A recent warning letter issued by the Food and Drug Administration (FDA) against a dietary supplement distributor cited United States v. Park, 421 U.S. 658 (1975), and United States v. Dotterweich, 320 U.S. 277 (1943), to support the agency’s contention that the distributor is responsible for the current good manufacturing practice violations of its contractor manufacturers.

Under the Park doctrine, the government may press misdemeanor charges against company officials for their companies’ alleged violations of the Food, Drug, and Cosmetic Act (FDCA) without showing that the official participated in or was aware of the violations. By citing both Park and Dotterweich (involving an officer’s vicarious liability for the acts of third party manufacturers), FDA may have signaled by implication its intent to hold distributor officers in positions of responsibility or authority strictly criminally liable for a contractor’s FDCA violations.