21 CFR 1107.18 - Required content and format of an SE Report.

View all text of Subpart C [§ 1107.16 - § 1107.24]

§ 1107.18 - Required content and format of an SE Report.

(a) Overview. The SE Report must provide information uniquely identifying the new tobacco product and the predicate tobacco product, and compare the new tobacco product to either a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or a tobacco product that FDA previously found to be substantially equivalent. The SE Report must provide sufficient information as described in this section to enable FDA to determine whether the new tobacco product is substantially equivalent to a tobacco product that was commercially marketed (other than for test marketing) in the United States as of February 15, 2007. If FDA cites deficiencies and requests information to support a statement in the SE Report, the applicant must provide that information for review to continue, or FDA may issue an order under § 1107.48. FDA generally intends to refuse to accept an SE Report for review if it does not comply with § 1105.10 and this section. The SE Report must contain the following information:

(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) of this section).

(b) Format. The applicant must submit the SE Report using the form(s) that FDA provides. The SE Report must contain a comprehensive index and table of contents, be well-organized and legible, and be written in English. As described in § 1107.62, the applicant must submit the SE Report and all information supporting the SE Report in an electronic format that FDA can process, read, review, and archive, unless FDA has provided a waiver under § 1107.62(b).

(1) The date the SE Report is submitted;

(2) Type of submission (e.g., the SE Report or amendment to a report);

(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., ventilation or characterizing flavor, the report must state “none” for that property) as provided in the following table:

Table 1 to § 1107.18(c)(7)(iii)

