Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues

Summary

In an increasingly interconnected country, public health concerns and crises originating from any state have the potential to impact the entire nation. A critical law to help promote national public health and prevent fraudulent activity with respect to food, drugs, and an array of other public health products that enter interstate commerce is the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA or the Act). Indeed, the primary purpose of the Act is to “safeguard” and “protect” the consumer from being exposed to dangerous products affecting public health and safety, and the FDCA does this by regulating covered articles from the moment of their introduction into interstate commerce all the way to the moment of their delivery to the ultimate consumer. This report provides an overview of the FDCA, answers frequently asked questions about the enforcement of the Act, and concludes with an overview of the various civil and criminal enforcement provisions contained within the FDCA.

The FDCA is the central federal law regulating the safety of most foods, food additives, color additives, dietary supplements, prescription and non-prescription drugs, medical devices, cosmetics, and tobacco products. While the Act regulates a host of disparate products, the FDCA, in Section 301, generally prohibits two basic acts: “adulteration” and “misbranding.” Specifically, Section 301 makes it illegal to directly or indirectly distribute a covered product in interstate commerce that is adulterated or misbranded. Many other provisions of the Act are devoted to defining what the terms “adulteration” and “misbranding” mean with respect to the specific products covered under the Act.

The FDCA is centrally enforced by the Food and Drug Administration (FDA), an agency whose mission is to “assure that the products it regulates are safe and truthfully labeled.” The FDA enforces the Act through a series of administrative mechanisms, such as pre-market reviews of certain products, examinations and investigations, and the dissemination of information to the public. Nonetheless, because the FDA does not have independent litigating authority, the agency must rely on the Department of Justice (DOJ) if a particular matter requires utilization of criminal or civil remedies. While private parties do not have the right to enforce the FDCA’s mandates through a lawsuit, in addition to the DOJ, a host of other federal agencies help enforce discrete parts of the Act. Still, the FDA remains the primary agency charged with enforcing the FDCA, and the FDA’s authority reaches to even purely intrastate activities that have some sort of nexus with interstate commerce, so long as the activity in question respects a product that is covered under the Act. Supreme Court case law confirms that the FDA enjoys significant discretion in choosing when to enforce most provisions of the FDCA, although certain mandates can eliminate the FDA’s discretion and impose a mandate on the agency to enforce the Act in specific circumstances.

If the agency, with the help of the DOJ, considers a particular matter sufficiently serious, the FDCA provides a wide range of civil and criminal remedies to enforce the substantive provisions of the Act. For example, the FDCA provides the government with the ability to sue violators of the Act in Court to punish or prevent future violations of the FDCA. Civil actions include the imposition of civil monetary penalties, injunctions, and seizures. If someone’s conduct is extremely serious, in rare cases, the FDA and DOJ have collaborated to bring criminal charges against those who violate the Act. While a criminal violation of the FDCA does not require that the perpetrator be aware of his conduct, intentional or repeated violations of the Act can result in multiple years of imprisonment and hefty criminal fines.