# Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2014-09491 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** April 25, 2014 - **Citation:** 79 FR 23142 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1100, 1140, and 1143 [Docket No. FDA-2014-N-0189] RIN 0910-AG38 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA) is proposing to deem products meeting the statutory definition of “tobacco product,” except accessories of a proposed deemed tobacco product, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. Option 1 of the proposed rule would extend the Agency's “tobacco product” authorities in the FD&C Act to all other categories of products, except accessories of a proposed deemed tobacco product, that meet the statutory definition of “tobacco product” in the FD&C Act. Option 2 of the proposed rule would extend the Agency's “tobacco product” authorities to all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of “tobacco product” in the FD&C Act. FDA also is proposing to prohibit the sale of “covered tobacco products” to individuals under the age of 18 and to require the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to address the public health concerns associated with the use of tobacco products. DATES: Submit either electronic or written comments on the proposed rule by July 9, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by May 27, 2014, (see the “Paperwork Reduction Act of 1995” section). ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-N-0189 and/or Regulatory Information Number (RIN) 0910-AG38, by any of the following methods, except that comments on information collection issues under the PRA must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the “Paperwork Reduction Act of 1995” section). Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name, Docket No. FDA-2014-N-0189, and RIN 0910-AG38 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section. Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Gerie Voss, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373, CTPRegulations@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Table of Contents Executive Summary I. Legal Authority II. Background for Deeming All Tobacco Products To Be Subject to the FD&C Act III. Continuum of Nicotine-Delivering Products IV. Deeming Tobacco Products To Be Subject to the FD&C Act A. Public Health Benefits of Deeming B. The Sottera Decision C. Options for Premium Cigars and Request for Comments Regarding Scope D. Request for Comments Regarding Regulation of E-Cigarettes E. Request for Comments Regarding Components, Parts, and Accessories V. Basis for Additional Provisions A. Addictive Nature of Products B. Health Risks of Products C. Consumer Confusion and Misinformation About Certain Covered Tobacco Products D. Use as Starter Products or Dual Use With Other Tobacco Products VI. Proposed Minimum Age and Identification Restrictions A. Effectiveness of Proposed Restrictions and Section 906(d) Standard B. Application to Proposed Vending Machine Restrictions VII. Proposed Required Warning Statements A. Requiring Health Warnings Is Appropriate for the Protection of the Public Health B. Effectiveness of Warnings C. Proposed Addictiveness Warning D. Age of Initiation for Cigar Smokers E. Proposed Required Warning Statements for Small and Large Cigars VIII. Description of the Proposed Rule A. Proposed Part 1100—Tobacco Products Subject to FDA Authority B. Proposed Changes to Part 1140—Cigarettes, Smokeless Tobacco, and Covered Tobacco Products C. Proposed Part 1143—Required Warning Statements IX. Paperwork Reduction Act of 1995 A. Existing Burdens Associated With Tobacco Products Currently Subject to the FD&C Act (i.e., Cigarettes, Cigarette Tobacco, Roll-Your-Own Tobacco, and Smokeless Tobacco) With Approved OMB Control Numbers B. Burdens Associated With Tobacco Products Currently Subject to the FD&C Act But Not Yet Approved by OMB C. New Collections of Information That Apply Only to Proposed Deemed Tobacco Products X. Executive Order 13132; Federalism XI. Environmental Impact XII. Analysis of Impacts: Summary XIII. Request for Comments A. General Information About Submitting Comments B. Public Availability of Comments C. Information Identifying the Person Submitting the Comment XIV. References Executive Summary Purpose of the Proposed Rule Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco were immediately covered by FDA's tobacco product authorities in chapter IX of the FD&C Act (21 U.S.C. 387 through 387u) when the Tobacco Control Act went into effect. For other kinds of tobacco products, FDA has authority to issue regulations to bring them under the law by “deeming” them to be subject to such authorities. Consistent with the statute, once a tobacco product is deemed, FDA may put in place “restrictions on the sale and distribution of a tobacco product,” including age-related access restrictions and advertising and promotion restrictions, if FDA determines the restrictions are appropriate for the protection of the public health. The proposed rule has two purposes: (1) To deem products that meet the definition of “tobacco product” under the law except accessories of a proposed deemed tobacco product and subject them to the tobacco control authorities in the FD&C Act and (2) to apply specific provisions that are appropriate for the protection of the public health to deemed tobacco products. To satisfy these purposes, FDA is proposing two options (Option 1 and Option 2), which would provide two alternatives for the scope of the deeming provisions and, consequently, the application of the additional specific provisions. Summary of the Major Provisions of the Regulatory Action The proposed rule has two main sections: (1) Deeming provisions and (2) additional provisions to protect public health. Deeming Provisions —Option 1 for the proposed rule would deem all products meeting the statutory definition of “tobacco product” except accessories of a proposed deemed tobacco product to be subject to FDA's tobacco product authorities under chapter IX of the FD&C Act. FDA considers accessories of proposed deemed products to be those items that are not included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product, and we expect that they will not have a significant impact on the public health. In addition, FDA considers accessories to be those items that may be used in the storage or personal possession of a proposed deemed product. Therefore, items such as hookah tongs, bags, cases, charcoal burners and holders, as well as cigar foil cutters, humidors, carriers, and lighters would be considered accessories and would not fall within the scope of this proposed rule. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product” to mean “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).” 1 Products that meet the statutory definition of “tobacco products” can include currently marketed products such as certain dissolvables, gels, hookah tobacco, electronic cigarettes, cigars, and pipe tobacco. Components and parts of tobacco products, but not their related accessories, would also be included in the scope of this proposed rule. Components and parts are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes. The proposed rule also deems any future tobacco products that meet the statutory definition of “tobacco product” except accessories of such product to be subject to FDA's authorities under chapter IX of the FD&C Act. For example, FDA envisions that there could be tobacco products developed in the future that provide nicotine delivery (e.g., via dermal or buccal absorption), similar to currently marketed medicinal nicotine products, but which are not marketed for therapeutic purposes. Such products would be “tobacco products” and subject to FDA's chapter IX authorities should the deeming rule be finalized. 1 FDA notes that products falling within the FD&C Act's definition of “tobacco product” may not be considered tobacco products for Federal excise tax purposes (see 26 U.S.C. 5702(c)). FDA is also proposing a second option to deem only a subset of cigars (i.e., to exclude from the scope of this proposed rule certain cigars that we refer to as “premium cigars”). With respect to current products, while FDA recognizes that all cigars are harmful and potentially addictive, it has been suggested that different kinds of cigars may have the potential for varying effects on public health, based on possible differences in their effects on dual use, youth initiation and frequency of use by youth and young adults. Accordingly, FDA is seeking comment on these options to determine whether all cigars should be subject to deeming and what provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars. In addition, FDA realizes that there are distinctions in the hazards presented by various nicotine-delivering products. Some have advanced views that certain new tobacco products that are noncombustible (such as e-cigarettes) may be less hazardous than combustible products given the carcinogens in smoke and the dangers of secondhand smoke from combustible products. Accordingly, FDA is seeking comment in this proposed rule as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products. We welcome comment on how to implement the provisions in the FD&C Act with respect to e-cigarettes. We also welcome any health and behavioral data about the effects of using e-cigarettes. Once finalized, products deemed under this rule will be subject to the same FD&C Act provisions that cigarettes, roll-your-own tobacco, and smokeless tobacco are subject to, with respect to the following: (1) Enforcement action against products determined to be adulterated and misbranded; (2) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products; (3) required registration and product listing for all tobacco products; (4) prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use; (5) prohibition on the distribution of free samples (same as for cigarettes); and (6) premarket review requirements. These actions would improve the public health by affording FDA critical information regarding the health risks of such products, preventing new products from entering the market if they are not appropriate for the protection of public health or found substantially equivalent to an identified predicate product, and reducing the use of misleading claims and descriptors about the relative risk of tobacco products, which may lead consumers to initiate tobacco product use or to continue using tobacco when they would otherwise quit. Additional Provisions —In addition to the provisions in the FD&C Act that would apply automatically if the proposed products are deemed, FDA has the authority to invoke its other authorities under the Tobacco Control Act in regulating these products. At this time, under section 906(d) of the FD&C Act (21 U.S.C. 387f(d)), FDA proposes to apply three additional provisions to covered tobacco products: (1) Requirement for a minimum age of purchase; (2) health warnings for product packages and advertisements (which FDA is also proposing to apply to cigarette tobacco and roll-your-own tobacco); and (3) prohibition of vending machine sales, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time. The term “covered tobacco products” would be defined as those products deemed to be subject to the FD&C Act under section 1100.2 of title 21 of the Code of Federal Regulations (CFR), other than a component or part that does not contain tobacco or nicotine. Request for Public Comment —In addition to seeking comment on the overall proposed rule, FDA is specifically seeking comment on the application of the proposed rule to certain products or in certain circumstances, including the following: 1. As noted previously, given that different kinds of cigars may have the potential for varying effects on public health, FDA is proposing two options for the categories of cigars that would be covered by this rule. FDA is specifically seeking comment on whether all cigars should be subject to deeming and what provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars. 2. FDA is aware that some tobacco products, such as e-cigarettes and certain cigars, are being marketed with characterizing flavors, and that these flavors can be especially attractive to youth. The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only. FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a “cigarette” as defined in section 900(3) of the FD&C Act and, consequently, subject to the prohibition against characterizing flavors, despite being labelled as a little cigar or other non-cigarette tobacco product. FDA is also seeking research regarding the long-term effects of flavored tobacco product usage including data as to the likelihood of whether users of flavored tobacco products initiate cigarette usage and/or become dual users with cigarettes. 3. Also as noted in this document, some have advanced views that certain new tobacco products that are noncombustible (such as e-cigarettes) may be less hazardous, at least in certain respects, than combustible products given the carcinogens in smoke and the dangers of secondhand smoke. FDA also notes the increase in e-cigarette use by youth and the availability of fruit and candy-flavored e-cigarette liquid. We do not currently have sufficient data about these products to determine what effects e-cigarettes have on the public health. Accordingly, FDA is seeking comment in this proposed rule as to how such products should be regulated. We particularly request comment on behavioral data related to co-use of e-cigarettes and more traditional tobacco products, including data on the effects of e-cigarettes on the initiation and continuation of use of other tobacco products. 4. FDA is proposing to deem those products meeting the definition of “tobacco product” in section 201(rr) of the FD&C Act, except the accessories of proposed deemed tobacco products to be subject to chapter IX of the FD&C Act. FDA is seeking comment on how its proposal to exclude accessories from the scope of the deeming rule would impact the public health. We also ask for comments, including supporting facts, research, and other evidence, as to whether FDA should define components and parts of tobacco products and how those items might be distinguished from accessories of tobacco products. 