	Introduction

In an increasingly interconnected world, public health concerns and crises have domestic and international implications. The Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act or the Act) promotes national public health by preventing fraudulent activity with respect to food, drugs, and an array of other public health products. The FD&C Act and its implementing regulations contain standards to protect and promote public health, including requirements for prescription drug approval and food safety. Providing an overview of the Act's enforcement, this report discusses the Act's civil and criminal provisions and enforcement mechanisms. Overview of the Food, Drug, and Cosmetic Act

The FD&C Act regulates most foods, food additives, color additives, dietary supplements, prescription and non-prescription drugs, medical devices, cosmetics, and tobacco products for safety. The Act's primary purpose is to "safeguard" and "protect" consumers from "dangerous products" affecting public health and safety 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." The FD&C Act is enforced through a variety of measures such as formal and informal administrative actions, criminal and civil penalties, injunctions, recalls, and/or seizures of FD&C Act-covered goods. Section 301 generally makes it illegal to distribute directly or indirectly a covered product in interstate commerce that is "adulterated" or "misbranded." General Questions About the Enforcement of the FD&C Act

This section answers several basic and overarching questions about the Act's enforcement. Established under FD&C Act Section 1003, the U.S. Food and Drug Administration (FDA) is the primary agency that administers and enforces the Act. Generally, FDA's mission is to promote and protect public health by ensuring the safety, efficacy, and truthful labeling of products subject to the Act. In addition to such pre-market authority, FDA also possesses significant post-market authority to monitor regulated products that have entered interstate commerce to ensure the product continues to adhere to the Act. FDA also uses "other enforcement tools not detailed in the FD&C Act," such as issuing warning and information letters to regulated entities that are violating the Act. These practices are discussed later in this report. Indeed, while FDA has significant authority to promote compliance with and to investigate violations of the Act, FDA, like most executive agencies, does not have independent litigating authority. Thus, to address noncompliance, FDA must coordinate with the Department of Justice (DOJ) to enforce the Act through product seizures, injunctions, civil penalty proceedings, or criminal prosecutions. In addition to DOJ, several other agencies have FD&C Act enforcement roles. To administer federal laws relating to imports, exports, and duties, the U.S. Customs and Border Protection (CBP) "must work in close cooperation" with FDA to prevent articles that violate the FD&C Act from entering the United States. More broadly, because the Act covers a range of products and subject matters, other federal and state agencies have roles in regulating FD&C Act-covered products. Significantly, the FD&C Act does not contain a private right of action under which members of the public can sue to enforce the Act. While the Supreme Court has recognized that private lawsuits can be used to enforce laws with mandates similar to those of the FD&C Act, the onus for enforcing the Act lies almost exclusively with the federal government. A product's nexus with interstate commerce may arise from many activities. As a consequence, recent federal court decisions have found that the FD&C Act requirement that articles be in interstate commerce poses "no obstacle" to FDA enforcing the Act with respect to seemingly wholly intrastate activities. For the Court, the FD&C Act's general enforcement provision, Section 702, was permissive in nature, merely "authorizing" the Secretary of Health and Human Services (and through a delegation of that authority, the Commissioner of FDA) "to conduct examinations and investigations for the purposes of" the Act, and indicated Congress's intent to give FDA discretion over initiating enforcement proceedings. Absent DOJ involvement, FDA has several administrative tools for enforcing the Act, including warning and untitled letters, import alerts, recalls, debarments, and civil money penalties. FDA's other civil enforcement actions, including injunctions and seizures, require DOJ assistance. For example, in Bellarno International Ltd.v. Civil Money Penalties

Under the FD&C Act, FDA may impose monetary civil penalties for specified violations of the Act. Seizures

To prevent harmful goods from reaching consumers, the FD&C Act provides for the seizure of foods, drugs, devices, cosmetics, and tobacco products that are adulterated or misbranded. FDA has indicated that an injunction is the agency's remedy of choice when there are
current and definite health hazards or a gross consumer deception requiring immediate action to stop the violative practice and a seizure is impractical; significant amounts of violative products owned by the same person, a voluntary recall by the firm was refused or is significantly inadequate to protect the public, and a seizure is impractical or uneconomical; or long-standing (chronic) violative practices that have not produced a health hazard or consumer fraud, but which have not been corrected through use of voluntary or other regulatory approaches. Criminal Enforcement of the FD&C Act

In addition to civil enforcement mechanisms, the FD&C Act also subjects individuals to criminal penalties, including fines and imprisonment, for violating certain provisions of the Act. Two Supreme Court cases established this principle. While the lack of a mens rea element in FD&C Act criminal cases could theoretically allow FDA and DOJ to "bring a criminal action ... in virtually every serious case" of an FD&C Act violation, two defenses may diminish the potential reach of the Act's criminal sanctions. Criminal Penalties Resulting from an FD&C Act Violation