Tobacco product category	Tobacco product subcategory	Product properties	(A) Cigarettes	(1) Filtered	—Package type (e.g., hard pack, soft pack, clam shell).			—Product quantity (e.g., 20 cigarettes, 25 cigarettes).			—Length (e.g., 89.1 millimeters (mm), 100 mm).			—Diameter (e.g., 6 mm, 8.1 mm).			—Ventilation (e.g., none, 10%, 25%).			—Characterizing Flavor(s) (e.g., none, menthol).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(2) Non-filtered	—Package type (e.g., hard pack, soft pack, clam shell).			—Product quantity (e.g., 20 cigarettes, 25 cigarettes).			—Length (e.g., 89.1 mm, 100 mm).			—Diameter (e.g., 6 mm, 8.1 mm).			—Characterizing Flavor(s) (e.g., none, menthol).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(3) Other	—Package type (e.g., hard pack, soft pack, clam shell).			—Product quantity (e.g., 20 cigarettes, 25 cigarettes).			—Length (e.g., 89.1 mm, 100 mm).			—Diameter (e.g., 6 mm, 8.1 mm).			—Ventilation (e.g., none, 10%, 25%).			—Characterizing Flavor(s) (e.g., none, menthol).			—Additional properties needed to uniquely identify the tobacco product (if applicable).	(B) Roll-Your-Own Tobacco Products	(1) Roll-Your-Own Tobacco Filler	—Package type (e.g., bag, pouch).			—Product quantity (e.g., 20.1 grams (g), 16 ounces (oz.)).			—Characterizing flavor(s) (e.g., none, menthol).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(2) Rolling Paper	—Package type (e.g., box, booklet).			—Product quantity (e.g., 50 sheets, 200 papers).			—Length (e.g., 79.1 mm, 100 mm, 110.2 mm).			—Width (e.g., 28.1 mm, 33 mm, 45.2 mm).			—Characterizing flavor(s) (e.g., none, menthol, tobacco).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(3) Filtered Cigarette Tube	—Package type (e.g., bag, box).			—Product quantity (e.g., 100 tubes, 200 tubes).			—Length (e.g., 89.1 mm, 100 mm).			—Diameter (e.g., 6 mm, 8.1 mm).			—Ventilation (e.g., none, 10%, 25%).			—Characterizing flavor(s) (e.g., none, menthol, tobacco).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(4) Non-Filtered Cigarette Tube	—Package type (e.g., bag, box).			—Product quantity (e.g., 100 tubes, 200 tubes).			—Length (e.g., 89.1 mm, 100 mm).			—Diameter (e.g., 6 mm, 8.1 mm).			—Characterizing flavor(s) (e.g., none, menthol, tobacco).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(5) Filter	—Package type (e.g., bag, box).			—Product quantity (e.g., 100 filters, 200 filters).			—Length (e.g., 8 mm, 12.1 mm).			—Diameter (e.g., 6 mm, 8.1 mm).			—Characterizing flavor(s) (e.g., none, menthol, tobacco).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(6) Paper Tip	—Package type (e.g., bag, box).			—Product quantity (e.g., 200 tips, 275 tips).			—Length (e.g., 12 mm, 15.1 mm).			—Width (e.g., 27.1 mm).			—Characterizing flavor(s) (e.g., none, menthol, tobacco).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(7) Other	—Package type (e.g., bag, box, booklet).			—Product quantity (e.g., 200 tips, 100 filters, 200 tubes).			—Characterizing flavor(s) (e.g., none, menthol, tobacco).			—Additional properties needed to uniquely identify the tobacco product.	(C) Smokeless Tobacco Products	(1) Loose Moist Snuff	—Package type (e.g., plastic can with metal lid, plastic can with plastic lid).			—Product quantity (e.g., 20 g, 2.1 oz.).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable, e.g., fine cut, long cut, straight cut).		(2) Portioned Moist Snuff	—Package type (e.g., plastic can with metal lid, plastic can with plastic lid).			—Product quantity (e.g., 22.5 g, 20 g).			—Portion count (e.g., 15 pouches, 20 pieces).			—Portion mass (e.g., 1.5 g/pouch, 1 g/piece).			—Portion length (e.g., 15 mm, 20.1 mm).			—Portion width (e.g., 10 mm, 15.1 mm).			—Portion thickness (e.g., 5 mm, 7.1 mm).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(3) Loose Snus	—Package type (e.g., plastic can with metal lid, plastic can with plastic lid).			—Product quantity (e.g., 20 g, 2.1 oz.).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(4) Portioned Snus	—Package type (e.g., plastic can with metal lid, plastic can with plastic lid).			—Product quantity (e.g., 22.5 g, 20 g).			—Portion count (e.g., 15 pouches, 20 pieces).			—Portion mass (e.g., 1.5 g/pouch, 1 g/piece).			—Portion length (e.g., 15 mm, 20.1 mm).			—Portion width (e.g., 10 mm, 15.1 mm).			—Portion thickness (e.g., 5 mm, 7.1 mm).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(5) Loose Dry Snuff	—Package type (e.g., plastic can with metal lid, plastic can with plastic lid).			—Product quantity (e.g., 20 g, 2.1 oz.).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(6) Dissolvable	—Package type (e.g., plastic can with metal lid, plastic can with plastic lid).			—Product quantity (e.g., 22.5 g, 20 g).			—Portion count (e.g., 15 sticks, 20 pieces).			—Portion mass (e.g., 1.5 g/strip, 1 g/piece).			