PART 1107—EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS Authority: 21 U.S.C. 371, 374, 387e(j), 387i, 387j; Pub. L. 117-103, 136 Stat. 49. Source: 76 FR 38974, July 5, 2011, unless otherwise noted. Subpart A—Exemptions § 1107.1 Exemptions. (a) General requirements. (1) Such modification would be a minor modification of a tobacco product that can be sold under the Federal Food, Drug, and Cosmetic Act (a legally marketed tobacco product); (2) A report under section 905(j)(1) intended to demonstrate substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; and (3) An exemption is otherwise appropriate. (b) Request for an exemption under section 905(j)(3) of the Federal Food, Drug, and Cosmetic Act. (1) The manufacturer's address and contact information; (2) Identification of the tobacco product(s); (3) A detailed explanation of the purpose of the modification; (4) A detailed description of the modification, including a statement as to whether the modification involves adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive; (5) A detailed explanation of why the modification is a minor modification of a tobacco product that can be sold under the Federal Food, Drug, and Cosmetic Act; (6) A detailed explanation of why a report under section 905(j)(1) of the Federal Food, Drug, and Cosmetic Act intended to demonstrate substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; (7) A certification ( i.e., (8) Other information justifying an exemption; and (9) An environmental assessment under part 25 of this chapter prepared in accordance with the requirements of § 25.40 of this chapter. (c) Exemption determination. (d) Rescission of an exemption. [76 FR 38974, July 5, 2011] § 1107.3 Recordkeeping. (a) Definition. (b) Record maintenance. (i) A copy of the abbreviated report and, if applicable, the exemption request and all amendments thereto. (ii) A copy of the acknowledgement letter issued in response to an abbreviated report and, if applicable, the exemption order issued by FDA. (iii) Documents related to formulation of product, design specifications, packaging, and related items. (iv) Documents showing design specifications are consistently met. (v) Documents related to product packing and storage conditions. (vi) Analytical test method records, including: (A) Performance criteria. (B) Validation or verification documentation; and (C) Reports/results from these test methods. (vii) Source data and related summaries. (2) An applicant that submits an abbreviated report for a modification to a Pre-Existing Tobacco Product must also maintain records demonstrating that the Pre-Existing Tobacco Product was commercially marketed in the United States as of February 15, 2007, such as the records described in § 1100.204 of this chapter. (3) An applicant that submits an abbreviated report for a modification to a tobacco product that previously received premarket authorization ( i.e., (4) An applicant that submits an abbreviated report for a modification to a tobacco product that is the subject of a pending SE report and is marketed pursuant to section 910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act must maintain all communications to and from FDA relating to the pending SE Report ( e.g., (c) Record quality. e.g., (d) Record retention. [86 FR 55412, Oct. 5, 2021] Subpart B—General Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted. § 1107.10 Scope. (a) Subparts B through E of this part apply to a substantial equivalence report (or an SE Report) for a new tobacco product, other than “premium” cigars as defined in § 1107.12, that has: (1) Characteristics different from a predicate tobacco product and for which information is submitted to demonstrate it is not appropriate to regulate the product under section 910(b) and (c) of the Federal Food, Drug, and Cosmetic Act because the new tobacco product does not raise different questions of public health or (2) The same characteristics as a predicate tobacco product. (b) These subparts set forth procedures and requirements for the submission to FDA of an SE Report under sections 905 and 910 of the Federal, Food, Drug, and Cosmetic Act; the basic criteria for establishing substantial equivalence; and the general procedures FDA will follow when evaluating submissions. § 1107.12 Definitions. For purposes of this part: Accessory (1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or (2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) Solely controls moisture and/or temperature of a stored product; or (ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product. Additive Applicant Brand Characteristic Commercial distribution Commercially marketed Component part (1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or (2) To be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product. Composition Constituent e.g., Container closure system Design Distributor Finished tobacco product e.g., Harmful or potentially harmful constituent (HPHC) (1) Is or potentially is inhaled, ingested, or absorbed into the body, including as an aerosol or any other emission; and (2) Causes or has the potential to cause direct or indirect harm to users or nonusers of tobacco products. Health information statement Health information summary Heating source Ingredient Material New tobacco product (1) Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or (2) Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007. Other features Package packaging Predicate tobacco product Premium cigars (1) Is wrapped in whole tobacco leaf; (2) Contains a 100 percent leaf tobacco binder; (3) Contains at least 50 percent (of the filler by weight) long filler tobacco ( i.e., (4) Is handmade or hand rolled ( i.e., (5) Has no filter, nontobacco tip, or nontobacco mouthpiece; (6) Does not have a characterizing flavor other than tobacco; (7) Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) Weighs more than 6 pounds per 1,000 units. Submission tracking number STN Substantial equivalence substantially equivalent (1) Has the same characteristics as the predicate tobacco product; or (2) Has different characteristics and the information submitted contains information, including clinical data if deemed necessary by FDA, that demonstrates that it is not appropriate to require premarket review under section 910(b) and (c) of the Federal Food, Drug, and Cosmetic Act because the new tobacco product does not raise different questions of public health. Substantial equivalence report SE Report Tobacco product Tobacco product manufacturer (1) Manufactures, fabricates, assembles, processes, or labels a tobacco product, or (2) Imports a finished tobacco product for sale or distribution in the United States. [86 FR 55275, Oct. 4, 2021, as amended at 88 FR 16552, Mar. 20, 2023] Subpart C—Substantial Equivalence Reports Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted. § 1107.16 Submission of a substantial equivalence report. An applicant may submit an SE Report intended to demonstrate that a new tobacco product is substantially equivalent to a predicate tobacco product. The applicant must submit the SE Report at least 90 calendar days prior to the date the applicant intends to introduce or deliver for introduction a new tobacco product into interstate commerce for commercial distribution. The applicant cannot begin commercial distribution of the new tobacco product until FDA has provided the applicant an order stating that the Agency has determined that the new tobacco product is substantially equivalent to a predicate tobacco product, unless the new tobacco product has received authorization to be marketed through another premarket pathway. § 1107.18 Required content and format of an SE Report. (a) Overview. (1) General information (as described in paragraph (c) of this section); (2) Summary (as described in paragraph (d) of this section); (3) New tobacco product description (as described in paragraph (e) of this section); (4) Predicate tobacco product description (as described in paragraph (f) of this section), including a statement that the predicate tobacco product has not been removed from the market at the initiative of FDA and has