIA WITH RESPECT TO HEALTHCARE.
Social media influencers have become the latest source of health information for many. This is especially true right now, amidst the ongoing and rapidly evolving COVID-19 pandemic. More and more influencers are being tapped to spread the word about public health campaigns, wellness goods and services, prescription drugs, and medical devices. Because these promotions and unsolicited advertisements are rampant, they deserve the close attention of not only consumers, but also our government.
Influencers have advertised a variety of health information, including flu shots at Walgreens, ovulation tracking devices, and drugs such as Celgene and AbbVie. But not all of the information they disseminate is accurate (or even close). And recently, certain celebrities have been spreading misinformation about the coronavirus: an Instagram post from Woody Harrelson (which has since been deleted) detailing the discredited theory that 5G transmission towers have contributed to the spread of COVID-19;1 an Instagram story from Chris Brown with a hoax audio file stating that the United States would soon be entering a mandatory, month-long quarantine period where people would not be allowed to leave their homes or buy groceries; and a Twitter post from Kelvin Peña (which has also been deleted) sharing “excellent advice by Japanese doctors treating COVID-19 cases,” all of which have been debunked.2 And these are only a few examples; in fact, a Reuters Institute study, which examined 225 social media posts published between January and March and concerning COVID-19, revealed that 38% of the posts were completely fabricated, while about 59% of them consisted of reconfigured information – i.e., “a twisting of the truth.”3 That being said, influencers can also be the source of accurate and educational information. On March 19, 2020, for example, the Surgeon General called upon Kylie Jenner, Kevin Durant, and other influencers to help young people understand the severity of COVID-19.4
The “influence” that influencers have is a double-edged sword. Their ability to disseminate accurate messages is something that should not be overlooked, but influencers must recognize that their messages can have serious impacts. Influencer marketing is a growing and complicated business, which can have far-reaching effects on our everyday health and well-being. Today, more than ever, consumers must conduct their own due diligence on health-related social media posts and influencers must be careful about the information they share. In this article, we explain how the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) regulate social media with respect to healthcare, present case studies demonstrating the drawbacks and (sometimes) dangers of influencer advertising, and propose additional measures that the FDA should implement to protect the public.
I. Current FDA and FTC Guidelines
The FDA and FTC have both considered and opined on the implications that social media influencers have on healthcare, and while the regulatory authority of the FDA and FTC overlap greatly, their roles also differ. The FDA has primary responsibility with respect to the regulation of the truth and falsity of prescription drug and restricted device advertising, as well as responsibility for regulating the labeling of foods, drugs, devices, and cosmetics. The FTC, on the other hand, has primary responsibility for regulating the truth or falsity of all advertising (other than labeling) of foods, drugs (with the exception of prescription drugs), devices, and cosmetics. The FTC’s responsibility includes the regulation of the truth or falsity of over-the-counter drugs (i.e., non-prescription drugs).5
When it comes to social media influencers, both the FDA and FTC have issued guidelines. The FDA published:
- “Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”6
And the FTC published:
- “Guides Concerning the Use of Endorsements and Testimonials in Advertising”
- “The FTC’s Endorsement Guides: What People Are Asking”
- “Disclosures 101 for Social Media Influencers.”7
The FDA’s guidance, which has not been updated since June 2014, suggests that “firms,” defined as manufacturers, packers, and distributors, should consider the following provisions, among others, when using the Internet or social media to promote prescription drugs or restricted devices: “[a]ny advertising that makes representations about the use of a firm’s prescription drug must include certain risk information;” “[p]rescription drug advertisements must present a fair balance between information relating to risk and information relating to benefit;” and “[r]isk information should be comparable in content and prominence to benefit claims within the product promotion (i.e., a balanced presentation).” The FDA takes the position that if a manufacturer (or an influencer on its behalf) cannot represent both the desired benefit claims and the risk profiles for their drug or device in a single social media post, then the manufacturer should not use that social media platform to advertise its product. The “Character Space Limitations” guidance, however, like the FDA’s other communications, is only presented as a “draft guidance” to describe the FDA’s “current thinking on this topic,” which “do[es] not establish legally enforceable rights or responsibilities,” and “does not operate to bind [the] FDA or the public.”8
The FTC’s guidance is more comprehensive and direct, with the newest guidance published in November 2019. The “Disclosures 101” guidance provides, among other things, that an influencer’s endorsement has to represent their actual experience and opinion. Influencers cannot post about their experience with a product or service if they have not tried it, and cannot claim it was effective or great when it was in fact not. Specifically, influencers “can’t make up claims about a product that would require proof the advertiser doesn’t have – such as scientific proof that a product can treat a health condition.” Also, influencers must “make a good disclosure of [their] relationship to the brand,” whether they received monetary payment or free or discounted products or services from the brand, or have a personal or employment relationship to the brand. Further, influencers need to keep in mind that even if they are posting from abroad, U.S. law may apply if it is “reasonably foreseeable” that the post will affect U.S. consumers.9
Together, the FDA and FTC operate under a 1971 Memorandum of Understanding, which dictates the primary responsibilities of each agency. The agencies have agreed to work together to “afford maximum protection to the consumer,” including in instances where “[t]he same, or similar claims are found in both labeling and advertising” or where “material may be construed as either advertising or [] labeling or both.”10 Depending on the product and the published content, Internet and social media posts may be subject to both FDA and FTC oversight, making it crucial for the agencies to work together. And recently, the agencies have been collaborating in an effort to protect consumers from products falsely characterized as being able to treat COVID-19.
