Dear Tribal Leader Letters
Letter Date and Link | Subject of Letter | Responsible Center/Office |
|---|---|---|
| June 30, 2026 | All Tribes Call The U.S. Food and Drug Administration (FDA or the Agency) is initiating consultation with federally recognized American Indian and Alaskan Native tribes on the Agency’s proposed rule entitled “Establishment Registration and Product Listing for Tobacco Products” (proposed rule). This proposed regulation would prescribe the format, content, and procedures for establishment registration and tobacco product listing. This consultation, conducted via an all tribes call with FDA's Center for Tobacco Products, will feature an overview of the proposed rule, provide an opportunity for tribal leaders to ask questions, and enable the Agency to receive feedback from tribal leaders and their designees. This consultation will take place on July 30, 2026, at 1:00 p.m. EDT. For additional details and required registration, you may view the Dear Tribal Leader Letter here. | Center for Tobacco Products |
| October 7, 2024 | All Tribes Call The U.S. Food and Drug Administration (FDA) invites federally recognized American Indian and Alaska Native Tribes to participate in an all tribes call with FDA to learn about FDA’s work to help reduce sodium in the food supply. Please join us on November 7, 2024, from 2pm-3pm. For additional details and registration, you may view the Dear Tribal Leader Letter here. | Human Foods Program (Formally known as Center for Food Safety and Applied Nutrition) |
| September 12,2024 | Dear Tribal Leader Letter: The U.S. Food and Drug Administration (FDA) has issued a final guidance for industry: “Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements.” This guidance describes FDA’s enforcement policy for the final rule, “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements,” which established new required health warnings for cigarette packages and advertisements. The guidance is intended to assist entities required to comply with the rule and is available at Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements | FDA. | Center for Tobacco Products |
| August 29,2024 | Dear Tribal Leader Letter: The U.S. Food and Drug Administration (FDA or the Agency) notification to Tribal governments and organizations of the issuance of the final rule: “Prohibition of Sale of Tobacco Products to Persons Younger than 21 Years of Age.” This final rule amends FDA’s regulations to reflect the increased Federal minimum age of sale for tobacco products. | Center for Tobacco Products |
| July 29, 2024 | 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. Unified Agenda may be viewed here. | Office of Policy, Legislation, and International Affairs/International Accreditation Services, Inc. |
| May 22, 2024 | Dear Tribal Leader Letter inviting Tribes to participate in and All Tribes' Call on June 24, 2024. The call will discuss the published final rule "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water" issued by the Center for Food Safety and Applied Nutrition. Recording may be viewed here. All Tribes Call Summary may be viewed here. | Center for Food Safety and Applied Nutrition |
| January 31, 2024 | Postponed until further notice. FDA Tribal Listening Session: The U.S. Food and Drug Administration invites the National Indian Health Board and Area Indian Health Boards to participate in a call with the FDA’s Stakeholder Engagement Staff and Intergovernmental Affairs (IGA) to discuss the FDA’s efforts to address misinformation and vaccine hesitancy. | Office of the Commissioner, Office of External Affairs |
| January 8, 2024 | FDA Tribal Listening Session: The U.S. Food and Drug Administration (FDA) invites federally recognized American Indian and Alaska Native Tribes to participate in an all tribes call with FDA to learn about FDA’s work related to front-of-package (FOP) nutrition labeling (FOP labels). The listening session may be viewed here. Summary of Listening Session may be viewed here. | Center for Food Safety and Applied Nutrition |
| December 7, 2023 | Center for Tobacco Products releases the “FDA Commercial Tobacco Retail Compliance Check Inspection Program" webinar as a resource for federally recognized AI/AN Tribes. The webinar may be viewed here. | Center for Tobacco Products |
| October 24, 2023 | Tribal Listening Session: The U.S. Food and Drug Administration (FDA) invites federally recognized American Indian and Alaska Native Tribes to participate in an all tribes call with the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) to learn about FDA’s nutrition initiatives. Meeting recording. | Center for Food Safety and Applied Nutrition |
| October 5, 2023 | Tribal Listening Session on Safe Disposal of Opioid Analgesics. Meeting recording. Summary of Tribal Listening Session may be viewed here. | Center for Drug Evaluation and Research |
| August 25, 2023 | Letter to Tribes regarding the release of draft guidance "Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products," issued by FDA's Oncology Center for Excellence. Please take this opportunity to review and provide comment. | Oncology Center for Excellence |
| March 10, 2023 | Tribal Consultation on the proposed rules for Requirement for Tobacco Product Manufacturing Practice (TPMP). Meeting recording. Summary of Tribal Consultation may be viewed here | Center for Tobacco Products |
| January 18, 2023 | 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 |
| April 4, 2019 | 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 |
| April 4, 2019 | 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 |
| May 10, 2018 | 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 |
| August 18, 2017 | 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 |
| April 7, 2017 | Invitation to Consultation on Tobacco Product Standard for N-nitrosonornicotine Level in Finished Smokeless Tobacco Products proposed rule | Center for Tobacco Products |
| December 22, 2016 | FDA Tribal Consultation Policy | Office of Policy, Planning, Legislation, and Analysis |
| May 26, 2016 | Mitigation Strategies to Protect Food Against Intentional Adulteration | Office of Foods and Veterinary Medicine |
| May 10, 2016 | Deeming tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act, final rule:
| Center for Tobacco Products |
| April 5, 2016 | Final FSMA Rule:
| Office of Foods and Veterinary Medicine |
| February 29, 2016 | Draft FDA Tribal Consultation Policy | Office of Policy, Planning, Legislation, and Analysis |
| February 12, 2016 | RFP on Tribal Training | Office of Foods and Veterinary Medicine |
| November 13, 2015 | 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 |
| September 25, 2015 | Tribal Retailer Inspections | Center for Tobacco Products |
| September 10, 2015 | Final FSMA Rules:
| Office of Foods and Veterinary Medicine |
| March 13, 2015 | Retail Inspections RFP | Center for Tobacco Products |
| December 31, 2014 | 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 |
| May 16, 2014 | Compliance and Enforcement collaboration, notification of webinars | Center for Tobacco Products |
| April 25, 2014 | Invitation to Consultation on Deeming Tobacco Products | Center for Tobacco Products |
| March 27, 2014 | Invitation to Regional consultation at the Indian Pueblo Cultural Center, NM on FSMA proposed rules | Office of Foods and Veterinary Medicine |
| September 12, 2013 | Invitation to FDA tribal consultation on FSMA proposed rules | Office of Foods and Veterinary Medicine |
| August 16, 2013 | Invitation to Consultation on Environmental Impact Statement for FSMA Produce Safety Rule | Office of Foods and Veterinary Medicine |
| April 25, 2013 | Working Together | Center for Tobacco Products |
ResourcesForYou
- For Federal, State, Local, Tribal, and Territorial Officials
- Engagement with American Indian and Alaska Native Tribal Governments (Center for Tobacco Products)