not been determined by judicial order to be adulterated or misbranded, and the submission tracking number of the SE order finding the predicate product SE, or the submission tracking number of, or information to support, that the predicate tobacco product was commercially marketed (other than for test marketing) in the United States as of February 15, 2007; (5) Comparison information (as described in paragraph (g) of this section); (6) Comparative testing information (as described in paragraph (h) of this section); (7) Statement of compliance with applicable tobacco product standards (as described in paragraph (i) of this section); (8) Health information summary or statement that such information will be made available upon request (as described in paragraph (j) of this section); (9) Compliance with part 25 of this chapter (as described in paragraph (k) of this section); and (10) Certification statement (as described in paragraph ( l (b) Format. (c) General information. (1) The date the SE Report is submitted; (2) Type of submission ( e.g., (3) FDA STN, if previously assigned; (4) Any other relevant FDA STN, such as a voluntary request for a determination that a tobacco product was commercially marketed in the United States as of February 15, 2007, or SE Report previously found substantially equivalent (if applicable), and cross-references to meetings with FDA regarding the new tobacco product; (5) Applicant name, address, and contact information (including email address); (6) Authorized representative or U.S. agent (for a foreign applicant), including the name, address, and contact information (including email address); (7) For both the new and predicate tobacco products, the following information to uniquely identify the products: (i) Manufacturer; (ii) Product name, including the brand and sub brand (or other commercial name used in commercial distribution); and (iii) Product category, product subcategory, and product properties (if the product does not have a listed product property, e.g., Table 1 to § 1107.18 (c)(7)(iii) Tobacco product category Tobacco product subcategory Product properties (A) Cigarettes ( 1 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Ventilation ( e.g., —Characterizing Flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Characterizing Flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Ventilation ( e.g., —Characterizing Flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). (B) Roll-Your-Own Tobacco Products ( 1 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Width ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Ventilation ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 6 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Width ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 7 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product. (C) Smokeless Tobacco Products ( 1 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable, e.g., ( 2 —Package type ( e.g., —Product quantity ( e.g., —Portion count ( e.g., —Portion mass ( e.g., —Portion length ( e.g., —Portion width ( e.g., —Portion thickness ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type ( e.g., —Product quantity ( e.g., —Portion count ( e.g., —Portion mass ( e.g., —Portion length ( e.g., —Portion width ( e.g., —Portion thickness ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 6 —Package type ( e.g., —Product quantity ( e.g., —Portion count ( e.g., —Portion mass ( e.g., —Portion length ( e.g., —Portion width ( e.g., —Portion thickness ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 7 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 8 —Package type ( e.g., —Product quantity ( e.g., —Portion count ( e.g., —Portion mass ( e.g., —Portion length ( e.g., —Portion width ( e.g., —Portion thickness ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 9 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product. (D) Electronic Nicotine Delivery Systems (ENDS) (Vapes) ( 1 —Package type ( e.g., —Product quantity ( e.g., —E-liquid volume ( e.g., —Nicotine concentration ( e.g., —Propylene Glycol (PG)/Vegetable Glycerin (VG) ratio ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type ( e.g., —Product quantity ( e.g., —E-liquid volume ( e.g., —Nicotine concentration ( e.g., —PG/VG ratio ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., e.g., —Wattage ( e.g., —Battery capacity ( e.g., —E-liquid volume ( e.g., —Nicotine concentration ( e.g., —PG/VG ratio ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., e.g., —Wattage ( e.g., —Battery capacity ( e.g., —E-liquid volume ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 6 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product. (E) Cigars ( 1 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Ventilation ( e.g., —Characterizing flavor ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Tip ( e.g., —Characterizing flavor ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., h;Diameter ( e.g., —Wrapper material ( e.g., —Characterizing flavor ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 6 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product. (F) Pipe Tobacco Products ( 1 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type ( e.g., —Product quantity ( e.g., —Tobacco cut style ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product. (G) Waterpipe Tobacco Products ( 1 —Package type ( e.g., —Product quantity ( e.g., —Height ( e.g., —Width ( e.g., —Diameter ( e.g., —No. of hoses ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type ( e.g., —Product quantity ( e.g., —Portion count ( e.g., —Portion mass ( e.g., —Portion length ( e.g., —Portion width ( e.g., —Portion thickness ( e.g., —Source of energy ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). (H) Heated Tobacco Products (HTP) ( 1 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., —Diameter ( e.g., —Wattage ( e.g., —Battery capacity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 2 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., e.g., —Wattage ( e.g., —Battery capacity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 3 —Package type ( e.g., —Product quantity ( e.g., —Length ( e.g., e.g., —Ventilation ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 4 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). ( 5 —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). Other Other —Package type ( e.g., —Product quantity ( e.g., —Characterizing flavor(s) ( e.g., —Additional properties needed to uniquely identify the tobacco product (if applicable). (8) Address and the FDA Establishment Identifier number(s) of the establishments involved in the manufacture and/or importation of the new and predicate tobacco products. (d) Summary. (1) A concise description of the characteristics of the new tobacco product; (2) A statement as to whether the applicant believes the new tobacco product has the same characteristics as the predicate tobacco product or has different characteristics but any differences in characteristics do not cause the new tobacco product to raise different questions of public health; and (3) A concise description of the similarities and differences between the new tobacco product and the predicate tobacco product with respect to their characteristics (materials, ingredients, design, composition, heating source, or other features). (e) New tobacco product description. (1) A narrative description of the new tobacco product and detailed drawings or schematics of the new tobacco product, including its container closure system, illustrating all components or parts of the product. For a portioned tobacco product, the SE Report must also include a diagram illustrating all components or parts of the individual unit of use; (2) A description and the function of each component or part of the new tobacco product, and an explanation of how each component or part is integrated into the design of the new tobacco product; and (3) A concise overview of the process used to manufacture the new tobacco product. If the manufacturing process for the new tobacco product does not affect the characteristics of the new tobacco product beyond what is