On September 16, 2025, the U.S. Food and Drug Administration (FDA) released more than 60 warning letters sent to specific pharmaceutical manufacturers, alleging misbranding of a particular drug through direct-to-consumer (DTC) advertisements in violation of the federal Food, Drug, and Cosmetic Act (FDCA).

The warning letters issued largely from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The FDA also released nearly 40 untitled letters sent to specific drug manufacturers from its Office of Prescription Drug Promotion on September 9 and 23, similarly informing them that one or more direct-to-consumer TV ads misbrands a specific drug.

These actions follow the September 9th announcement that the U.S. Department of Health and Human Services (HHS) and the FDA would be targeting “misleading” DTC pharmaceutical advertisements—the same day that a presidential memorandum directed HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin A. Makary to act.

The letters also reflect a broader shift in the FDA’s oversight of pharmaceutical advertising, particularly in DTC channels. With regulators taking a more aggressive posture across both broadcast and social media platforms, companies should be prepared for shifting regulatory requirements and heightened enforcement risk.

FDA ‘Crackdown on [Allegedly] Deceptive Drug Advertising’

According to the agency announcements, the “sweeping reforms” in this area will include:

1. Enforcing the Existing Law

Makary announced on September 9, 2025, that he would be sending thousands of letters to “every single sponsor of an approved drug or biologic,” providing notice to all application holders that the FDA will be actively enforcing the FDCA and implementing regulations. Pharmaceutical manufacturers were directed to “remove any and all DTC prescription drug advertising that violates the law.” Makary further announced the issuance of “approximately 100 cease-and-desist letters,” meaning those released on September 16th.

“FDA is concerned patients are not seeing a fair balance of the information regarding a drug product,” the Makary letter states. “The concern is magnified when serious risks are not clearly presented, or the information is too difficult for seniors to read or hear.”

It should be noted that FDA has, for decades, reviewed all DTC drug advertising for FDA-approved prescription drug products (these are, by law, required to be submitted to FDA for review). Under longstanding federal law and regulations, prescription drug ads must meet specific content requirements, including clear communication of risks and effectiveness. FDCA § 502n sets forth requirements regarding prescription drug ads—including printing and labeling requirements; and a brief summary relating to side effects, contraindications, and effectiveness, as required by regulations. The implementing regulations for prescription drug ads, located at 21 C.F.R. § 202.1, contain more specific requirements.

The agency’s archive contains letters dating as far back as 1998, challenging specific promotional practices. So when HHS and FDA discuss “enforcing the existing law,” it may better be viewed as a change in how the agency will enforce existing law.

2. Eliminating the “Adequate Provision” Standard

The FDA will be initiating rulemaking to close what Makary referred to as the “adequate provision loophole…which drug companies have used to conceal critical safety risks in broadcast and digital ads, fueling inappropriate drug use and eroding public trust,” the FDA announcement states.

The law currently allows broadcast advertisements to include only the most important risk information in the audio or audiovisual parts of an ad. 21 C.F.R. § 202.1(e) generally provides that all ads for prescription drugs “must present a true statement of information in brief summary relating to side effects, contraindications…and effectiveness.” Broadcast ads, such as those broadcast through radio, television, or telephone systems must: 1) include information relating to the major side effects and contraindications (“major statement”) of the advertised drugs; and 2) contain a brief summary of “all necessary information related to side effects and contraindications[.]”

Yet, the latter requirement is not mandated if broadcast ads make “adequate provision” for dissemination of the product’s approved or permitted product labeling in connection with the ad. This means that the ads may tell viewers or listeners where to find more complete prescribing information. The regulation further requires that in DTC advertisements for prescription drugs, the “major statement” must be presented in a “clear, conspicuous, and neutral manner.”

The HHS announcement asserts that until 1997, pharmaceutical manufacturers were required to report full contraindications, boxed warnings, and common precautions in advertisements, but that:

[t]he FDA at that point established a loophole that allowed companies to recite a vague ‘major-risk statement’ and then point viewers to a website, toll-free number, or print insert for more complete information. The FDA’s return to the pre-loophole status requires drug advertisers to present factual uncontroversial statements that are already legally mandated and avoids undue burdens by preserving advertisers’ rights to continue to engage in commercial speech.

