{ "id": "R43609", "type": "CRS Report", "typeId": "REPORTS", "number": "R43609", "active": true, "source": "EveryCRSReport.com", "versions": [ { "source": "EveryCRSReport.com", "id": 578428, "date": "2018-02-09", "retrieved": "2018-02-15T14:12:15.227185", "title": "Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues", "summary": "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\u2019s primary purpose is to \u201csafeguard\u201d and \u201cprotect\u201d 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\u2019s enforcement, and discusses the Act\u2019s various civil and criminal enforcement provisions.\nThe 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: \u201cadulteration\u201d and \u201cmisbranding.\u201d 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 \u201cadulteration\u201d and \u201cmisbranding\u201d with respect to specific products.\nThe 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\u2019s 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. \nFor 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 \u201cguilty mind.\u201d Intentional or repeated violations of the Act may result in multiple years of imprisonment and significant criminal fines.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://crs.gov/Reports/R43609", "sha1": "c7dc4976ba65e95d74217d76ab165ad93360a253", "filename": "files/20180209_R43609_c7dc4976ba65e95d74217d76ab165ad93360a253.html", "images": {} }, { "format": "PDF", "encoding": null, "url": "http://crs.gov/Reports/pdf/R43609", "sha1": "f963cdfd6977dfe81261258753471a21a09bdf5c", "filename": "files/20180209_R43609_f963cdfd6977dfe81261258753471a21a09bdf5c.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source": "EveryCRSReport.com", "id": 432057, "date": "2014-06-19", "retrieved": "2016-04-06T20:19:35.363278", "title": "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 \u201csafeguard\u201d and \u201cprotect\u201d 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.\nThe 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: \u201cadulteration\u201d and \u201cmisbranding.\u201d 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 \u201cadulteration\u201d and \u201cmisbranding\u201d mean with respect to the specific products covered under the Act.\nThe FDCA is centrally enforced by the Food and Drug Administration (FDA), an agency whose mission is to \u201cassure that the products it regulates are safe and truthfully labeled.\u201d 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\u2019s 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\u2019s 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\u2019s discretion and impose a mandate on the agency to enforce the Act in specific circumstances.\nIf 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\u2019s 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.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R43609", "sha1": "8a5fc619750377dcb1eda9dac5703ae773b58b22", "filename": "files/20140619_R43609_8a5fc619750377dcb1eda9dac5703ae773b58b22.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R43609", "sha1": "fe1cf8fee43899954654b3e2bacdb0edf25a0d32", "filename": "files/20140619_R43609_fe1cf8fee43899954654b3e2bacdb0edf25a0d32.pdf", "images": null } ], "topics": [ { "source": "IBCList", "id": 2678, "name": "Medical Product Regulation" } ] } ], "topics": [ "Domestic Social Policy" ] }