In an increasingly interconnected world, public health concerns and crises have domestic and international implications. In 2015, a salmonella outbreak associated with cucumbers imported from Mexico affected 907 people in 40 states, causing 6 deaths; while an October 2012 outbreak of fungal meningitis caused by steroid injections prepared at a Massachusetts compounding pharmacy resulted in over 60 deaths. In another incident, counterfeit Heparin imported from China in 2008 resulted in at least 80 deaths in the United States, and contaminated products in at least 10 other countries' drug supplies. Beyond preventing public health crises, Congress has a strong interest in ensuring that products consumed by Americans work as intended and are truthfully labeled. 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. 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. Congress enacted the FD&C Act in 1938, acting pursuant to its constitutional authority to regulate interstate commerce. 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. Though the FD&C Act has been "substantially amended since 1938," the Act "still retains its basic structure." The "heart of the enforcement provisions of the" FD&C Act is Section 301, which enumerates specific prohibited acts. The FD&C Act prohibitions have been described as "a catalogue of definitions elaborating two basic concepts: 'adulteration' and 'misbranding.'" Section 301 generally makes it illegal to distribute directly or indirectly a covered product in interstate commerce that is "adulterated" or "misbranded." The FD&C Act "ascrib[es] the labels 'adulterated' or 'misbranded' to products whose composition, production or labeling fails" to meet the Act's substantive requirements. For example, the FD&C Act deems a "food" adulterated if it has been held under "insanitary conditions," and a "drug" misbranded if its label does not contain the "name and place of business of the manufacturer, packer, or distributor." The language of the FD&C Act is "purposefully broad," providing the executive branch significant discretion over implementing rules and guidelines. Table 1 notes FD&C Act sections that identify when a particular product can be deemed "adulterated" or "misbranded." 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. Consistent with this mission, FDA is statutorily empowered to provide administrative guidance on the FD&C Act's broad mandates and to enforce the Act through administrative actions. For example, before certain articles may lawfully be sold in interstate commerce, FDA must rigorously review them to ensure that they meet certain standards, such as being safe and effective for their intended use. 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. For example, the Act empowers FDA to request information from pharmaceutical manufacturers, to inspect food producer facilities, or to order recalls of medical devices that may cause "serious, adverse health consequences." The FD&C Act also authorizes FDA to "conduct examinations and investigations" to administer the Act, to disseminate information about regulated products involving "imminent danger to health" or "gross deception to the consumer," and to publicize information on all formal enforcement actions resolved in court. 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. FDA, however, is not the only federal agency that enforces the FD&C Act. 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. To this end, when FDA discovers that the Act has been or is being violated, the relevant FDA district office, in consultation with FDA's Office of the Chief Counsel, generally evaluates the violation and determines whether to refer it to DOJ's Office of Consumer Litigation (OCL). The OCL and DOJ's field representative, the U.S. Attorney for the judicial district in which FDA anticipates seeking judicial relief, in consultation with FDA, ultimately decide whether to seek judicial relief on behalf of FDA. 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. As a result, CBP alerts FDA when an FD&C Act-regulated product arrives at a port of entry. If FDA finds the product's importation would violate the Act, FDA asks CBP to issue a "Notice of Refusal of Admission" to the importer and to destroy any shipment that is not exported within 90 days. 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. For example, under the Act, FDA is to ensure that drug and device manufacturers properly label their products so as not to mislead consumers, a power that courts have broadly interpreted to allow FDA to regulate advertising relating to drugs or medical devices. However, the Federal Trade Commission (FTC), an independent agency tasked with promoting economic competition and consumer protection by eliminating "unfair or deceptive" acts or practices, likewise has authority over advertising of goods, including drugs and medical devices, in interstate commerce. Because their jurisdictions overlap, FDA and FTC have entered into a memorandum of understanding (MOU) regarding their respective authorities over the marketing of FD&C Act-regulated products. As a consequence, FTC is the primary agency overseeing over-the-counter drugs and medical device advertising. FDA has also entered into MOUs with other government agencies, including the U.S. Department of Agriculture (USDA), the Department of the Treasury, the Department of Defense (DoD), and the Centers for Disease Control and Prevention (CDC). Other "principal cooperating agencies" that FDA works with include the Environmental Protection Agency, the Consumer Product Safety Commission, the Drug Enforcement Administration, the National Institutes of Health, the Nuclear Regulatory Commission, the Office of Management and Budget, and the Securities and Exchange Commission. In addition, the FD&C Act authorizes state governments, working in conjunction with FDA, to enforce certain aspects of the Act. In short, while FDA is the primary agency enforcing the FD&C Act, other entities have roles. 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. Instead, under the FD&C Act, generally all proceedings "for the enforcement, or to restrain violations, of" the Act must be in the name of the United States. As the Supreme Court has noted, "the [FD&C Act] and its regulations provide the United States with nearly exclusive enforcement authority," and "[p]rivate parties may not bring enforcement suits." 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. FDA's regulatory authority comes from Congress's constitutional power to regulate interstate commerce. Article I, Section 8, Clause 3 of the U.S. Constitution grants Congress power "[t]o regulate commerce with foreign nations, and among the several States, and with the Indian Tribes." While early 20 th century case law interpreted the Commerce Clause narrowly to preclude federal regulation of local economic activity that had only "indirect" impacts on interstate commerce, in 1937, the Supreme Court began reading the Commerce Clause more expansively, finding Congress to have power to regulate intrastate economic activity that has "a substantial effect on interstate commerce." The Court's expansive interpretations of the Commerce Clause have led one commentator to state that "Congress ... appears to retain virtually unlimited power to regulate even the wholly intrastate production and sale of food, drugs, devices, and cosmetics." A product's nexus with interstate commerce may arise from many activities.