Health Law Advisor

On September 16, 2025, the U.S. Food and Drug Administration (FDA) released more than 60 warning letters sent to specific pharmaceutical manufacturers, alleging misbranding of a particular drug through direct-to-consumer (DTC) advertisements in violation of the federal Food, Drug, and Cosmetic Act (FDCA). The warning letters issued largely from the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The FDA also released nearly 40 untitled letters sent to specific drug manufacturers from its Office of Prescription Drug Promotion on September 9 and 23, similarly informing them that one or more direct-to-consumer TV ads misbrands a specific drug.

These actions follow the September 9th announcement that the U.S. Department of Health and Human Services (HHS) and the FDA would be targeting “misleading” DTC pharmaceutical advertisements—the same day that a presidential memorandum directed HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Martin A. Makary to act.

The letters also reflect a broader shift in the FDA’s oversight of pharmaceutical advertising, particularly in DTC channels. With regulators taking a more aggressive posture across both broadcast and social media platforms, companies should be prepared for shifting regulatory requirements and heightened enforcement risk.

The market for direct-to-consumer (“DTC”) genetic testing has increased dramatically over recent years as more people are using at-home DNA tests.  The global market for this industry is projected to hit $2.5 billion by 2024.  Many consumers subscribe to DTC genetic testing because they can provide insights into genetic backgrounds and ancestry.  However, as more consumers’ genetic data becomes available and is shared, legal experts are growing concerned that safeguards implemented by U.S. companies are not enough to protect consumers from privacy risks.

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