5. The statute establishes a “substantial equivalence” (SE) pathway for a new tobacco product to enter the market if it is substantially equivalent to a “predicate product,” meaning a product commercially marketed in the United States as of February 15, 2007. FDA is aware of new product category entrants into the market after the February 15, 2007, reference date and that the SE pathway may not be available to these newer products. Because this date is written into the statute, we do not believe that we have the authority to amend it with respect to e-cigarettes or other products. FDA is proposing to extend the compliance period for submitting a marketing application under this pathway to 24 months following the effective date of a final rule. FDA is also proposing a 24-month compliance period for the submission of premarket tobacco applications (PMTAs). In addition, we intend to continue the compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule's effective date. FDA is specifically seeking comment on whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the SE pathway. 6. FDA recognizes that there may be the potential for varying levels of harm and negative effects on public health for different categories of tobacco products. FDA is considering whether it might be appropriate for the protection of the public health to stagger the compliance dates for certain provisions for different categories of products. FDA seeks comment on this issue. 7. FDA recognizes that some of the proposals in this document might impose significant costs on certain manufacturers, consistent with current practice under Federal Trade Commission (FTC) consent decrees with several large manufacturers, including the requirement to register and list products and the requirement for cigar manufacturers to randomly distribute and rotate warning statements on packages and advertisements, respectively. FDA seeks comment and data on alternative approaches for manufacturers to satisfy these requirements that would reduce costs for manufacturers yet would still be appropriate for the protection of the public health. We request comment on whether and how we should revise our existing guidance to provide for flexibility in this area, while still being appropriately protective of the public health. 8. Some have advanced views that certain new tobacco products that are non-combustible (such as e-cigarettes) may be less hazardous, at least in certain respects, than combustible products given the carcinogens in smoke and the dangers of secondhand smoke. Nevertheless, all tobacco products containing nicotine are addictive, and FDA is not currently aware of any tobacco products that do not contain nicotine. Thus, FDA is seeking comments, including supporting research, facts, and other evidence, as to whether all tobacco products should be required to carry an addiction warning and, if yes, whether different warnings should be placed on different categories of products. 9. FDA is not proposing the fifth FTC warning (Tobacco Use Increases The Risk Of Infertility, Stillbirth And Low Birth Weight), because although cigarette smoke causes these health effects (and cigar smoke is similar to cigarette smoke), the Agency is not aware of studies specifically linking cigars to these reproductive effects. FDA requests comment on its proposal to require the use of only four of the five current FTC warnings for cigars. 10. FDA is proposing that any cigar that is sold in product packaging bear a health warning that would be randomly displayed and distributed on cigar product packages and rotated in advertisements. In addition, FDA is proposing that warnings for cigars sold individually and not within product packages all be included on a sign located at the point-of-sale at each cash register in any retail establishment where such cigars are sold. FDA requests comment as to whether all cigars sold without product packaging, including those cigars we refer to as “premium cigars,” should be exempt from the warning requirements. 11. As explained in the Initial Regulatory Flexibility Analysis, FDA finds that this rule would have a significant economic impact on a substantial number of small entities. FDA is seeking comments about any unique challenges faced by small manufacturers of proposed deemed tobacco products and how they should be addressed. 12. FDA is also seeking comment on the proposed addictiveness warning and any potential for consumer confusion, the proposed size of the health warnings that would be required by this rule, and on the role that the size of such warnings has in helping to convey consumer information. 13. FDA is seeking comment on the relative merits of Option 1 versus Option 2, taking into account what is appropriate for the public health, including possible benefits to the public health or possible negative public health consequences of adopting one Option or the other. Effective Dates —The deeming provisions and age restrictions would be effective 30 days from the date of publication of the final rule. The proposed health warning requirements would be effective 24 months after the final rule is issued. In addition, manufacturers could continue to introduce into domestic commerce existing inventory that may not contain the warning statements required under the final rule for an additional 30 days after the health warnings take effect. Compliance Dates for PMTAs and SE Reports —As stated previously, we understand that, for some products, there may not be predicate products that were on the market as of February 15, 2007, to which to claim substantial equivalence. This may be particularly true for e-cigarettes and similar novel products. For this reason, we are proposing that these manufacturers who cannot use the SE pathway submit PMTAs to FDA no later than 24 months following the effective date of the final rule. We are also proposing a 24-month compliance period for the submission of SE reports. Therefore, FDA does not intend to initiate enforcement action against products on the market for failing to have made an appropriate submission until 24 months following the effective date of the final rule. If a manufacturer submits a PMTA or SE application for its affected products within the 24-month time frame, FDA does not intend to initiate action against those products for failing to have a marketing authorization unless and until such a time as we have responded to the application. Costs and Benefits The proposed rule consists of two coproposals, Option 1 and Option 2. The proposed Option 1 deems all products meeting the statutory definition of “tobacco product,” except accessories of a proposed deemed tobacco product, to be subject to chapter IX of the FD&C Act. Option 1 also proposes additional provisions that would apply to proposed deemed products as well as to certain other tobacco products. The other coproposal, Option 2, is the same as Option 1 except that it exempts premium cigars. The proposed deeming action directly requires proposed deemed “tobacco products” to comply with the substantive requirements of chapter IX of the FD&C Act and its implementing regulations. We expect that asserting our authority over these tobacco products will enable us to take further regulatory action in the future as appropriate; those actions will have their own costs and benefits and would, as is the case with all rulemaking, be subject to notice and comment. The proposed rule would generate some direct benefits by providing information to consumers about the risks and characteristics of tobacco products, which may result in consumers reducing their use of cigars and other tobacco products or engaging in compensatory health behaviors. Other potential benefits follow from premarket requirements, which could prevent more harmful products from appearing on the market and worsening the health effects of tobacco product use. The proposed rule would impose costs in the form of registration, submission, labeling, and other requirements; other likely costs are not quantifiable based on current data. The quantified costs of the proposed rule are shown in Table 1A. Table 1A—Summary of Quantified Costs Over 20 Years Lower bound (3%) Primary (3%) Upper bound (3%) Lower bound (7%) Primary (7%) Upper bound (7%) Present Value Option 1 365.2 592.0 1,010.1 281.4 467.6 810.2 Present Value Option 2 304.0 476.4 779.2 233.8 375.0 622.6 Annualized Value Option 1 23.8 38.6 65.9 24.8 41.2 71.5 Annualized Value Option 2 19.8 31.1 50.8 20.6 33.1 54.9 I. Legal Authority The Tobacco Control Act was enacted on June 22, 2009, amending the FD&C Act and providing FDA with the authority to regulate tobacco products (Pub. L. 111-31). Specifically, section 101(b) of the Tobacco Control Act amends the FD&C Act by adding a new chapter that provides FDA with tools to regulate tobacco products. Section 901 of the FD&C Act (21 U.S.C. 387a), as amended by the Tobacco Control Act, states that the new chapter in the FD&C Act (Chapter IX—Tobacco Products) applies “to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary [of Health and Human Services] by regulation deems to be subject to this chapter.” Under the statute, to extend FDA's “tobacco product” authorities to other tobacco products not specifically enumerated in the statute, FDA must issue a regulation deeming them to be subject to the FD&C Act. With Option 1 of this proposed rule, FDA is proposing to deem all products meeting the statutory definition of “tobacco product” except accessories of a proposed deemed tobacco product to be subject to the FD&C Act. Option 2 would propose to deem a certain subset of cigars, as well as other products meeting the definition of “tobacco product,” but excluding the accessories of a proposed deemed tobacco product. Section 201(rr) of the FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product” to mean “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)” that is not a drug, device, or combination product under the FD&C Act. This proposed rule would extend FDA's “tobacco product” authorities to products that meet the statutory definition of “tobacco product” in section 201(rr) of the FD&C Act (including the components and parts of a tobacco product), except the accessories of a tobacco product. Section 903 of the FD&C Act provides that a tobacco product is misbranded unless “the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that tobacco product—. . . (B) a brief statement of—(i) the uses of the tobacco product and relevant warnings, precautions, side effects, and contraindications.” Under section 906(d)(1) of the FD&C Act, FDA may require restrictions on the sale and distribution of a tobacco product, if the Agency determines that “such regulation would be appropriate for the protection of the public health.” The finding as to whether “such regulation would be appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.” Based on the available data on the addictiveness of nicotine (as discussed in section V.A), the known adverse health effects of some of the products covered by this proposed rule, such as certain cigars and waterpipes, the likelihood that users of these products could co-use or migrate to other tobacco products like cigarettes, and the risk that failure to act will reinforce consumers' existing confusion and misinformation about these products' safety or lack of harmfulness, FDA believes that the sale and distribution restrictions the Agency is proposing—minimum age and identification requirements (including vending machine requirements) and health warning requirements—meet the public health standard set forth in section 906(d) of the FD&C Act. Specifically, FDA has concluded that the restrictions would be appropriate for the protection of the public health with respect to the risks and benefits to the population as a whole, including the increased likelihood that existing users will quit using tobacco products and the decreased likelihood that new users will initiate tobacco product use. This determination is made on the basis of several factors. First, the available data on the addictiveness of nicotine suggests the adolescent brain is more vulnerable to developing nicotine dependence than the adult brain, that exposure to substances such as nicotine can disrupt brain development and have long-term consequences on executive cognitive function and on the risk of developing a substance abuse disorder and various mental health problems as an adult (Ref. 1), and this exposure to nicotine can also have long-term results on decreasing attention performance and increasing impulsivity which could promote the maintenance of nicotine use behavior (id.). Second, some of the products covered by this rule, such as combustible products like cigars, pipes, and waterpipes, are known causes of adverse health effects, including certain cancers and heart disease (see section V.B). Third, there is the potential for users of products covered by this rule to migrate to cigarettes or other currently regulated products, and evidence shows extensive co-use. For example, in 2012, 32 percent of high school tobacco users had smoked cigarettes and cigars in the past 30 days (Ref. 2). Current cigarette smokers are also more likely to have been waterpipe and e-cigarette users than non-smokers (Ref. 3). In 2012, 80.5 percent of current high school e-cigarette users reported current conventional cigarette smoking (Ref. 4). We believe that if this rulemaking is finalized, its provisions may lead to a decline in youth initiation for covered products, such as waterpipes and e-cigarettes. If use of those products tends to lead to use of traditional cigarettes, this rule should avert that cigarette usage. Finally, there is the risk that failure to act will reinforce consumers' existing confusion and misinformation about these products' safety or lack of harmfulness. II. Background for Deeming All Tobacco Products To Be Subject to the FD&C Act Adolescence is the peak time for tobacco product use initiation and experimentation (Ref. 5). In recent years, new types of tobacco products, sometimes referred to as “novel tobacco products,” have become an increasing concern to public health due, in part, to their appeal to youth and young