—Portion length (e.g., 10 mm, 15.1 mm).			—Portion width (e.g., 5 mm, 8.1 mm).			—Portion thickness (e.g., 3 mm, 4.1 mm).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(7) Loose Chewing Tobacco	—Package type (e.g., bag, pouch, wrapped).			—Product quantity (e.g., 20 g, 3.1 oz.).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(8) Portioned Chewing Tobacco	—Package type (e.g., plastic can with metal lid, plastic can with plastic lid).			—Product quantity (e.g., 22.5 g, 20 g).			—Portion count (e.g., 10 bits).			—Portion mass (e.g., 2.1 g/bit).			—Portion length (e.g., 8 mm, 10.1 mm).			—Portion width (e.g., 6 mm, 8.1 mm).			—Portion thickness (e.g., 5.1 mm, 7 mm).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(9) Other	—Package type (e.g., box, bag, can).			—Product quantity (e.g., 20.1 g, 22.5 g, 3 oz.).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen, tobacco).			—Additional properties needed to uniquely identify the tobacco product.	(D) Electronic Nicotine Delivery Systems (ENDS) (Vapes)	(1) Open E-Liquid	—Package type (e.g., bottle, box, pod).			—Product quantity (e.g., 1 bottle, 5 bottles).			—E-liquid volume (e.g., 0.5 milliliters (ml)), 2 ml, 5.1 ml).			—Nicotine concentration (e.g., 0 mg/ml), 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/bottle).			—Propylene Glycol (PG)/Vegetable Glycerin (VG) ratio (e.g., not applicable (N/A), 0/100, 50/50, 100/0).			—Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(2) Closed E-Liquid	—Package type (e.g., cartridge, pod).			—Product quantity (e.g., 1 cartridge, 5 cartridges).			—E-liquid volume (e.g., 0.5 ml, 2 ml, 5.1 ml).			—Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/bottle).			—PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0).			—Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(3) Closed E-Cigarette	—Package type (e.g., box, none, plastic clamshell).			—Product quantity (e.g., 1 e-cigarette, 5 e-cigarettes).			—Length (e.g., 100 mm, 120 mm) —Diameter (e.g., 6 mm, 8 mm).			—Wattage (e.g., 100 watts (W), 200 W).			—Battery capacity (e.g., 100 milliampere hours (mAh), 200 mAh).			—E-liquid volume (e.g., 0.5 ml, 2 ml, 5.1 ml).			—Nicotine concentration (e.g., 0 mg/ml, 0.2 mg/ml, 0.4 mg/ml, 1%, 0.2 mg/e-cigarette).			—PG/VG ratio (e.g., N/A, 0/100, 50/50, 100/0).			—Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(4) Open E-Cigarette	—Package type (e.g., box, none, plastic clamshell).			—Product quantity (e.g., 1 e-cigarette, 5 e-cigarettes).			—Length (e.g., 100 mm, 120 mm) —Diameter (e.g., 6 mm, 8 mm).			—Wattage (e.g., 100 W, 200 W).			—Battery capacity (e.g., 100 mAh, 200 mAh).			—E-liquid volume (e.g., 0.5 ml, 2 ml, 5.1 ml).			—Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry, wintergreen).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(5) ENDS Component	—Package type (e.g., box, none, plastic clamshell).			—Product quantity (e.g., 1 coil).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen, tobacco).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(6) Other	—Package type (e.g., box, none, plastic clamshell).			—Product quantity (e.g., 1 e-cigarette, 5 bottles).			—Characterizing flavor(s) (e.g., none, menthol, cherry, wintergreen, tobacco).			—Additional properties needed to uniquely identify the tobacco product.	(E) Cigars	(1) Filtered, Sheet-Wrapped	—Package type (e.g., hard pack, soft pack, clam shell).			—Product quantity (e.g., 20 filtered cigars, 25 filtered cigars).			—Length (e.g., 89.1 mm, 100 mm).			—Diameter (e.g., 6 mm, 8.1 mm).			—Ventilation (e.g., none, 0%, 10%, 25%).			—Characterizing flavor (e.g., none, menthol).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(2) Unfiltered, Sheet-Wrapped	—Package type (e.g., box, film sleeve).			—Product quantity (e.g., 1 cigar, 5 cigarillos).			—Length (e.g., 100.1 mm, 140 mm).			—Diameter (e.g., 8 mm, 10.1 mm).			—Tip (e.g., none, wood tips, plastic tips).			—Characterizing flavor (e.g., none, menthol, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(3) Unfiltered, Leaf-Wrapped	—Package type (e.g., box, film, sleeve, none).			—Product quantity (e.g., 1 cigar, 5 cigars).			—Length (e.g., 150.1 mm, 200 mm).			h;Diameter (e.g., 8 mm, 10.1 mm).			—Wrapper material (e.g., burley tobacco leaf, Connecticut shade grown tobacco leaf).			—Characterizing flavor (e.g., none, whiskey).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(4) Cigar Component	—Package type (e.g., box, booklet).			—Product quantity (e.g., 10 wrappers, 20 leaves).			—Characterizing flavor (e.g., none, menthol, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(5) Cigar Tobacco Filler	—Package type (e.g., bag, pouch).			—Product quantity (e.g., 20 g, 16.1 oz.).			—Characterizing flavor (e.g., none, tobacco, menthol, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(6) Other	—Package type (e.g., box, booklet).			