Although the agencies often work together, they still have distinct roles, making it important for the FDA to update its guidance to match the FTC’s guidance and stand on its own when the agencies are working independently.
II. Case Studies
a. Diclegis: “OMG. Have you heard about this?”
On July 20, 2015, Kim Kardashian posted the following paid endorsement about Diclegis, a prescription drug used to treat morning sickness in pregnant women:
OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DicelgisImportantSafetyInfo.com[.]11
The social media post, which could be viewed on Kardashian’s Instagram, Facebook, and Twitter accounts, presented various efficacy claims for Diclegis, but omitted all risk information and failed to indicate limitations of use (for instance, the drug has not been studied in women with hyperemesis gravidarum). Kardashian failed to provide material information regarding the drug, particularly about the consequences that may result from using it, ultimately misleading consumers about the drug’s safety. However, Duchesnay, Inc., the manufacturer of Diclegis, preapproved the post.12
In response, the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to Duchesnay, finding that: “[t]he social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts.” The OPDP noted that Kardashian’s post violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) and explained that such “violations are concerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated.” The FDA found it particularly concerning because it had previously warned Duchesnay about its promotional activities with respect to Diclegis.13
Kardashian subsequently deleted the “false [and] misleading” post and posted a “#CorrectiveAd” with extensive information concerning the risks and limitations of using Diclegis. Kardashian also acknowledged that her previous post did not meet FDA requirements.14 Kardashian, however, faced no penalties.
In the end, despite the FDA’s actions, Kardashian gave Duchesnay the attention it sought – broadcasting the brand’s name to her millions of social media followers. Her original Instagram post garnered almost 500,000 likes and there was a reported 500% increase in digital awareness of Diclegis within the following weeks.15 Duchesnay even saw a 21% increase in sales by fall of that year. Indeed, the warning letter and #CorrectiveAd did not appear to sour the relationship between Kardashian and Duchesnay. Two years later, during the time her surrogate was pregnant, Kardashian posted additional sponsored content for Diclegis. She has also posted sponsored content for Bonjesta, another Duchesnay drug.16
b. Jeuveau: #NewTox
Jeuveau, a prescription drug created to improve the look of wrinkles (think Botox), has been on the market for over a year and is already ranked third among neurotoxins. In 2019 alone, Jeuveau made over $34 million in sales.17 How Jeuveau reached those numbers, though, may seem troubling. In May 2019, immediately before its release, Evolus, Inc., Jeuveau’s manufacturer, invited the country’s top plastic surgeons and cosmetic dermatologists to a weekend retreat at the Ritz-Carlton in Cancun. Billed as an advisory board meeting, the event was in reality an extravagant launch party. Using Evolus' chosen hashtag, #NewTox, and without disclosing that the company had paid for their trips, these top medical professionals raved about the lavish event, all while promoting the product with “social media moments,” using an Evolus-themed runway and confetti. Branded items like flip-flops, beach towels, and water bottles also saturated doctors’ social media pages.
The FTC mandates that influencers disclose whether they received monetary payment or free or discounted products or services. The FDA mandates that companies appropriately communicate risk information, which is done in part by balancing a drug’s benefits with its risks in any advertising. Arguably, the doctors at the Evolus launch party did neither.
