Still Preempting OTC Drug Claims Over Alleged Contamination

Litigation attorney Eric Alexander published a blog for Drug & Device Law analyzing two recent class actions over alleged benzene in over-the-counter (OTC) drugs that were dismissed on federal preemption grounds. In Kouyate v. Harvard Drug Group and Leonard v. CVS Pharmacy, courts held that plaintiffs' state‑law labeling and adulteration theories sought requirements "different from or in addition to" the U.S. Food and Drug Administration's (FDA) monograph and Abbreviated New Drug Application (ANDA) frameworks, and that nonbinding guidance did not alter the preemption analysis. The article describes how trace contaminant allegations, absent noncompliance with binding FDA requirements or viable product liability claims, continue to falter under express and impossibility preemption.

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