backIn 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a surprising number of enforcement letters to manufacturers, as well as online retailers, clinics, telehealth providers, and compounding pharmacies, targeting advertising and promotion violations for prescription drugs and medical devices. The sudden surge in enforcement letters compared to prior years can be chiefly attributed to FDA’s aggressive “crackdown” on drug advertising, particularly direct-to-consumer (DTC) advertising, announced on September 9. For more on this initiative, see our Client Alert summarizing the Department of Health and Human Services and FDA’s enforcement activities.
The following highlights some noteworthy trends and issues identified in these letters. We will discuss these and related developments in more depth during our annual “Year in Review” webinar (registration link below).
Notable Prescription Drug and Biologics Enforcement Trends in 2025
In 2025, FDA issued over 200 enforcement letters challenging the advertising and promotion of prescription drugs. Of these, 73 letters – including 10 Warning Letters and 63 Untitled Letters – were issued to pharmaceutical and biologic manufacturers. Two of these were issued by the Center for Biologics Evaluation and Research’s Advertising & Promotion Labeling Branch, while the rest were issued by the Center for Drug Evaluation and Research and/or FDA’s Office of Prescription Drug Promotion (OPDP). Only five of these letters were issued prior to September 9, highlighting the significant and substantial enforcement activities that occurred on September 9 and thereafter.
The remaining 2025 enforcement letters were issued to various online retailers, telehealth providers, and compounding pharmacies for the advertising and promotion of unapproved drugs. Among these were 58 Warning Letters issued on September 9 to challenge the advertising of compounded GLP-1 agonists and erectile dysfunction drugs. Over the course of the year, other Warning Letters to non-manufacturer entities challenged the advertising of a range of other unapproved drugs, with a focus on injectable lipolytic products, opioids, injectable botulinum toxin type A, and selective androgen receptor modulators.
The total enforcement letters in 2025 for pharmaceutical advertising and promotion violations mark the highest annual total in nearly 25 years. The summary below focuses on the 73 letters issued to pharmaceutical and biologic manufacturers.
Key Observations
Of the 73 enforcement letters issued to pharmaceutical and biologic manufacturers, 42 targeted DTC television (TV) ads, while others addressed social media, virtual backgrounds, newsletters, sales aids, exhibit booth panels, print ads, sponsored links, online videos, and webpages. Although most enforcement letters focused on DTC promotion, 16 letters challenged promotion to healthcare professionals (HCPs). The following summarizes the main types of violations cited in letters to manufacturers.
- False or Misleading Risk Presentation
Consistent with prior years, FDA’s 2025 enforcement letters continued to prioritize false or misleading risk presentations, particularly in DTC TV ads. FDA’s letters emphasize that the major statement in DTC TV ads must be presented in a clear, conspicuous, and neutral (CCN) manner, consistent with the CCN requirements that went into effect in 2024. This includes avoiding audio and visual elements that distract the viewer, presenting the information in dual modality, and using readable text size, style, and placement. Although FDA took issue with substantive risk omissions in some letters, most letters focus on the overall risk presentation, citing insufficient font size and prominence of supers, and/or the presence of distracting visuals during the major statement. Examples of distracting visuals challenged by FDA include rapid scene changes, movement and activity within scenes, and “attention‑grabbing” visuals and storylines, such as animated figures, romantic meetups, quick camera movements and zooms, dancing, and fast‑paced music.
- False or Misleading Benefit Presentation
FDA’s enforcement also underscores the Agency’s increasing focus on misleading efficacy claims. In 2025, this was illustrated in alleged overstatements of efficacy through both explicit claims and visual representations, including exaggerated improvements in quality of life and the complete resolution of symptoms. FDA repeatedly objected to efficacy claims grounded in single‑arm studies, reiterating its position that time‑to‑event endpoints are not interpretable without an appropriate control. The Agency also flagged misleading unsubstantiated superiority claims, as well as misleading mechanism of action claims when the mechanism of action is not established or fully understood.