described elsewhere in the SE Report, an applicant must state that to satisfy this provision. (f) Description of predicate tobacco product. (2) A tobacco product to which a new tobacco product is compared must: (i) Have been either: (A) Commercially marketed (other than for test marketing) in the United States as of February 15, 2007, as shown by either specific information sufficient to support this in the SE Report, including a statement that “I, (insert name and position title of responsible official), confirm that the predicate tobacco product associated with this submission, (insert name of predicate tobacco product), was commercially marketed (other than for test marketing) in the United States as of February 15, 2007,” and, if applicable, reference to an STN for a previous determination by FDA that the predicate product was commercially marketed (other than for test marketing) in the United States as of February 15, 2007; or (B) Previously determined to be substantially equivalent by FDA; (ii) Be an individual product and not a composite of multiple products; (iii) Not be the subject of a rescission action by FDA, as described in § 1107.50; and (iv) Not have been removed from the market at the initiative of FDA and not have been determined by judicial order to be adulterated or misbranded. (g) Comparison information. e.g., (h) Comparative testing information. (1) Has the same characteristics as the predicate or (2) Does not raise different questions of public health. (i) Statement of compliance with applicable tobacco product standards. (1) List and describe the action(s) taken by the applicant to comply with applicable requirements under section 907 of the Federal Food, Drug, and Cosmetic Act; or (2) State there are no applicable requirements under section 907 of the Federal Food, Drug, and Cosmetic Act. (j) Health information summary or statement regarding availability of such information. (1) Health information summary. (i) Provide accurate, complete, and not false or misleading, additional health information, including information, research, or data about adverse health effects, that the applicant has or knows about concerning the new tobacco product that is not contained in the SE Report; or (ii) Provide the following statement, if true, about the new tobacco product: “Applicant does not have or know of any additional health information, including information, research or data regarding adverse health effects, about the new tobacco product that is the subject of this SE Report.” (2) Statement regarding availability of health information. the position held in company by person required to submit the SE Report, preferably the responsible official of the applicant company name (3) Content of health information. (i) Accurate, complete, and not false or misleading, additional health information, including information, research, or data about adverse health effects, that the applicant has or knows about concerning the new tobacco product and that is not contained in the SE Report; or (ii) The following statement, if true, about the new tobacco product: “( Company name (4) Requests for information. (5) No modified risk violations. (k) Compliance with part 25 of this chapter. (2) The environmental assessment must include a statement explaining whether the new tobacco product is intended to replace the predicate tobacco product after the new tobacco product receives market authorization, is intended to be a line extension of the predicate tobacco product, is intended to be introduced as an additional product by the same manufacturer, or if the new tobacco product will be introduced as an additional product but by a different manufacturer. (l) Certification statement. name of responsible official applicant applicant (2) The SE Report must include the following certification, as well as a justification for the certification, if an applicant chooses to certify that certain characteristics are identical in lieu of providing data for each characteristic of the new and predicate tobacco products. This certification must include the appropriate information inserted (as indicated by parenthetical text) and be signed by an authorized representative of the applicant: “I, ( name of responsible official name of company new tobacco product name name of predicate tobacco product describe modification(s), e.g., change in product quantity or change in container closure system name of company name of company § 1107.19 Comparison information. The SE Report must include a comparison of the characteristics of the new tobacco product to the predicate tobacco product. Where test data is submitted, the testing information must include the test protocols, quantitative acceptance criteria, and test results (including means and variances, data sets, and a summary of the results). Comparison testing must be conducted on a sufficient sample size and on test samples that reflect the finished tobacco product composition and design. The SE report must state whether the same test methods were used for the new tobacco product and the predicate product, and if the methods differed, an explanation as to how the results of the different test methods can be compared. The SE report must identify national and international standards used to test the new and predicate tobacco products and explain any deviations from the standard, or state that no standards were used for the testing. The SE report must include the following: (a) Comparison of product design. i.e., (1) Cigarettes. Table 1 to § 1107.19 (a)(1) Provide Target Specification With Upper and Lower Range Limits for: —Cigarette length (mm). —Cigarette circumference or diameter (mm). —Tobacco filler mass (mg). —Tobacco rod density (g/cm 3 —Tobacco moisture or oven volatiles (%). —Tobacco cut size (mm or cuts per inch (CPI)). —Filter ventilation (%). —Tipping paper length (mm). —Cigarette paper base paper porosity (CORESTA unit (CU)) or permeability. —Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigarette paper band width (mm). —Cigarette paper band space (mm). —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged ( e.g., 3 —Filter length (mm). —Filter pressure drop (mm H 2 Table 2 to § 1107.19 (a)(1) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Tobacco filler mass (mg). —Tobacco moisture (%) or oven volatiles (%). —Filter ventilation (%). —Tobacco cut size (mm or CPI). —Cigarette paper base paper porosity (CU). —Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged ( e.g., 3 —Filter pressure drop (mm H 2 (2) Smokeless Tobacco. Table 3 to § 1107.19 (a)(2) Provide Target Specification With Upper and Lower Range Limits for: Portioned Smokeless Tobacco Products: —Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). —Tobacco moisture (%). —Portion length (mm). —Portion width (mm). —Portion mass (mg). —Pouch material thickness (mm) (if applicable). —Pouch material porosity or permeability (CU or L/m 2 —Pouch material basis weight (g/m 2 —Nicotine dissolution rate (%/min) (if applicable). Non-portioned Smokeless Tobacco Products: —Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). —Tobacco moisture (%). Table 4 to § 1107.19 (a)(2) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: Portioned Smokeless Tobacco Products: —Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). —Tobacco moisture (%). —Portion mass (mg). —Pouch material porosity or permeability (CU or L/m 2 —Pouch material basis weight (g/m 2 —Nicotine dissolution rate (%/min) (if applicable). Non-portioned Smokeless Tobacco Products: —Tobacco cut size (mm or CPI) or tobacco particle size (mm or micron). —Tobacco moisture (%). (3) Roll-your-own tobacco, rolling papers. Table 5 to § 1107.19 (a)(3) Provide Target Specifications With Upper and Lower Range Limits for: —Paper length (mm). —Paper width (mm). —Mass per paper (mg). —Cigarette paper base paper basis weight (g/m 2 —Cigarette paper base paper porosity or permeability (CU). —Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigarette paper band width (mm) (if applicable). —Cigarette paper band space (mm) (if applicable). Table 6 to § 1107.19 (a)(3) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Mass