Pharmaceutical companies brace for heightened enforcement. On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced significant new enforcement and rulemaking initiatives targeting direct-to-consumer (DTC) prescription drug advertising. As part of this effort, they have issued more than one hundred cease-and-desist letters for pharmaceutical companies to remove deceptive ads, and thousands of additional letters warning others to remove ads FDA characterizes as misleading. In addition, FDA and HHS also announced plans to pursue rulemaking targeting what they dubbed as the “adequate provision loophole,” in describing a long-standing federal policy on DTC pharmaceutical advertising.
In a published fact sheet, FDA announced it will begin aggressive enforcement of DTC violations. This represents a major shift in the regulatory landscape and will have immediate implications for companies across the industry. As part of their response, the agency stated that they will also close “digital loopholes” by expanding oversight to encompass all social media and promotional activities, including:
- Influencer partnerships and sponsored content on all platforms;
- Algorithm-driven targeted 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.
In a concurrent press-release, FDA further underscored how it will use advanced surveillance technologies, including AI, to proactively monitor advertising and aggressively enforce compliance with federal law.
The “Adequate Provision” Policy
Prior to 1997, prescription drug commercials on television were rarer because of federal regulation requirements that these ads include the full “brief summary” of prescribing information, which included extensive details on side effects, contraindications, and effectiveness. [i] While this was manageable in print, where companies could devote space to lengthy disclosures, it was practically unworkable in broadcast media. A thirty second TV or radio ad, for example, wasn’t realistically able to accommodate pages of safety data without overtaking the add itself.
To address this challenge, in 1997, the FDA introduced the “adequate provision” policy, allowing direct-to-consumer pharmaceutical advertisers to provide a “major statement” of the most significant risks while also directing consumers to websites, toll-free numbers, or print advertisements for complete safety information. This approach aimed to balance the practical limitations of broadcast media with the need for consumers to access critical safety information.
In 2023, the FDA strengthened this requirement through rulemaking by requiring the major statement relating to side effects and contraindications to be presented in a clear, conspicuous, and neutral manner.[ii] The final rule establishes five standards to ensure the major statement is clear and effective: it must use easily understandable language; the audio must be as clear as the rest of the ad; in television ads, the audio risks must also appear on screen long enough to be read; the text must be formatted for readability; and no distracting elements may interfere with comprehension.[iii]
It is against this backdrop that FDA now characterizes its own long-standing regulatory framework as a “loophole,” announcing plans to dismantle it while coupling this with a new aggressive enforcement policy. This initiative signals a significant shift in FDA’s position. Companies should anticipate greater scrutiny of both traditional and digital advertising, including social media campaigns and influencer partnerships.
Key Takeaways and Recommendations
Companies should proactively conduct comprehensive review of all current promotional materials, including social media campaigns and influencer partnerships to ensure compliance with FDA’s new policy. This includes ensuring that all claims are supported by substantial evidence as required under federal regulations,[iv] that all advertising meets FDA’s fair and balanced disclosure requirements, and that promotional materials do not suggest unapproved uses of the drug.
Companies should also develop robust monitoring protocols to adapt to evolving FDA regulations and prepare for increased enforcement actions. FDA’s use of advanced surveillance technologies, including AI, will enhance its ability to detect non-compliance. This underscores the importance of maintaining transparency and accuracy in all promotional activities to avoid potential cease-and-desist or Warning Letters from the agency.
Frier Levitt attorneys are closely monitoring these developments. Our team is available to assist with compliance reviews, risk assessments, and response strategies. If you have received a cease and desist or Warning Letter, our team of FDA Regulatory and Life Science attorneys can provide immediate assistance.
Frier Levitt provides strategic, industry-focused legal counsel tailored to your needs. Contact our team today to learn how we can help you.
This alert is for informational purposes only and does not constitute legal advice. The regulatory landscape is evolving rapidly, and we recommend consulting with legal counsel regarding your specific circumstances.
[i] 21 CFR § 202.1 (Prescription-drug advertisements), 21 USCS § 352.
[ii] 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, 88 Fed. Reg. 80,958 (Nov. 21, 2023) (to be codified at 21 C.F.R. § 202).
[iii] Id at
[iv] 21 CFR § 202.1 Prescription-drug advertisements.,
Senior Associate
