TTB Newsletter for July 3, 2025

Discontinuance of the Automated Export System TTB Export Message Set

We will no longer collect TTB-specific export data through the electronic Automated Export System. We informed exporters of this change through CSMS # 65439382 - Alcohol and Tobacco Tax and Trade Bureau (TTB) removed from the Automated Export System Trade Interface Requirements (AESTIR).

This electronic data collection had been initiated as part of a pilot program and submission of the data had never been required by TTB. Industry members must continue to obtain proof of exportation to support relief from tax liability on alcohol and tobacco products exported without payment of tax in accordance with 27 CFR Parts 28 and 44 and the alternate method at Industry Circular 2004-3, as well as to substantiate any drawback claims filed with TTB following the exportation of taxpaid products.

In Observation of Independence Day

TTB offices will be closed on July 4, 2025, in observation of Independence Day.

Food and Drug Administration Tobacco Notices

TTB-regulated industries may find these notices of interest.

Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products

SOURCE: Federal Register / Vol. 90, No. 122 / Friday, June 27, 2025

AGENCY: Food and Drug Administration, HHS

ACTION: Notice

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ''Exemptions From Substantial Equivalence Requirements for Tobacco Products.''

DATES: Either electronic or written comments on the collection of information must be submitted by August 26, 2025.

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007

SOURCE: Federal Register / Vol. 90, No. 122 / Friday, June 27, 2025

AGENCY: Food and Drug Administration, HHS

ACTION: Notice

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007.

DATES: Either electronic or written comments on the collection of information must be submitted by August 26, 2025.

Agency Information Collection Activities; Proposed Collection; Comment Request; Meetings With Industry and Investigators on the Research and Development of Tobacco Products

SOURCE: Federal Register / Vol. 90, No. 122 / Friday, June 27, 2025

AGENCY: Food and Drug Administration, HHS

ACTION: Notice

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in FDA's guidance titled ''Meetings with Industry and Investigators on the Research and Development of Tobacco Products (Revised).''

DATES: Either electronic or written comments on the collection of information must be submitted by August 26, 2025.

Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act

SOURCE: Federal Register / Vol. 90, No. 122 / Friday, June 27, 2025

AGENCY: Food and Drug Administration, HHS

ACTION: Notice

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act.

DATES: Either electronic or written comments on the collection of information must be submitted by August 26, 2025.

Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission

SOURCE: Federal Register / Vol. 90, No. 122 / Friday, June 27, 2025

AGENCY: Food and Drug Administration, HHS

ACTION: Notice

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection associated with tobacco health document submissions.

DATES: Either electronic or written comments on the collection of information must be submitted by August 26, 2025.