TikTokers Put Consumers at Risk as Drug Ads Go Unchecked by FDA
The Food and Drug Administration is doing little to cut down on misleading drug claims on social media despite having the power to oversee prescription drug marketing, an examination of agency records shows.
For decades the FDA has regulated advertising on television, radio, and in magazines. It released guidelines for social media in 2014.
Since then it’s done little to regulate influencers who may or may not have direct ties to the manufacturers, yet tout their success with medications such as
“Medical mis/disinformation from social media can place tremendous strain on the healthcare system, leading to dangerous, and often aggressively pursued, consumer decisions about health care,” said Gary Kreps, director of the Center for Health and Risk Communication at George Mason University.
Pharmaceutical companies, paid social media influencers, and telehealth companies that sell the drugs are required to balance promotional information with warnings about side effects in social media ads, similar to the lengthy, FDA-mandated warnings in television and magazine ads. But in practice, Bloomberg Law found, social media ads often contain limited to no warnings.
Investigations by Bloomberg Law have shown how the agency has slow-rolled guidance on cutting down the presence of heavy metals in baby food, and ceded much of its oversight of food additives in commercial products to the industry itself. The lack of focus on social media marketing shows that similar problems arise in drug oversight as well.
Commissioner Robert M. Califf has called health misinformation a leading cause of death in the US, and has said combating these falsehoods is one of his top priorities.
“The FDA is strongly committed to protecting public health by helping to ensure that prescription drug promotional communications issued by or on behalf of a drug manufacturer, packer, or distributor are truthful, balanced and accurately communicated,” agency spokesperson Carly Pflaum said in an emailed statement.
Out of the 40 publicly available letters the FDA’s prescription drug office has sent since 2017 notifying pharmaceutical companies of ad violations or questionable promotional activities, only seven dealt with sponsored posts on platforms including Facebook, Instagram, and YouTube.
None mention TikTok, the social media platform that has 150 million active users a month in the US, which didn’t exist when the FDA’s most recent guidelines were written. The hashtag #prescriptiondrugs has 5.8 million views on the site. People have viewed content with #medicine there more than 33 billion times.
Some of those posts have led others to start taking medications only to later wish they’d looked into the drug’s side effects more.
Christina Salagea got her information about Ozempic from TikTok before she started taking it.
“I saw how women were losing weight, feeling great, and eating less without severe side effects,” Salagea said in an interview.
When the 30-year-old office manager and medical assistant started taking the drug, however, her experience was far from those the influencers portrayed. During six weeks on Ozempic, a trip to the bathroom took 20 minutes and caused bleeding and lingering pain that made sitting difficult. Bowel movements grew less frequent, just once or twice a week.
The influencer posts didn’t include warnings about how severe and long-lasting the side effects could be, Salagea said; the videos said side effects such as nausea would subside and pushing through would be worth it in the end.
Salagea stopped taking Ozempic after losing 22 pounds.
“I should have done more research,” she said.
Novo Nordisk said it does “not currently work with any influencers to share their experience” with Ozempic or Wegovy—the version of the drug specifically indicated for weight loss—through influencers’ “personal social media channels.”
“Any social media content sponsored by Novo Nordisk is identified and labeled as such,” the company said in an email.
Carly Talley, a 23-year-old single mom in Arkansas, asked her doctor about taking Ozempic after seeing several “good reviews” on TikTok.
Her doctor warned of potential side effects, like headaches and dizziness, but Talley was eager to try the medication for weight loss anyway.
Soon she was confined to her home. Family members had to help care for her 2-year-old daughter.
“I was constantly just sick, vomiting,” Talley said of the week following her first injection. “I’ve been pregnant. It felt like I was pregnant but worse.”
Around this time, she found Salagea’s TikTok page and watched her describe a similar experience. Salagea took her first injection March 27. In May, she shared a video explaining her decision to stop taking the medication.
“I was like, whoa, I’m not the only one,” Talley said in an interview.
Novo Nordisk’s website lists Ozempic’s “most common side effects” as nausea, vomiting, diarrhea, abdominal pain, and constipation. Talley admits she didn’t do much research and instead relied heavily on TikTok.
The platform has its own policies stating ads for pharmaceuticals and other health-care products must target users 18 years old and older and “comply with all applicable laws and regulations of the target country,” TikTok said in an email.
