{ "id": "R45867", "type": "CRS Report", "typeId": "R", "number": "R45867", "active": true, "source": "CRSReports.Congress.gov, EveryCRSReport.com", "versions": [ { "source_dir": "crsreports.congress.gov", "title": "FDA Regulation of Tobacco Products", "retrieved": "2021-08-15T04:03:43.198299", "id": "R45867_11_2021-07-09", "formats": [ { "filename": "files/2021-07-09_R45867_a6e3aa3530f306227b9be0f12016e90e286be0a0.pdf", "format": "PDF", "url": "https://crsreports.congress.gov/product/pdf/R/R45867/11", "sha1": "a6e3aa3530f306227b9be0f12016e90e286be0a0" }, { "format": "HTML", "filename": "files/2021-07-09_R45867_a6e3aa3530f306227b9be0f12016e90e286be0a0.html" } ], "date": "2021-07-09", "summary": null, "source": "CRSReports.Congress.gov", "typeId": "R", "active": true, "sourceLink": "https://crsreports.congress.gov/product/details?prodcode=R45867", "type": "CRS Report" }, { "source": "EveryCRSReport.com", "id": 617051, "date": "2020-02-10", "retrieved": "2020-02-13T23:21:37.383860", "title": "FDA Regulation of Tobacco Products", "summary": "Cigarette use remains the leading cause of preventable death in the United States, claiming an estimated 480,000 lives or more each year. Although cigarette use in the United States continues to decline, according to the Centers for Disease Control and Prevention (CDC), 34.2 million American adults smoked cigarettes every day or some days in 2018, and nearly 1.2 million American middle and high school students smoked cigarettes in the past 30 days in 2019. \nIn recent years, electronic nicotine delivery systems (ENDS) have become increasingly popular. ENDS is an umbrella term for various types of electronic tobacco products, including electronic cigarettes (e-cigarettes). An e-cigarette is a battery-operated device typically containing nicotine, flavorings, and other chemicals that, when heated, creates inhalable vapor. According to CDC analyses, 8.1 million American adults used e-cigarettes every day or some days in 2018, and about 5.4 million American middle and high school students used an e-cigarette in the past 30 days in 2019. There has been debate in the public health community regarding the impact of ENDS on public health. Some view ENDS as a safer alternative for adult cigarette smokers, while others are alarmed by increased use among youth. Further, the emergence of e-cigarette, or vaping, product use-associated lung injury (EVALI) that has resulted in 60 deaths and the hospitalization of 2,711 individuals as of January 21, 2020 has raised further concern among public health stakeholders, Congress, and the general public.\nFDA Regulation of Tobacco Products\nThe Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), is responsible for regulating the manufacture, marketing, distribution, and sale of tobacco products. FDA\u2019s Center for Tobacco Products (CTP)\u2014established in 2009 pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA; P.L. 111-31)\u2014is primarily responsible for tobacco product regulation. The TCA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a new chapter IX (\u201ctobacco products\u201d), which, as enacted, applied to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, FDA has the broad authority to regulate any other tobacco products deemed by the agency to meet the definition of a tobacco product and thus to be subject to chapter IX of the FFDCA. In 2016, pursuant to this authority, FDA promulgated regulations (known as \u201cthe deeming rule\u201d) that extended the agency\u2019s authority over all tobacco products that were not already subject to the FFDCA, including ENDS.\nBecause tobacco products have no reported health benefits, FDA\u2019s regulation of these products differs in certain respects from FDA\u2019s regulation of medical products (e.g., prescription drugs, medical devices). Similar to medical product manufacturers, tobacco product manufacturers are subject to manufacturer requirements, including payment of user fees and premarket review, among other requirements. However, while medical product manufacturers are generally required to meet a standard of safety and effectiveness to receive premarket approval from FDA, tobacco product manufacturers are instead generally required to meet a standard \u201cappropriate for the protection of public health\u201d to receive marketing authorization. Tobacco product manufacturers, importers, distributors, and retailers are also required to comply with tobacco-specific requirements as a result of the harm that tobacco products pose to human health. Examples of such requirements include the development of tobacco product standards, submission of health information to the agency, and distribution and promotion restrictions, among others.\nPolicy Considerations\nBoth FDA and Congress have taken steps to address regulation of ENDS in light of EVALI and the youth ENDS epidemic. FDA recently finalized a guidance document expressing its enforcement priorities pertaining to certain ENDS products. Some public health stakeholders contend that the policy will not effectively address youth use of ENDS. In parallel, legislation introduced in the 116th Congress includes more stringent proposals than those planned by FDA to address youth ENDS use, such as banning all flavors in tobacco products (including ENDS). In FY2020 appropriations, Congress enacted provisions raising the federal age of tobacco purchasing from 18 to 21. To apply certain existing FFDCA requirements to tobacco product manufacturers and retailers, such as requiring ENDS manufacturers and importers to pay user fees, Congressional action would need to be taken.