§1114.41. Reporting requirements. — Inbound Citations

(2) If an applicant is required to, but has not yet submitted a postmarket report, the applicant must submit a report as part of its application that contains all of the information for the original tobacco product that would otherwise be required in a report under § 1114.41 covering the period of time from when it received a marketing granted order for the original tobacco product to when it submits the supplemental PMTA.

(3) Requirements to establish and maintain records, and submit postmarket reports under section 910(f) of the Federal Food, Drug and Cosmetic Act in addition to those described in § 1114.41, including but not limited to information such as labeling, advertising, marketing, promotional materials, or marketing plans not previously submitted to FDA.