per paper (mg). —Cigarette paper base paper basis weight (g/m 2 —Cigarette paper base paper porosity or permeability (CU). —Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 (4) Roll-your-own tobacco, non-filtered tubes. Table 7 to § 1107.19 (a)(4) Provide Target Specifications With Upper and Lower Range Limits for: —Tube length (mm). —Tube circumference or diameter (mm). —Tube mass (mg). —Cigarette paper base paper basis weight (g/m 2 —Cigarette paper base paper porosity (CU). —Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigarette paper band width (mm) (if applicable). —Cigarette paper band space (mm) (if applicable). Table 8 to § 1107.19 (a)(4) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Tube mass (mg). —Cigarette paper base paper basis weight (g/m 2 —Cigarette paper base paper porosity (CU). —Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 (5) Roll-your-own tobacco, filtered tubes. Table 9 to § 1107.19 (a)(5) Provide Target Specifications With Upper and Lower Range Limits for: —Tube length (mm). —Tube circumference or diameter (mm). —Tube mass (mg). —Tipping paper length (mm). —Filter ventilation (%). —Cigarette paper base paper basis weight (g/m 2 —Cigarette paper base paper porosity or permeability (CU). —Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigarette paper band width (mm) (if applicable). —Cigarette paper band space (mm) (if applicable). —Filter length (mm). —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged ( e.g., 3 —Filter pressure drop (mm H 2 Table 10 to § 1107.19 (a)(5) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Tube mass (mg). —Filter ventilation (%). —Cigarette paper base paper basis weight (g/m 2 —Cigarette paper base paper porosity or permeability (CU). —Cigarette paper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigarette filter is unchanged ( e.g., 3 —Filter pressure drop (mm H 2 (6) Roll-your-own tobacco. Table 11 to § 1107.19 (a)(6) Provide Target Specifications With Upper and Lower Range Limits for: —Tobacco cut size (mm or CPI). —Tobacco moisture (%) or oven volatiles (%). Table 12 to § 1107.19 (a)(6) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Tobacco cut size (mm or CPI). —Tobacco moisture (%) or oven volatiles (%). (7) Filtered, sheet-wrapped cigars. Table 13 to § 1107.19 (a)(7) Provide Target Specifications With Upper and Lower Range Limits for: —Cigar mass (mg). —Cigar wrapper basis weight (g/m 2 —Cigar binder length (mm). —Cigar binder width (mm). —Cigar binder basis weight (g/m 2 —Cigar length (mm). —Cigar overall diameter (mm). —Cigar minimum diameter (mm) (if applicable). —Cigar maximum diameter (mm) (if applicable). —Tobacco filler mass (mg). —Tobacco rod density (g/cm 3 —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). —Cigar wrapper porosity or permeability (CU). —Cigar wrapper length (mm). —Cigar wrapper width (mm). —Cigar wrapper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigar wrapper band width (mm) (if applicable). —Cigar wrapper band space (mm) (if applicable). —Tipping paper length (mm). —Cigar binder porosity or permeability (CU). —Cigar binder band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigar binder band width (mm) (if applicable). —Cigar binder band space (mm) (if applicable). —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the cigar filter is unchanged ( e.g., 3 —Filter pressure drop (mm H 2 —Filter length (mm). —Filter diameter (mm). —Filter ventilation (%). Table 14 to § 1107.19 (a)(7) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Cigar mass (mg). —Puff count. —Cigar wrapper basis weight (g/m 2 —Cigar wrapper porosity or permeability (CU). —Cigar binder porosity or permeability (CU). —Cigar binder basis weight (g/m 2 —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the filter is unchanged ( e.g., 3 —Tobacco filler mass (mg). —Tobacco rod density (g/cm 3 —Tobacco cut size (CPI or mm). —Tobacco moisture or oven volatiles (%). —Cigar wrapper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigar binder band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigar binder band width (mm) (if applicable). —Cigar binder band space (mm) (if applicable). —Cigar minimum diameter (mm) (if applicable). —Cigar maximum diameter (mm) (if applicable). —Filter ventilation (%). —Filter pressure drop (mm H 2 (8) Unfiltered, sheet-wrapped cigars. Table 15 to § 1107.19 (a)(8) Provide Target Specifications With Upper and Lower Range Limits for: —Cigar length (mm). —Cigar mass (mg). —Cigar overall diameter (mm). —Cigar minimum diameter (mm) (if applicable). —Cigar maximum diameter (mm) (if applicable). —Tobacco filler mass (mg). —Tobacco rod density (g/cm 3 —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). —Cigar wrapper porosity or permeability (CU). —Cigar wrapper length (mm). —Cigar wrapper width (mm). —Cigar wrapper basis weight (g/m 2 —Cigar binder porosity or permeability (CU). —Cigar binder width (mm) (if applicable). —Cigar binder basis weight (g/m 2 —Cigar tip mass (mg) (if applicable). —Tip length (mm) (if applicable). —Tip inner diameter (mm) (if applicable). —Cigar binder band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigar binder band width (mm) (if applicable). —Cigar binder band space (mm) (if applicable). —Cigar wrapper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigar wrapper band width (mm) (if applicable). —Cigar wrapper band space (mm) (if applicable). Table 16 to § 1107.19 (a)(8) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Puff count. —Cigar mass (mg). —Tobacco rod density (g/cm 3 —Tobacco cut size (CPI or mm). —Tobacco moisture or oven volatiles (%). —Tobacco filler mass (mg). —Cigar wrapper basis weight (g/m 2 —Cigar wrapper porosity or permeability (CU). —Cigar binder width (mm) (if applicable). —Cigar binder basis weight (g/m 2 —Cigar binder porosity or permeability (CU). —Cigar wrapper band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigar binder band porosity or permeability (CU) (alternately, band diffusivity (cm 2 —Cigar tip mass (mg) (if applicable). —Cigar minimum diameter (mm) (if applicable). —Cigar maximum diameter (mm) (if applicable). (9) Unfiltered, leaf-wrapped cigars. Table 17 to § 1107.19 (a)(9) Provide Target Specifications With Upper and Lower Range Limits for: —Cigar length (mm). —Cigar mass (mg). —Overall diameter (mm). —Cigar minimum diameter (mm) (if applicable). —Cigar maximum diameter (mm) (if applicable). —Tobacco filler mass (mg). —Tobacco rod density (g/cm 3 —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). —Cigar wrapper length (mm). —Cigar wrapper width (mm). —Cigar wrapper basis weight (g/m 2 —Cigar binder width (mm). —Cigar binder basis weight (g/m 2 Table 18 to § 1107.19 (a)(9) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Puff count. —Cigar mass (mg). —Tobacco filler mass (mg). —Tobacco rod density (g/cm 3 —Tobacco cut size (CPI or mm). —Cigar wrapper basis weight (g/m 2 —Cigar binder basis weight (g/m 2 —Tobacco moisture or oven volatiles (%). —Cigar minimum diameter (mm) (if applicable). —Cigar maximum diameter (mm) (if applicable). (10) Cigar filler. Table 19 to § 1107.19 (a)(10) Provide Target Specifications With Upper and Lower Range Limits for: —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). Table 20 to § 1107.19 (a)(10) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). (11) Cigar component. Table 21 to § 1107.19 (a)(11) Provide Target Specifications With Upper and Lower Range Limits for: —Cigar wrapper length (mm). —Cigar wrapper width (mm). —Cigar wrapper porosity (CU). —Cigar wrapper basis weight (g/m 2 Table 22 to § 1107.19 (a)(11) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Cigar wrapper length (mm). —Cigar wrapper width (mm). —Cigar wrapper basis weight (g/m 2 (12) Pipes. Table 23 to § 1107.19 (a)(12) Provide Target Specifications With Upper and Lower Range Limits for: —Bowl chamber outer diameter (mm). —Bowl chamber inner diameter (mm). —Draught hole diameter (mm). —Draught hole location. —Draught hole shape. —Bowl chamber hole shape. —Bowl chamber volume (cm 3 —Stem length (mm). —Stem diameter (mm). —Shank length (mm). —Shank diameter (mm). —Draught