(a) Definition. The term “Pre-Existing Tobacco Product” means a tobacco product (including those products in test markets) that was commercially marketed in the United States as of February 15, 2007. A Pre-Existing Tobacco Product is not subject to the premarket requirements of section 910 of the Federal Food, Drug, and Cosmetic Act.

(b) Record maintenance. (1) Each applicant who submits an abbreviated report under section 905(j)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act and receives a letter acknowledging the receipt of an abbreviated report from FDA must maintain all records (including those created by third parties on the applicant's behalf) that support the submission. Such records may include, but are not limited to:

(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., an exemption (and for which the applicant has submitted an abbreviated report under section 905(j)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act, a substantially equivalent order under section 910(a), or a marketing granted order under section 910(c)) must maintain a copy of the exemption order, substantially equivalent order, or marketing granted order.

(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., acknowledgement letter, deficiency letters), including the SE Report.

(c) Record quality. All records must be legible, in the English language, and available for inspection and copying by officers or employees duly designated by the Secretary. Documents that have been translated from another language into English (e.g., advertisements written in a language other than English) must be accompanied by the original language version of the document, a signed statement by an authorized representative of the manufacturer certifying that the English language translation is complete and accurate, and a brief statement of the qualifications of the person that made the translation.

(d) Record retention. All records required by this subpart must be retained for a period of 4 years from the date that an acknowledgement letter is issued by FDA.

[86 FR 55412, Oct. 5, 2021]