adults. Currently, non-regulated tobacco products come in many forms, including electronic cigarettes, nicotine gels, and certain dissolvable tobacco products (i.e., those dissolvable products that do not currently meet the definition of “smokeless tobacco” in section 900(18) of the FD&C Act (21 U.S.C. 387(18)) because they do not contain cut, ground, powdered, or leaf tobacco and instead contain nicotine extracted from tobacco). These products are widely available. Electronic cigarettes (or e-cigarettes), for example, are widely available in retail outlets such as kiosks in shopping malls and on the Internet and their online popularity has surpassed that of snus and nicotine replacement therapies which have been on the market far longer than e-cigarettes (Refs. 6 and 7). Additionally, young adults often mistakenly think non-cigarette tobacco products are safe alternatives to cigarettes (Ref. 8). Research has shown that youth are also particularly vulnerable to the appeal of novel tobacco products (Refs. 9, 10, 11, and 12). Because of their addictiveness and the marketing and sale of these products (and their subsequent use by youth), some non-cigarette tobacco products can introduce youth into a lifetime of addicted tobacco product use and related harms, including premature death (Refs. 13, 14, 15, and 16). Further, many of the products proposed to be covered by this rule are offered in fruit and candy flavors, such as chocolate and grape flavors, making them especially attractive to children and young adults. For example, from 2010 to 2012, one cigar company introduced grape, white grape, and blueberry flavors to its line of little cigars and cigarillos (Ref. 17). In 2012, a manufacturer of nicotine solutions for e-cigarettes introduced Mint Mocha and Spiced Apple Cider flavors for their e-cigarette solutions (id.). The first nationally representative study (derived from more than 4,000 young adults aged 18 to 34) to examine the prevalence of the use of flavored tobacco products following the 2009 FDA flavor ban in cigarettes found that 20 percent of tobacco users in the study currently use a flavored tobacco product (Ref.17). The most common flavored products include flavored pipe tobacco, little cigars, and hookah tobacco (id.). Research has shown that flavored product use is higher among 18-to-24-year-olds than 25-to-34-year-olds, and that sugar preference is strongest among youth and young adults and declines with age (id.). Such findings indicate that flavored product use may influence tobacco-use patterns in young adulthood, a critical period when lifelong patterns of tobacco use are often established (Ref. 17 citing Ref. 18). See section V.A for further discussion regarding the impact of nicotine on youth and young adults. See also section V.B for a description of health risks associated with the proposed deemed tobacco products. Given this initial data regarding the increased prevalence of flavored tobacco products following the 2009 flavored cigarette ban, FDA seeks comments, data, and research regarding the following: • Aside from this proposed rule, what additional actions, if any, should FDA take to address the sale of candy and/or fruit-flavored tobacco products to children and young adults? For example, what data should FDA request manufacturers submit in new tobacco product applications to establish that flavorants either do not raise different questions of public health, in the case of SE reports, or are appropriate for the protection of public health in the case of premarket tobacco product applications? • What is the likelihood that individuals who engage in flavored tobacco product use will initiate cigarette use and/or become dual users with cigarettes? • The prohibition against characterizing flavors established in the Tobacco Control Act applies to cigarettes only. Consequently, when this regulation is finalized and other tobacco products are deemed subject to FDA's tobacco product authority, the statutory prohibition against characterizing flavors will not apply automatically to those products. However, once they are deemed, FDA may establish a product standard prohibiting flavors in those products. FDA requests information and data that would support establishing such a standard. FDA is concerned that manufacturers may be labeling, packaging, or otherwise representing tobacco products that are, in fact, cigarettes to be little cigars, cigarillos, or similar products in order to evade the prohibition against characterizing flavors in cigarettes. FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a “cigarette” as defined in section 900(3) of the FD&C Act and, consequently, subject to the prohibition against characterizing flavors, despite being labelled as a little cigar or other non-cigarette tobacco product. Moreover, efforts to improve public health by reducing the prevalence of cigarette smoking may be undermined by tobacco users switching to other tobacco products. The scientific evidence remains as yet unclear what the public health impact will be from products such as e-cigarettes. More youth who report they would never have used a tobacco product are experimenting with e-cigarettes (Ref. 4, 18); the number of cigarette smokers who actually quit tobacco product use with e-cigarettes is low (Ref. 19); current cigarette users experimenting with e-cigarettes have become dual users (id.)—with unknown health impacts. Although the health consequences of e-cigarettes are not well understood because of their relatively new entrance into the market, the health concerns and addictive properties of other tobacco products have been widely recognized in Surgeon General Reports and scientific literature. When similar products are taxed or regulated differently, substitutions across products occur. For example, industry documents indicate that tobacco firms have been aware of disparities in the legal treatment of cigarettes and cigars and have made efforts to develop small cigars that cigarette smokers would smoke (Refs. 20 and 21). Sales of small cigars quadrupled in the early 1970s, when cigars were taxed at a much lower rate than cigarettes and cigarette (but not small cigar) advertisements were banned from television and radio (Ref. 21). 2 2 FDA notes that taxation falls under the jurisdiction of the U.S. Department of Treasury/Alcohol and Tobacco Tax and Trade Bureau (TTB) and that neither FDA's act of “deeming” nor any other FDA regulations directly affect the taxation of any tobacco product. This substitution is evidenced in the recent trends regarding cigarette consumption compared to the use of other combustible tobacco products (e.g., small and large cigars, pipe tobacco, and roll-your-own tobacco). For example, the Centers for Disease Control and Prevention (CDC) reported a 32.8 percent decrease in cigarette consumption between 2000 and 2011, while the consumption of non-cigarette combustible products increased from 15.2 billion “cigarette equivalents” (i.e., small cigars and large cigars, and per-cigarette equivalents for pipe tobacco and roll-your-own tobacco) to 33.8 billion—a 123.1 percent increase over the same time period (Ref. 22). Pipe tobacco consumption during this period increased 482.1 percent, and consumption of large cigars increased 233.1 percent (id.). This research suggests that recent changes in consumption of non-cigarette combustible products, particularly increases in large cigar and pipe tobacco use, are associated with a decline in cigarette consumption, and indicate that certain cigarette smokers may switch to non-cigarette combustible products (id. at 567). While researchers posited that this change in prevalence rates is likely due to the lower taxes (and ultimately lower cost to the consumer) (id. at 566), the lack of regulation over certain tobacco products may be a contributing factor. Without a common regulatory framework, tobacco firms can exploit differences in regulatory requirements to drive consumers to different product markets. III. Continuum of Nicotine-Delivering Products There are public health questions and concerns about currently unregulated tobacco products. Nevertheless, there are distinctions in the hazards presented by various nicotine-delivering products. Some have advanced views that certain new non-combustible tobacco products (such as e-cigarettes) may be less hazardous, at least in certain respects, than combustible products given the carcinogens in smoke and the dangers of secondhand smoke. To the extent that certain products are shown to be less harmful, they could help reduce the overall death and disease toll from tobacco product use at a population level in the United States. This is a function of the existence of a continuum of nicotine-delivering products that pose differing levels of risk to the individual. Cigarette smoking is the major contributor to the death and disease attributable to tobacco use. The challenge for FDA, in considering currently regulated products and any additional products that would be deemed to be subject to the FD&C Act, is that regulatory policy under the Tobacco Control Act must account for the net public health impacts at the population level. This includes impacts on initiation, cessation, and an evaluation of product harm. Emerging technologies such as the e-cigarette may have the potential to reduce the death and disease toll from overall tobacco product use depending on who uses the products and how they are used. If such products result in minimal initiation by children and adolescents while significant numbers of smokers quit, then there is a potential for the net impact at the population level to be positive. If, on the other hand, there is significant initiation by young people, minimal quitting, or significant dual use of combustible and non-combustible products, then the public health impact could be negative. FDA is aware that some e-cigarettes (as well as other products that would be deemed under this proposed rule) are being marketed with flavors that may be attractive to young people. FDA asks for comments, data, and research to determine whether the Agency's evaluation of the relative risk or potential for harm reduction of such a product should be different in the presence of flavors in these products, especially if there is evidence that these flavors make the products more attractive to children. Because e-cigarettes are not currently subject to FDA jurisdiction (unless they are marketed for therapeutic purposes), FDA currently lacks the authority to collect vital information about these products. Deeming these products would permit us to collect information about their ingredients to ensure that other potentially harmful constituents are not present. Deeming would also allow us to collect information regarding health and behavioral effects of these products. IV. Deeming Tobacco Products To Be Subject to the FD&C Act At this time, based on the statute, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco are subject to the self-executing provisions in the Tobacco Control Act, including: (1) General controls (e.g., registration, product listing, ingredient listing, user fees for certain products, and adulteration and misbranding provisions) and (2) premarket review requirements for certain products. See, e.g., sections 902 (adulteration provisions), 903 (misbranding provisions), 904 (ingredient listing), 905 (registration and product listing), 910 (premarket review for “new” “tobacco products”), 911 (premarket review for “modified risk tobacco products”), and 919 (user fees) of the FD&C Act (21 U.S.C. 387b, 387c, 387d, 387e, 387j, 387k, and 387s). This proposed rule would apply these FD&C Act provisions that are currently applicable to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco to other tobacco products meeting the statutory definition of tobacco product. Option 1 would apply this proposed rule to all products meeting the statutory definition of “tobacco product,” except accessories of a proposed deemed tobacco product, to be subject to the FD&C Act. Option 2 would propose to deem a certain subset of cigars (not including premium cigars), as well as other products meeting the definition of “tobacco product,” but excluding the accessories of a proposed deemed tobacco product. These two options, as well as FDA's definition of a “covered cigar,” are further discussed in section IV.C. FDA requests comments, data, and research as to which option should be utilized for the scope of this rule and, if Option 2 is selected as the scope of the final rule, the appropriateness of the definition of “covered cigar.” A. Public Health Benefits of Deeming Deeming “tobacco products” (except accessories) to be subject to the FD&C Act would result in significant benefits for the public health. Once deemed, tobacco products become subject to the FD&C Act and its implementing regulations, affording FDA additional tools to use to reduce the number of illnesses and premature deaths associated with the use of tobacco products. For example, it would provide FDA with critical information regarding the health risks of the proposed deemed tobacco products including information derived from ingredient listing submissions and reporting of hazardous and potentially hazardous constituents required under the FD&C Act. Deeming would provide FDA with information on the location and number of regulated entities and allow the Agency to establish effective compliance programs. Deeming also would help to correct consumer misperceptions, due to variations in the regulatory status of tobacco products, that tobacco products not currently regulated by FDA are safe alternatives to currently regulated tobacco products (see section V.C). In addition, it would reduce the use of misleading claims on the products to allow for better-informed decision-making by consumers and would prohibit these products from being targeted to youth populations. It would prevent new products from entering the market that are not appropriate for the protection of public health or are not substantially equivalent to a predicate product already on the market. Newly deemed tobacco products also may be subject to future regulations if FDA determines that such regulation would be appropriate for the protection of the public health (section 