hole area (mm 2 —Pressure drop through air valve (mm H 2 —Air flow through air valve (cc/min). —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the filter is unchanged ( e.g., 3 —Filter pressure drop (mm H 2 —Filter length (mm). Table 24 to § 1107.19 (a)(12) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Bowl chamber volume (cm 3 —Air flow through air valve (cc/min). —Filter length (mm). —Filter pressure drop (mm H 2 —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the filter is unchanged ( e.g., 3 (13) Pipe filler. Table 25 to § 1107.19 (a)(13) Provide Target Specifications With Upper and Lower Range Limits for: —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). Table 26 to § 1107.19 (a)(13) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). (14) Waterpipes. Table 27 to § 1107.19 (a)(14) Provide Target Specifications With Upper and Lower Range Limits for: —Hose length (mm). —Hose internal diameter (mm). —Hose materials. —Stem length (mm). —Stem internal diameter (mm). —Base diameter (mm). —Base volume (cm 3 —Base shape. —Pressure drop (mm H 2 —Water filter efficiency (%). —Hose air permeability (CU). —Head height (mm). —Head top diameter (mm). —Head bottom diameter (mm). —No. of holes. —Head volume (mm 3 —Heating source type. —Head materials. Table 28 to § 1107.19 (a)(14) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Hose length (mm). —Hose internal diameter (mm). —Stem length (mm). —Stem internal diameter (mm). —Base diameter (mm). —Base volume (cm 3 —Pressure drop (mm H 2 —Water filter efficiency (%). —Head height (mm). —Head top diameter (mm). —Head bottom diameter (mm). —Head volume (mm 3 (15) Waterpipe, heating source. Table 29 to § 1107.19 (a)(15) Provide Target Specifications With Upper and Lower Range Limits for: —Heating element mass (mg). —Heating element density (g/cm 3 —Heating element resistance (ohms) (if applicable). —No. of heating elements. —Heating element configuration. —Heating element diameter (gauge). —Battery current rating (mA) (if applicable). —Battery capacity (mAh) (if applicable). —Battery voltage operating range (volts) (if applicable). —Battery current operating range (amps) (if applicable). —Power delivery unit (PDU) voltage operating range (volts) (if applicable). —PDU current operating range (amps) (if applicable). —PDU wattage operating range (watts) (if applicable). —PDU temperature cut-off ( °C) (if applicable). Table 30 to § 1107.19 (a)(15) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Heating element temperature range ( °C) (if applicable). —Heating element mass (mg). —Heating element density (g/cm 3 —Heating element resistance (ohms) (if applicable). —Heating element diameter (gauge). —Battery current rating (mA) (if applicable). —Battery capacity (mAh) (if applicable). —Battery voltage operating range (volts) (if applicable). —Battery current operating range (amps) (if applicable). —Power delivery unit (PDU) voltage operating range (volts) (if applicable). —PDU current operating range (amps) (if applicable). —PDU wattage operating range (watts) (if applicable). —PDU temperature cut-off ( °C) (if applicable). (16) Waterpipe component, head. Table 31 to § 1107.19 (a)(16) Provide Target Specifications With Upper and Lower Range Limits for: —Head height (mm). —Head top diameter (mm). —Head bottom diameter (mm). —No. of holes. —Head volume (mm 3 —Head materials. Table 32 to § 1107.19 (a)(16) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Head height (mm). —Head top diameter (mm). —Head bottom diameter (mm). —Head volume (mm 3 (17) Waterpipe component, foil. Table 33 to § 1107.19 (a)(17) Provide Target Specifications With Upper and Lower Range Limits for: —Length (mm) (for square or rectangular shape foil). —Width (mm) (for square or rectangular shape foil). —Diameter (mm) (for circular shape foil). —Foil thickness (mm). —No. of holes. —Diameter of the holes (mm). Table 34 to § 1107.19 (a)(17) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Length (mm) (for square or rectangular shape foil). —Width (mm) (for square or rectangular shape foil). —Diameter (mm) (for circular shape foil). —Foil thickness (mm). —Diameter of the holes (mm). (18) Waterpipe filler. Table 35 to § 1107.19 (a)(18) Provide Target Specifications With Upper and Lower Range Limits for: —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). Table 36 to § 1107.19 (a)(18) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Tobacco moisture or oven volatiles (%). —Tobacco cut size (CPI or mm). (19) Electronic Nicotine Delivery System (ENDS). Table 37 to § 1107.19 (a)(19) Provide Target Specifications With Upper and Lower Range Limits for: —Draw resistance (mm H 2 —Puff count (for full tank/cartridge). —Atomizer tank/cartridge volume (mL). —No. of heating elements ( e.g., —Heating element diameter (gauge). —Heating element length (mm). —Heating element resistance (Ohms). —Heating element temperature range ( °C). —Heating element configuration (target only). —Battery voltage operating range (V). —Battery current operating range (mA). —Battery capacity (mAh). —Battery nominal voltage (V). —Battery current rating (mA). —Battery charging temperature limits ( °C). —Battery discharge temperature limits ( °C). —Battery end of discharge voltage (V). —Battery maximum charging current (mA). —Battery maximum discharging current (mA). —Battery upper limits charging voltage (V). —Power Delivery Unit (PDU) voltage operating range (V). —PDU current operating range (mA). —PDU wattage operating range (watts). —PDU temperature cut-off ( °C) (if applicable). —PDU current cut-off (mA) (if applicable). —Airflow rate (L/min) (if applicable). —Ventilation (%). —Inhaled aerosol temperature ( °C). Table 38 to § 1107.19 (a)(19) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Draw resistance (mm H 2 —Puff count (for full tank/cartridge). —Atomizer tank/cartridge volume (mL). —Heating element diameter (gauge). —Heating element resistance (Ohms). —Heating element temperature range ( °C). —Battery voltage operating range (V). —Battery current operating range (mA). —PDU voltage operating range (V). —PDU current operating range (mA). —PDU wattage operating range (watts). —PDU current cut-off (mA) (if applicable). —Inhaled aerosol temperature ( °C). —PDU temperature cut-off ( °C) (if applicable). —Battery capacity (mAh). —Battery nominal voltage (V). —Battery current rating (mA). —Heating element length (mm). —Battery charging temperature limits ( °C). —Battery discharge temperature limits ( °C). —Battery maximum charging current (mA). —Battery maximum discharging current (mA). —Battery upper limits charging voltage (V). —Airflow rate (L/min) (if applicable). —Ventilation (%). (20) E-liquids. Table 39 to § 1107.19 (a)(20) Provide Target Specifications With Upper and Lower Range Limits for: —E-liquid viscosity (at 20 °C). —E-liquid volume (ml). —Particle number concentration (#/cm 3 —Count median diameter (nm). —PM 2.5 3 Table 40 to § 1107.19 (a)(20) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —E-liquid viscosity (at 20 °C). —E-liquid volume (ml). —Particle number concentration (#/cm 3 —Count median diameter (nm). —PM 2.5 3 (21) Heated Tobacco Products (HTP). Table 41 to § 1107.19 (a)(21) Provide Target Specifications With Upper and Lower Range Limits for: —Overall Device: —Mass (mg). —Length (mm). —Width (mm). —Height (mm). —Diameter (mm). —Draw resistance (mm H 2 —Puff count (for full tank/cartridge). —Puff volume (mL). —Product volume (mL). —Airflow rate (L/min) (if applicable). —Ventilation (%). —Operational temperature ( °C). —Temperature sensor (if applicable). —Material wrapper length (mm) (if applicable). —Material wrapper width (mm) (if applicable). —Material wrapper basis weight (g/m 2 —Material porosity or permeability (CU) (if applicable). —Heating element: —Heating element source/type/approach (electrical, carbon, aerosol, etc.). —Heating element temperature range ( °C). —Heating element operational temperature ( °C). —Heating element maximum temperature (boost temperature) ( °C). —Heating element material. —Heating element configuration. —Heating element length (mm). —Heating element mass (mg). —Heating element