Dear Tribal Leader Letters
Letter Date and Link |
Subject of Letter |
Responsible Center/Office |
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March 10, 2023 | Invitation to Consultation on the proposed rules for Requirement for Tobacco Product Manufacturing Practice (TPMP). | Center for Tobacco Products |
The U.S. Food and Drug Administration (FDA or the Agency) is pleased to share the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda) to ensure that federally recognized Tribal Nations are aware of FDA’s plans related to issuance of regulations and guidance documents. | Office of Policy, Legislation, and International Affairs/International Accreditation Services, Inc. | |
November 8, 2022 | Letter to Tribes regarding FDA’s authority to regulate non-tobacco nicotine products Meeting Recording | Center for Tobacco Products |
October 3, 2022 | October 3, 2022 Comment Period Extended through December 28, 2022: Invitation to Consultation on the proposed rules for Institutional Review Boards; Cooperative Research and Protection of Human Subjects and Institutional Review Boards. These proposed rules are intended to further FDA's harmonization with the Federal Policy for the Protection of Human. | Office of the Commissioner |
May 13, 2022 |
Invitation to Consultation on the proposed rules for Tobacco Product Standards for Menthol in Cigarettes and Tobacco Product Standard for Characterizing Flavors in Cigars A recording of the FDA tribal consultation is available here. |
Center for Tobacco Products |
Updated: January 27, 2022 |
Invitation to Consultation on the proposed rule “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” A recording of the FDA tribal consultation is available here. |
Center for Food Safety and Applied Nutrition and Office of Food Policy and Response |
December 17, 2021 |
Providing information to tribal leaders to share with tribal tobacco retailers on Tobacco 21 (T21). |
Center for Tobacco Products |
May 17, 2021 |
Publication of a fiscal year 2021 Request for Proposal (RFP) to contract with American Indian and Alaska Native (AI/AN) Tribes to conduct compliance check inspections of tobacco product retailers on tribal lands to help ensure retailer compliance with federal tobacco laws and regulations. |
Center for Tobacco Products |
October 21, 2020 |
Invitation to Consultation on the proposed rule on Requirements for Additional Traceability Records for Certain Foods |
Center for Food Safety and Applied Nutrition and Office of Food Policy and Response |
June 30, 2020 |
Publication of a Request for Proposal (RFP) to contract with American Indian and Alaska Native (AI/AN) Tribes to conduct compliance check inspections of tobacco product retailers on tribal lands to help ensure retailer compliance with federal tobacco laws and regulations. |
Center for Tobacco Products |
Invitation to Consultation on the proposed rule on the content and format of substantial equivalence applications, and FDA actions on substantial equivalence reports |
Center for Tobacco Products |
|
August 15, 2019 |
Invitation to Consultation on the proposed rule requiring new health warnings on cigarette packages and in advertisements to promote greater public understanding of the negative health consequences of smoking |
Center for Tobacco Products |
Invitation to Consultation on the proposed rule on the content and format of substantial equivalence applications, and FDA actions on substantial equivalence reports |
Center for Tobacco Products |
|
Publication of a Request for Proposal to contract with American Indian and Alaska Native Tribes to conduct compliance check inspections of tobacco retailers on tribal lands to help ensure retailer compliance with federal tobacco laws and regulations |
Center for Tobacco Products |
|
Publication of a Request for Proposal to contract with American Indian and Alaska Native Tribes to conduct compliance check inspections of tobacco retailers on tribal lands to help ensure retailer compliance with federal tobacco laws and regulations |
Center for Tobacco Products |
|
Invitation to Consultation on Tobacco Product Standard for N-nitrosonornicotine Level in Finished Smokeless Tobacco Products proposed rule |
Center for Tobacco Products |
|
FDA Tribal Consultation Policy |
Office of Policy, Planning, Legislation, and Analysis |
|
Mitigation Strategies to Protect Food Against Intentional Adulteration |
Office of Foods and Veterinary Medicine |
|
Deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act, final rule:
|
Center for Tobacco Products |
|
Final FSMA Rule:
|
Office of Foods and Veterinary Medicine |
|
Draft FDA Tribal Consultation Policy |
Office of Policy, Planning, Legislation, and Analysis |
|
RFP on Tribal Training |
Office of Foods and Veterinary Medicine |
|
Final FSMA Rules:
Final Environmental Impact Statement for the Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption |
Office of Foods and Veterinary Medicine |
|
Tribal Retailer Inspections |
Center for Tobacco Products |
|
Final FSMA Rules:
|
Office of Foods and Veterinary Medicine |
|
Retail Inspections RFP |
Center for Tobacco Products |
|
Draft Environmental Impact Statement for the Proposed Rule: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule) |
Office of Foods and Veterinary Medicine |
|
Compliance and Enforcement collaboration, notification of webinars |
Center for Tobacco Products |
|
Invitation to Consultation on Deeming Tobacco Products |
Center for Tobacco Products |
|
Invitation to Regional consultation at the Indian Pueblo Cultural Center, NM on FSMA proposed rules |
Office of Foods and Veterinary Medicine |
|
Invitation to FDA tribal consultation on FSMA proposed rules |
Office of Foods and Veterinary Medicine |
|
Invitation to Consultation on Environmental Impact Statement for FSMA Produce Safety Rule |
Office of Foods and Veterinary Medicine |
|
Working Together |
Center for Tobacco Products |
|
ResourcesForYou
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For Federal, State, Local, Tribal, and Territorial Officials
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Engagement with American Indian and Alaska Native Tribal Governments (Center for Tobacco Products)