906(d) of the FD&C Act). The following public health benefits would result directly from the deeming provisions of this proposed rule: • Adulteration and misbranding prohibited for all tobacco products (section 902 and 903 of the FD&C Act): Applying sections 902 and 903 of the FD&C Act would ensure that every tobacco product meets the same basic requirements and ensure that the labeling of such products is not false or misleading. FDA would be able to take enforcement action against any tobacco products that did not meet these basic standards. For example, if a product was produced in insanitary conditions or was contaminated, or if its labeling contained a misleading claim, it would be subject to FDA enforcement action, including seizure or injunction. • Requirement for ingredient listing and reporting of HPHCs for all tobacco products (section 904 of the FD&C Act): Under this requirement, manufacturers and importers of all tobacco products would provide ingredient listings and reporting of HPHCs to FDA. FDA would be able to take enforcement action with respect to those tobacco products for which an ingredient listing or report of HPHCs was not provided. Ingredient listings and reports of HPHCs would assist FDA in better understanding the contents of regulated products and their health consequences. That information would assist FDA in assessing potential health risks and determining if future regulations to address the health risks posed by particular products are warranted. However, FDA recognizes that it could be difficult for manufacturers of certain proposed deemed products (e.g., small businesses) to fulfill these requirements. Accordingly, FDA requests comments as to whether smaller manufacturers may be unable to satisfy these requirements and how FDA might be able to address those manufacturers' concerns. • Requirement for registration and product listing (section 905 of the FD&C Act): With application of this requirement, FDA would require registration of all tobacco product manufacturing establishments and product listings for all tobacco products. FDA would be able to conduct more efficient inspections and bring enforcement action, if necessary, against a tobacco firm not in compliance with the requirements of the Tobacco Control Act. While this requirement would provide FDA with critical information, the Agency also recognizes that it could be costly for certain manufacturers of proposed deemed products. Therefore, FDA requests comment and data on possible ways to implement this requirement (e.g., delaying compliance with this provision) that would reduce costs for manufacturers yet still be appropriate for the protection of public health. • Review of premarket applications and SE reports (section 905 and 910 of the FD&C Act): With the SE pathway, FDA can evaluate whether a new product raises different questions of public health compared to its predicate product. Through the premarket application pathway, FDA could authorize the introduction of products into the market where appropriate for the protection of public health and prevent introduction of products that are detrimental to the public health. Implementation of these proposed provisions would allow FDA to monitor product development and changes and to prevent more harmful or addictive products from reaching the market. The proposed provisions would also provide a mechanism through which those products that are less harmful or addictive could enter the market. The greater regulatory certainty created by premarket authorizations should help companies to invest in creating novel products, with greater confidence that improved products will enter the market without having to compete against equally novel, but more dangerous products. For example, a company wishing to invest the additional resources needed to ensure that its e-cigarette is designed and manufactured with appropriate methods and controls will be more likely to do so if the product is not competing against products that are more cheaply and crudely made, yet appear to be identical to the consumer. FDA, through its authorities to authorize and deny the introduction of new products, can help reduce tobacco-related morbidity and mortality. Over time, the employment of the premarket authorities can spur innovation and help to create a market where available products are less dangerous when consumed, less likely to lead to initiation of tobacco use, and/or easier to quit. Further, FDA's premarket review of the proposed deemed products will increase product consistency. For example, FDA's oversight of the constituents of e-cigarettes cartridges would help to ensure quality control relative to the chemicals and their quantities being aerosolized and inhaled. At present, there is significant variability in the concentration of chemicals amongst products—including variability between labeled content and concentration and actual content and concentration. The health consequences of these products are still largely unknown and the popularity of these products is growing exponentially (Refs. 23, 24, and 25). Without a regulatory framework, users who expect consistency in these products may instead be subject to significant variability in nicotine content among products, raising potential public health and safety issues. • Elimination of “light,” “low,” and “mild” descriptors and other unproven modified risk claims (section 911 of the FD&C Act): Applying this requirement to proposed deemed products would help reduce consumer confusion and misconceptions about such products. Congress has concluded that the health dangers of tobacco products marketed as modified risk tobacco products that “do not in fact reduce risk” are “so high” that FDA's premarket review is necessary to protect public health and ensure that such products will reduce health risks (section 2(39), (40), and (43) of the Tobacco Control Act). Given that certain users have initiated and continued using certain tobacco products rather than others (or quitting entirely) based on unproven modified risk claims and consumers' unsubstantiated beliefs that some tobacco products are less hazardous than others, this requirement could lead to increased cessation and reduced initiation. • Prohibition of free samples of the proposed deemed products (section 102 of the Tobacco Control Act): This prohibition would eliminate a pathway for youth to access tobacco products, reducing youth initiation and therefore short-term and long-term morbidity and mortality resulting from these products. The Institute of Medicine (IOM) has stated that free samples of cigarettes “encourage experimentation by minors with a risk free and cost-free way to satisfy their curiosity” (Ref. 26). While the IOM was speaking in the context of cigarettes, the same rationale would apply to the proposed deemed products. In addition, the United States Court of Appeals for the Sixth Circuit previously recognized that FDA has provided “extensive” evidence that free tobacco samples constitute an “easily accessible source” for youth ( Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509, 541 (6th Cir. 2012) (citing 61 FR 44396 at 44460, August 28, 1996), cert. denied, 133 S. Ct. 1966 (2013)). FDA requests comments and data showing the extent to which this restriction would reduce youth use of the proposed deemed products. • Authority to propose product standards for proposed deemed tobacco products (section 907 of the FD&C Act (21 U.S.C. 387g)): If products meeting the definition of tobacco products are deemed to be subject to the tobacco authorities in the FD&C Act, FDA would have the authority to propose product standards that would apply to proposed deemed tobacco products, if such standards were appropriate for the protection of public health. For example, FDA could issue a standard regarding additives, constituents, or other components of a proposed deemed tobacco product under section 907 of the FD&C Act. This would help to ensure that tobacco products meet standards that are appropriate for the protection of the public health. B. The Sottera Decision In 2008 and early 2009, FDA detained several shipments of electronic cigarettes and their accessories offered for import by Smoking Everywhere and Sottera, Inc. (doing business as NJOY) and eventually refused admission into the United States to two of Smoking Everywhere's shipments on the ground that the products appeared to be unapproved drug/device combination products. Smoking Everywhere—subsequently joined by Sottera, Inc.—sued the Agency and argued, among other things, that the Supreme Court's decision in Food & Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) foreclosed regulation of electronic cigarettes under the drug and device provisions of the FD&C Act unless the products were intended for therapeutic use. The district court agreed and issued a preliminary injunction. ( See Smoking Everywhere, Inc. v. FDA, 680 F. Supp. 2d 62 (D.D.C. 2010).) The government appealed this decision to the United States Court of Appeals for the D.C. Circuit. On December 7, 2010, the D.C. Circuit affirmed the preliminary injunction, holding that products meeting the FD&C Act's definition of “tobacco product,” including electronic cigarettes, are “drugs” and/or “devices” under the FD&C Act if they are “marketed for therapeutic purposes,” whereas “customarily marketed tobacco products” are “tobacco products” under the Tobacco Control Act. ( See Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010).) On January 24, 2011, the D.C. Circuit denied the government's petitions for rehearing and rehearing en banc (by the full court). ( See Sottera, Inc. v. FDA, No. 10-5032 (D.C. Cir. Jan. 24, 2011) ( per curiam ).) This case affirms that FDA cannot regulate “customarily marketed” tobacco products, including pipe tobacco, small and large cigars, e-cigarettes, and hookah tobacco, until a regulation that deems them to be subject to the FD&C Act is finalized. On April 25, 2011, FDA issued a letter to stakeholders announcing that the government had decided not to seek further review of the Sottera decision and that it would comply with the jurisdictional lines established by Sottera (see Ref. 27). The Agency noted that the Tobacco Control Act places certain “tobacco products” (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) immediately under the general controls and premarket review requirements of the FD&C Act (see section 901(b) of the FD&C Act). The Tobacco Control Act also permits FDA, by regulation, to extend those controls to other categories of “tobacco products” (id.). Further, the stakeholder letter announced FDA's intention to propose a regulation that would extend the Agency's “tobacco product” authorities in the FD&C Act to other categories of tobacco products that meet the statutory definition of “tobacco product” in section 201(rr) of the FD&C Act. C. Options for Premium Cigars and Request for Comments Regarding Scope As discussed in sections V and VI, although all cigars are harmful and potentially addictive, it has been suggested that different kinds of cigars (e.g., small cigars, cigarillos, large cigars, premium cigars) may have the potential for varying effects on public health, if there are differences in their effects on youth initiation, the frequency of their use by youth and young adults, and other factors. In addition, the proportion of cigar smokers showing clear signs of dependence remains unknown, and usage patterns indicate that cigar only use beginning in adulthood is less likely to produce addiction than the use of cigarettes. Thus, by proposing two options for the scope of this rule, FDA is seeking comment on whether all cigars should be subject to deeming and what additional restriction(s) may or may not be appropriate for different kinds of cigars. In particular, FDA is seeking comment on the relative merits of Option 1 versus Option 2, taking into account what is appropriate to protect the public health, including possible benefits to the public health or possible negative public health consequences of adopting one Option or the other. Under Option 1, the proposed rule would extend FDA's authority to all products meeting the definition of “tobacco product,” except the accessories of such products. (See section IV.E for more information regarding FDA's proposal not to include accessories in the scope of this rule). This scope would include all cigars, including small, large, and premium cigars. FDA considers a cigar to be a tobacco product that: (1) Is not a cigarette and (2) is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco. (See 26 U.S.C. 5702(a)). Under Option 2, the proposed rule would extend FDA's authority to a subset of cigars (defined as “covered cigars”) and to other products meeting the definition of “tobacco product,” except the accessories of such products. In order to define the products that would be subject to this approach, FDA would propose to define a covered cigar to mean: any cigar as defined in this part, except a cigar that: (1) Is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains primarily long filler tobacco; (4) is made by combining manually the wrapper, filler, and binder; (5) has no filter, tip, or non-tobacco mouthpiece and is capped by hand; (6) has a retail price (after any discounts or coupons) of no less than $10 per cigar (adjusted, as necessary, every 2 years, effective July 1st, to account for any increases in the price of tobacco products since the last price adjustment); (7) does not have a characterizing flavor other than tobacco; and (8) weighs more than 6 pounds per 1000 units. While FDA is proposing this second option to possibly define a subset of cigars and provide a separate regulatory regime for them, FDA may determine that it is most appropriate to include elements of both options in any final rule. For example, FDA may decide to deem all cigars subject to the tobacco product authorities in Chapter IX of the FD&C Act but may impose different additional restrictions for a certain subset of those cigars. We ask for comments, including supporting facts, research, and other evidence, on the following questions regarding this issue: • Is this proposed definition of “covered cigar” appropriate to capture those products that, because of how they