- Spokespersons
Historically, OPDP has regularly challenged DTC promotion in which celebrities or other spokespersons, including HCPs, promote drug benefits without adequate risk information, undermining fair balance requirements and rendering communications misleading. That focus continued in 2025, with nine letters that targeted promotion based on spokesperson activities – two letters targeted DTC TV ads while the remaining seven letters challenged media appearances. Five letters featured celebrities and four featured company executives, two of which also included HCP consultants. While most of these letters represented typical violations for omission or minimization of risk, two Warning Letters suggest that FDA has adopted an aggressive approach to assigning responsibility for product-related communications. Specifically, these letters targeted a 42-minute, DTC video special titled An Oprah Special: Shame, Blame, and the Weight Loss Revolution, which featured company executives from Eli Lilly and Novo Nordisk and HCP consultants who received funding from these manufacturers. Among other things, FDA criticized the minimal airtime devoted to side effects versus the extensive benefit discussion and objected to characterizations of risks as “overhyped.” Although the video was not sponsored and the consultants appeared to be speaking independently and not on behalf of the manufacturers, FDA nevertheless attributed the consultants’ statements to the manufacturers. FDA’s position appears to drastically shift existing policy for responsibility to include an agent’s activities that are otherwise independent of the company’s ownership, control, collaboration, creation, influence, or review.
Notable Medical Device Enforcement Trends in 2025
In 2025, 32 enforcement letters targeted medical device marketing violations. These were Warning Letters sent by FDA’s Office of Product Evaluation and Quality (OPEQ), within FDA’s Center for Devices and Radiological Health (CDRH).
Twenty of the 32 Warning Letters involved companies that marketed devices without the required FDA clearance/approval and/or misbranded their products by failing to submit a premarket notification before commercial distribution. Ten letters cited the marketing of devices without notifying FDA, via a 510(k) submission, of significant changes in intended use or indications for use, technology, design, or compatibility that could affect safety and effectiveness. Notably, seven of the 20 letters involved devices marketed under 510(k) exemptions, where FDA determined the company’s promotional claims exceeded the scope of those exemptions. In four letters, FDA had previously notified the company of its concerns, yet the company continued to market the devices despite the prior communication. Two letters raised issues with devices that incorporate AI-based algorithms. Five letters cited failures to apply Unique Device Identifiers and submit Global Unique Device Identification Database (GUDID) data, underscoring increased enforcement of labeling and device identification obligations. Finally, continuing a theme from recent years, one of the Warning Letters cited the marketing of a research use only (RUO) in vitro diagnostic device for clinical diagnostic use, rather than research use.
Twelve of the 32 Warning Letters were issued to manufacturers and retailers of breast binders. FDA generally classifies breast binders under product code HEF as therapeutic medical binders, which are exempt from 510(k) premarket notification and most quality system regulation requirements. FDA determined that promotional claims on certain manufacturers’ and retailers’ websites reflected intended uses outside the exempt classification, including claims that demonstrated an intended use for individuals with gender dysphoria or after surgery to minimize swelling. Though not stated explicitly in the letters, presumably FDA considered the references to gender dysphoria to represent treatment claims for a medical condition, thereby rendering the products medical devices that require establishment registration and device listing. Although the letters do not cite claims regarding use by minors, these letters are consistent with the coordinated effort by HHS to limit access to gender-affirming care for minors. In fact, the letters were posted to FDA’s website on the same day the FDA Commissioner announced their issuance at an HHS press conference outlining regulatory actions aimed at limiting minors’ access to gender-affirming care.1Dept. of Health & Human Serv., Press Conference on Child Health Care Policy, at 27:37-28:26 (YouTube, Dec. 18, 2025), https://www.youtube.com/watch?v=0b__alQbf68.
Summary of Enforcement Letters
For your reference, we have prepared charts that list the enforcement letters issued to pharmaceutical drug and medical device manufacturers for promotional violations in 2025 (excluding letters issued for compounded and other unapproved drugs), including key facts, such as the target product, promotional media, and type of promotional violations, among others, along with hyperlinks to each letter and promotional material, where available.
Click here for the chart summarizing 2025 prescription drugs and biologics advertising and promotion enforcement letters.
Click here for the chart summarizing 2025 medical device marketing enforcement letters.
Webinar: Year in Review for Drug and Device Advertising and Promotion
Join us on January 28 for a review of key takeaways from FDA’s 2025 drug and device advertising and promotion enforcement letters and a discussion of other noteworthy developments relevant to drug and medical device marketing. Our experienced panel will discuss:
- Trends in enforcement letters, such as DTC advertising and promotion, DTC TV ads, CFL efficacy claims, and policy priorities
- Related developments, including the status of “Adequate Provision,” social media and influencers, AI-enabled devices, and FTC updates
- Predictions for what may be expected in 2026
Click here to RSVP.