It should be noted that, in both broadcast and other media (e.g., social media), FDA’s stated intention in focusing on major risks in the past was designed to help patients (and providers) weigh those risks that were considered most relevant. In particular, FDA’s goal was to avoid consumer desensitization to risk information by highlighting the most important risk information with the option to access more extensive resources to learn more. For example, HHS’s Final Rule on “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” of November 21, 2023 (“2023 Rule”) states:

[a]lthough prescription drugs must be prescribed by a healthcare provider (HCP) and cannot be accessed by consumers directly, consumers make decisions that have a critical effect on health and well-being, such as whether to fill a prescription, whether to initiate taking the prescribed drug, and whether to continue taking the drug in adherence to a prescribed regimen. The clear, conspicuous, and neutral presentation of risk information in DTC TV/radio ads, in addition to benefit information, helps ensure that these ads convey a truthful and non-misleading net impression about the advertised drug and that consumers are better informed when they participate in healthcare decision making. [Emphasis added].

There may, in fact, be questions of whether full risk information, including the most irrelevant safety factors, might run contrary to the general fair balance standard for communicating information. The 2023 Rule recognized the importance of avoiding distraction in “order to support the effective presentation of required disclosures,” stating, for example:

In prescription drug ads, the presentation of the major statement occupies only a part of the ad, so in a 30 or 60-second ad, consumers are not given much time to notice and understand that important information. If, during the presentation of the major statement, the consumer’s attention is focused on other elements of the ad, the major statement may be relayed without being understood.

One can envision situations where ancillary disclosures of minor issues can obscure major risks. 

3. Expanding Regulatory Oversight to Encompass Social Media Promotional Activities

According to the accompanying HHS Fact Sheet, this oversight will include:

  • Influencer partnerships and sponsored content across all platforms;
  • Algorithm-driven targeting advertising and “dark ads”;
  • AI-generated health content and chatbot interactions;
  • Platform-specific promotional strategies designed to evade detection; and
  • Emerging digital technologies and promotional methods.

“[Eighty-eight percent] of advertisements for top-selling drugs are posted [on social media] by individuals and organizations that fail to adhere to FDA “fair balance” guidelines,” the FDA’s announcement states. The announcement refers to a statistic in a 2024 review of pharmaceutical industry promotional activities on social media, which cites in turn a 2012 article regarding advertisements on YouTube for the top 25 drug manufacturers—based on a one-month study in September 2009 of ads that included (per the authors) 88 percent “FDA-unregulated” advertisements.

The September 2009 study concluded that “[a]s consumers are exposed to a large number of FDA-unregulated advertisements for prescription drugs on YouTube, education is needed to enable consumers to distinguish between FDA-regulated and FDA-unregulated videos”—not that 88 percent of regulated, broadcast advertisements lacked fair balance. Further, since 2009 there have been considerable changes regarding regulation of social media communications and FDA standards risk communications across platforms, so the relevance of the 2009 data is unclear.

Again, it should be noted that materials, including all social media, are generally submitted by drug manufacturers on a monthly basis to FDA for review. FDA has, in warning letters, called out advertising having an alleged lack of fair balance on many occasions.

Additional Thoughts on Enforcement

FDA’s “untitled letters” ordinarily are used for situations considered less concerning than those in “warning letters,” but both are used by the agency to publicly allege noncompliance with the FDCA, and both include requests for prompt remedial action—including ceasing and desisting using the language that the FDA finds misbrands the product. These letters signal that the recipient faces a significant increase in the risk of enforcement if FDA concerns are not addressed.