are used, may have less of a public health impact than other types of cigars? • Should long filler tobacco content be included as one of required elements of a “premium” cigar (excluded from the definition of a “covered cigar”)? If so, what percentage of the tobacco contained in the cigar should be required to be long filler tobacco in order for the cigar to be considered “premium”? • Is it appropriate to include the $10 price point in differentiating “premium” cigars from other cigars? Please provide any data or information that supports the selection of a $10 price point or, if you believe a different price point is more appropriate, that supports the selection of that price point. • Should a volume/rate restriction (e.g., “is produced at a rate of no more than [insert number] units per minute”) be included as one of required elements of a “premium” cigar (excluded from the definition of a “covered cigar”)? If we were to include this restriction, what should the rate be? How would FDA determine compliance with such a restriction? • Is it appropriate to include the proposed weight restriction (6 pounds per 1000 units) in differentiating “premium” cigars from other cigars? • Would a different regulatory scheme for covered cigars, as defined here, or other category of cigars adequately address the dangers of tobacco use by adults or the proven dangers associated with use of cigars (such as increased risk of several cancers even among those users who do not inhale, and risk associated with lower levels of use as discussed in section VII)? • How should the fact that studies indicate that young adults likely prefer cigarillos, as opposed to traditional large cigars, affect FDA's decision about whether to regulate “premium” cigars? Although the Agency is proposing a definition with respect to Option 2, FDA remains concerned that any attempts to create a subset of premium cigars that are excluded from regulatory authority might sweep other cigar products under its umbrella. Therefore, we ask for any comment as to how FDA could further refine this definition, within the context of Option 2, to ensure that the exclusion would apply only to those cigars that, because of how they are used, may have less of a public health impact than other types of cigars. 1. Option 1: Do Not Restrict Categories of Cigars Under Option 1, FDA would not restrict the categories of cigars that fall under the umbrella of deeming and the additional provisions proposed here (i.e., minimum age and identification; vending machine restrictions; and health warning requirements). Therefore, small, large, and premium cigars would all be subject to FDA's tobacco product authorities under this option. As FDA has explained throughout the rule, all cigars are harmful and potentially addictive (including small cigars, cigarillos, large cigars, and premium cigars). Cigar smoking is strongly related to certain cancers (including oral, esophageal, laryngeal, and lung cancers), heart disease, and premature death (Refs. 28 and 30). Cigar smoking can cause cancers of the mouth and throat even for smokers who do not inhale (Ref. 28 at 120-130). As a result, cigar smokers who do not inhale have disease risks higher than those who have never smoked, including a 7 to 10 times higher overall risk of mouth and throat cancer (Ref. 28 at ii, 125). This similarity in risk is likely due to the similar doses of tobacco delivered directly to the oral cavity and esophagus by cigars and cigarettes (Ref. 30 at 738). In addition, cigar smokers, regardless of whether they inhale, receive a high smoke exposure to the mouth and tongue. The esophagus is exposed to the carcinogens of tobacco smoke, which collect on the mouth's surface and are swallowed with saliva, rendering cigar smoking a cause of esophageal cancer (Ref. 28 at 130). See section VII.E for further discussion of the dangerous health risks associated with cigar smoking, including data regarding risks of additional cancers and disease. Cigar tobacco contains nicotine in concentrations similar to those observed in cigarettes; however, given that most cigars contain more tobacco, many typically contain greater quantities of nicotine than cigarettes (Ref. 28 at 81). A large cigar may contain as much tobacco as a whole pack of cigarettes (Refs. 30 and 31). Nicotine levels in cigar smoke can be up to 8 times higher than levels in cigarette smoke—1.7 mg in nonfiltered cigarettes, 1.1 mg in filtered cigarettes, 3.8 mg in little cigars, 9.8 mg in cigars, and 13.3 mg in premium cigars (Ref. 28 at 67). Even cigar smokers who do not inhale can become addicted to the product given the absorption of nicotine through the buccal mucosa (Ref. 28 at 183-184). Regardless of whether large cigar and pipe smokers inhale, smoke particles are deposited into the lungs and stomach area (Ref. 32). All cigars, regardless of size, produce higher levels of carcinogenic tobacco-specific nitrosamines per gram in mainstream cigar smoke than cigarettes produce in mainstream cigarette smoke (Ref. 28 at 75-76). A large cigar may contain as much tobacco as a whole pack of cigarettes (Refs. 30 and 31). Cigar smoke also produces measurable amounts of lead and cadmium (Ref. 28 at 75-76), and the concentrations of some toxic and carcinogenic compounds are higher in cigar smoke than in cigarettes (Ref. 33). The National Cancer Institute (NCI) found that “cigar smoke is as, or more, toxic and carcinogenic than cigarette smoke; and differences in disease risks produced by using cigarettes and cigars relate more to differences in patterns of use, and differences in inhalation, deposition and retention of cigar smoke than to differences in smoke composition” (Ref. 28 at 3). Furthermore, a recent analysis of cigar use by young adults (aged 18 to 29) was presented at the meeting of the Society for Research on Nicotine and Tobacco providing preliminary confirmation that young adults do use premium cigars. This analysis was derived from data from the National Adult Tobacco Survey, a nationally representative survey conducted by the Centers for Disease Control and Prevention (CDC). The analysis shows that the percentage of young adults reporting current premium cigar use (15.1 percent) was just as high as the percent reporting current use of little filtered cigars (11.9 percent) (Ref. 34). Although the patterns of use may be quite different, this analysis shows that current premium cigar use is being reported by young adults and that such use is not restricted to older adults. In addition, among all young adults aged 18 to 29, 2.5 percent reported current use of premium cigars, compared with 1.7 percent among those aged 30 to 44, 1.2 percent among those aged 45 to 64, and 0.4 percent among those aged 65 and over (id.). Given that this analysis has not yet been included in a peer reviewed journal, FDA is including this analysis in the docket and specifically requests comment on it. Under this option, FDA is proposing that all cigars be treated in a similar manner and that they all be deemed to be subject to FDA's authorities in the FD&C Act as well as the additional provisions proposed under this rule. 2. Option 2: Restrict Rule to Covered Cigars FDA has heard from numerous interested parties, including manufacturers and retailers of premium cigars, on issues related to how premium cigars should be regulated. Some have contended that usage patterns of certain types of cigars (typically known as premium cigars) can vary dramatically from usage patterns of other cigars. They claim that the premium cigars category includes cigars that are used on celebratory occasions only a few times per year. In order to evaluate this contention and determine the proper scope for this rule, FDA has attempted to define the category of premium cigars by defining “covered cigar” and excluding what might be considered “premium cigars” from that definition. As stated throughout this section, FDA requests comment on its proposed definition of a “covered cigar.” Although FDA recognizes that all cigars are potentially addictive, the ability of cigars to deliver nicotine at a level capable of producing dependence is based on the degree of cigar smoke inhalation, the rate of oral nicotine absorption, the development of tolerance to nicotine, the age of initiation, and the duration of exposure (Ref. 28 at 183). The proportion of cigar smokers showing clear signs of dependence also remains unknown (Ref. 28 at 189). Some members of industry have noted that these factors suggest that those who smoke certain types of cigars are not addicted to them. In addition, as explained in section VII.D, young adults appear to be particularly interested in cigarillos, rather than large cigars. It has been suggested that adolescents are not attracted to large and premium cigars, because they are offered for sale at a much higher cost relative to other types of tobacco products and are more difficult to access (e.g., large and premium cigars are typically sold at tobacconists' shops versus convenience stores). This is supported by the study of youth use of cigars by the Office of Inspector General for the Department of Health and Human Services which states that “[m]anufactured cigars, rather than premium cigars, are most commonly used by teens due to their ease of purchase, low cost . . . .” (Ref. 35). Some industry representatives have stated that there is “no evidence to suggest that premium cigar use is increasing among youths” (FDA-2011-P-0623). They also question whether adolescents use cigars, citing to the NCI Monograph No. 9, which states that “[f]ew surveys have questioned cigar smokers about the quantity and type of cigars typically consumed” (Ref. 28). The International Premium Cigar and Pipe Retailers Association (IPCPRA), in its citizen petition seeking to exempt large and premium cigars from FDA regulation, acknowledged that a premium, hand-rolled cigar may be a “tobacco product” under the Act, but “there is no evidence to suggest that it carries anywhere near the public health risks of a cigarette.” (FDA-2011-P-0623). Therefore, they claim that premium cigars are not a public health problem requiring FDA regulation. To support this argument, the IPCPRA notes that NCI has remarked about the dose-response relationship between the numbers of cigars smoked and the risk of disease, stating that “as many as three-quarters of cigar smokers smoke only occasionally . . . [and t]his difference in frequency of exposure translates into lower disease].” (id.). In addition, they note that the health risk tables in NCI's Monograph No. 9 refer to those who smoke 1-2 cigars per day and, therefore, the NCI Monograph does not even provide health risk data for the 75 percent majority of smokers who NCI identifies as “occasional” cigar smokers. They also state that “smokers of 1-2 cigars per day are at no greater risk statistically . . . for risk of numerous cancers, coronary heart disease, chronic obstructive pulmonary disease (COPD), and cerebrovascular disease.” (FDA-2011-P-0623). Moreover, given the difference in inhalation patterns between cigarettes and cigars smokers noted by NCI, the IPCPRA claimed that the vast majority of premium cigar smokers are occasional users who do not inhale and, therefore, there would be little public health benefit if FDA were to regulate premium cigars. FDA requests any comments, data, and information regarding IPCPRA's analysis of this NCI data or other data related to disease risk, nicotine addiction, and how premium cigars are used. D. Request for Comments Regarding Regulation of E-Cigarettes FDA realizes that while all tobacco products are potentially harmful and potentially addictive, different categories of tobacco products may have the potential for varying effects on public health. For example, some have advanced views that certain new non-combustible tobacco products (such as e-cigarettes) may be less hazardous, at least in certain respects, than combustible products given the carcinogens in smoke and the dangers of secondhand smoke. FDA is aware of the recent significant increase in the prevalence of e-cigarette use and continues to research how e-cigarette use is impacting the public health. In a computer-based mail-in survey of more than 10,000 U.S. adults, the prevalence of those who had ever used e-cigarettes (referred to as “ever use”) quadrupled from 2009 to 2010 (Ref. 25). In 2011, 6.2 percent of all adults and 21.2 percent of current smokers had ever used e-cigarettes, representing an almost two-fold increase from 2010 estimates (Ref. 24). Data from Wave 8 of the International Tobacco Control (ITC) Four-Country Survey (collected from July 2010 to July 2011) indicated that 20.4 percent of those aware of e-cigarettes had reported trying the product (Ref. 36). The numbers of individuals that have tried e-cigarettes in the previous 30 days also are indicative of the recent popularity of these products. An analysis of data from a nationally representative online study found that 3.4 percent of the general population had ever used e-cigarettes and 35.9 percent of the group that had used the products had used them within the previous 30-day period (Ref. 23). In addition, according to the 2011 and 2012 National Youth Tobacco Survey given to middle and high school students, e-cigarette use more than doubled, rising from 3.3 percent to 6.8 percent over these 2 years, including an increase of concurrent cigarette and e-cigarette use from 0.8 percent to 1.6 percent—a statistically significant increase (Refs. 4, 37). A study of 4,444 students from 8 colleges also found that 4.9 percent of students had ever used e-cigarettes, and 1.5 percent reported use in the past 30 days (Ref. 38). We do not currently have sufficient data about e-cigarettes and similar products to determine what effects they have on the public health. Nevertheless, several recent studies of limited numbers of users suggest that e-cigarettes may have the potential to help smokers, particularly those who have had limited success with currently approved cessation programs (Refs. 39, 40, 41, 42, and 43). There is no evidence to date that e-cigarettes are effective cessation devices. For example, one trial examining cessation success between e-cigarettes, nicotine replacement patches, and placebos found that “[a]chievement of abstinence was substantially lower than we anticipated.” (Ref. 19). This study demonstrated cessation in 21 of 289 smokers (7.3 percent) versus 17 of 295 (5.8 percent) with nicotine patches. However, none of these results reached statistical significance (Ref. 19). 