location. —No. of heating elements ( e.g., —Heating element diameter (gauge) (if applicable). —Heating element resistance (Ohms) (if applicable). —Tobacco/E-liquid: —Tobacco mass (mg) (if applicable). —Tobacco density (g/cm 3 —Tobacco moisture or oven volatiles (%) (if applicable). —Tobacco cut size (CPI or mm) (if applicable). —E-liquid volume (mL) (if applicable). —E-liquid viscosity (at 20 °C) (if applicable). —Battery (if applicable): —Battery capacity (mAh). —Battery voltage operating range (V) or wattage (W). —Battery current charging range (amps). —Battery nominal voltage (V). —Battery current rating (mA). —Battery charging temperature limits ( °C). —Battery discharge temperature limits ( °C). —Battery end of discharge voltage (V). —Battery maximum charging current (mA). —Battery maximum discharging current (mA). —Battery upper limits charging voltage (V). —Power Delivery Unit (PDU) voltage operating range (V). —PDU current operating range (mA). —PDU wattage operating range (watts). —PDU temperature cut-off ( °C) (if applicable). —PDU current cut-off (mA) (if applicable). —Aerosol: —Inhaled aerosol temperature ( °C). —Aerosol particle number concentration (#/cm 3 —Count median diameter (nm). —PM 2.5 3 —Filter (if applicable): —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the filter is unchanged ( e.g., 3 —Filter pressure drop (mm H 2 —Filter length (mm). —Filter diameter (mm). —Filter ventilation (%). Table 42 to § 1107.19 (a)(21) Where Test Data Are Necessary, As Explained in Paragraph (a) of This Section, Provide This Information for the Following Parameters: —Overall device: —Draw resistance (mm H 2 —Puff count (for full tank/cartridge) (dimensionless). —Product volume (mL). —Airflow rate (L/min) (if applicable). —Ventilation (%). —Operational temperature ( °C). —Temperature sensor (if applicable). —Material wrapper length (mm) (if applicable). —Material wrapper width (mm) (if applicable). —Material wrapper basis weight (g/m 2 —Material porosity or permeability (CU) (if applicable). —Heating element: —Heating element diameter (gauge) (if applicable). —Heating element resistance (Ohms) (if applicable). —Heating element temperature range ( °C). —E-liquid: —E-liquid viscosity (at 20 °C) (if applicable). —E-liquid volume (ml) (if applicable). —Tobacco: —Tobacco moisture or oven volatiles (%) (if applicable). —Tobacco cut size (CPI or mm) (if applicable). —Tobacco density (g/cm 3 —Battery: —Battery voltage operating range (V) or wattage (W). —Battery current operating range (mA). —PDU voltage operating range (V). —PDU current operating range (mA). —PDU wattage operating range (watts). —PDU current cut-off (mA) (if applicable). —PDU temperature cut-off ( °C) (if applicable). —Battery capacity (mAh). —Battery nominal voltage (V). —Battery current rating (mA). —Battery charging temperature limits ( °C). —Battery discharge temperature limits ( °C). —Battery maximum charging current (mA). —Battery maximum discharging current (mA). —Battery upper limits charging voltage (V). —Aerosol: —Inhaled aerosol temperature ( °C). —Aerosol particle number concentration (#/cm 3 —Count median diameter (nm). —PM 2.5 3 —Filter (if applicable): —Filter efficiency (%) (If no filter efficiency data is available for the products, include information sufficient to show that the filter is unchanged ( e.g., 3 —Filter ventilation (%). —Filter pressure drop (mm H 2 (b) Comparison of heating sources. (c) Comparison of product composition. (1) Materials. (i) The material name and common name(s), if applicable; (ii) The component or part of the tobacco product where the material is located; (iii) The subcomponent or subpart where the material is located, if applicable; (iv) The function of the material; (v) The quantities (including ranges or means, acceptance limits) of the material(s) in each new tobacco product and predicate tobacco product (with any specification variation, if applicable); (vi) The specification(s) (including quality/grades, suppliers) used for the new tobacco product and predicate tobacco product (with any specification variations, if applicable); and (vii) Any other material properties necessary to characterize the new and predicate tobacco products. (2) Ingredients other than tobacco. (i) The International Union of Pure and Applied Chemistry (IUPAC) chemical name and common name, if applicable; (ii) The Chemical Abstracts Service (CAS) number(s) or FDA Unique Ingredient Identifier (UNII); (iii) The function of the ingredient; (iv) The quantity with the unit of measure (including ranges or means, acceptance limits) of the ingredient in the new tobacco product and predicate tobacco product reported as mass per gram of tobacco for non-portioned tobacco products and as mass per portion for portioned tobacco products (with any specification variation, if applicable); (v) The specification(s) (including purity or grade and supplier); (vi) For complex purchased ingredients, each single chemical substance reported separately; and (vii) Any other ingredient information necessary to characterize the new and predicate tobacco products. (3) Tobacco ingredients. (i) The type ( e.g., (ii) The curing method ( e.g., (iii) The quantity of each type with the unit of measure (including ranges or means, acceptance limits) of tobacco in the new tobacco product and predicate tobacco product reported as mass per gram of tobacco for non-portioned tobacco products and as mass per portion for portioned tobacco products; (iv) A description of any genetic engineering of the tobacco; and (v) Any other information necessary to characterize the new and predicate tobacco products. (vi) If the new tobacco product does not contain tobacco, then include a statement that the new tobacco product does not contain tobacco. (4) Container closure system. (d) Comparison of other features. (1) Constituents. (i) The new tobacco product has the same characteristics as the predicate tobacco product, or (ii) Any differences in characteristics between the new and predicate product do not cause the new tobacco product to raise different questions of public health, including: (A) The constituent names in alphabetical order; (B) The common name(s); (C) The Chemical Abstract Services number(s); (D) The mean quantity and variance with unit of measure; (E) The number of samples and measurement replicates for each sample; (F) The analytical methods used, associated reference(s), and full validation reports for each analytical method; (G) The testing laboratory or laboratories and documentation showing that the laboratory or laboratories is (or are) accredited by a nationally or internationally recognized external accreditation organization; (H) Length of time between dates of manufacture and date(s) of testing; (I) Storage conditions of the tobacco product before it was tested; (J) Reference product datasets (if applicable); (K) Full test data (including test protocols, any deviation(s) from the test protocols, quantitative acceptance (pass/fail) criteria and complete data sets) for all testing performed. Test data for combusted or inhaled tobacco products must reflect testing conducted using both intense and non-intense smoking or aerosol-generating regimens, where established; and (L) Complete descriptions of any smoking or aerosol-generating regimens used for analytical testing that are not standardized or widely accepted by the scientific community, if applicable. (2) Any other features. (e) Comparison of tobacco processing. (1) Fermentation process. (i) Description of the fermentation process; (ii) Composition of the inoculum (starter culture) with genus and species name(s) and concentration(s) (if applicable); (iii) Any step(s) taken to reduce microbes already present during processing ( e.g., (iv) Specifications and test data for pH, temperature, and moisture content or water activity; (v) Frequency of aeration or turning (if applicable); (vi) Duration of fermentation; (vii) Added ingredients; (viii) Method used to stabilize or stop fermentation (( e.g., e.g., (ix) Storage conditions of the fermented tobacco prior to further processing or packaging and duration of storage (if applicable). (2) Heat