To move from pre-enforcement warnings (warning and untitled letters) to actual enforcement action raises additional considerations beyond the agency priorities and the recipient’s response. There are certain provisions of the FDCA that allow for the assessment of civil monetary penalties (CMP) for DTC advertising violations, though recent court decisions have called into question the constitutionality of FDA CMP authorities (see Wulferic, LLC v. FDA, No. 4:24-cv-1183-O (N.D. Tex. Aug. 1, 2025, citing SEC v. Jarkesy, 603 U.S. 109 (2024)). Outside of CMPs, which may not withstand judicial scrutiny, seeking civil or criminal penalties would generally require the U.S. Department of Justice (DOJ) to bring the action on behalf of the government. As such, an action would need to not only be an FDA priority, but a DOJ priority as well.

For those drug and biological products which are imported into the United States, there is a means of soft enforcement through FDA’s “import alerts,” which essentially act as an import ban on a product due to the “appearance” of a violation. A warning or untitled letter which alleges non-compliance is a sufficient justification under FDA policies to provide for the appearance of a violation that could prevent entry of products. Thus, the risk profile of those companies that rely on international manufacturing could be higher than those that rely upon finished drug production in the United States.

MAHA Strategy and Legislation

The announcement of the agency initiative came on the same day that HHS’s Make America Healthy Again (MAHA) Commission released its health strategy regarding children (MAHA Strategy). The MAHA Strategy stated while the U.S. pharmaceutical industry “has the right to have these advertisements, studies suggest that they have a strong influence on those who view them, potentially increasing inappropriate prescriptions.”

Legislation introduced in Congress over the summer, S. 2068 and H.R. 4605, would amend the FDCA to ban drug manufacturers from using DTC advertising, including social media, to promote their products. Another bill, S. 652, introduced in February, would regulate communications regarding prescription drugs, including those by social media influencers or health care providers making false or misleading communications regarding a drug, with a civil penalty.

Yet these bills have not moved forward, and the Pharmaceutical Research and Manufacturers of America (PhRMA) said in response to the MAHA Strategy that DTC advertising “provides patients with important fact-based, useful and accessible information about potential treatment options” and that its member companies “are committed to responsible, accurate advertising.”

Compounders and Telehealth

It is worth noting that the vast majority of the warning letters sent to drug manufacturers went to those compounding semaglutide and tirzepatide. Bloomberg Law reported that the letters included notices to online telehealth companies marketing compounded products, which again speaks to a paradigm shift with respect to enforcement. The MAHA Strategy states, under the heading of “Direct-to-Consumer Pharma Advertising”:

FDA, HHS, the Federal Trade Commission (FTC), and Department of Justice will increase oversight and enforcement under current authorities for violations of direct-to-consumer (DTC) prescription drug advertising laws. Egregious violations demonstrating harm from current practices will be prioritized, including by social media influencers and DTC telehealth companies (including dissemination of risk information and quality of life through misleading and deceptive advertising on social media and digital platforms.  

Drug advertising may also implicate the federal False Claims Act (FCA) when it leads to the submission of false or fraudulent claims for payment to government health care programs. Were DOJ to take a more aggressive approach with respect to use of the FCA to buttress the FDA and HHS regulatory positions, this could, even more than fines and penalties under the FDCA, have an especially chilling effect, given the large judgments that are sought in such cases.

Takeaways

DTC advertising has become a much more dynamic area, and these recent FDA developments are certainly not going to be the last word on the story. In this environment, companies will want to closely monitor agency activities and potential court challenges as they assess and reassess how to address the shifting paradigm with respect to DTC advertising. FDA and HHS have made clear they intend to aggressively press forward with their DTC reform initiative, and that deviating from new agency thinking on the topic is likely to prompt a swift response from the agencies.

It will also be important to view the positions being outlined more broadly than just DTC broadcast advertisements. As the Makary letter suggests, lines with respect to social media are blurred between influencer promotion, editorial content, user-generated material, and pharmaceutical advertising, meaning that pharmaceutical companies may not have control. Any company involved in advertising and promotion of drugs and biological products would be wise to consider how to address both broadcast and social media in the context and reviewing their policies and contracts with respect to these matters, because the risk of enforcement in this area just got a lot higher.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.

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