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How the Federal Government Regulates Tobacco

The FDA is in charge of keeping smoking products safe

Cigarette use remains the leading cause of preventable death in the United States, claiming an estimated 480,000 lives or more each year. Further, between 2009 and 2012, cigarette smoking-attributable economic costs totaled over $289 billion in the United States. Although cigarette use in the United States continues to decline, according to Centers for Disease Control and Prevention (CDC) analyses, 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. Electronic nicotine delivery systems (ENDS) have become popular in recent years, particularly among youth. 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 aerosol (i.e., vapor). There has been debate in the public health community regarding the public health impact of ENDS products. Some view them as a safer alternative for adults who smoke cigarettes because the aerosol produced from e-cigarettes is considered less harmful in the short-term than combusted smoke produced from cigarettes. However, others are alarmed by the marked increase in ENDS use among youth and are concerned that these products may undo the years of tobacco control efforts that have successfully reduced cigarette smoking among both youth and adults. Further, the emergence of e-cigarette, or vaping, product use-associated lung injury (EVALI) that has resulted in 60 deaths and 2,711 hospitalizations as of January 21, 2020 has raised concern among public health stakeholders, Congress, and the general public. The 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's Center for Tobacco Products (CTP) established in 2009 pursuant to the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 is primarily responsible for tobacco product regulation. The TCA established FFDCA [Federal Food, Drug, and Cosmetic Act] chapter IX, under which FDA is authorized to regulate tobacco products. Within CTP, the Tobacco Products Scientific Advisory Committee (TPSAC) provides recommendations on tobacco regulatory decisions or any other matter listed in chapter IX of the FFDCA. The TPSAC includes 12 members with diversified experience and expertise. Because tobacco products have no added health benefits, the FDA's regulation of these products differs in certain respects from the FDA's regulation of medical products under its jurisdiction (e.g., prescription drugs, biologics, and medical devices). Similar to medical product manufacturers, tobacco product manufacturers are subject to manufacturer requirements, including payment of user fees, registration establishment, and premarket review, among others. 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 of "appropriate for the protection of public health" to receive marketing authorization. In addition, tobacco product manufacturers, importers, distributors, and retailers are required to comply with certain tobacco-specific requirements that have been authorized under the TCA as a result of the unique harms that tobacco products pose to human health. Examples of such requirements include the development of tobacco product standards, testing and reporting of ingredients, submission of health information to the agency, and distribution and promotion restrictions, among others. n FDA's Authority to Regulate Tobacco Products A tobacco product is defined as "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)." Any article that is a drug, device, or combination product (a combination of a From the Congressional Research Service report FDA Regulation of Tobacco Products, Feb. 10, 2020. See fas.org/sgp/crs/misc/R45867.pdf. 8 Congressional Digest n www.CongressionalDigest.com n February 2021 drug, device, or biological product) is excluded from the definition of tobacco product. Drugs, devices, and combination products are subject to chapter V authorities under the FFDCA. However, it is not always clear whether a product that is derived from tobacco should be regulated as a drug, device, combination product, or a tobacco product (e.g., an ENDS product that makes certain health claims). As such, FDA has promulgated regulations to provide assistance to manufacturers intending to market products that are made or derived from tobacco based on the products' "intended uses." Upon enactment, the TCA explicitly covered the following tobacco products: cigarettes and cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. However, the TCA gave FDA the broad authority to regulate any other tobacco products deemed by the agency to meet the definition of a tobacco product and thus subject to chapter IX of the FFDCA. In 2016, FDA promulgated regulations (known as "the deeming rule") that extended the agency's authority over all tobacco products that were not already subject to the FFDCA, including ENDS, cigars, pipe tobacco, hookah tobacco, nicotine gels, dissolvable tobacco, and other tobacco products that may be developed in the future. n Policy Considerations ENDS. Many in the public health community are alarmed by the marked increase in the use of ENDS products among youth, which is now the most popular tobacco product used among this age group. Research studies suggest that this change has occurred, in large part, as a result of access to flavored ENDS products. The availability of flavored ENDS products has created tension between industry and the public health community. Industry-funded research suggests that the availability of flavored ENDS may be more appealing to adult cigarette smokers (in comparison to nonsmoking teens) and could help adult cigarette smokers quit cigarette smoking. Conversely, one systematic review of the literature found that both youth and adults enjoy flavors in e-cigarettes. However, the authors of this review stated that "in terms of whether flavored e-cigarettes assisted [adults] quitting smoking, we found inconclusive evidence." In combination, numerous studies have documented that flavors entice youth to initiate and continue using tobacco products, including ENDS. Further, the NASEM concluded that there is substantial evidence that ENDS use among youth increases the risk of such youth ever using cigarettes, leading to concern that tobacco control efforts that have successfully reduced cigarette smoking among both youth and adults will be diminished. The culmination of these factors raises questions about how to regulate ENDS products going forward and, specifically, how to address flavors in tobacco products (including ENDS). In March 2019, FDA released a draft guidance document specifying its intended enforcement activities related to flavored ENDS. This guidance specified that FDA would prioritize enforcement of premarket review, distribution, and sale requirements related to certain flavored ENDS products that may be most accessible to youth. For example, FDA would prioritize enforcement of distribution and sale requirements in retail locations where certain flavored ENDS products may be most accessible to youth, such as in convenience stores and gas stations that do not have