3 In addition, several large studies appear to raise questions as to whether e-cigarettes are effective cessation aids in real-world use. In a nationally representative survey of 1,836 current or recently former adult smokers, researchers found that, compared with smokers who had never tried to quit, ever-use of e-cigarettes was not associated with successful quit attempts, but was associated with unsuccessful quit attempts (Ref. 44). In another study that analyzed data from 2,758 callers to 6 state tobacco quitlines, e-cigarette users were significantly less likely to be tobacco abstinent at 7 months than participants who had never tried e-cigarettes (Ref. 45). 3 The observed p-value for cessation with e-cigarettes versus nicotine patches was p=0.46, and the observed p-value for cessation with e-cigarettes versus placebo was p=0.44 (Ref. 19). Some studies on very small numbers of subjects have found that e-cigarettes may have the potential to help with cessation by delivering a sufficient nicotine dose, particularly for experienced e-cigarette users (Refs. 39, 40, 41, 42, 43, and 46). Other studies have suggested that the sensory aspects associated with e-cigarettes may also have the potential to provide some short-term smoking reduction benefits. For example, in the study of 25 smokers utilizing e-cigarettes to address the short-term potential for smoking reduction, researchers found promising results but indicated that such “results are not predictive of long-term reduction or quitting” (Ref. 39). This study found that in smokers who had utilized e-cigarettes for 1 week, 10 puffs from the e-cigarette over a 4.5-minute period resulted in acute increases in plasma nicotine and heart rate and a median 55 percent reduction in craving (id.). In addition, the study noted a considerable individual variation in smoking topography and found that whether a user can obtain a sufficient nicotine dose depends on whether he or she is an experienced user (id.). Even though there is no evidence to date of a long-term cessation benefit, some researchers believe that e-cigarettes are at least capable of suppressing the urge to smoke (Ref. 41). Separately, although this is unrelated to smoking reduction, some researchers have stated that substituting e-cigarettes for tobacco cigarettes “may substantially reduce exposure to tobacco-specific toxicants” (Ref. 47). Although e-cigarettes may have short-term smoking reduction benefits, FDA cautions that long-term studies are not available to conclude that e-cigarettes are a proven cessation product nor to establish what effects e-cigarettes have in users who might have otherwise quit, but instead engage in dual use of e-cigarettes and another tobacco product. There also is very limited information currently available on the positive and negative subjective effects, including craving and withdrawal, and the topography of e-cigarettes. FDA believes it is important to evaluate e-cigarettes based on their individual characteristics and their influence on behaviors in order to learn more about the potential benefits and drawbacks of the products. FDA will continue to analyze the potential benefits and harms of e-cigarettes, as well as their impact on nonusers and the population level as a whole, if the deeming rule is finalized. Thus, FDA is seeking comments, including supporting research, facts, and other evidence, as to how e-cigarettes should be regulated based on the continuum of nicotine-delivering products (as discussed in section III) and the potential benefits associated with e-cigarettes. Without more data, it is not possible to know the impact of these products either on reducing usage of cigarettes or in possibly prolonging usage of cigarettes while continuing to expose users to the harmful carcinogens in combustible tobacco products (Ref. 23). E. Request for Comments Regarding Components, Parts, and Accessories FDA asks for comments, including supporting facts, research, and other evidence, as to whether FDA should define components and parts of tobacco products and how those items might be distinguished from accessories of tobacco products. As stated throughout this document, the FD&C Act defines “tobacco product” to include the components, parts, and accessories of such tobacco products (section 201(rr) of the FD&C Act). At this time, FDA is proposing to deem those products meeting the definition of tobacco product, except the accessories of proposed deemed products, to be subject to its tobacco control authorities. Therefore, components and parts of the proposed deemed tobacco products would fall under the scope of this rule, but accessories would not. We are proposing to include components and parts within the scope of this proposed rule, because they are included as part of a finished tobacco product or intended for consumer use in the consumption of a tobacco product. However, because accessories are not expected to be used in the consumption of a tobacco product, we expect that accessories will have little impact on the public health. FDA is seeking comment on its proposal to exclude accessories from the scope of the deeming rule. FDA believes that components and parts of tobacco products are those items that are included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product. Components and parts that would be covered under this proposal include those items sold separately or as part of kits sold or distributed for consumer use or further manufacturing or included as part of a finished tobacco product. Such examples would include air/smoke filters, tubes, papers, pouches, or flavorings used for any of the proposed deemed tobacco products (such as flavored hookah charcoals and hookah flavor enhancers) or cartridges for e-cigarettes. In addition, FDA considers accessories to be those items that are not included as part of a finished tobacco product or intended or expected to be used by consumers in the consumption of a tobacco product, but may be used, for example, in the storage or personal possession of a proposed deemed product. Therefore, items such as hookah tongs, hookah bags and cases, hookah charcoal burners and holders, cigar foil cutters, humidors, or cigar carriers would be considered accessories and would not fall within the scope of this proposed rule. At this time, FDA is not proposing definitions for components, parts, or accessories. If FDA were to develop definitions of these categories of products, the definitions likely would include factors such as whether these items are directly involved in the consumption, storage, or personal possession of tobacco products. These definitions also likely would take into account the foreseeable effect on public health of these items and whether a tobacco product can effectively be consumed without such items. If you believe FDA should define these terms, we seek comment on how to define the categories of “components,” “parts,” and “accessories.” We also ask for comments on whether and how the use of certain components, parts, or accessories might be used to alter the effects of the tobacco product on public health, the constituents delivered by the product, or the potential initiation of new tobacco users. V. Basis for Additional Provisions Substantial research informs the Agency's view that the access provisions proposed as part of this rule (e.g., age restrictions under 18; prohibition on vending machines) are effective in reducing initiation of cigarette and smokeless tobacco use, increasing cessation of cigarette and smokeless tobacco use, and otherwise reducing cigarette and smokeless tobacco product use among youth and adults. The research also reflects that health warnings on packages and advertisements effectively help consumers to understand and appreciate the health risks of tobacco use. Because historically most tobacco users in the United States have smoked cigarettes or used smokeless tobacco (Ref. 28), tobacco product use research and tobacco control efforts thus far have focused primarily on these products (Ref. 29) and not on many of the tobacco products, particularly novel products like certain dissolvables and gels, covered by this proposed rule (Ref. 48). Research findings regarding the use of cigarettes and smokeless tobacco products, including research regarding restrictions on those products that are identical to the restrictions proposed on products subject to deeming in this rule, also support FDA's proposed action here. FDA's reliance on these data is appropriate because of the addictive nature of tobacco products in general and the similar well-documented risks of several other tobacco products subject to this rule. In addition, consumer confusion and misinformation, reflected in mistaken beliefs that non-cigarette tobacco products are safe alternatives to cigarettes, also support the Agency's determination that the proposed restrictions are appropriate for the protection of the public health. A. Addictive Nature of Products The Surgeon General has long recognized the addictive nature of tobacco products due to the presence of highly addictive nicotine that can be absorbed into the bloodstream (see, e.g., Ref. 49 at 6-9). While the amount of nicotine delivered and the means through which it is delivered can either reduce or enhance the nicotine's potential for abuse and physiological effects (Ref. 50 at 113), nicotine is addictive (as discussed in section V.A), and FDA believes that all tobacco products currently available contain nicotine (Ref. 49). The quicker the delivery, rate of absorption, and attainment of high concentrations of nicotine, the greater the potential for addiction (Ref. 50 at 113). At the same time, the ultimate levels of nicotine absorbed into the blood from tobacco products currently on the market can be similar in magnitude regardless of the product forms used to deliver nicotine (Ref. 49). For example, research has shown that oral use of smokeless tobacco products that do not emit smoke results in “high venous concentrations of nicotine equal to those for use of cigarettes” (Ref. 50 at 113). 1. Impact of Nicotine on Youth and Young Adults Adolescence is when most tobacco users begin to develop their behavior (Ref. 51 at 5, 58, 65-67). If individuals do not start using cigarettes during childhood or adolescence, they are unlikely ever to smoke (id.). Research shows that more than 80 percent of established adult smokers began smoking before the age of 18 (Ref. 52). An analysis by the World Health Organization (WHO) of studies performed among final-year high school students in the United States suggests that fewer than two out of five smokers who believe that they will quit within 5 years actually do quit. In high-income countries, about 7 out of 10 adult smokers say they regret initiating smoking and would like to stop (Ref. 53 at 2). When tobacco product use persists into adulthood, the risk of long-term, severe health consequences (such as cancer, heart disease, lung disease, and other serious medical conditions) increases as duration of use increases (Ref. 50). In addition, there are data suggesting that the adolescent brain is more vulnerable to developing nicotine dependence than the adult brain. There is also evidence to suggest that these brain changes are permanent (Refs. 54 and 55). The Surgeon General reported that “most people begin to smoke in adolescence and develop characteristic patterns of nicotine dependence before adulthood” (Ref. 51 at 29). These youth develop physical dependence and experience withdrawal symptoms when they try to quit smoking (id.). As a result, addiction to nicotine is often lifelong (Ref. 56). Youth and young adults generally “underestimate the tenacity of nicotine addiction and overestimate their ability to stop smoking when they choose” (Ref. 57). For example, one survey revealed that “nearly 60 percent of adolescents believe that they could smoke for a few years and then quit” (Ref. 58). Moreover, exposure to substances such as nicotine can disrupt brain development and have long-term consequences on executive cognitive function (such as task-switching and planning) and on the risk of developing a substance abuse disorder and various mental health problems (particularly affective disorders such as anxiety and depression) as an adult (Ref. 1). This exposure to nicotine can also have long-term effects including decreased attention performance and increased impulsivity, which could promote the maintenance of nicotine use behavior (id.). Further, the 2010 Surgeon General's report noted that symptoms of dependence could result from even a limited exposure to nicotine during adolescence (Ref. 50). Thus, FDA seeks to limit youth exposure to nicotine and other addictive constituents in tobacco by proposing restrictions on the age at which individuals can purchase covered tobacco products. FDA is proposing to prohibit sales of proposed deemed products to individuals under 18 years of age, consistent with the current regulatory prohibition on sales of cigarettes and smokeless tobacco products to individuals under 18 years of age. Nicotine addiction research studies suggest that nicotine increases sensitivity to rewarding stimuli in the environment, which may reinforce smoking behavior in vulnerable individuals and contribute to nicotine addiction (Ref. 59). Researchers have found that adolescent brains are particularly vulnerable to the rewarding effects of nicotine, and nicotine exposure during adolescence diminished the negative effects of high nicotine exposure as an adult (Ref. 60 at 658). Nicotine also may play a role in neurodevelopment in adolescence, alter future responsiveness to nicotine, and increase brain activation related to smoking cues (Ref. 61 at 1968, Ref. 62 at 152, and Ref. 63 at 7). Ingredients in tobacco or tobacco smoke other than nicotine may have reinforcing or synergistic effects of their own (Ref. 50 at 111). See section VII.C for additional discussion regarding the addictiveness of nicotine. 