The Food and Drug Administration (FDA) issued a press release on Sept. 9 announcing a “crackdown” on direct-to-consumer (DTC) pharmaceutical advertising and promising “sweeping reforms" in line with President Trump's same-day memorandum directing Health and HUman Services (HHS) and FDA to take “appropriate action” against alleged misleading advertising. While the agency's directive is presented in the context of DTC pharma ads, a closer look reveals that the agency's enforcement priorities could broadly impact individual influencers, advertising agencies, social media platforms, and medical device brands, among others. FDA's approach dovetails with the September 9, 2025, MAHA Strategy report in that both FDA and the MAHA Commission particularly scrutinize social and digital media advertising.

Below is a brief summary of FDA's actions to date, and what it means for entities involved in medical product advertising.

1.FDA's Issuance of “Thousands” of Letters to Pharmaceutical Companies

FDA's first step in ramping up its scrutiny of medical product advertising involves its announcement that the agency had issued thousands of template letters warning pharmaceutical companies to remove misleading advertising. Presumably, FDA is sending the letters to virtually all pharmaceutical companies registered with the agency. The form letter focuses on two key issues:

• Fair Balance Concerns and Senior Audiences: The letter asserts that FDA's requirement to present a "fair balance" between the risks and benefits of a drug in DTC advertising is "regularly ignored," and the agency will "no longer tolerate such deceptive practices." Interestingly, FDA pays particular attention to situations in which seniors may not be able to read or hear the risks. FDA's fair balance rules, to date, do not speak to particular considerations or requirements for seniors. Manufacturers, advertising agencies, and influencers may now need to pay particular attention to this viewing audience when considering whether safety risks are clearly presented in advertisements.
• Social and Digital Media Content and Influencers: In a far more pointed attack, FDA's letter states that “deceptive advertising is sadly the current norm” on social media channels. In doing so, FDA cites a 2024 article from the Journal of Pharmaceutical Health Services Research claiming the majority of ads for top-selling drugs are “posted by individuals” and organizations that fail to follow fair balance.  We know that FDA has not shied away from issuing untitled letters to pharma companies for influencer posts that fail to follow fair balance rules. FDA's reference to posts by individuals is a reminder to all influencers that FDA is particularly attuned to concerns around influencer advertising in digital and social media outlets.

2. Hundreds of “Cease and Desist Letters,” and Likely More to Come

In addition to the form letter, FDA also claimed to issue hundreds of “cease and desist” letters to drug companies that the agency views as in violation of DTC advertising rules. It is unclear whether such C&D letters will be treated, from an enforcement perspective, as similar to traditional Untitled Letters.  However, the tone and structure appear as a departure from prior Untitled Letters, with a demand to take “immediate action” to cease and desist violative advertising.  Importantly, the letters raise issues beyond DTC advertising, including ads targeted to a healthcare provider audience.  FDA has also indicated that it plans to return to an era of hundreds of letters issued a year, up from its current level of 10-20 untitled letters annually.

In terms of impact, FDA's broad and strong stance against perceived false and misleading advertising directly targets DTC ads but also serves as a reminder to marketers of other regulated products, including compounders and medical device distributors. Notably, FDA's rules governing fair balance apply to “medical products,” which are defined as drugs and devices, particularly devices that are subject to pre-market approval (PMA) requirements.

3. Closing the Adequate Provision “Loophole” 

While it is no secret that Trump and HHS would likely prefer to restrict DTC drug advertising altogether, as indicated by prior statements, the First Amendment presents extreme hurdles to such efforts. However, in lieu of a ban, the FDA has indicated its intent to issue a rulemaking to eliminate the “adequate provision” rule that currently allows drug manufacturers to avoid putting all safety risks in broadcast or radio advertisements (and instead to focus on a statement of “major” risks) so long as the advertisement directs consumers to where additional information can be found (e.g., talking to their doctor or linking to a website). While the adequate provision is expressly permitted under the rules and is not, therefore, a “loophole” in the law, FDA positions the rule permitting the “hiding” of safety information.

In sum, all entities involved in the advertising of drug (and device) products to consumers, including agencies, brands, influencers and others should stay apprised of FDA's priorities in this space and not be surprised to see an uptick in enforcement actions. It is more important than ever to ensure that consumer ads, particularly social media and digital ads, comply with FDA rules and guidance. As additional enforcement actions are issued, we will gain further guidance on the areas of greatest risk when it comes to medical product advertising.