United States of America | Premarket Tobacco Product Applications and Recordkeeping Requirements (140 page(s), in English)

Title of document
Premarket Tobacco Product Applications and Recordkeeping Requirements (140 page(s), in English)

Description
Final rule - The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.

Notifying member: United States of America

Notification: G/TBT/N/USA/1786

Objective tag
Prevention of deceptive practices and consumer protection; Protection of human health or safety

Documents

• 2021-21011.pdf
• 21_6435_00_e.pdf

Agency responsible
Food and Drug Administration (FDA), Health and Human Services (HHS) [1815]

Timing:

• Submission: 05/10/2021
• Reception: 06/10/2021
• Distribution: 06/10/2021
• Final date for comments: N/A
• Proposed date of adoption: N/A