treatment process. (i) Description of the heat treatment process; (ii) Type of heat treatment; (iii) Conditions of heat treatment, including time, temperature, and moisture; and (iv) Method validation data, including microbial loads (including bacteria, spores, yeast and fungi) and tobacco-specific nitrosamines (TSNAs) before and after heat treatment. (f) Shelf life and stability information. (1) The length of the shelf life, a description of how shelf life is determined, and a description of how shelf life is indicated on the tobacco product, if applicable. If a tobacco product does not have a defined shelf life, state as such; (2) Any known or expected impacts of the differences between the new and predicate products on the product stability. If no impact is known or expected, state that; (3) Stability data assessed at the beginning (zero time), middle, and end of the expected shelf life. If a tobacco product does not have a defined shelf life, provide stability data over a specified amount of time and a justification for why that time period is appropriate. Stability testing must be performed for the microbial and chemical endpoints as follows: (i) Microbial content data including total aerobic microbial count and total yeast and mold count; (ii) Water activity; and (iii) Tobacco-specific nitrosamine yields (total, N-nitrosonornicotine (NNN), and 4-methylnitrosamino)-1-(3-pydridyl)-1-butanone) (NNK)). (4) Stability testing details for each microbial and chemical endpoint, including: (i) The mean quantity and variance with unit of measure; (ii) The number of samples and measurement replicates for each sample; (iii) The methods used, associated reference(s), and full validation reports for each method (as applicable); (iv) The testing laboratory or laboratories and documentation showing that the laboratory or laboratories is (or are) accredited by a nationally or internationally recognized external accreditation organization; (v) Length of time between dates of tobacco product manufacture and date(s) of testing; (vi) Storage conditions of the tobacco products before they were tested; (vii) A statement that the testing was performed on a tobacco product in the same container closure system in which the tobacco product is intended to be marketed; and (viii) Full test data (including test protocols, any deviation(s) from the test protocols, quantitative acceptance (pass/fail) criteria, complete data sets, and a summary of the results) for all stability testing performed. (g) Applicant's basis for substantial equivalence determination. (1) The same characteristics as the predicate tobacco product and the basis for this determination, or (2) Different characteristics than the predicate tobacco product. Where an applicant states that its new tobacco product has different characteristics than the predicate tobacco product, the applicant must also include an explanation as to why a difference in any of the following characteristics do not cause the new product to raise different questions of public health: Product design (paragraph (a) of this section); heating source (paragraph (b) of this section); materials and ingredients (paragraph (c) of this section); and other features (paragraph (d) of this section). In addition, to demonstrate that a new tobacco product is substantially equivalent, an applicant must also explain why any differences in the manufacturing process between the new tobacco product and the predicate tobacco product would not change the characteristics of the new tobacco product such that the new tobacco product could raise different questions of public health (§ 1107.18(e)). Similarly, for smokeless tobacco products and tobacco products that contain fermented tobacco, an applicant must explain why any difference in stability between the new tobacco product and the predicate tobacco product does not cause the new tobacco product to raise different questions of public health (paragraph (f) of this section). (h) Comparison to original predicate tobacco product. § 1107.20 Amendments. (a) Except as provided in paragraphs (b) and (c) of this section, the applicant may submit an amendment to an SE Report in accordance with subpart C of this part. If an applicant chose to submit a health information summary with its SE Report under § 1107.18(j)(1), the applicant must submit with the amendment a redacted copy of the amendment that excludes research subject identifiers and trade secret and confidential commercial information as defined in §§ 20.61 and 20.63 of this chapter. (b) An applicant may not amend an SE Report to change the predicate tobacco product. (c) An applicant may not amend an SE Report after FDA has closed the SE Report under § 1107.44 or it has been withdrawn under § 1107.22. (d) In general, amendments will be reviewed in the next review cycle as described in § 1107.42. § 1107.22 Withdrawal by applicant. (a) An applicant may at any time make a written request to withdraw an SE Report for which FDA has not issued an order. The withdrawal request must state: (1) Whether the withdrawal is due to a health or safety concern related to the tobacco product; (2) The submission tracking number; and (3) The name of the new tobacco product that is the subject of the SE Report. (b) An SE Report will be considered withdrawn when FDA issues a notice stating the SE Report has been withdrawn. (c) The SE Report is an Agency record, even if withdrawn. FDA will retain the withdrawn SE Report under Federal Agency records schedules. The availability of the withdrawn SE Report will be subject to FDA's public information regulations in part 20 of this chapter. § 1107.24 Change in ownership of an SE Report. An applicant may transfer ownership of its SE Report. On or before the time of transfer, the new and former applicants are required to submit information to FDA as follows: (a) The former applicant must sign and submit a notice to FDA that states that all of the former applicant's rights and responsibilities relating to the SE Report have been transferred to the new applicant. This notice must identify the name and address of the new applicant and the SE Report transferred. (b) The new applicant must sign and submit a notice to FDA containing the following: (1) The new applicant's commitment to agreements, promises, and conditions made by the former applicant and contained in the SE Report; (2) The date that the change in ownership is effective; (3) Either a statement that the new applicant has a complete copy of the SE Report and order (if applicable), including amendments and records that are required to be kept under § 1107.58, or a request for a copy of the SE Report from FDA's files by submitting a request in accordance with part 20 of this chapter. In accordance with the Freedom of Information Act, FDA will provide a copy of the SE Report to the new applicant under the fee schedule in FDA's public information regulations in § 20.45 of this chapter; and (4) A certification that no modifications have been made to the new tobacco product since the SE Report was submitted to FDA. Subpart D—FDA Review Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted. § 1107.40 Communications between FDA and applicants. (a) General principles. (b) Meeting. (c) Acceptance of an SE Report for review. (d) Notification of deficiencies in an SE Report submitted under § 1107.18. (e) Withdrawal of SE Report. § 1107.42 Review cycles. (a) Initial review cycle. (b) Additional review cycles. (c) Inadequate response. § 1107.44 FDA action on an SE Report. After receipt of an SE Report, FDA will: (a) Refuse to accept the SE Report for review if it does not comply with § 1107.18 and § 1105.10 of this chapter; (b) Request additional information as provided in § 1107.40(d); (c) Issue a letter administratively closing the SE Report if it is not possible to make a determination on an SE Report; (d) Issue a letter canceling the SE Report if FDA finds the SE Report was created in error; (e) Issue an order as described in § 1107.46 finding the new tobacco product to be substantially equivalent and in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act; or (f) Issue an