Under Section 303(a)(1) of the FD&C Act, criminal violations of the Act are generally treated as misdemeanors, meaning they are punishable by a fine or imprisonment of a year or less.
In an increasingly interconnected world, public health concerns and crises have domestic and international implications. In the United States, the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act or the Act) promotes public health by preventing fraudulent activity with respect to food, drugs, and an array of other public health products that enter interstate commerce. Indeed, the Act's primary purpose is to "safeguard" and "protect" consumers from exposure to dangerous products affecting public health and safety. The FD&C Act does this by regulating covered articles from their introduction into interstate commerce to their delivery to the ultimate consumer. This report provides an overview of the FD&C Act, answers frequently asked questions about the Act's enforcement, and discusses the Act's various civil and criminal enforcement provisions.
The FD&C Act is the main 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, it generally prohibits two basic acts: "adulteration" and "misbranding." Specifically, FD&C Act Section 301 makes it illegal to distribute directly or indirectly a covered product in interstate commerce that is adulterated or misbranded. The Act defines the terms "adulteration" and "misbranding" with respect to specific products.
The FD&C Act is chiefly enforced by the U.S. Food and Drug Administration (FDA), an agency whose general mission is to promote and protect the public health by ensuring the safety, efficacy, and truthful labeling of the products it regulates. FDA enforces the Act through administrative mechanisms, such as pre-market reviews of certain products, examinations and investigations, and dissemination of information to the public. While primarily focused on interstate commerce, FDA's authority extends to intrastate activities that have a nexus with interstate commerce and concern a product that the Act covers. Supreme Court precedent recognizes that FDA enjoys significant discretion over enforcement of most FD&C Act provisions. Because FDA, like most executive agencies, does not have independent litigating authority, it must coordinate with the Department of Justice (DOJ) to pursue criminal or civil remedies. In addition to DOJ, other federal agencies play a role in enforcing discrete parts of the Act; private parties, however, do not have rights to enforce the FD&C Act through lawsuits.
For serious FD&C Act violations, the FDA, in coordination with DOJ, has a wide range of civil and criminal remedies. For example, the FD&C Act authorizes the government to sue violators of the Act in court in order to punish or prevent future violations. Such civil actions include imposing money penalties, injunctions, and seizures. Other enforcement actions include warning letters, import alerts, recalls, and debarments. For extremely serious violations, FDA and DOJ may collaborate to bring criminal charges. A criminal violation of the FD&C Act does not require that the perpetrator have a "guilty mind." Intentional or repeated violations of the Act may result in multiple years of imprisonment and significant criminal fines.
In an increasingly interconnected world, public health concerns and crises have domestic and international implications. In the United States, the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act or the Act) promotes public health by preventing fraudulent activity with respect to food, drugs, and an array of other public health products that enter interstate commerce. Indeed, the Act's primary purpose is to "safeguard" and "protect" consumers from exposure to dangerous products affecting public health and safety. The FD&C Act does this by regulating covered articles from their introduction into interstate commerce to their delivery to the ultimate consumer. This report provides an overview of the FD&C Act, answers frequently asked questions about the Act's enforcement, and discusses the Act's various civil and criminal enforcement provisions.
The FD&C Act is the main 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, it generally prohibits two basic acts: "adulteration" and "misbranding." Specifically, FD&C Act Section 301 makes it illegal to distribute directly or indirectly a covered product in interstate commerce that is adulterated or misbranded. The Act defines the terms "adulteration" and "misbranding" with respect to specific products.
The FD&C Act is chiefly enforced by the U.S. Food and Drug Administration (FDA), an agency whose general mission is to promote and protect the public health by ensuring the safety, efficacy, and truthful labeling of the products it regulates. FDA enforces the Act through administrative mechanisms, such as pre-market reviews of certain products, examinations and investigations, and dissemination of information to the public. While primarily focused on interstate commerce, FDA's authority extends to intrastate activities that have a nexus with interstate commerce and concern a product that the Act covers. Supreme Court precedent recognizes that FDA enjoys significant discretion over enforcement of most FD&C Act provisions. Because FDA, like most executive agencies, does not have independent litigating authority, it must coordinate with the Department of Justice (DOJ) to pursue criminal or civil remedies. In addition to DOJ, other federal agencies play a role in enforcing discrete parts of the Act; private parties, however, do not have rights to enforce the FD&C Act through lawsuits.
For serious FD&C Act violations, the FDA, in coordination with DOJ, has a wide range of civil and criminal remedies. For example, the FD&C Act authorizes the government to sue violators of the Act in court in order to punish or prevent future violations. Such civil actions include imposing money penalties, injunctions, and seizures. Other enforcement actions include warning letters, import alerts, recalls, and debarments. For extremely serious violations, FDA and DOJ may collaborate to bring criminal charges. A criminal violation of the FD&C Act does not require that the perpetrator have a "guilty mind." Intentional or repeated violations of the Act may result in multiple years of imprisonment and significant criminal fines.