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1 1 (September 30, 2019)

handle is hein.crs/govbbex0001 and id is 1 raw text is: I M11 Ir rgiUcelledbwsne11 Congressional Research Service 0 September 30, 2019 Federal Regulation of Tobacco: Legal Framework and Issues for the 116th Congress The Family Smoking Prevention and Tobacco Control Act (TCA), P.L. 111-31, establishes the central federal regulatory regime for the manufacture, marketing, and distribution of tobacco products. The statute aims to balance competing interests in protecting the public's health against the harmful effects of smoking and youth tobacco use, while preserving access to lawfully marketed tobacco products for adult consumers. The TCA largely amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and grants the Food and Drug Administration (FDA) primary Federal authority over tobacco product regulation. This In Focus summarizes the TCA's legal framework and discusses key TCA-related issues in the 116th Congress. Overview of the TCA The TCA regulates tobacco products, which generally are any products made or derived from tobacco and intended for human consumption, including the product's components, parts, or accessories. While the TCA explicitly applies to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco, the statute also permits FDA to deem other tobacco products subject to the law. FDA has exercised this authority over additional tobacco products, including electronic nicotine delivery system (ENDS) products (e.g., e-cigarettes and vape pens) and cigars. Key components of tobacco product regulation under the TCA include the following: Premarket Review A marked change to federal tobacco regulation, the TCA establishes a premarket review process for new tobacco products (i.e., products not commercially marketed as of February 15, 2007, or products marketed after that date, but later modified). Grandfathered products on the market before February 15, 2007, may be sold without prior authorization. In general, to market a particular new product, a manufacturer must submit a premarket tobacco product application (PMTA) and receive a PMTA marketing order from FDA, unless the manufacturer can successfully show that the product is either substantially equivalent to a predicate product or may be exempt from this substantial equivalence demonstration. Premarket Tobacco Product Application: To receive a marketing order from FDA, manufacturers must submit a PMTA, which includes information on health risk investigations; the composition, ingredients, and operation of the tobacco product; and the product's manufacture, processing, and proposed product labeling. To issue a PMTA marketing order, FDA must determine whether, among other things, allowing the new tobacco product to be on the market would be appropriate to protect public health. https:!icrsrepo * Substantial Equivalence (SE): Nearly all new tobacco products are marketed through the SE pathway. As a less rigorous alternative to a PMTA submission, FDA may permit a new tobacco product to be marketed based on a demonstration that it is substantially equivalent to an existing product marketed as of February 15, 2007, and complies with other federal tobacco-related requirements. A tobacco product is substantially equivalent to its earlier counterpart if, in general, it has the same characteristics (e.g., ingredients, design, heating source, or other features) of the reference product or does not raise different public health questions. Additionally, certain new tobacco products commercially marketed after February 15, 2007, but before March 22, 2011 (provisional SE tobacco products), may be marketed unless FDA issues an order that the new product is not substantially equivalent. * Substantial Equivalence Exemption: FDA may exempt certain new tobacco products with minor modifications from having to show substantial equivalence. Products eligible for an exemption are those modified by adding or deleting a tobacco additive, or by increasing or decreasing the quantity of an existing tobacco additive. Manufacturer Requirements The TCA creates several requirements that tobacco product manufacturers must meet to market a product. For example, the act directs FDA to issue regulations related to tobacco product manufacturing practices, to protect public health, and ensure that tobacco products are in compliance with federal law. FDA can grant exemptions and variances from such regulations under specified circumstances. The TCA also generally directs manufacturers to maintain records, issue reports, and provide other information to FDA, as the agency may require by regulation. For instance, the TCA compels manufacturers to submit a report listing all product constituents, including smoke constituents identified as harmful or potentially harmful by FDA. The statute also authorizes FDA to conduct or require testing and reporting of tobacco product constituents, ingredients, and additives that the agency determines need testing to protect the public health. Tobacco Product Standards To reduce the allure of flavored tobacco products to minors, the TCA bans flavors (other than tobacco and menthol) in traditional cigarettes and components. The TCA also empowers FDA to adopt certain tobacco product standards if the agency determines that a standard is appropriate to protect the public health. Such standards may relate to 09sqconcss-

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