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# FDA Drug Ad Enforcement Letters Hit 25-Year High
- URL: https://www.fdaweb.com/fda-drug-ad-enforcement-letters-hit-25-year-high/
- Published: 2026-01-22T12:00:00.000Z
- Updated: 2026-09-14T15:31:21.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5160528

Six King & Spalding attorneys say the over 200 drug advertising and promotion enforcement letters FDA issued in 2025 hit a nearly-25-year high. Writing in an online blog [post](https://www.jdsupra.com/legalnews/2025-year-in-review-fda-drug-and-device-3224222/?ref=fdaweb.com), the attorneys say the vast majority of the letters were issued after the agency’s 9/9/2025 announcement of an aggressive [crackdown](https://www.fdaweb.com/fda-orders-crackdown-on-misleading-prescription-drug-ads/) on drug advertising, particularly direct-to-consumer ads.

The attorneys write that 73 of the drug enforcement letters (10 Warning Letters and 63 Untitled Letters) went to drug and biologic manufacturers, with the rest going to various online retailers, telehealth providers, and compounding pharmacies for the advertising and promotion of unapproved drugs.

The post lists these key observations from the letters to manufacturers:

- false or misleading risk presentation;
- false or misleading benefit presentation; and
- spokespersons.

On the medical device side, the attorneys report that 32 enforcement letters targeted marketing violations, with 20 involving companies that marketed devices without the required agency clearance or approval and/or misbranded their products by failing to submit a premarket notification before commercial distribution. Ten letters cited the marketing of devices without submitting a 510(k) to FDA for significant changes in intended use or indications for use, technology, design, or compatibility that could affect safety or effectiveness.

The post contains charts summarizing all the drug and medical device enforcement letters issued in 2025.