With the US Food and Drug Administration’s (FDA) September 9, 2025 announcement that it will increase its enforcement of the Federal Food, Drug, and Cosmetics Act (FFDCA), its rules governing direct-to-consumer (DTC) prescription drug advertising, and the subsequent issuance of more than 100 “cease and desist” letters, the agency has demonstrated it believes that DTC marketing of prescription drugs may have gone too far and that it is committed to bringing the industry back into regulatory compliance.
This shift in enforcement activity should lead medical device companies to pause and consider the potential broader implications of FDA’s crackdown on device marketing and promotion practices. As we discussed previously, policy shifts in the drug space can often creep into other FDA-regulated product areas. Despite differences in the applicable legal and regulatory scheme, FDA’s actions against DTC advertising of drugs may signal policy and enforcement trends applicable to medical device advertising and promotion.
FDA Oversight of Medical Device Advertising
Unlike the regulation of drug advertising, FDA generally does not pre-approve the language used in device labeling or promotional materials (except for class III and restricted devices). FDA also does not distinguish between DTC advertising and advertising to medical professionals.
Instead, FDA focuses on whether medical device labeling (defined expansively to include package labels and also all materials that accompany or supplement the device, such as websites, brochures, videos, and even mobile applications) is truthful and non-misleading and whether the claims made are on-label (i.e., consistent the device authorization) and do not otherwise change the regulatory status of the device (e.g., by adding a new intended use that requires premarket authorization).
Evolving FDA Enforcement Policies
Over the last 10 years or so, FDA enforcement actions taken against medical device manufacturers based solely on labeling violations have been rare. And while compliance with FDA’s labeling requirements remained important to protect manufacturers from competitor allegations, whether through the National Advertising Division of BBB National Programs (NAD) or litigation under the Lanham Act, FDA enforcement of marketing claims was not a primary concern of device manufacturers.
FDA’s announcement, however, indicates that change is on the horizon as FDA intends to expand its enforcement in the advertising and promotion space. And while we have yet to see a similar announcement or uptick in enforcement for medical devices, companies should also keep in mind that the FFDCA is a strict liability criminal statute. Promotional claims and representations that are false, misleading, or fail to fairly balance benefits with risks can lead not only to FDA-issued enforcement letters and notices and reputational damage, but also to criminal misbranding charges.
In such cases, the US Department of Justice (DOJ) may pursue prosecutions against both companies and individuals. And it is worth considering that enforcement may not be limited to FDA, as FTC and state attorneys general also can also pursue cases against perceived deceptive advertising. Although companies may have legitimate defenses to any such allegations, considering the themes emerging from the first batch of FDA letters and making minor adjustments when warranted to promotional materials may help mitigate or avoid any potential enforcement action.
Key Takeaways from FDA’s Crackdown on DTC Drug Advertising
Based on the letters sent to drug companies, FDA focused on social media advertising and the failure to ensure that advertisements are fair and balanced in their presentation of risks and benefits. While not new considerations, the letters closely analyzed the artistic details of each advertisement, such as the tone of the voice-over, lyrics of the background music, and images displayed, and cited violations when artistic details were not aligned with data on the risks, limitations, and performance of the drug. Given the shifting regulatory terrain, medical device manufacturers should consider the following lessons from the drug space:
Creativity must not compromise a fair and balanced presentation. A key tenet of both FDA and FTC oversight, the fair and balanced requirement entails accurately representing without minimizing (implicitly or explicitly) through wording or visuals the known risks of the product or overstating its benefits. No detail is too small. Make sure any song lyrics and images used are consistent with the expected outcome from use of the device. Links to company pages where risk information is presented more fully can be helpful, but do not eliminate the requirement that the risks be presented in equal measure to the benefits in the primary marketing piece.
Beware of the repost. FDA will treat company reposts of third-party content as if the company authored the content. Meaning FDA will be looking for a truthful and non-misleading representation of the device’s benefits, risks, and claims consistent with the authorized intended use in any third-party material reposted by company officials. The risk of third-party content running afoul of FDA’s expectations is high given that the authors are often not familiar with the regulatory requirements, nor are they well acquainted with the nuances associated with a device’s authorization, including any limitations on use of the device or required warning statements. While it is tempting and easy to repost third-party content on social media platforms, company executives should think twice before doing so or have their marketing and promotion teams thoroughly vet third-party material before clicking the repost button.
Use influencers with caution. While influencer marketing on social media may seem like an effective strategy to reach consumers, using influencers to promote medical devices comes with similar risks to reposting third-party content.Influencers are generally not aware of or trained in the regulatory requirements for marketing medical devices. And they are not familiar with the marketing requirements for a particular device. All of which, makes it too easy for an influencer to misstep.
Be sure performance claims closely align with the evidence. While this may seem like marketing 101, in a second round of untitled letters (these letters were released a few days after but dated as being issued on the same day as the cease-and-desist letters), FDA cited drug companies for making claims that FDA determined were not supported by scientific evidence. To establish these violations, FDA closely scrutinized the drug applications and identified areas where the agency determined that the data was at odds with the marketing claims. FDA’s approach to these untitled letters demonstrates, yet again, that this enforcement push is not solely focused on obvious violations and that FDA is willing to dive into the nitty-gritty details of specific approval decisions to establish a violation of the law. FDA’s focus on detail underscores the need for deliberate drafting and thorough vetting of all claims made in marketing materials.
Conclusion
Device companies have recently experienced relative freedom to explore creative, consumer-focused strategies with little FDA oversight, but the recent FDA actions against drug companies are a good reminder of the risks associated with pushing the boundaries in marketing materials. To avoid potential reputational damage or legal liability, companies must ensure that long-established guardrails are being followed whenever a device and its use are promoted—regardless of the platform or medium.
To that end, companies should consider auditing all advertising and promotional materials, strengthening internal review processes, and training all staff and executives on FDA’s promotion and advertising requirements, including on social media use. Companies that engage in such a reevaluation of their marketing materials and procedures will be well positioned to weather this shift in policy.
How We Can Help
Our team is closely monitoring developments and can assist with compliance reviews of advertising and promotional content and processes, provide a refresher training for marketing and legal teams given the changing risk profile in the space, provide guidance on developing response strategies in the event an FDA letter is received, and advise on how best to position a company for possible DOJ enforcement actions.
Our team guides and provides strategic counseling for life sciences, medtech, and digital health companies, assisting them in assessing, anticipating, and navigating regulatory and legal changes. We have broad experience in the regulation of medical devices and regularly advise clients on issues related to FTC and FDA requirements for labeling, advertising, and promotion.