This subpart sets out requirements under the Federal Food, Drug, and Cosmetic Act for the maintenance of records by tobacco product manufacturers that introduce a Pre-Existing Tobacco Product, or deliver it for introduction, into interstate commerce.

For the purposes of this subpart:

Commercially marketed means selling or offering for sale a tobacco product in the United States to consumers or to any person for the eventual purchase by consumers in the United States.

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.

Tobacco product means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). The term “tobacco product” does not mean an article that under the Federal Food, Drug, and Cosmetic Act is: a drug (section 201(g)(1)); a device (section 201(h)); a combination product (section 503(g)); or a food (section 201(f)) if such article contains no nicotine or no more than trace amounts of naturally occurring nicotine.

Tobacco product manufacturer means any person, including any repacker or relabeler, who—

(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.

(i) Any tobacco product manufacturer that introduces a Pre-Existing Tobacco Product, or delivers it for introduction, into interstate commerce must maintain records that demonstrate that the tobacco product was commercially marketed in the United States as of February 15, 2007, as described in this subpart. These records may include items such as:

(A) Dated copies of advertisements;

(B) Dated catalog pages;

(C) Dated promotional material;

(D) Dated trade publications;

(E) Dated bills of lading;

(F) Dated freight bills;

(G) Dated waybills;

(H) Dated invoices;

(I) Dated purchase orders;

(J) Dated customer receipts;

(K) Dated manufacturing documents;

(L) Dated distributor or retailer inventory lists; or

(M) Any other dated document that demonstrates that the tobacco product was commercially marketed in the United States as of February 15, 2007.

(ii) 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.

(iii) All records required by this subpart must be retained for a period of not less than 4 years after the date either FDA makes a determination that the product is a Pre-Existing Tobacco Product, or the tobacco product manufacturer permanently ceases the introduction or delivery for introduction into interstate commerce of the tobacco product, whichever occurs sooner.