Decoding FDA’s Recent Advertising Enforcement Actions

The Agency’s Advertising Enforcement Letters Reveal Shifting Regulatory Priorities

On Tuesday, September 16, 2025, FDA posted 40 Untitled Letters and 8 Warning Letters directed at prescription drug and biologic Sponsors’ promotional communications. This is the first round of letters following FDA’s sweeping marketing and advertising enforcement announcement regarding its crackdown on deceptive drug advertising, and this blitz provides some clarity on the Agency’s regulatory direction and priorities.

Here’s what we have learned:

Recent FDA Enforcement Letters Mark a Major Departure from Past Practices

The recent batch of marketing and advertising enforcement letters issued by FDA deviate significantly from enforcement letters issued over the last 15 years. Gone are references to CDER’s Office of Prescription Drug Promotion (OPDP) and CBER’s Advertising and Promotional Labeling Branch (APLB). Letters now state that the US Food and Drug Administration has reviewed the subject promotional materials and determined the communications to be False or Misleading under the Food, Drug, and Cosmetic Act (FD&C Act). Additionally, the letters have been signed by the Center Directors for CDER and CBER, George Tidmarsh and Vinay Prasad, respectively. This represents an unexplained departure from prior practice when Untitled Letters were signed by Regulatory Reviewers and Warning Letters signed by Division Directors.

The structure and content of the newest round of letters also differ significantly from prior letters. Only Warning Letters now include statutory and regulatory citations providing the legal basis for the objections identified in the letter. Each recent Untitled Letter carries the same identical charge stating the “FDA has determined that the ad is false or misleading” without citing to a supporting statute and regulation. Further, the introduction omits the public health statement describing the risk-based approach applied by the Agency when developing and issuing the letter. Also gone are several sections that previously helped clarify the Agency’s thinking and the nature of the objections.

Prior to last week, FDA enforcement letters included a Background section that clearly articulated the risk profile and full indication of the product. In the main body of the letter, objections were framed with specific section headers and standard explanatory language detailing the basis for the violation. The new batch of letters dispense with the Background and immediately dive into a description of the violative promotional piece and describe the elements the FDA has identified to support their charge. Overall, the lack of detailed explanation of the Agency’s thinking and the absence of supporting regulatory citations will make it challenging for Sponsors to not only correct existing promotional communications but to also ensure that future promotional campaigns meet the Agency’s regulatory standards.

FDA’s Recent Round of Enforcement Letters Highlight New Advertising Priorities and Surveillance Shifts

While it’s not yet known if the Agency has posted all the enforcement letters issued on September 9, 2025, the current group of posted letters provide insights into the Agency’s regulatory priorities. Of the 48 letters posted on September 16, all but five letters cited a television or internet video advertisement targeted to consumers. The non-television or video promotional communications included a webpage, a print ad, and three paid search presentations. It’s unclear if the non-television materials somehow align with the Agency’s newly articulated enforcement priorities or if they are simply legacy compliance actions that have been released now to increase the number of issued letters.

In another departure from prior practice, nine Sponsors received two or more compliance letters for the same product. It is unclear if any of the Sponsors previously submitted the subject advertisements for Advisory Comment as the Agency has removed the Prior Communications section from most of the letters. This section, while often heavily redacted, would signal a prior dialogue between the Sponsor and the Agency.

Also notably missing from the enforcement letters, are any mention of the BadAd program. Touted as one of the key conduits for both healthcare providers and consumers to submit reports of potentially false and misleading advertising, the absence of any mention of the BadAd program raises questions about the Agency’s targeting of the subject ads. If none of these ads were submitted through BadAd, what changes has the Agency made to their surveillance program?

Navigating Uncertainty: What Sponsors Can Do Today to Ensure Future Compliance?

We expect more enforcement letters to be made public, but the timeline for the FDA to do so is not clear. As more insight and information becomes available, we will continue to analyze the posted compliance letters and will post updates regularly. For now, here are some actions you can take:

Design TV Ads to Meet CCN Standards and Avoid Distracting Elements

• Multiple letters include objections stating the ad is misleading because it includes distracting visuals or music, rapid scene changes, or other distracting elements during the presentation of the major statement. Other objections include references to contrast, placement, and prominence of onscreen text during the presentation of the major statement. Sponsors should ensure all TV Ads conform to the requirements described in the Clear, Conspicuous, and Neutral (CCN) Final Rule.

Rely on Strong Data—Disclaimers Cannot Fix Misleading Claims

• Numerous letters acknowledged Sponsors’ use of disclaimers to communicate the limitations of data used to support product claims while also noting that these efforts did not mitigate the misleading impression of the presentation. FDA has once again reminded us that you cannot disclaim away bad data.

Avoid Unsupported Quality-of-Life Claims in Promotional Materials

• Roughly one quarter of the posted letters object to Sponsors’ use of quality of life claims in promotional communications. While the Agency has a robust history of objecting to quality of life presentations in product promotion, it is critical to avoid claims that are not well-supported. This includes using rating scales or other patient reported outcomes that are not designed or validated to support a given promotional claim.

Always Present the Established Name Alongside the Proprietary Name

• One Warning Letter cited 21 CFR 202.1(b)(1) for failing to include the established name with the presentation of the proprietary name. This signals a newfound willingness on the part of the FDA to cite non-compliant presentations of the proprietary name in promotional communications.

Withdraw Unused or Expired Promotional Materials to Minimize Enforcement Risk

• In the current era of heightened enforcement, it is vital for Sponsors to ensure they withdraw any materials submitted on Form FDA 2253 that they have decided not to disseminate. Likewise, Sponsors should consider submitting a general correspondence to FDA notifying the Agency when promotional materials have been discontinued or expired. These strategies can help reduce the risk of receiving an enforcement letter for a promotional communication that is either no longer publicly disseminated or may have never run in the first place.

Seek Clarity on FDA’s Use of AI in Enforcement and Ensure Submissions Are AI-Readable

• While the current batch of letters deviate significantly from prior letters, it’s important to avoid speculation around the Agency’s use of artificial intelligence in compliance procedures. Sponsors should seek clarification on how the Agency has applied artificial intelligence to the development and drafting of any enforcement letter they may receive. It is incumbent on the Agency to share the specifics of how artificial intelligence is integrated with the surveillance process so Industry can ensure that all submissions to the Agency are properly structured and formatted to be accurately read by any AI system that may be employed by the Agency.