Postmarketing Report Checklists

May 15, 2024

Nicotine product manufacturers are required to submit postmarketing reports after receiving a marketing granted order for their products. There are two main types of postmarket reports that applicants must submit: periodic reports and adverse experience reports. Periodic reports typically need to be submitted within 60 calendar days of the reporting date specified in the marketing order. These reports provide ongoing information about the product's performance, any changes made to the product, and other relevant data. This checklist is an excerpt from a FDA CTP Regulatory Health Project Manager (RHPM) Postmarketing and Periodic reporting checklist.

Examples of a Postmarketing Report Checklist:

Appropriate for the Protection of Public Health

A summary of how the tobacco product continues to be appropriate for the protection of public health should be included in the report.

• Data on current product users. Data should be collected about new users, current  users, those who have switched tobacco products, and multiple product users. Results should be broken down by key demographic variables including age, gender, and race/ethnicity. Report any change in the intended target market for the product. Data may include sales and post-marketing analysis.

Adverse Experience Reporting

Indicate if the applicant reported any serious adverse experiences.

• A summary of any adverse experiences associated with this tobacco product which has been reported to the applicant. This is to include a listing and analysis of all adverse experiences including any serious and unexpected adverse experiences reported during this reporting period. The analysis should be accompanied by a statement of any changes to the reference risk information and a summary of important risks, including the nature, frequency, and potential risk factors

Chance to Manufacturing, Facilities, or Controls

The report should describe each change made to the manufacturing, facilities, or control. Indicate if the following are included.

• A table or narrative summary comparison of each chanschange to what was described in the PMTA.

• The rationale for making each change.

• A certification that the reported change did not result in any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of the tobacco product with the basis for for concluding that each change did not result in any modification to the final product.

Manufacturing Deviation

The report should include a description of any manufacturing deviations and the action(s) taken.

• A summary of all manufacturing deviations, including those associated with processing, testing, packing, labeling, storage, holding and distribution.

• A summary table or narrative indicating if the deviation described may affect the characteristics of the final product.

Advertising and Labeling

• Full-color copies of all advertising for the tobacco product that has not been previously submitted, along with the original date the advertisements were first disseminated and the date the advertisements were discontinued

• For all periodic reports: a description of any or all labeling changes and submission of revised full color final printed labeling to include all the panels. The labeling should be presented in the actual size and color with legible text.