Ad Complaints
Pharmaceutical companies, among the largest advertisers in traditional media, increasingly are shifting their focus from TV to social media platforms and websites. The Standard Media Index reported a 4-percentage-point drop in pharmaceutical linear TV advertising in 2022 and an increase of about 3 percentage points in digital ad spending.
Since 2016, the FDA has received more than 1,800 complaints—an average of more than 230 per year—from health-care providers, consumers, and others on potentially false or misleading prescription drug ads, according to agency data obtained by Bloomberg Law through a Freedom of Information Act request.
The FDA allows health-care providers, consumers, and others to mail, email, or call the agency to report potentially false or misleading pharmaceutical advertising through its Bad Ad program.
The FDA’s Office of Prescription Drug Promotion said it can respond to consumer complaints and issue warning letters to companies for claims not supported by evidence, that misrepresent study data, or that overstate a drug’s benefits.
The FDA also issues what it calls “untitled” letters, which are generally used for ad violations considered less serious and that are not repeated infractions.
In the past five years, OPDP has issued only two warning letters about pharmaceutical ads on social media platforms.
The first, issued in October 2018, dealt with a Facebook post from MannKind Corporation for the insulin inhalation powder Afrezza. In its letter the FDA wrote that MannKind made misleading claims “suggesting that there are no safety concerns associated with the use of the drug.” The FDA sent the second letter in February 2022 to CytoDyn, Inc. over a YouTube video improperly suggesting the experimental HIV drug leronlimab “provides a clinical benefit to individuals” with Covid-19.
Out of the 40 warning and untitled letters dated since 2017 in the FDA’s public database, 11 were in response to complaints submitted to the Bad Ad Program. These include the post about Afrezza, a sponsored Google link for a controlled substance with a high potential for abuse, and a television and YouTube ad for Nurtec ODT featuring Khloé Kardashian.
The FDA only provided the number of Bad Ad complaints it received each year, and not copies of the complaints themselves or which prescription drugs they addressed.
The agency only categorizes complaints based on whether the ad is directed to consumers or health-care providers, not what platform it came from. That leaves an incomplete picture of what updated guidance for prescription drug promotion should be.
Agency Guidance
The FDA’s draft social media guidance from nearly a decade ago, which was never finalized, suggests pharmaceutical companies correct online misinformation related to their products by commenting on the posted content, or directly contacting the individual or entity behind it. But the agency can’t legally require manufacturers to do so.
And it tells companies promoting prescription drugs or medical devices on platforms with character-space limitations, like X, formerly known as Twitter, to “present a fair balance” of information on a product’s benefits and risks.
Instead of focusing on specific platforms, the FDA said its approach to policy development has been on developing recommendations that have long-term applicability.
FDA officials knew when they were drafting the policies in 2014 that social media would evolve, said Bryant Godfrey, senior lead regulatory counsel for the Office of Prescription Drug Promotion at the time. The guidance couldn’t be so specific that it would soon be outdated.
“There’s so many different social media channels out there that FDA clearly didn’t have an idea of what would be down the line,” said Godfrey, who is now the co-chair of Foley Hoag LLP’s FDA Practice Group and counsels pharmaceutical companies on advertising regulations.
Any updated guidance on social media is dependent on the time the FDA’s prescription drug ad office has to work on broader policy priorities, versus day-to-day review activities, Godfrey said. The office reviews thousands of submissions from drug companies, he said.
The OPDP, which has about 70 full-time employees, is monitoring social media to determine whether updated recommendations are necessary, an agency official said.
The head of OPDP, Catherine Gray, has acknowledged that emerging social media platforms present new challenges in monitoring prescription drug promotion.
“We will continue to evolve and find solutions to these challenges,” Gray said in a Sept. 14 webinar hosted by the Duke-Margolis Center for Health Policy.
The FDA declined Bloomberg Law’s request for an interview with Gray.
OPDP is conducting research projects to help it better understand how viewers understand information presented in direct-to-consumer advertising, including specific quantitative claims about a given product.
It’s likely the agency will use these research findings to inform updated social media guidance, said Joanne Hawana, an attorney at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. who counsels pharmaceutical companies on FDA regulations.
“A huge priority for them is getting new information,” Hawana said. “I envision that at some point in the next couple of years, some of the findings from that research will end up in whether it’s a revised guidance or a finalization of the social media ones.”