But Evolus’ CEO, David Moatazedi, said that the event was a standard advisory board meeting and the doctors were not paid or provided any incentives to promote the product. Moatazedi also said that Evolus should be viewed more as a “performance beauty” company as opposed to a traditional drug maker. Some disagree, finding that the company and certain doctors were treating the product “too casually” because it is an FDA-approved drug which comes with serious warnings (i.e., it can potentially cause swallowing and breathing problems in rare cases).18 This begs the question whether the FDA and FTC should impose heightened burdens on companies like Evolus when it comes to social media posts and other endorsements by health professional influencers.
c. Cyanora: A Poisonous Weight Loss Drink
In December 2019, it was reported that three well-known British reality-stars-turned-social-media-influencers agreed to promote a fake weight loss drink called “Cyanora,” despite being told that it included hydrogen cyanide as an ingredient. Hydrogen cyanide is a poisonous chemical that was used during World War II by Nazis in gas chambers. But Cyanora was only a hoax. The BBC, going undercover, filmed the influencers auditioning to promote the weight loss drink as part of an investigation into whether influencers actually use the products they are paid to promote on social media. It turned out the answer was not always. All three reality stars agreed to promote Cyanora despite being given a script that clearly said it contained hydrogen cyanide and without having tried it. Two of the influencers’ agents later clarified that they “would never promote anything that contained poison and proper checks would have been made before any promotion” and they would “not promote a product without trying it first.”19
Although the products would have been promoted from outside the U.S., the FTC has made it clear that U.S. law will apply if it is “reasonably foreseeable” that an advertisement will affect U.S. consumers. Further, the FTC requires influencers to have tried a product or service before posting about their experience with it. As such, it is likely that these reality stars would have been warned by the FTC had Cyanora been an actual product. The FDA’s guidance, however, is silent on whether the agency’s power extends to social media posts made outside the U.S. Moreover, unlike the FTC, the FDA does not require that an influencer try a product before promoting it.
d. COVID-19: The Spread of Misinformation
With the spread of the coronavirus has come the spread of false and misleading health information concerning the same. On March 9, 2020, the FDA and FTC announced that, in conjunction, they issued warning letters to seven companies selling unapproved products that violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus. The Jim Bakker Show,20 Herbal Amy Inc., Xephyr LLC dba N-Ergetics, Colloidal Vitality LLC dba Vital Silver, Quinessence Aromatherapy Ltd., GuruNanda, LLC, and Vivify Holistic Clinic were the initial companies that received the warnings letters. The products cited in the warning letters included teas, essential oils, tinctures, and colloidal silver, which the agencies found to be unapproved and misbranded products in violation of the FD&C Act and the claims exaggerated in violation of the FTC Act. The FDA and FTC requested a response within 48 hours describing the specific steps the companies had taken to correct the violations.21
In its press release, the FDA specified that it “is particularly concerned that products that claim to cure, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm” and that “[t]here are currently no vaccines or drugs approved to treat or prevent COVID-19.” The FDA also announced that “[a]n FDA cross-agency task force has been established and dedicated to closely monitor for fraudulent products related to COVID-19” and that the task force is working with major retailers and online marketplaces to monitor and remove such listings.22 The FDA and FTC have continued to issue warning letters to entities and individuals that are selling fraudulent COVID-19 products.
And, on April 9, 2020, before President Trump discussed disinfectants at his press conference, the FDA and FTC sent a warning letter to Genesis II Church of Health & Healing and associated individuals (collectively, “Genesis II”) concerning their sale of a chlorine dioxide product called “Miracle Mineral Solution” (“MMS”) for the prevention and treatment of COVID-19.23 In response to the warning letter, Genesis II said that it would take no corrective action and would continue to sell MMS. As such, the FDA requested that the U.S. Department of Justice file a lawsuit on behalf of the United States against Genesis II, which it did on April 16, 2020, by filing a complaint and ex parte motion for temporary restraining order and preliminary injunction against Genesis II in the United States District Court for the Southern District of Florida. On April 17, 2020, the district court entered a temporary restraining order against Genesis II requiring it to, among other things, stop distributing its chlorine dioxide product. A preliminary injunction was subsequently entered on May 1, 2020.24
While Jim Bakker, Genesis II, and others that have recently received the attention of the FDA and FTC may not be considered influencers (or celebrities), influencers should note that the FDA and FTC will not hesitate to take action when it comes to false and misleading information regarding the prevention and treatment of COVID-19.
