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FDA Civil Enforcement of the FD&C Act



The United States Food and Drug Administration (FDA) is the primary agency responsible for administering and enforcing the Federal Food, Drug, and Cosmetic (FD&C) Act. FDA enforces the FD&C Act through both civil and criminal enforcement actions. Civil enforcement actions, which do not require involvement from the Department of Justice (DOJ), include warning and untitled letters, import alerts, recalls, debarments, civil money penalties, and seizures.


Warning and untitled letters are advisory action letters issued by FDA to alert individuals or firms of identified "violations of regulatory significance." Warning letters request corrective action, while untitled letters are used to address violations that do not merit a warning letter. Warning letters may include notice of further enforcement actions if the recipient does not comply, but they are informal and advisory in nature and do not constitute "final agency action." Similarly, untitled letters are less serious than warning letters and do not include a warning that failure to comply may result in subsequent enforcement action.

FDA issues import alerts or automatic detention lists to prevent articles that may violate the FD&C Act from entering the United States. FDA can detain these articles without physical examination until further notice, after which the owner or consignee has the opportunity to testify on the articles' admissibility. FDA may either permit or refuse the articles' entry into the United States based on this information. FDA's use of import alerts has been challenged in court, primarily on procedural grounds.

Recalls may be more efficient than other formal or administrative processes for removing potentially hazardous products from the market and alerting the public, thereby creating additional incentive for companies to comply with the FD&C Act. Under section 306 of the FD&C Act, FDA is authorized to "debar" or prohibit corporations or individuals from participating in certain FDA-regulated activities based on their related conduct. Debarment appears to create strong incentives to comply with the FD&C Act because it poses significant consequences for those participating in FDA-regulated industries, possibly necessitating career changes.


FDA may impose monetary civil penalties for specified violations of the FD&C Act. The maximum penalty that FDA may assess ranges from approximately $1,000 to over $1 million per violation depending on the prohibited act. To determine the penalty for many violations, the agency must consider the nature and circumstances surrounding the violation, the person's ability to pay, the effect on the person's ability to continue to do business, and any history of similar acts. FDA may assess penalties against both individuals and corporations.


Finally, the FD&C Act provides for the seizure of foods, drugs, devices, cosmetics, and tobacco products that are adulterated or misbranded. Seizures may be small, involving only a few articles, or they may be large, involving entire manufacturing facilities. According to a House report accompanying the FD&C Act, a seizure is considered the harshest civil remedy under the Act and should be discouraged or confined to those cases where the public protection requires such action.


These actions are intended to prevent violations of the Act, protect public health, and create incentives for compliance with the law.


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


Wondering about FDA's criminal enforcement authority? We will be covering this in an upcoming article, so stay tuned.


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