To help better track on which platforms audiences are seeing the largest number of misleading ads, the FDA could establish an online form or another formalized intake measure for submitting complaints to its Bad Ad Program, Godfrey said.
“If there was something more in place, such as an online reporting mechanism, the agency would be able to better see trends and kind of get ahead of it, even from a policy standpoint,” Godfrey said.
An FDA official said the agency is taking this suggestion into consideration.
The FDA maintains that even without updated guidance it has the authority to monitor social media posts from physicians or anyone, including influencers, who promote a drug on behalf of a manufacturer or distributor. The Federal Trade Commission also has a role in social media promotion, but for prescription drugs it regulates disclosures that someone is being paid to post something, not the posts’ content.
The FTC’s guidelines say social media influencers must disclose any financial relationship with a brand they’re posting about. On space-limited platforms, this can be done in simple language, like #MinuteMDPartner.
TikTok also requires influencers to turn on the platform’s content disclosure setting, which adds the label “paid partnership” to posts promoting a company’s product or service.
Influencer Ads
While Novo Nordisk said it doesn’t pay influencers to talk about Ozempic or Wegovy on their personal channels, multiple telehealth companies that prescribe and distribute the drug and other versions of it partner with TikTokers to share success stories.
The FDA acknowledged that federal prescription drug regulations may apply to telehealth providers and websites, depending on their activities and structure.
Ivim Health markets itself on its website as “America’s #1 provider of the most effective weight loss medications (GLP-1s).” Patients can fill out a questionnaire and be partnered with one of the company’s certified health-care providers, who will send a prescription to a patient’s pharmacy or ship it to them.
One influencer, Jernine Trott, has roughly 22,000 followers on TikTok, and includes a referral link to the Ivim Health website in her profile. The Atlanta-based flight attendant has been taking Eli Lilly & Co.’s Mounjaro to help lose weight and treat her type 2 diabetes.
The FDA on Nov. 8 granted approval for Lilly’s Zepbound, a version of Mounjaro specifically for weight management in adults who are overweight with at least one weight-related condition, or have obesity.
Trott gets Mounjaro through a separate telehealth provider but said Ivim approached her about a partnership after she worked with the company to get supplements to address fatigue and to help with additional fat burning while on Mounjaro.
In a Sept. 22 TikTok, Trott described Ivim as a good health-care provider option for people who are having trouble getting their doctor to prescribe medications similar to Ozempic.
Trott said Ivim gives her free reign on what information on weight-loss medications she shares with her providers.
“It’s truly an organic experience,” Trott said in an interview.
Taylor Kantor, Ivim’s co-founder and medical director, said in an email the company has “dozens of patients that have shared their testimonials on both the medical and non-medical aspects of their journey and how Ivim has helped foster success.”
These testimonials are used for advertisements and marketing, and Ivim pays patients based on video performance metrics, such as video views, or the number of new newsletter or email registrations, Kantor said.
He said while Ivim offers patients tips on how to share their journey online with safety and efficacy information, the company doesn’t verify or approve any videos posted on patients’ private or personal social media pages.
“We encourage all of our patients at Ivim Health to engage in a diverse social community and share their stories and progress via social media outlets to create a widespread community that can foster and support one another,” Kantor said.
Another telehealth company, MinuteMD, partners with TikTok users such as Katherine Joest. She posts almost daily about her experience with semaglutide, the generic name for Ozempic, and how her more than 10,000 followers can access it through MinuteMD.
In one video from September, Joest goes over differences in appetite suppression that patients may experience while taking various GLP-1 medications. The nearly 2-minute-long video includes a text disclaimer: “I am not a medical professional. This is just my experience.”
Joest declined to comment on her experience and company partnership. MinuteMD didn’t respond to multiple requests for comment.
Generation Patient, a young adult patient advocacy group, is calling on the FDA to clarify its authority to regulate social media posts from patients and other third parties promoting products on behalf of pharmaceutical companies.
Limited federal oversight on social media “leaves room for flexibility and creativity for companies to market therapeutics in a way that they want to,” said Sneha Dave, the 25-year-old founder and executive director of Generation Patient. She was diagnosed with severe ulcerative colitis at age 6.
“Part of the problem is that (government decision-makers) are not the people most affected by this issue, and are not seeing the potential for harm that can come if we don’t regulate these right now.”
— Data visualization and development by Atthar Mirza.
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