—Product quantity (e.g., 1 cigar, 5 cigars, 20 leaves, 16 g).			—Characterizing flavor(s) (e.g., none, menthol, cherry).			—Additional properties needed to uniquely identify the tobacco product.	(F) Pipe Tobacco Products	(1) Pipe	—Package type (e.g., box, none).			—Product quantity (e.g., 1 pipe).			—Length (e.g., 200 mm, 300.1 mm).			—Diameter (e.g., 25.1 mm).			—Characterizing flavor(s) (e.g., none, menthol, cavendish, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(2) Pipe Tobacco Filler	—Package type (e.g., box, none).			—Product quantity (e.g., 20 g, 16.1 oz.).			—Tobacco cut style (e.g., standard cut, such as shag cut, bugler cut, loose cut, etc., or a pressed cut, such as flake, cube cut, roll cake, etc. or a mixture).			—Characterizing flavor(s) (e.g., none, menthol, cavendish, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(3) Pipe Component	—Package type (e.g., box, bag, none).			—Product quantity (e.g., 1 bowl, 1 stem, 100 filters).			—Characterizing flavor(s) (e.g., none, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(4) Other	—Package type (e.g., box, bag, none).			—Product quantity (e.g., 1 pipe, 1 bowl, 1 stem, 100 filters).			—Characterizing flavor(s) (e.g., none, cherry).			—Additional properties needed to uniquely identify the tobacco product.	(G) Waterpipe Tobacco Products	(1) Waterpipe	—Package type (e.g., box, none).			—Product quantity (e.g., 1 waterpipe).			—Height (e.g., 200 mm, 500.1 mm).			—Width (e.g., 100.1 mm, 300 mm).			—Diameter (e.g., 100.1 mm, 300 mm).			—No. of hoses (e.g., 1, 2, 4).			—Characterizing flavor(s) (e.g., none).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(2) Waterpipe Tobacco Filler	—Package type (e.g., bag, pouch).			—Product quantity (e.g., 20 g, 16.1 oz.).			—Characterizing flavor(s) (e.g., none, tobacco, menthol, apple).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(3) Waterpipe Heat Source	—Package type (e.g., box, film sleeve, bag, none).			—Product quantity (e.g., 150 g, 680 g).			—Portion count (e.g., 20 fingers, 10 discs, 1 base).			—Portion mass (e.g., 15 g/finger, 10 g/brick).			—Portion length (e.g., 40 mm, 100 mm).			—Portion width (e.g., 10 mm, 40 mm).			—Portion thickness (e.g., 10 mm, 40 mm).			—Source of energy (e.g., charcoal, battery, electrical).			—Characterizing flavor(s) (e.g., none, menthol, apple).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(4) Waterpipe Component	—Package type (e.g., box, bag, none).			—Product quantity (e.g., 1 base, 1 bowl, 1 hose, 10 mouthpieces).			—Characterizing flavor(s) (e.g., none, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(5) Other	—Package type (e.g., box, bag, none).			—Product quantity (e.g., 1 base, 1 bowl, 1 hose, 10 mouthpieces).			—Characterizing flavor(s) (e.g., none, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).	(H) Heated Tobacco Products (HTP)	(1) Closed HTP	—Package type (e.g., box, none, plastic clamshell).			—Product quantity (e.g., 1 device, 1 HTP).			—Length (e.g., 100 mm, 120 mm).			—Diameter (e.g., 6 mm, 8.1 mm).			—Wattage (e.g., 100 W, 200 W).			—Battery capacity (e.g., 100 mAh, 200 mAh).			—Characterizing flavor(s) (e.g., none).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(2) Open HTP	—Package type (e.g., box, none, plastic clamshell).			—Product quantity (e.g., 1 device, 1 HTP).			—Length (e.g., 100 mm, 120 mm) —Diameter (e.g., 6 mm, 8.1 mm).			—Wattage (e.g., 100 W, 200 W).			—Battery capacity (e.g., 100 mAh, 200 mAh).			—Characterizing flavor(s) (e.g., none).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(3) HTP Consumable	—Package type (e.g., hard pack, soft pack, plastic clamshell).			—Product quantity (e.g., 20 sticks, 25 cartridges).			—Length (e.g., 60 mm, 82 mm.) —Diameter (e.g., 6 mm, 8.1 mm).			—Ventilation (e.g., none, 10%, 25%).			—Characterizing flavor(s) (e.g., none, menthol).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(4) HTP Component	—Package type (e.g., box, none, plastic clamshell).			—Product quantity (e.g., 1 mouthpiece, 1 spacer).			—Characterizing flavor(s) (e.g., none, tobacco, menthol).			—Additional properties needed to uniquely identify the tobacco product (if applicable).		(5) Other	—Package type (e.g., box, bag, plastic clamshell, none).			—Product quantity (e.g., 1 base, 5 capsules).			—Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry).			—Additional properties needed to uniquely identify the tobacco product (if applicable).	Other	Other	—Package type (e.g., box, bag, plastic clamshell, none).			—Product quantity (e.g., 1 base, 5 capsules).			—Characterizing flavor(s) (e.g., none, tobacco, menthol, cherry).			—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. The SE Report must include a summary at the beginning of the SE Report that includes the following:

