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. The SE Report must include a description of the product designs of the new and predicate tobacco products and an identification of any differences. The SE Report must include, in a tabular format, a side-by-side comparison of each design parameter of the new and predicate tobacco products. The target specification and upper and lower range limits must be provided for each design parameter. Test data (including test protocols, quantitative acceptance criteria, data sets (i.e., measured values), and a summary of the results) must be provided for the new and predicate tobacco products when the target specification or range limits of the new tobacco product differ from the predicate tobacco product. For tobacco cut size or particle size, when target specifications and range limits are not available, the following alternative information may be submitted in place of this information: A description of the tobacco cutting process (including a complete description of the milling, cutting, and sifting process; the control parameters of the miller or cutter; and any sift specifications) or the measured particle size distribution for the new and predicate tobacco products.

(1) Cigarettes. For cigarettes, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(2) Smokeless Tobacco. For portioned and non-portioned smokeless tobacco products, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(3) Roll-your-own tobacco, rolling papers. For roll-your-own tobacco rolling papers, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(4) Roll-your-own tobacco, non-filtered tubes. For roll-your-own tobacco non-filtered tubes, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(5) Roll-your-own tobacco, filtered tubes. For roll-your-own tobacco filtered tubes, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(6) Roll-your-own tobacco. For roll-your-own tobacco, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(7) Filtered, sheet-wrapped cigars. For filtered, sheet-wrapped cigars, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(8) Unfiltered, sheet-wrapped cigars. For unfiltered, sheet-wrapped cigars, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(9) Unfiltered, leaf-wrapped cigars. For unfiltered, leaf-wrapped cigars, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(10) Cigar filler. For cigar filler, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(11) Cigar component. For cigar components, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(12) Pipes. For pipes, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(13) Pipe filler. For pipe filler, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(14) Waterpipes. For waterpipes, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(15) Waterpipe, heating source. For waterpipe heating sources, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(16) Waterpipe component, head. For waterpipe heads, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(17) Waterpipe component, foil. For waterpipe foil, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(18) Waterpipe filler. For waterpipe filler, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(19) Electronic Nicotine Delivery System (ENDS). For ENDS (vapes), the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(20) E-liquids. For e-liquids, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(21) Heated Tobacco Products (HTP). For HTPs, the required design parameter information to be provided for each predicate and new tobacco product is as follows:

(b) Comparison of heating sources. The SE Report must include a description of the heating source for the new and predicate tobacco products and identify any differences, or state that there is no heating source.

(c) Comparison of product composition. The SE Report must include descriptions of the product composition of the new and predicate tobacco products and identify any differences. The SE Report must include, in a tabular format, a side-by-side comparison of the materials and ingredients for each component or part of the new and predicate tobacco products. For each material and ingredient quantity, the target specifications and range of acceptable values, actual measured value (where applicable), and range of measured values (where applicable) reported as mass per component or part, must be provided.

(1) Materials. For each material in the products include:

(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. For each ingredient other than tobacco in each material or component or part of the product include:

(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. For tobacco include:

(i) The type (e.g., Bright, Burley, reconstituted);

(ii) The curing method (e.g., flue cured, dark air cured);

(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. A description of the container closure system for the new and predicate tobacco products, including a side-by-side quantitative comparison of the components and materials and annotated illustrations.

(d) Comparison of other features. The SE Report must include descriptions of any other features of the new and predicate tobacco products, such as those described in paragraphs (d)(1) and (2) of this section, and identify any differences. If a specific feature specified in paragraphs (d)(1) and (2) of this section is not applicable to the product design, this must be stated clearly. If FDA requests a scientific justification explaining why a feature is not applicable, the applicant must provide the justification to FDA. The comparison of other features must include information on:

(1) Constituents. HPHCs and other constituents, as appropriate, to demonstrate that:

(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. A description and comparison of any other features of the new tobacco product and the predicate tobacco product.

(e) Comparison of tobacco processing. The SE Report must include information on the tobacco processes in paragraphs (e)(1) and (2) of this section for the new and predicate tobacco products, if applicable, and identify any differences.

(1) Fermentation process. For smokeless tobacco products and tobacco products that contain fermented tobacco (including naturally fermented tobacco), the SE Report must contain the following information regarding the fermentation process of the new and predicate tobacco products and identify any differences:

(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., cleaning of contact surfaces);

(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., heat treatment), if applicable), including parameters of the method (e.g., length of treatment, temperature) and method validation data; and

(ix) Storage conditions of the fermented tobacco prior to further processing or packaging and duration of storage (if applicable).

(2) Heat treatment process. For tobacco products that are heat treated, the SE Report must contain the following information regarding the heat treatment process of the new and predicate tobacco products and identify any differences:

(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. With the exception of SE Reports for roll-your-own tobacco products and cigarettes that are not HTPs, SE Reports for all tobacco products must contain information on the stability of the new and predicate tobacco products over the shelf life, including the following 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. The applicant must state that the new tobacco product has either:

(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. If the applicant is comparing the new tobacco product to a predicate tobacco product that FDA has previously found to be substantially equivalent, FDA may request that the applicant include information related to the original predicate tobacco product that was commercially marketed (other than for test marketing) in the United States as of February 15, 2007, even if that original predicate tobacco product is back several predicate tobacco products. FDA will request this information when necessary to ensure that any order the Agency issues finding the new tobacco product substantially equivalent complies with section 910(a)(2)(A)(i)(I) of the Federal Food, Drug, and Cosmetic Act. FDA may need to review the first SE Report that received a finding of substantial equivalence using the original predicate tobacco product as a predicate tobacco product in order to make this finding.