2. Nicotine Levels Tobacco product users absorb nicotine readily from tobacco smoke through the lungs and through the mouth or nose for noncombustible forms of tobacco (Ref. 49 at iii). Nicotine can also be absorbed through the skin, as evidenced by the use of the nicotine patch for relieving nicotine withdrawal symptoms. With regular use, nicotine levels accumulate in the body during the day from the tobacco product use and then decrease overnight as the body clears the drug (id). Nicotine introduced through the lungs is rapidly distributed to the brain (Ref. 49 at 12). Although somewhat slower, absorption of nicotine through the oral mucosa and skin is substantial and can produce blood levels comparable to those achieved through lung absorption. The effects of nicotine on the central nervous system occur rapidly after absorption of nicotine from tobacco products (id.). Mild nicotine intoxication even occurs in first-time smokers (Ref. 49 at 15-16). Tolerance to the effects of nicotine develops rapidly. The nicotine level in proposed covered tobacco products varies, both across product types and brands of the same product type. Given the ease with which nicotine can be absorbed into the body, and the impacts on tobacco users (particularly youth) as described in section V.A, the nicotine consumption associated with the proposed deemed products is a primary reason why FDA believes that deeming these products to be subject to FDA's tobacco product authorities is necessary and the proposed additional restrictions are appropriate for the protection of public health. Each of the products described in this document contains nicotine and, therefore, has the potential to addict consumers. a. Nicotine in, and Absorption of Nicotine From, Cigars Cigar tobacco contains nicotine in concentrations similar to those observed in cigarettes; however, given that most cigars contain more tobacco, many typically contain greater quantities of nicotine than cigarettes (Ref. 28 at 81). The amount of nicotine in a cigar can range from the equivalent of a single cigarette to the equivalent of an entire package of cigarettes, depending on cigar size and the amount of tobacco incorporated into its components (Refs. 28 at 182 and 30 at 736). A study of 10 cigars selected at random from a cigar retailer found that the cigars ranged in nicotine concentration from 4.70 milligrams per gram (mg/g) to 22.00 mg/g (Ref. 28 at 183). In fact, nicotine levels in cigar smoke can be up to 8 times higher than levels in cigarette smoke—1.7 mg in nonfiltered cigarettes, 1.1 mg in filtered cigarettes, 3.8 mg in little cigars, 9.8 mg in cigars, and 13.3 mg in premium cigars (Ref. 28 at 67). Whether cigars deliver nicotine at a level capable of producing dependence is based on the degree of cigar smoke inhalation, the rate of oral nicotine absorption, the development of tolerance to nicotine, the age of initiation, and the duration of exposure (Ref. 28 at 183). Even cigar smokers who do not inhale can become addicted to the product given the absorption of nicotine through the buccal mucosa. The nicotine exposure from inhaling the smoke from a single cigarillo is similar to exposures from inhaling smoke from single cigarettes (Ref. 64). The proportion of cigar smokers showing clear signs of dependence remains unknown (Ref. 28 at 189). Nicotine can exist in protonated and free base (or unprotonated) form; and when in free base form, it is the most addictive and readily absorbed via respiratory tissues, skin, and the gastrointestinal tract, which results in the cigar being more addictive and even more difficult for the user to cease using than the cigar would be if it only delivered nicotine in the protonated form (Refs. 49 at 593 and 50 at 16). “The amount of nicotine available as free, unprotonated nicotine is generally higher in cigars than in cigarettes due to the higher pH of cigar smoke” (Ref. 28 at 97). Nicotine absorbed across the buccal mucosa can provide sustained amounts of “free base” nicotine to the user, which may explain why cigar smokers are less likely to inhale than cigarette smokers (id.). Thus, a cigar also can deliver nicotine much like chewing tobacco or oral snuff with nicotine extraction from the unburned tobacco absorbed directly through the buccal mucosa and lips (Ref. 28 at 183-184). Researchers have found that some cigar smokers, particularly those who formerly smoked or currently smoke cigarettes, were likely to obtain the nicotine by inhaling smoke directly into the lungs, where it was absorbed as rapidly as cigarette smoke (Ref. 28 at 186). Usage patterns suggest that cigar-only use that begins in adulthood may be less likely to produce dependence than cigarette smoking, and it is not likely “that substantial levels of physical dependence would be observed in people who rarely smoked on 2 or more consecutive days” (Ref. 28 at 189-190) (emphasis added). However, studies suggest that cigar use is underreported by adolescents in part due to misunderstanding of the definition of “cigar” in national surveys (Ref. 65 at 845 and Ref. 66 at 2, 4). For example, when a group of students were re-administered a national survey but asked whether they had used cigars with the brand name “Black and Mild” in the past 30 days rather than just “cigars, little cigars, or cigarillos,” the percentage of students reporting cigar use nearly doubled—from 12.9 percent to 20.7 percent. (Ref. 65 at 842). Therefore, adolescents need to be aware that small and large cigars, like cigarettes, contain nicotine that can cause addiction (see section V.A for further discussion regarding the effects of nicotine on adolescent brains). b. Nicotine in, and Absorption of Nicotine From, E-Cigarettes The amount of nicotine in e-cigarettes varies among brands. In a 2012 study, researchers tested the products under conditions in which e-cigarette users use their products (Ref. 6). They found that “high nicotine” cartridges delivered between 0.5 mg and 15.4 mg of nicotine, and cartridges labeled “low” or “medium” delivered between 0.5 mg and 3.1 mg of nicotine (id.). The efficacy of the nicotine aerosolization also varied widely—with some e-cigarettes aerosolizing within a range of 21 to 85 percent of the relative amounts of nicotine present in the cartridges (id.). As a result, nicotine levels of a single puff of 70 milliliters may be estimated between 1.7 micrograms (mcg) and 51.3 mcg (id.). We are also aware that some e-cigarettes currently being marketed claim to permit users to adjust the level of nicotine delivery and that some users may attempt to employ this claimed feature to reduce their nicotine use over time. c. Nicotine in Hookah Tobacco Researchers have found that the nicotine level to which users are exposed while smoking hookah tobacco is greater than the level from cigarette smoking and, therefore, that hookah smoking also carries the potential for addiction (Ref. 67). In a study of frequent hookah tobacco users, half of the men and a third of the women reported trying, but failing, to quit smoking hookah tobacco in the past (id.). The researchers note that “[h]ookah smoking exposes users to smoke and may be a gateway to nicotine addiction” (id.). d. Nicotine in Dissolvables To date, little evidence is available to ascertain the pharmacological properties and harmful effects of dissolvable tobacco products or compare them with FDA-approved nicotine replacement products or other tobacco products (Ref. 68). The dose of unprotonated nicotine in dissolvable tobacco products can vary widely across product formulations and brands, as well as the manufacture date, lot, and batch (id.) Researchers at Indiana University-Purdue University Indianapolis published the first chemical analysis of dissolvable tobacco and found that “dissolvables contain nicotine levels comparable to those in a single cigarette” (Ref. 69, citing Ref. 70). Rapid intake of nicotine leads to the highest blood and brain concentrations at the lowest doses of nicotine, but oral administration requires higher doses of nicotine to produce the same toxic effects (Ref. 70). B. Health Risks of Products The health effects of cigarettes have been well documented (see, e.g., Refs. 49, 50, and 51). Like cigarettes, many of the tobacco products proposed to be deemed through this rule have well-documented adverse health effects. The health risks of some of these proposed deemed products are discussed in this section. See section VII for additional rationales for specific proposed health warnings. In the “Findings” section of the Tobacco Control Act (section 2), Congress notes that the “use of tobacco products by the Nation's children is a pediatric disease of considerable proportions that results in new generations of tobacco-dependent children and adults” and that a “consensus exists within the scientific and medical communities that tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects.” In enacting the Tobacco Control Act, Congress found that providing FDA with authority to regulate tobacco products, including the advertising and promotion of such products, would result in significant benefits to the American public in human and economic terms (section 2(12) of the Tobacco Control Act). The U.S. Government has a substantial interest in reducing the number of Americans, particularly youth and young adults, who use cigarettes and other tobacco products, to prevent the life-threatening health consequences associated with tobacco product use (section 2(31) of the Tobacco Control Act). Virtually all new users of most tobacco products are youth, and a reduction in tobacco product use by this population alone could significantly reduce tobacco-related death and disease in the United States (Ref. 51). Congress also expressed concern about the addictiveness of these “inherently dangerous products” (section 2(2) of the Tobacco Control Act). In 1988 the Surgeon General found that “all tobacco products contain substantial amounts of nicotine” (Ref. 49). Addictiveness means “[t]he state or quality of being addictive; addictedness, addiction; an instance of this.” (Ref. 71). Because the covered tobacco products (i.e., those products deemed to be subject to the FD&C Act under § 1100.2, other than a component or part that does not contain tobacco or nicotine) are made or derived from tobacco and contain nicotine, they are addictive (Refs. 72, 73, 74, 75, and 76). There are several symptoms that are indicative of addiction to drugs including nicotine. The primary criteria are highly controlled or compulsive use, psychoactive effects, and drug-reinforced behavior (Ref. 50 at 105-106). Additional criteria are stereotypic patterns of use, despite harmful effects, relapse following abstinence, and recurrent drug cravings (id.). Dependence-producing drugs often produce tolerance and physical dependence (id.). “Tobacco use is the leading preventable cause of disease, disability, and death in the United States” (Ref. 77). When people do not use tobacco products, the positive impact on public health is great. For example, smoking declines in the last half century are responsible for nearly 40 percent of the reduction in male lung cancer deaths between 1991 and 2003 (Ref. 78). By extending FDA's “tobacco product” authorities to tobacco products meeting the statutory definition, FDA would be better able to ensure that the health risks of these products are effectively communicated to consumers and that youth do not have access to these products. These steps would increase the likelihood that existing users will quit using tobacco products, and decrease the likelihood that new individuals, including youth, will initiate tobacco product use. 1. Dissolvable Products As stated previously, dissolvable products that do not currently meet the definition of smokeless tobacco under 21 U.S.C. 387(18), because they do not contain cut, ground, powdered, or leaf tobacco and instead contain nicotine extracted from tobacco, are not currently regulated by FDA. This proposed rule would ensure that all dissolvable products are subject to FDA regulation. The “Monitoring the Future” study found that the use of noncombustible tobacco products (including pouches and dissolvables, which contain nicotine, tobacco carcinogens, and toxicants) has increased amongst youth in grades 8, 10, and 12 over the past several years (Ref. 83). Compared to cigarettes, scientists have found that dissolvables have a higher proportion of unprotonated nicotine but that dose can vary widely (Ref. 68). The potential for acquiring nicotine dependence exists for individuals who initiate tobacco product use with dissolvable products, but the information about hazardous or potential hazardous constituents in such products is sparse (id.). Certain dissolvable smokeless tobacco products also have the potential for unintended poisonings given the candy-like appearance of certain dissolvable tobacco products. Data from 2010 indicates that 13,705 tobacco product ingestion cases were reported and more than 70 percent of those cases involved infants under a year old (Ref. 79). While it is unclear exactly how many of these cases involved dissolvables, smokeless tobacco products (in all forms, including dissolvables) were the second most common tobacco product ingested by children, after cigarettes (id.). 