FDA’s Deceptive Drug Ad Focus Leaves Telehealth Sites Guessing

The Trump administration’s focus on pharmaceutical advertising has sparked questions about the FDA’s authority to regulate telehealth companies that use social media influencers to promote boutique versions of popular drugs.

The Food and Drug Administration embarked on a crackdown last month to rein in deceptive drug advertisements, including an investigation into drug promotions by paid social media influencers. The agency hasn’t laid out its regulatory rationale for policing influencer messages touting compounded drugs—which are copycat or specialized versions of brand-name products that run the gamut from pain medications like naltrexone and weight loss treatments like semaglutide.

Telehealth companies and the attorneys who counsel them say the FDA needs to clarify who is responsible for the messages paid influencers promote, especially when it comes to compounded drugs.

“There’s got to be a little bit more transparency from the FDA so we can focus on what’s good practice,” said Kyle Rao, president and CEO of Secure Medical, which owns an online platform called eDrugstore. The website sells a range of medical products, including weight loss drugs such as tirzepatide, from compounding pharmacies.

The agency has clear oversight of influencers paid to promote prescription drugs, but it’s more obscure for promotion of compounded drugs by telehealth companies such as eDrugstore or Hims & Hers, which have skyrocketed for medicines treating obesity.

But the agency expressly signaled its authority when it issued more than 40 warning letters to compounding pharmacies and telehealth companies last month, including to eDrugstore, which has been providing telehealth services for more than 25 years.

The move to go after online content creators follows years of the agency doing little to regulate them, a Bloomberg Law investigation found in 2023.

The FDA’s plans for future enforcement will remain unclear without additional regulation or legislation directly addressing the vast network of influencer advertising on TikTok, Instagram, and other platforms that’s so far gone largely unregulated, attorneys say.

“They haven’t articulated their legal analysis or their legal reasoning, and it is chilling speech to just throw out a hundred letters and then tell everybody you’re coming for them,” said Joanne Hawana, an attorney at Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., who counsels the pharmaceutical industry on FDA regulations.

The FDA declined to comment on its ongoing investigation.

Agency Authority

Some attorneys say compounded drug ads fall within the agency’s authority under a 2013 update to federal statute stating a drug or device is considered misbranded “if the advertising or promotion of a compounded drug is false or misleading in any particular.”

The FDA signaled with its warning letters that the provision applies not only to pharmacies making the compounded products, but also to telehealth platforms and other third parties that promote them.

Drug compounders, however, have argued that their promotions don’t fall under FDA jurisdiction, but rather that of the Federal Trade Commission, which primarily requires that ad claims are truthful and non-deceptive.

“Compounded drugs don’t undergo the same FDA review for safety, labeling, or standardized warnings, which limits the FDA’s ability to act against their promotion,” said Courtney Sullivan, an attorney at Boesen & Snow Law advising telehealth companies.

The FDA also appears to take “the position that you can’t say you’re like these other drugs, but we still want you to have the same warnings as these other drugs,” said Suzanne Bassett, an associate at Polsinelli. “It really puts companies in a difficult spot.”

Dianne Munevar, head of Healthsperien’s center for health, research, policy, and strategy, said that while telehealth companies offering prescription drugs would still fall under FDA jurisdiction, “there are regulatory gray areas when these companies offer compounded medications that do not receive FDA approval.”

Munevar co-authored a study this year on ways to strengthen oversight of drug promotions on social media, suggesting the agency should clarify its regulatory authority under the Federal Food, Drug, and Cosmetic Act with respect to false and misleading advertising of compounded drugs.

Enforcement

The FDA may also find it difficult to directly go after social media influencers without updating its regulations.

The agency’s enforcement approach has traditionally targeted a company because promotional content through an influencer constitutes advertising on behalf of the company, attorneys say.

A prime example was when the FDA warned Duchesnay in 2015 over a sponsored Instagram post by Kim Kardashian that violated fair balance rules.

“FDA arguably has more jurisdictional authority over brands that are directly responsible for selling the products to consumers,” said Kristen Klesh, a partner at Loeb & Loeb LLP.

Any effort to clarify its authority, however, will likely have to come through legislation, rather than guidance or rulemaking, said Bryant Godfrey, chair of Foley Hoag LLP’s FDA Practice Group who previously served as the Office of Prescription Drug Promotion’s senior lead regulatory counsel. He cited the Trump administration’s limits on new rulemaking across agencies and significant cuts to the federal workforce.

“It’s hard, just given the current climate, for there to be any type of formal guidance development,” Godfrey said.

A bill introduced in February by Sens. Richard Durbin (D-Ill.) and Roger Marshall (R-Kan.) could extend the FDA’s jurisdiction to include surveillance of social media influencers and telehealth companies.

“We’re still not in a world where the FDA is going to proactively go after the influencer,” said Carolina Wirth, a former regulatory counsel at the FDA, now a shareholder at Hall Render. “Without some congressional intervention, I think it’s going to be hard for the FDA to do that under the existing authority.”