(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. The applicant must identify one new tobacco product in the SE Report for comparison to one predicate tobacco product. The SE Report must describe the new tobacco product in sufficient detail to enable FDA to evaluate its characteristics. This part of the SE Report must include:

(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. (1) The applicant must identify a predicate tobacco product that is either a tobacco product commercially marketed (other than for test marketing) as of February 15, 2007, or a tobacco product that FDA previously found to be substantially equivalent.

(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. The SE Report must include a comparison of the characteristics of the new tobacco product and the predicate tobacco product. If the new tobacco product has limited changes to a characteristic(s) when compared to the predicate tobacco product, and all other characteristics are identical (e.g., a change to product quantity), the applicant must provide comparison information related to any characteristic(s) that have changed, but may certify that the other characteristics are identical under paragraph (l)(2) of this section. The applicant must maintain records supporting the certification consistent with § 1107.58.

(h) Comparative testing information. Other than for characteristics that are identical, and for which the applicant has certified that the characteristics are identical under paragraph (l)(2) of this section, the SE Report must provide comparative testing information that has been demonstrated to be fully validated on the characteristics of the new and predicate tobacco products except where the applicant adequately justifies that such comparative testing information is not necessary to demonstrate that the new product:

(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. The SE Report must either:

(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. The SE Report must include either a health information summary or a statement that such information will be made available upon request, as provided in section 910(a)(4) of the Federal Food, Drug, and Cosmetic Act, in accordance with the following:

(1) Health information summary. If including a health information summary with the SE Report, the applicant must provide a copy of the full SE Report that excludes research subject identifiers and trade secret and confidential commercial information as defined in §§ 20.61 and 20.63 of this chapter; and either

(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. If the applicant chooses to make the health information available upon request, the SE Report must include the following statement, with the appropriate applicant information inserted as indicated by parenthetical text, signed by an authorized representative of the applicant, made on a separate page of the SE Report, and clearly identified as “910(a)(4) health information statement”: “I certify that, in my capacity as (the position held in company by person required to submit the SE Report, preferably the responsible official of the applicant) of (company name), I will make available, upon request, the information identified in 21 CFR 1107.18(j)(3) within 30 calendar days of a request.”

(3) Content of health information. The health information the applicant agrees to make available in paragraph (j)(2) of this section must be a copy of the full SE Report, excluding all research subject identifiers, trade secrets, and confidential commercial information, as defined in §§ 20.61 and 20.63 of this chapter; and either:

(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) 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 the provided SE Report.”

(4) Requests for information. All requests for information under paragraph (j)(2) of this section must be made in writing to the authorized representative of the applicant, whose contact information will be posted on the FDA website listing substantial equivalence determinations. The applicant must provide FDA any updated information if the contact information changes.

(5) No modified risk violations. To the extent information is included in the health information summary or health information provided upon request under paragraphs (j)(1) and (2) of this section that is not required by section 910(a)(4) of the Federal Food, Drug, and Cosmetic Act or this paragraph (j), that information must not contain a statement that would cause the tobacco product to be in violation of section 911 of the Federal Food, Drug, and Cosmetic Act upon the introduction or delivery for introduction of the proposed new product into interstate commerce.

(k) Compliance with part 25 of this chapter. (1) The SE Report must include an environmental assessment prepared in accordance with § 25.40 of this chapter, or a valid claim of categorical exclusion. If the applicant believes that the action qualifies for an available categorical exclusion, the applicant must state under § 25.15(a) and (d) of this chapter that the action requested qualifies for a categorical exclusion, citing the particular exclusion that is claimed, and that to the applicant's knowledge, no extraordinary circumstances exist under § 25.21.

(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. (1) The SE Report must contain the following certification, with the appropriate information inserted (as indicated by parenthetical text), and be signed by an authorized representative of the applicant: “I (name of responsible official) on behalf of (applicant), hereby certify that (applicant) will maintain all records to substantiate the accuracy of this SE Report for the period of time required in 21 CFR 1107.58 and ensure that such records remain readily available to the FDA upon request. I certify that this information and the accompanying submission are true and correct, that no material fact has been omitted, and that I am authorized to submit this on the applicant's behalf. I understand that under section 1001 of title 18 of the United States Code anyone who knowingly and willfully makes a materially false, fictitious, or fraudulent statement or representation in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States is subject to criminal penalties.”

(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), on behalf of (name of company), certify that (new tobacco product name) has the following modification(s) as compared to (name of predicate tobacco product): (describe modification(s), e.g., change in product quantity or change in container closure system). Aside from these modifications, the characteristics of (new tobacco product name) and (name of predicate tobacco product) are identical. I certify that (name of company) understands this means there is no other modification to the materials, ingredients, design features, heating source, or any other feature. I also certify that (name of company) will maintain records to support the comparison information in 21 CFR 1107.19 that substantiate the accuracy of this statement for the period of time required in 21 CFR 1107.58, and ensure that such records remain readily available to FDA upon request.”