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "https://www.crs.gov/Reports/R45867", "sha1": "bbf5166569ef2b403a3ef840f989e8b210806db4", "filename": "files/20200210_R45867_bbf5166569ef2b403a3ef840f989e8b210806db4.html", "images": { "/products/Getimages/?directory=R/html/R45867_files&id=/1.png": "files/20200210_R45867_images_ab62860e70cca1b93e31d90ac05f5ba3c78f2974.png", "/products/Getimages/?directory=R/html/R45867_files&id=/0.png": "files/20200210_R45867_images_80e7ed75d91d15329b4bb82f4353b54c493d0633.png" } }, { "format": "PDF", "encoding": null, "url": "https://www.crs.gov/Reports/pdf/R45867", "sha1": "acf1a5865ba37d6c7c1465ba9f962f6208a03d6f", "filename": "files/20200210_R45867_acf1a5865ba37d6c7c1465ba9f962f6208a03d6f.pdf", "images": {} } ], "topics": [ { "source": "IBCList", "id": 4880, "name": "FDA Product Regulation & Medical Research" } ] }, { "source_dir": "crsreports.congress.gov", "title": "FDA Regulation of Tobacco Products", "retrieved": "2021-08-15T04:03:43.192725", "id": "R45867_5_2020-02-07", "formats": [ { "filename": "files/2020-02-07_R45867_c0363df8256760a09d6e06daac9dfb3c3d5b85ce.pdf", "format": "PDF", "url": "https://crsreports.congress.gov/product/pdf/R/R45867/5", "sha1": "c0363df8256760a09d6e06daac9dfb3c3d5b85ce" }, { "format": "HTML", "filename": "files/2020-02-07_R45867_c0363df8256760a09d6e06daac9dfb3c3d5b85ce.html" } ], "date": "2020-02-07", "summary": null, "source": "CRSReports.Congress.gov", "typeId": "R", "active": true, "sourceLink": "https://crsreports.congress.gov/product/details?prodcode=R45867", "type": "CRS Report" }, { "source": "EveryCRSReport.com", "id": 603601, "date": "2019-08-13", "retrieved": "2019-08-14T22:14:23.758772", "title": "FDA Regulation of Tobacco Products", "summary": "Cigarette use remains the leading cause of preventable death in the United States, claiming an estimated 480,000 lives or more each year. Although cigarette use in the United States continues to decline, according to the Centers for Disease Control and Prevention (CDC), 34.3 million American adults smoked cigarettes every day or some days in 2017, and nearly 1.4 million American middle and high school students smoked cigarettes in the past 30 days in 2018. \nIn recent years, electronic nicotine delivery systems (ENDS) have become increasingly popular. ENDS is an umbrella term for various types of electronic tobacco products, including electronic cigarettes (e-cigarettes). An e-cigarette is a battery-operated device typically containing nicotine, flavorings, and other chemicals that, when heated, creates inhalable vapor. According to CDC analyses, 6.9 million American adults used e-cigarettes every day or some days in 2017, and about 3.6 million American middle and high school students used an e-cigarette in the past 30 days in 2018. There has been debate in the public health community regarding the impact of ENDS on public health. Some view ENDS as a safer alternative for adult cigarette smokers, while others are alarmed by increased use among youth.\nFDA Regulation of Tobacco Products\nThe Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), is responsible for regulating the manufacture, marketing, distribution, and sale of tobacco products. FDA\u2019s Center for Tobacco Products (CTP)\u2014established in 2009 pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009 (TCA; P.L. 111-31)\u2014is primarily responsible for tobacco product regulation. The TCA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a new chapter IX (\u201ctobacco products\u201d), which, as enacted, applied to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, FDA has the broad authority to regulate any other tobacco products deemed by the agency to meet the definition of a tobacco product and thus to be subject to chapter IX of the FFDCA. In 2016, pursuant to this authority, FDA promulgated regulations (known as \u201cthe deeming rule\u201d) that extended the agency\u2019s authority over all tobacco products that were not already subject to the FFDCA, including ENDS.\nBecause tobacco products have no reported health benefits, FDA\u2019s regulation of these products differs in certain respects from FDA\u2019s regulation of medical products (e.g., prescription drugs, medical devices). Similar to medical product manufacturers, tobacco product manufacturers are subject to manufacturer requirements, including payment of user fees and premarket review, among other requirements. However, while medical product manufacturers are generally required to meet a standard of safety and effectiveness to receive premarket approval from FDA, tobacco product manufacturers are instead generally required to meet a standard \u201cappropriate for the protection of public health\u201d. Tobacco product manufacturers, importers, distributors, and retailers are also required to comply with tobacco-specific requirements as a result of the harm that tobacco products pose to human health. Examples of such requirements include the development of tobacco product standards, submission of health information to the agency, and distribution and promotion restrictions, among others.\nPolicy Considerations\nBoth FDA and Congress are interested in addressing ENDS use among youth. Former FDA Commissioner Scott Gottlieb and other public health officials have termed such use an \u201cepidemic\u201d, and Commissioner Gottlieb considered this issue a priority during his tenure. However, FDA\u2019s next steps on addressing youth ENDS use are somewhat uncertain following his departure. In parallel, legislation introduced in the 116th Congress includes more stringent proposals than those planned by FDA to address youth ENDS use, such as banning all flavors in tobacco products (including ENDS). Congressional action would specifically be needed to apply certain existing FFDCA requirements to tobacco product manufacturers and retailers, such as raising the federal age of tobacco purchasing from 18 to 21 or requiring ENDS manufacturers to pay user fees.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "https://www.crs.gov/Reports/R45867", "sha1": "b21e213126430b85ccc2b9ee998442f6e7f0b67a", "filename": "files/20190813_R45867_b21e213126430b85ccc2b9ee998442f6e7f0b67a.html", "images": { "/products/Getimages/?directory=R/html/R45867_files&id=/1.png": "files/20190813_R45867_images_ab62860e70cca1b93e31d90ac05f5ba3c78f2974.png", "/products/Getimages/?directory=R/html/R45867_files&id=/0.png": "files/20190813_R45867_images_80e7ed75d91d15329b4bb82f4353b54c493d0633.png" } }, { "format": "PDF", "encoding": null, "url": "https://www.crs.gov/Reports/pdf/R45867", "sha1": "a2c81374020cf4ffa6be26175a5167d61f97d696", "filename": "files/20190813_R45867_a2c81374020cf4ffa6be26175a5167d61f97d696.pdf", "images": {} } ], "topics": [] } ], "topics": [ "Health Policy" ] }