2. Cigars Regardless of whether large cigar and pipe smokers inhale, smoke particles are deposited into the lung (Ref. 32). A large cigar may contain as much tobacco as a whole pack of cigarettes (Refs. 30 and 31). In addition, the concentrations of some toxic and carcinogenic compounds are higher in cigar smoke than in cigarettes, and tobacco smoke is a major source of fine-particle and carbon monoxide indoor air pollution (Ref. 33). A smoker's risk of cardiovascular disease is particularly high for former cigarette smokers who switch to cigars, because they are more likely to be regular users and to inhale the smoke (Ref. 28 at 155). As discussed further in section VII.E, cigar smoking also is strongly related to certain cancers (including oral, esophageal, laryngeal, and lung cancers), heart disease, and premature death (Refs. 28 and 62). Cigar smokers who inhale have a similar risk of death and disease as cigarette smokers (see, e.g., Ref. 28). Research suggests that smoking small cigars, in particular, is associated with smoke inhalation that leads to significant exposure to carbon monoxide and presumably other toxic components of tobacco smoke, which can lead to respiratory diseases usually associated with cigarette smoking (Ref. 64). Moreover, age of initiation data illustrates the increasing popularity of cigars, in particular small cigars, and the potential risks for youth and young adults. According to the 2010 and 2011 data from the National Survey on Drug Use and Health (NSDUH), 2.95 million people aged 12 or older initiated cigar use in 2010—1.087 million of whom where between the ages of 12 and 18. In 2011, 2.8 million initiated cigar use, of which 1.113 million were between the ages of 12 and 18 (Refs. 6, 80, 81, and 82). The 2010 “Monitoring the Future” study showed that 23 percent of 12th graders reported smoking small cigars in the past year (Ref. 83). While there was a dip in the number of high school seniors smoking small cigars, that number remained high at 19.5 percent in 2011 (Ref. 84). Additional discussion of the health risks associated with cigars is included in section VII.E. 3. Pipe Tobacco Studies of pipe smokers illustrate a risk of tobacco-related disease similar to the risk in those who inhale cigar smoke or smoke cigarettes (Ref. 85). The Surgeon General previously found that pipe and cigar smokers experience oral and laryngeal cancer risks similar to that of a cigarette smoker (Ref. 86). Moreover, when compared with never having used tobacco, researchers found that pipe smokers have an increased risk of death from cancers of the lung, oropharynx, esophagus, colorectum, pancreas, larynx, and from coronary heart disease, cerebrovascular disease, and COPD (Refs. 32 and 85). Further, in a Norwegian study involving 16,932 participants, researchers found that pipe smokers have an elevated risk of premature mortality similar to that of cigarette smokers who smoke at comparable consumption levels (Ref. 87). This finding applies to total mortality and mortality for smoking-related diseases (i.e., ischaemic heart disease, stroke, cardiovascular disease, and other smoking related cancers), except for lung cancer where smokers of only cigarettes have the highest mortality (id.). Notably, even men with the lowest daily consumption of pipe tobacco (less than three pipefuls per day) were found to have significantly higher health risks than never users (id.). 4. Waterpipe Smoking Waterpipe smoking (also known as hookah, shisha, and narghile) uses specially made tobacco that comes in different flavors, such as apple, mint, cherry, chocolate, and licorice (Ref. 88). This type of tobacco use carries similar health risks as smoking cigarettes with respect to the large amounts of ultrafine particles emitted during a waterpipe smoking session (Ref. 89). Waterpipe smoke contains many of the same carcinogens and heavy metals as cigarette smoke, and because waterpipe smoking sessions last longer than smoking a cigarette and there is increased smoke volume, a single session of waterpipe smoking (which typically lasts 20 to 80 minutes) could potentially be more dangerous than smoking a cigarette (which typically takes 5 to 7 minutes) (Refs. 90 and 91). When compared to smoking a single cigarette, a meta-analysis of studies regarding waterpipe use showed that a single episode of waterpipe use is associated with exposure to 1.7 times the nicotine, 6.5 times the carbon monoxide, and 46.4 times the tar (Ref. 9). In one study of participants aged 18 to 50 years old, researchers found that a single waterpipe session leads to measurable transient dysfunction in cardiac autonomic regulation and suggests an increased risk of adverse cardiovascular events for hookah users (Ref. 92). When compared to individuals who do not use waterpipes, researchers also have found that waterpipe users (as ascertained by analyses in multiple studies of participants ages 10 to 80) more than double their risk of lung cancer, respiratory illness, and low birth weight when users are expectant mothers (Refs. 10, 93, and 94). Studies also have demonstrated the presence of high levels of tobacco-related carcinogens such as certain polycyclic aromatic hydrocarbons (PAHs) and tobacco-specific nitrosamines (TSNAs) in waterpipe users, which increase cancer risk in users (Ref. 95 citing Refs. 96 and 97; and Ref. 98). For example, a study of exposure to nicotine, carbon monoxide, and carcinogens in subjects who used waterpipes under controlled conditions found that users had significantly higher carbon monoxide levels than even cigarette smokers, which can pose potential health risks especially for people with cardiovascular and pulmonary diseases (Ref. 98). This study also found increased urinary levels of TSNAs and PAHs following waterpipe smoking (id.). In fact, the excretion of all PAH metabolites increased 50 percent following waterpipe smoking, indicating that it is a significant source of exposure to this class of carcinogens (id.). Waterpipe use also poses additional public health risks due to shared mouthpieces and the heated, moist smoke that waterpipes produce. As a result, users are at increased risk of contracting communicable diseases and viruses (Ref. 99). Moreover, waterpipe use appears to be increasing among youth in the United States, further illustrating the potential risks for youth and young adults (Ref. 90). In 2010, results of the “Monitoring the Future” study showed that 17 percent of 12th graders reported smoking tobacco in a waterpipe (Ref. 83). The following year, 18.5 percent of high school seniors reported smoking tobacco in a waterpipe (Ref. 84). Researchers also studied waterpipe use among 689 students from 3 high schools in San Diego County. Of the study participants, 26.1 percent had used hookah and the mean age of initiation was 15.8 years (Ref. 90). Waterpipe users are exposed to tobacco toxicants and thus are at risk for the same types of harms caused by cigarette smoking and, in addition, may become cigarette smokers or dual tobacco users (Ref. 88). 5. E-Cigarettes We do not currently have sufficient data about e-cigarettes to determine what effects they have on the public health. Some studies have revealed the existence of toxicants in both the e-cigarette liquid and the exhaled aerosol of some e-cigarettes. For example, FDA previously noted the presence in a certain e-cigarette cartridge of contaminants such as diethylene glycol (DEG)—a chemical that has caused poisonings in other consumer products such as acetaminophen and cough syrup and which FDA has stated “is toxic to humans” (Ref. 100, Ref. 101 citing Refs. 102, 103, and 104). While the presence of DEG in any product is of great concern, we note that it was found in only 1 of 18 cartridges studied and it was not found at all in another 16 studies (Ref. 41). Further, one study found that toxic chemicals such as formaldehyde and acetaldehyde were detected in the cartridges as well as the aerosol from certain e-cigarette nicotine solutions (Ref. 47). Acrolein, which can cause irritation to the nasal cavity and damage to the lining of the lungs and may contribute to cardiovascular disease in cigarette smokers, was also found in the aerosol (id.). While the level of carcinogenic formaldehyde from the e-cigarette aerosol was somewhat comparable to the amount received from cigarette smoking, the overall levels of the toxicants tested in this study were 9 to 450 times lower than those in cigarette smoke (id.). In another study, a total of 22 chemical elements, some of which can cause adverse health effects in the respiratory and nervous systems, were identified in e-cigarette aerosol (Ref. 105). Among those elements were lead, nickel, and chromium, which are included on the Agency's harmful and potentially harmful constituents list (id., citing 77 FR 20034, April 3, 2012). Research published in 2013 reported that under near real-use conditions, e-cigarettes increased indoor air levels of polycyclic aromatic hydrocarbons, 1,2-propanediol, 1,2,3-propanetriol, glycerine, nicotine, fine particles, ultrafine particles, particle number concentrations, and aluminum. (Refs. 106 and 107). Despite the existence of certain toxicants in e-cigarette devices and the exhaled aerosol, several studies support the notion that the quantity of toxicants is significantly less than those in tobacco cigarettes and tobacco smoke and similar to those contained in recognized nicotine-replacement therapies. For example, researchers reviewing the result of 16 laboratory analyses of e-cigarettes only found trace levels of TSNAs, and these were at levels similar to those in the nicotine patch (Ref. 41). Testing on some devices also has revealed the existence of TSNAs in cartridge fluid, but generally at low levels similar to those in nicotine replacement therapies (Refs.108). Another study, published in 2013, also found cadmium, lead, and nickel in the e-cigarette aerosol but only in trace levels and comparable to those levels found in the Nicorette inhaler (Ref. 47). Two researchers stated in 2011 that the “preponderance of the available evidence shows [e-cigarettes] to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products” (Ref. 41). Even if such findings are applicable to many products, e-cigarette manufacturers may vary in the quality of production, as discussed in section V.B.5. with respect to contamination with DEG, and as discussed further with respect to significant variability in nicotine content, and such variation may be dangerous. As such, given the existence of toxic chemicals in at least some e-cigarettes and the fact that most contain nicotine, FDA believes that its oversight of these products (which would occur if this deeming ruling becomes final) is appropriate for the protection of the public health. Researchers have identified instances of poor quality control and significant variability in nicotine content when testing certain e-cigarette cartridges (Refs. 6, 102, 109, and 110). For example, in one study, researchers found that actual nicotine amounts differed from label amounts by more than 20 percent in 9 out of 20 original e-cigarette cartridges tested, and in 3 out of 15 refill cartridges tested (Ref. 6). Yet, in another study, researchers theorized that manufacturing processes may have improved over time, because the nicotine content in both the original and-refill bottles was close to what was on the label and the difference between the content and labels was smaller than was previously reported (Ref. 111). However, it is unclear whether manufacturing processes have actually improved over time, because this study was conducted before or at the same time as studies finding significant variability in nicotine content. This potential variability in nicotine content could be misleading to consumers who believe that they are consuming one level of nicotine but instead may be consuming higher levels in certain instances. More recently, some have noted the availability of flavored e-cigarette liquids and expressed concern about the possibility that these candy flavors could appeal to youth. E-cigarettes are available in numerous flavors including vanilla, chocolate, peach schnapps, bubblegum, and cola (Refs. 112 and 113). Following the release of a 2013 report by CDC noting the increased prevalence of e-cigarette use in middle school and high school students, students have been quoted in newspaper articles noting that classmates use e-cigarettes and that they prefer flavors like gummy bears “because it tastes really good” (Ref. 114). If this deeming rule becomes final, FDA would have the authority to issue regulations to prevent youth access to e-cigarettes (such as the minimum age and identification provision, which is being proposed with this rule). FDA asks for comments, data, and research regarding the following: • Given the data showing a significant increase in e-cigarette usage among youth (Ref. 4) and the availability of fruit and candy-flavored nicotine liquids, what other regulatory actions should the Agency consider taking with respect to e-cigarettes? • Does one's use of fruit and candy-flavored nicotine liquids impact the likelihood that such individual will initiate use of combustible tobacco products and/or become a dual user with combustible tobacco products? How should that affect FDA's regulatory decisions regarding e-cigarettes? Another area for concern regarding e-cigarettes is their potential for acute toxicity. In February 2014, 41.7 percent of the combined calls to poison control centers for conventional cigarettes and e-cigarettes were for e-cigarette exposures (Ref. 115). In addition, 51.1 percent of those exposures were for children aged 0 to 5 years (id.). Although the public health impact of e-cigarettes is unknown, FDA believes e-cigarettes that contain nicotine derived from tobacco should be deemed to be tobacco products in order to obtain product and ingredient listing information and levels of harmful and potentially harmful constituents to ensure that users are not exposed to inhaled chemicals known to be harmful. We also believe that more information is needed to determine the public health impact of these products. Notably, in light of the impact of nicotine on youth (see section V.A), and given the data on co-use and poly-use of tobacco products by youth and others (see section V.D), FDA is proposing that tobacco products in all forms, as defined by statute, not just cigarettes and smokeless tobacco, be similarly regulated. C. Consumer Confusion and Misinformation About Certain Covered Tobacco Products 1. Misinformation About the Harmfulness of Various Tobacco Products Despite the addictiveness of nicotine and the documented adverse health effects of cigarettes, smokeless tobacco, cigars, and hookah tobacco, studies show that many consumers wrongly view certain tobacco products, including novel tobacco products, as safe alternatives to cigarettes and smokeless tobacco. Variations in the regulatory status of tobacco products may reinforce that mistaken perception. Research reflects that many people inaccurately think cigars, as well as waterpipes and other tobacco products covered by this proposed rule, are safe alternat [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2014-09491. Public record. Not legal advice.