## Facts

- Buffalo Pharmacal Company, a drug wholesaler, bought drugs from manufacturers, repackaged them under its own label, and shipped them in interstate commerce.
- The United States charged that certain shipments contained adulterated and misbranded drugs, violating § 301 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 331.
- Joseph H. Dotterweich, the company’s president and general manager, was prosecuted alongside the corporation.
- The case proceeded on three counts: two for shipping misbranded drugs and one for shipping an adulterated drug.
- The jury did not reach a verdict as to the corporation but found Dotterweich guilty on all counts; the district court entered judgment against him.
- The court of appeals reversed, concluding the FDCA did not clearly impose personal criminal liability on an officer absent personal participation or knowledge of the shipments.

## Issues

1. Whether FDCA § 305’s requirement that the Administrator give an alleged violator an “opportunity to present his views” before referral for prosecution is a condition precedent to a criminal case.
2. Whether the jury was legally barred from convicting a corporate officer when it did not convict (or did not reach a verdict as to) the corporation.
3. Whether the FDCA permits misdemeanor liability for a corporate officer, as a “person,” without proof that the officer personally participated in or knew of the misbranding or adulteration.

## Decision

- The Supreme Court reversed the court of appeals and reinstated Dotterweich’s conviction.
- Section 305’s pre-referral opportunity to present views was not a prerequisite to prosecution.
- The jury could convict the officer even though it did not convict the corporation.
- The district court properly submitted to the jury whether Dotterweich bore responsibility for the unlawful shipments, and the evidence was sufficient to support the verdict.
- The Court construed the FDCA as imposing public-welfare criminal liability that can reach corporate officers in responsible positions without proof of awareness of the specific violations.

## Legal Principles

- Regulatory statutes aimed at protecting public health may impose misdemeanor liability without requiring proof of conscious wrongdoing.
- Under the FDCA, “any person” who violates the shipment prohibitions may be criminally liable; this includes corporate officers who have a responsible role in the regulated transactions.
- Corporate criminal liability does not displace individual liability; a corporate officer may be convicted even if the corporation is not convicted.
- A statutory pre-prosecution administrative step requiring an opportunity to present views does not, absent clear congressional direction, operate as a jurisdictional bar to criminal prosecution.

## Conclusion

The Court held that the FDCA authorizes misdemeanor convictions of corporate officers who stand in a responsible relation to unlawful shipments of adulterated or misbranded drugs, even without proof of personal knowledge or participation, and that neither § 305’s administrative procedure nor the corporation’s nonconviction prevents an officer’s conviction.


United States v. Dotterweich, 320 U.S. 277 (1943)