The FDA's Drug Ad Crackdown Reaches Telehealth

"Same active ingredient as Ozempic and Wegovy."

Seven words. On its face it sounds like a plain fact. The FDA has now put it in a warning letter and called it false or misleading.²⁴

That is the news hiding inside the headlines about a "crackdown." The FDA is not only going after the big pharmaceutical TV spot anymore. It is reading the websites of online prescribers, line by line, and it is quoting their marketing back to them. The audit has already started, and you do not get to choose whether you are in it.

This is general education for operators, not legal advice. Have a healthcare regulatory attorney review your claims, pages and ads.

What did the FDA announce on September 9?

A broad push against misleading prescription drug ads. The FDA said it was sending thousands of letters to pharmaceutical companies to remove misleading ads and about 100 cease-and-desist letters to companies with deceptive ads. It also said it would begin rulemaking to close the "adequate provision" loophole created in 1997, which drug companies have used to conceal critical safety risks in broadcast and digital ads.¹

The numbers behind the move

The FDA's own account of its enforcement history is stark. It said the agency once sent more than a hundred warning letters a year, and that the number fell to one in 2023 and zero in 2024.¹

The agency also said it is using AI and other technology to monitor drug ads, and pointed to concerns about ads that omit or underplay serious risks and about undisclosed paid influencer promotion on social media.¹

HHS Secretary Robert F. Kennedy, Jr. framed the goal in the announcement: "We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising."¹

How did it reach telehealth?

Through two doors, both public.

The warning letters to Hims & Hers

The FDA's Center for Drug Evaluation and Research sent warning letters to Hims & Hers Health, one covering hims.com and one covering forhers.com, both dated September 9, 2025 and showing content current as of September 16.²³ The FDA said it reviewed the websites in August 2025 and found compounded drug products, including semaglutide, which it described as "new drugs" that are not FDA-approved.²

It flagged claims including "Same active ingredient as Ozempic and Wegovy," "Clinically proven ingredients" and, on the other site, "Weekly injectable GLP-1 with the same active ingredient as Ozempic and Wegovy."²³ The core objection, in the FDA's words: "Compounded drug products are not FDA-approved."² The legal basis was misbranding for false or misleading labeling and advertising, and the letter noted that "overstatements of efficacy or minimization of risk are of particular concern." The company had 15 working days to respond.²³

Fortune, reporting on AP coverage, quoted the letter's logic directly: "Your claims imply that your products are the same as an FDA-approved product when they are not." It added that Hims said it looks forward to engaging with the FDA and that its website notes compounded treatments are not FDA-approved or evaluated.⁴

The commissioner's public stance

In a JAMA article that week, FDA Commissioner Marty Makary called direct-to-consumer drug advertising a "public health crisis." He pledged to address promotions by online pharmacies and telehealth firms that emphasize benefits and downplay safety, and singled out a Hims & Hers Super Bowl ad that promoted the benefits of GLP-1 drugs without any mention of side effects or disclaimers.⁵

Fortune noted that Hims and similar platforms have argued they are not subject to traditional drug advertising rules, and described this as the first time the FDA has directly targeted such online platforms.⁴ The same report said the FDA posted more than 100 letters to drugmakers and online prescribing companies on September 16.⁴

What exactly was flagged, and why?

Three patterns show up across the letters and statements. They are worth separating, because each needs a different fix.

Equivalence language

"Same active ingredient as" a branded drug sounds like a technical description. The FDA read it as an implication of sameness. Compounded products are not FDA-approved, and the agency said the claim suggests they are the same as approved drugs when they are not.² If your copy compares a compounded product to a branded one, that comparison is now on a regulator's reading list (the earlier piece on what clinics can and cannot claim is a good starting point).

Proof language

"Clinically proven" is a substantiation claim.² The FTC's long-standing health products guidance says claims about health benefits or safety need substantiation in the form of competent and reliable scientific evidence, and that testimonials alone do not constitute substantiation.⁶ The question to ask about every efficacy claim is simple: what is the evidence, about which product, and can I produce it today?

Missing risk information

Makary's criticism of the Super Bowl ad was about omission: benefits shown, no side effects, no disclaimers.⁵ The FDA's announcement also cited concerns about ads that leave patients without a fair balance of information.¹ For a telehealth brand, the lesson is that benefit-forward creative needs risk information that is hard to miss. The FTC's guidance adds that disclosures must be clear and conspicuous and should not be undercut by anything else in the ad.⁶

Does this apply to your telehealth business?

The letters went to specific companies. But two facts make it relevant to almost everyone in the category.

First, the FDA said the claims it cited were not an exhaustive list of violations.² Second, a high-profile target gets copied. When a regulator publicly explains why a sentence is misleading, every similar sentence becomes easier to challenge, by regulators, competitors and platforms.

I would also expect scrutiny to affect costs. A Citi analyst, reported by Bloomberg Law, said Hims' marketing campaigns would likely face close scrutiny and that this would likely raise customer acquisition costs.⁷ That is one analyst's view, but it points to a real dynamic: compliant creative is often more expensive to produce and may convert differently.

What should you audit and change?

Do this as a structured audit, not a panic edit.

What a defensible claim file looks like

When I say "keep the evidence on file," I mean something specific and boring. For each claim, one row: the exact wording, where it appears, the product it describes, the source that supports it, the date someone checked it and the person who approved it. If a regulator, a platform or a partner ever asks where a sentence comes from, the answer is a document you can send in ten minutes, not a search through old emails.

Build the habit that no new claim goes live without a row. That one rule, kept consistently, does more for compliance than any single rewrite, because it moves the question from "can we defend this?" to "did we defend it before publishing?"

Language to review with counsel

What does the crackdown mean for how you advertise?

It raises the price of sloppy claims and the value of clear ones.

For years, the easiest way to stand out in this category was the boldest promise. That is a worse bet now. The brands that last will be the ones that can answer a regulator, a partner or a journalist who asks, "Show me where that claim comes from." That is a competitive advantage as much as a defensive one.

It also changes how I think about creative testing. When you test ad angles, put a compliance check before the test, not after the winner. The best performing angle is useless if it triggers a letter. A letter is not the only gatekeeper either: LegitScript and the telehealth ad approval bottleneck is the other one to plan for.

Directing ads for three 8-figure brands and one 9-figure brand, I saw one pattern again and again: platforms and regulators move on their own timetable, and the businesses that survive are the ones whose marketing was already defensible when the rules tightened.

The takeaway

Do not wait for a letter. The FDA has told you in public what it is reading and how it reads it. Use the next two weeks to inventory your claims, match them to evidence, separate approved from compounded and put risk information where people can see it.

You are going to have this review one way or another. It is far cheaper to run it on your own schedule. How I approach compliant telehealth growth is laid out on my telehealth page.

Keep building.Ekai