The FDA's Legal Powers to Combat Counterfeit Drugs
The FDA has specific statutory tools for counterfeit drug enforcement, working alongside customs authorities and, in serious cases, criminal law enforcement.
By the GLP Semaglutide editorial team · Last updated September 28, 2025
The FDA has authority under the Federal Food, Drug, and Cosmetic Act to pursue counterfeit drug cases, including product seizures, warning letters, and referrals for criminal prosecution in serious cases involving intentional distribution of fake medication.
Multiple agencies typically involved
Counterfeit drug enforcement often involves coordination between the FDA, U.S. Customs and Border Protection for imported products, and in criminal cases, agencies like the FBI or Department of Justice — reflecting that counterfeiting can violate several federal statutes at once.
Reporting a suspected counterfeit
The FDA's MedWatch program accepts reports of suspected counterfeit products from consumers and healthcare providers, which can trigger investigation even for products purchased through channels that appeared legitimate at the time.
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