§ 1100.204 Recordkeeping requirements.

(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.