Dear Tribal Leader Letters

Letter Date and Link	Subject of Letter	Responsible Center/Office
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: Clarifies FDA authority to regulate all tobacco products Restrictions on sales and requirements for health warnings Summary of the final rule	Center for Tobacco Products
April 5, 2016	Final FSMA Rule: Sanitary Transportation of Human and Animal Food	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: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Foreign Supplier Verification Programs for Importers of Food for Humans and Animals Accreditation of Third-Party Auditors 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: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls Food for Animals	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

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Responsible Center/Office