order as described in § 1107.48 denying marketing authorization because the new tobacco product is: (1) Not substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States on February 15, 2007, or (2) Not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. § 1107.46 Issuance of an order finding a new tobacco product substantially equivalent. If FDA finds that the information submitted in the SE Report establishes that the new tobacco product is substantially equivalent to a predicate tobacco product that was commercially marketed (other than for test marketing) in the United States on February 15, 2007, and finds that the new tobacco product is in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, FDA will send the applicant an order authorizing marketing of the new tobacco product. A marketing authorization order becomes effective on the date the order is issued. § 1107.48 Issuance of an order denying marketing authorization. (a) General. (1) The information submitted in the SE Report does not establish that the new tobacco product is substantially equivalent to a predicate tobacco product that was commercially marketed (other than for test marketing) in the United States on February 15, 2007; or (2) The new tobacco product is not in compliance with the Federal Food, Drug, and Cosmetic Act. (b) Basis for order. § 1107.50 Rescission of order. (a) Grounds for rescinding a substantially equivalent order. (1) The tobacco product for which the order has been issued: (i) Does not have the same characteristics as the predicate tobacco product; or (ii) Has different characteristics and there is insufficient information demonstrating that it is not appropriate to require a premarket tobacco product application under section 910(b) of the Federal Food, Drug, and Cosmetic Act because the product does not raise different questions of public health; or (2) The SE Report (including any submitted amendments) contains an untrue statement of material fact; or (3) Concerning an SE Report that compared the new tobacco product to a tobacco product that FDA previously found substantially equivalent, (i) The predicate tobacco product relied on in the SE Report has been found ineligible because its SE Report (including any amendments) contains an untrue statement of material fact; or (ii) A predicate tobacco product on which any of the previous substantial equivalence determinations was based, going back to the original predicate tobacco product, has been found ineligible because its SE Report (including any amendments) contains an untrue statement of material fact; or (4) FDA or the applicant has removed from the market, due to a health or safety concern related to the tobacco product: (i) The predicate tobacco product on which the substantial equivalence determination is based; or (ii) A predicate tobacco product on which any of the previous substantial equivalence determinations is based, going back to the original predicate tobacco product, if the substantial equivalence SE Report compared the new tobacco product to a tobacco product that FDA previously found substantially equivalent. (b) Opportunity for a hearing. (2) FDA may rescind a substantially equivalent order prior to notice and opportunity for a hearing under part 16 of this chapter if it finds that there is a reasonable probability that continued marketing of the tobacco product presents a serious risk to public health. In that case, FDA will provide the manufacturer an opportunity for a hearing as soon as possible after the rescission. (3) FDA may rescind a substantially equivalent order without notice and opportunity for a hearing under part 16 of this chapter if the applicant has notified the Agency of a mistake in the application, FDA has determined that the mistake is part of the underlying scientific determination of the order which makes the order invalid, and the applicant has agreed that FDA can rescind the order without providing notice and opportunity for a hearing under part 16 of this chapter. Subpart E—Miscellaneous Source: 86 FR 55275, Oct. 4, 2021, unless otherwise noted. § 1107.58 Record retention. Each applicant that receives an order under § 1107.46 authorizing the marketing of a new tobacco product must maintain all records required by this subpart and that support the SE Report for a substantial equivalence order. These records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. All records must be retained for a period of not less than 4 years from the date of the order even if such product is discontinued. § 1107.60 Confidentiality. (a) General. (b) Confidentiality of data and information prior to an order. (1) FDA will not publicly disclose the existence of an SE Report unless: (i) The tobacco product has been introduced or delivered for introduction into interstate commerce for commercial distribution; or (ii) The applicant has publicly disclosed or acknowledged the existence of the SE Report (as such disclosure is defined in § 20.81 of this chapter), or has authorized FDA in writing to publicly disclose or acknowledge, that the applicant has submitted the SE Report to FDA. (2) FDA will not disclose the existence of or contents of an FDA communication with an applicant regarding its SE Report except to the extent that the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, the existence of or contents of that particular FDA communication. (3) FDA will not disclose information contained in an SE Report unless the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, that particular information. If the applicant has publicly disclosed or acknowledged, or authorized FDA in writing to publicly disclose or acknowledge, that particular information contained in an SE Report, FDA may disclose that particular information. (c) Disclosure of data and information after issuance of an order under § 1107.46. (1) All data previously disclosed to the public, as such disclosure is defined in § 20.81 of this chapter; (2) Any protocol for a test or study, except to the extent it is shown to fall within the exemption established for trade secrets and confidential commercial information in § 20.61 of this chapter; (3) Information and data submitted to demonstrate that the new tobacco product does not raise different questions of public health, except to the extent it is shown to fall within the exemptions established in § 20.61 of this chapter for trade secrets and confidential commercial information, or in § 20.63 of this chapter for personal privacy; (4) Correspondence between FDA and the applicant, including any requests FDA made for additional information and responses to such requests, and all written summaries of oral discussions between FDA and the applicant, except to the extent it is shown to fall within the exemptions in § 20.61 of this chapter for trade secrets and confidential commercial information, or in § 20.63 of this chapter for personal privacy; and (5) In accordance with § 25.51 of this chapter, the environmental assessment or, if applicable, the claim of categorical exclusion from the requirement to submit an environmental assessment under part 25 of this chapter. (d) Disclosure of data and information after issuance of an order under § 1107.48. e.g., e.g., (e) Health information summary or statement. § 1107.62 Electronic submission. (a) Electronic format requirement. (b) Waivers from electronic format requirement. www.fda.gov/tobaccoproducts (1) The name and address of the applicant, list of individuals authorized for the applicant to serve as the contact person, and contact information including an email address. If the applicant has submitted an SE Report previously, the regulatory correspondence must also include any identifying information for the previous submission. (2) A statement that creation and/or submission of information in electronic format is not reasonable for the person requesting the waiver, and an explanation of why creation and/or submission in electronic format is not reasonable. This statement must be signed by the applicant or by an employee of the applicant who is authorized to make the declaration on behalf of the applicant. (c) Paper submission.