adult-only sections. In September 2019, FDA announced that it would finalize this guidance document "in the coming weeks," with the intention of clearing "the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use." Delays in guidance finalization led to a Congressional hearing on December 4, 2019 to investigate the cause for the delay. In January 2020, FDA released the final guidance document, with some changes compared to the draft guidance. Specifically, the March 2019 draft guidance focused on enforcement of premarket authorization requirements based on how and where ENDS products are sold, while the final guidance focuses on enforcement of premarket authorization requirements based on ENDS product characteristics (e.g., cartridge-based products). Some public health stakeholders expressed concern that the final guidance does not go far enough to reduce ENDS use among youth. In response to concerns regarding youth access to ENDS products, including flavored ENDS products, Congress may consider further limiting when flavors can be used in ENDS. Congress may also choose to outright ban all flavors (including menthol) in ENDS as well as in other tobacco products as some legislation introduced in the 116th Congress has proposed. Congress may consider proposals that reduce any tobacco product use, including ENDS, among youth while leaving the option of ENDS use open for adult cigarette smokers in order to benefit the public's health. Congress may also consider how the availability of flavored tobacco products would fit into those proposals. E-cigarette, or Vaping, Product Use-Associated Lung Injury. Amidst a rise in ENDS use among youth, the emergence of EVALI has raised concern among public health stakeholders, the general public, and Congress. According to CDC, data suggest that the outbreak began Congressional Digest n www.CongressionalDigest.com n February 2021 9 in June 2019. Emergency department (ED) visits reached a peak in September 2019, but have since declined. As of January 21, 2020, 60 deaths have been confirmed in states and D.C., and 2,711 hospitalized EVALI cases have been reported to CDC in all 50 states, D.C., Puerto Rico, and the U.S. Virgin Islands. Among hospitalized EVALI patients with available data, 66 percent were male and 76 percent were under 35 years old. Further, among a subset of hospitalized EVALI patients, 82 percent reported using tetrahydrocannabinol (THC)-containing products. Although the causes of EVALI are still unknown, laboratory data suggest that vitamin E acetate an additive found in some THC-containing ENDS products is closely associated with EVALI. Vitamin E acetate is commonly used as a dietary supplement and in skin creams. While the ingestion and dermal use of vitamin E acetate is not generally associated with adverse health effects, the safety of inhaling vitamin E acetate has not been closely examined. FDA and CDC, along with state and local health departments, have been working together closely to investigate the issue. FDA, the Drug Enforcement Administration (DEA), and local and state authorities have also been investigating the supply chain of ENDS associated with EVALI. FDA and DEA announced that they have seized 44 websites that were advertising the sale of illicit THC-containing vape cartridges, although none of the products advertised on the websites have been linked to any cases of EVALI. Such THC-containing products may raise a larger question of federal oversight pertaining to these products that are available in states permitting the sale of marijuana for recreational or medicinal purposes. Marijuana including marijuana-derived compounds such as THC is an illicit substance at the federal level subject to DEA enforcement and regulatory control. However, some states have implemented their own laws on marijuana pertaining to recreational and medicinal use, and the DEA has largely focused resources on criminal networks involved in the illicit marijuana trade. Therefore, THC-containing ENDS products available for sale in states that are allowing recreational and medicinal marijuana may not be the focus of DEA's current enforcement efforts and regulation. Further, ENDS products that do not contain any components, parts, or accessories that are derived from tobacco (e.g., do not contain nicotine) and are not expected to be consumed like a tobacco product may not meet the definition of a tobacco product under the FFDCA. Therefore, such products may not be subject to FDA regulatory requirements pertaining to tobacco products. FDA has indicated that the agency would regulate such products on a "case-by-case basis, based on the totality of the circumstances." Tobacco to 21. In [fiscal year] 2020 appropriations, Congress amended the FFDCA to raise the federal minimum age of tobacco product sales to 21. FDA is also required to update its regulations by June 20, 2020 to reflect the new federal minimum age of tobacco purchasing, as well as the federal minimum age verification requirement (age verification required for individuals less than 30 years of age). The final rule is required to take effect by September 20, 2020. While public health stakeholders view this development in a positive light, some are concerned that the tobacco industry supported this initiative to avoid other measures that could also curb tobacco use including ENDS use among youth. Remote Sales. Some have identified remote sales (i.e., non-face-to-face sales) as an opportunity for minors to illegally purchase tobacco products, due to difficulties in enforcing purchasing restrictions through this medium. While the Prevent All Cigarette Trafficking (PACT) Act of 2009 placed certain restrictions on remote sales of cigarettes and smokeless tobacco, it did not outright prohibit them. Further, the PACT Act limits the ability of states and local governments to regulate the delivery carriers involved in remote sales complicating enforcement efforts and did not place such restrictions on other tobacco products, such as ENDS. Section 906 of the FFDCA requires FDA to promulgate regulations on remote sales of tobacco products, including age verification requirements. In 2011, FDA issued an [Advance Notice of Proposed Rulemaking] regarding remote sales and distribution of tobacco products but has not taken further regulatory action since that time. ENDS User Fees. FDA does not collect user fees from ENDS manufacturers and importers. Given recent concerns around ENDS products, CTP has dedicated a portion of its user fees paid by other tobacco product manufacturers and importers to address ENDS-specific issues. Therefore, some stakeholders have suggested that manufacturers and importers of ENDS products be subject to tobacco user fees to offset costs associated with FDA's current and future ENDS-specific activities. However, FDA has determined that it currently does not have the authority to assess user fees from ENDS manufacturers and importers because Congress did not specify an enumerated class for ENDS products and did not provide a framework by which FDA could potentially assess user fees for ENDS products.