III. Recent Developments in Regulating Social Media Influencers
As illustrated above, social media influencers have made various missteps when it comes to advertising health information, including spreading misinformation about COVID-19. Medical professionals and the FDA, however, are taking initial steps toward regulating social media influencers.
a. The Association for Healthcare Social Media
In May 2019, the Association for Healthcare Social Media (“AHSM”) was launched. AHSM considers itself to be the first 501(c)(3) non-profit professional society devoted to the use of social media by health care professionals,25 and its mission is to “develop[] best practices for social media use in health and to advocate for the recognition of social media as an important public health tool in the fight to combat misinformation.”26 AHSM “stands to neither prohibit, nor promote, involvement in influencer marketing by healthcare professionals and students on social media platforms” because it “aim[s] to recognize and support the value of creativity and entrepreneurship by those professionally involved in healthcare fields.” The association, however, notes that its “support is limited to those individuals clearly practicing transparency, continually displaying high ethical standards, and consistently focusing on evidence-based information as the foundation of positive social media use.”27
b. The FDA Plans to Study Influencer Marketing
On January 28, 2020, the FDA announced a proposed study entitled “Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion” to examine how consumers respond to endorsers and payment disclosures in relation to the promotion of pharmaceuticals in print and on social media. The agency is specifically interested in the role of endorsement and payment status on participants’ recall, benefit and risk perceptions, and behavioral intentions. The FDA proposes examining four types of endorsers – i.e., celebrity, physician, patient, and influencer – in two separate studies and researching whether the presence of a disclosure of their payment status influences participant reactions. It also proposes testing two different types of disclosure language: one direct and more consumer-friendly (e.g., “Paid ad…”), and one less direct (e.g., #sp for “sponsored”). Notably, one of the studies reflects the FDA’s interest in the impact of social media influencers as it intends to recruit followers of an Instagram influencer with more than 500,000 followers who has posted about endometriosis and expose the participants to an Instagram post for a fictitious endometriosis product. Comments on the proposed study were accepted through March 30, 2020.28
IV. Recommendations for the FDA
In light of the above, and taking into consideration an increasing number of paid partnerships between influencers and pharmaceutical companies, and the recent spread of COVID-19 misinformation, we offer a non-exhaustive list of recommendations for the FDA to consider in order to better regulate social media influencers when it comes to healthcare and particularly prescription drugs. Among other things, we propose that the FDA look to its recent partner, the FTC.
First, the FDA should update its guidance with respect to social media because it is outdated. While the FTC released a new publication for online influencers in November 2019, the FDA’s guidance on social media advertising is from June 2014 – six years ago. The FDA’s guidance fails to mention Instagram and incorrectly states that Tweets are limited to 140 characters – they are now limited to 280 characters. The FTC, which published new guidance less than a year ago, recently announced that it is seeking public comment on whether to make changes to its “Guides Concerning the Use of Endorsements and Testimonials in Advertising” as part of the agency’s systematic review of all its current rules and guides. Other than its plan to study influencer marketing, the FDA has not made similar updates or sought public comment with respect to its guidance.
Second, the FDA should follow the FTC’s lead and require social media influencers and their partner pharmaceutical companies to disclose any financial relationships. Indeed, an FDA spokesperson previously explained that the agency “has not issued guidance regarding disclosure of the financial interests of spokespeople in prescription drug or medical device promotion, including disclosures by social media influencers acting on behalf of a medical product manufacturer,” and instead directed attention to the FTC’s guidance.29
Third, the FDA should, like the FTC, require social media influencers to have tried a prescription drug before they post about their experience with the drug. Influencers should not be able to post about their experience with a prescription drug if they have not tried it, and should not be able to claim it was effective or great when it was in fact not.
And fourth, the FDA should provide drug companies with the option to submit their social media posts for approval before the content is posted by influencers. Although the FDA generally does not have the authority to require preapproval for advertisements,30 a voluntary review and approval system before publication, as opposed to a warning letter and possible litigation after publication, would be more efficient for the FDA and companies and would benefit consumers.
Social media influencers might be disrupting healthcare, but it is the FDA’s responsibility (in addition to the responsibility of other regulatory agencies) to regulate social media posts and protect consumers, particularly when it comes to prescription drugs which can carry significant risks.
1 https://www.socialmediatoday.com/news/new-study-shows-celebrities-are-key-distributors-of-covid-19-misinformation/575753/.
2 https://www.insider.com/coronavirus-influencers-celebrities-hoaxes-chris-brown-debunked-conspiracies-misinformation-fake-2020-3.
