US | Final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product

Title of document
Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports (77 page(s), in English)

Description
Final rule - The Food and Drug Administration (FDA, the Agency, or we) is  issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports.

Notifying member: United States of America

Notification: G/TBT/N/USA/1785

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

Documents

• 2021-21009.pdf
• 21_6434_00_e.pdf

Agency responsible
Food and Drug Administration (FDA), Health and Human Services (HHS) [1814]

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