§1105.10. Refusal to accept a premarket submission. — Inbound Citations

(a) 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

(a) Refuse to accept the SE Report for review if it does not comply with § 1107.18 and § 1105.10 of this chapter;

(iii) Does not pertain to a tobacco product subject to chapter IX of the Federal Food, Drug, and Cosmetic Act (as required by § 1105.10 of this chapter); or