Evolving Standards, Enduring Principles

What you’ll learn:

Executive Summary

The Food and Drug Administration (FDA) recently issued and released over 100 enforcement letters, with nearly half directly tied to promotional materials. While the scale was unprecedented, the themes were familiar: overstated efficacy, unbalanced or unclear risk presentation, and distracting formats that undermined comprehension. 

TV ads were a particular focus, with many citing violations of the Clear, Conspicuous, and Neutral (CCN) standards around readability, dual-modality risk presentation, and minimizing distractions. Similar concerns arose in testimonial videos, paid search, and quality-of-life claims.

The recent actions by the FDA send a clear signal: consumer-facing promotional content will be evaluated by how the entire experience shapes an average consumer's understanding of benefits and risks. None of the underlying regulations are new, but the way we, as an industry, have historically evaluated and applied them is evolving. By integrating balance, readability, and prioritizing consumer comprehension in creative development, teams can align with evolving expectations, minimize regulatory risk, and preserve the impact of their communications.

Background

On September 16, 2025, the FDA published a total of 75 Warning Letters and 41 Untitled Letters issued to companies following the September 9th announcement in which the U.S. Department of Health and Human Services (HHS) and FDA revealed an effort to increase transparency and regulatory compliance in direct-to-consumer (DTC) prescription drug advertising. While the number of letters released is large and unprecedented, the regulations and citations they reference are not. The issues raised are grounded in existing regulations and guidance, with the majority tied to false or misleading efficacy claims or false or misleading presentations of risk and/or safety information. Every Untitled Letter issued since 2024 has highlighted these same concerns, underscoring that the appropriate presentation of risk information and the risk-benefit ratio has been, and will continue to be, a clear priority for the FDA. 

From Letters to Evolving Insights: Tracing Trends in the FDA’s Communications

Of the 116 total letters issued, only 49 of the Untitled and Warning Letters were directly relevant to promotional materials. We conducted a comprehensive evaluation of these 49 letters, beginning with an AI-driven analysis to extract key data points. To ensure accuracy and precision, the results were then verified by human experts. This validated dataset was subsequently reviewed, allowing us to identify patterns and uncover meaningful trends and insights.

Key Themes and Common Issues

The letters covered a diverse mix of assets, with the majority directed at TV ads, followed by interview videos and paid search, with the latter skewing more heavily toward being issued Warning Letters.

Across all assets, the most common issues cited included false or misleading presentation of benefits or risk, and false or misleading efficacy claims.

Some letters received more than one violation, whereas others received only one.

TV Ads

TV advertising was at the center of the FDA’s recent enforcement, underscoring the importance of audio/visual media directed at consumers, where tone, visuals, and pacing can shape perception as powerfully as the words themselves. 

Issues observed in these letters included:

This is the first set of Untitled and Warning Letters issued after the CCN guidance, which provides clear insight into the FDA’s priorities, with particular emphasis on eliminating distractions during the major statement, a requirement that a TV or radio ad must prominently present the drug’s most important risks fulfilling the CCN standards. Notably, the vast majority of TV ads cited had at least one CCN violation. 

High-Risk Categories

As expected, several letters were issued to products with a Boxed Warning or controlled substances. In the letters, the FDA most often focused on:

Channel-Specific Interviews and Testimonial Videos

In previous letters, the FDA has raised concerns regarding talk show interviews, citing issues such as efficacy overstatement, missing or minimized risk information, and not filing a 2253 submission. This trend has continued with this latest batch of letters. Of particular note was the balance between the discussion of benefits being paired with brief or end-loaded safety segments and/or no clear direction to find full risk information.    

Paid Search

An emphasis on paid search, consistent with previous concerns, continues in this batch of letters. Notable trends included:

Post Hoc Analyses

Several letters raised concerns about post hoc analyses, stating that results not based on pre-defined statistical methods should be characterized as exploratory and hypothesis-generating rather than  confirmed findings.

Quality-of-Life Claims

Many of the letters also highlighted QoL claims, noting that imagery of patients with improved lifestyles or dramatic before-and-after montages implied overstated efficacy without appropriate data to support it. The FDA also indicated that disclaimers did not mitigate these overstatements.

Key Takeaways

Implications and Best Practices for Industry

The recent FDA enforcement actions are not new and remain highly relevant, providing valuable intel that complements prior guidance. This moment presents an opportunity to reinforce already well-established practices and refine processes where risk is highest. Thorough reviews not only protect patients but also safeguard brands by aligning communications with both regulatory expectations and internal standards.

Remember to “balance by design” by integrating risk information throughout materials and not just at the end or through disclaimers, and work closely with Medical, Legal, and Regulatory teams.

When auditing current promotional materials or developing new assets, consider the following core recommendations: 

Final Thoughts

While additional letters are anticipated, this current batch reinforces existing expectations rather than introducing new ones. The Klick Science + Regulatory team will continue to monitor these releases and share updates to help navigate evolving expectations and instill confidence.