3 https://www.socialmediatoday.com/news/new-study-shows-celebrities-are-key-distributors-of-covid-19-misinformation/575753/; see also https://reutersinstitute.politics.ox.ac.uk/types-sources-and-claims-covid-19-misinformation.
4 https://www.businessinsider.com/coronavirus-surgeon-general-calls-on-kylie-jenner-influencers-millenials-teens-2020-3.
5 https://www.fda.gov/drugs/prescription-drug-advertising/basics-drug-ads; see also https://www.fda.gov/about-fda/domestic-mous/mou-225-71-8003.
6 See https://www.fda.gov/media/88551/download.
7 See https://www.ftc.gov/sites/default/files/attachments/press-releases/ftc-publishes-final-guides-governing-endorsements-testimonials/091005revisedendorsementguides.pdf; https://www.ftc.gov/tips-advice/business-center/guidance/ftcs-endorsement-guides-what-people-are-asking; https://www.ftc.gov/system/files/documents/plain-language/1001a-influencer-guide-508_1.pdf.
8 https://www.fda.gov/media/88551/download.
9 https://www.ftc.gov/system/files/documents/plain-language/1001a-influencer-guide-508_1.pdf.
10 https://www.fda.gov/about-fda/domestic-mous/mou-225-71-8003.
11 https://www.fda.gov/media/93230/download.
12 https://www.politico.com/story/2015/08/kim-kardashian-fda-duchesnay-121263; see also https://www.documentcloud.org/documents/4593918-Kim-Kardashian-Diclegis-Agreement.html.
13 https://www.fda.gov/media/93230/download.
14 https://www.instagram.com/p/7B07j_uSww/?utm_source=ig_embed.
15 https://www.thecut.com/2015/08/kim-kardashians-run-in-with-the-fda-explained.html.
16 https://www.complex.com/pop-culture/2018/07/kim-kardashian-reportedly-got-500k-for-sponsored-instagram-pill-posts.
17 https://www.fiercepharma.com/marketing/evolus-leads-beauty-not-pharma-direct-to-millennial-strategy-for-upstart-aesthetic; see also https://investors.evolus.com/news-releases/news-release-details/evolus-reports-fourth-quarter-and-full-year-2019-results-and.
18 https://www.nytimes.com/2019/05/15/health/evolus-wrinkles-toxin-jeuveau.html.
19 https://www.vice.com/en_us/article/akwz9e/influencers-unknowingly-promote-fake-drink-made-with-cyanide.
20 James “Jim” Bakker and his production company were previously sent a cease and desist letter by the New York State Office of the Attorney General and subsequently sued by the state of Missouri Office of the Attorney General for misrepresentations about the effectiveness of “Silver Solution” as a treatment for coronavirus. See https://ag.ny.gov/sites/default/files/bakker_cease_and_desist_letter_notification.pdf; https://ago.mo.gov/home/news/2020/03/10/ag-schmitt-files-suit-against-jim-bakker-for-selling-fake-coronavirus-cure.
21 https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or; https://www.ftc.gov/news-events/press-releases/2020/03/ftc-fda-send-warning-letters-seven-companies-about-unsupported.
22 https://www.fda.gov/news-events/press-announcements/coronavirus-update-fda-and-ftc-warn-seven-companies-selling-fraudulent-products-claim-treat-or.
23 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-warns-seller-marketing-dangerous-chlorine-dioxide-products-claim.
24 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church; see also United States of America v. Genesis II Church of Health and Healing et al., No. 1:20-cv-21601-KMW (S.D. Fla.).
25 https://www.clinicaloncology.com/Current-Practice/Article/09-19/Association-for-Healthcare-Social-Media-Launches/55947.
26 https://ahsm.org/about-ahsm/.
27 https://ahsm.org/healthcare-influencer-marketing-position-statement/. With respect to COVID-19, the association recommends social media accounts of “[k]ey opinion leaders for covid-19” to follow, including @DrTedros, @CDCgov, @CDCDirector, and various scientists on Twitter; @cdcgov, @hhsgov, @who, @nihgov, and @niaid on Instagram; and @who and @worldeconomicforum on TikTok. See https://ahsm.org/social-accounts-to-follow/.
28 https://www.regulations.gov/document?D=FDA-2019-N-5900-0001.
29 https://www.vox.com/the-goods/2019/2/15/18211007/medical-sponcon-instagram-influencer-pharmaceutical.
30 https://www.fda.gov/drugs/prescription-drug-advertising/prescription-drug-advertising-questions-and-answers#approve_advertisements.
