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FDA Criminal Enforcement of the FD&C Act

The Food, Drug, and Cosmetic Act (FD&C Act) gives FDA power to enforce civil and criminal penalties on those who violate its provisions. While criminal prosecutions under the FD&C Act are rare, FDA's Office of Criminal Investigations (OCI) investigates suspected criminal violations of the FD&C Act and related laws. If prosecution is appropriate, OCI makes a recommendation to the Department of Justice (DOJ), which has the authority to prosecute FD&C Act violations. The strict liability standard applies to criminal violations of the FD&C Act, which means that a defendant can be held criminally liable without proof of knowledge or intention to perform the act resulting in a violation.

Under the FD&C Act, criminal convictions require proof of three elements. The government must prove that the article at issue:

  1. Is either a "food," "drug," "device," "tobacco," or "cosmetic"

  2. Is "adulterated" or "misbranded,"

  3. Was introduced into interstate commerce.

The FD&C Act criminal provisions do not include a "guilty mind" requirement. Instead, criminal liability under the FD&C Act is strict liability, meaning that all who have "a responsible share in the furtherance of the transaction which the statute outlaws" can be held accountable. The responsible corporate officer doctrine holds that a showing of criminal liability under the FD&C Act does not require an "awareness of some wrongdoing" by the defendant, but instead, merely requires the defendant to be in a position in a corporation in which they had responsibility and authority to prevent or promptly correct the violation complained of and failed to do so.

The threat of criminal penalties may create incentives to comply with the FD&C Act. Although criminal prosecutions are rare, the potential threat to an individual's liberty, such as the factory manager, the corporate chief executive, or the researcher, is a significant deterrent. FDA generally provides hearings absent a regulatory bar, and DOJ has discretion to reject FDA's recommendation. Still, it typically adheres to the recommendations of FDA and acts in partnership with attorneys from FDA.

Have additional questions about FDA's criminal enforcement of the FD&C Act? Give our office a call today.

Wondering about FDA's civil enforcement authority? Check out our article covering exactly that here.

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