Upcoming Consultation Call:
- FDA will be hosting an All Tribes’ Call on October 30, 2019 at 2:00 p.m. EST with federally recognized Indian tribes to consult on the proposed rule, “Premarket Tobacco Product Applications and Recordkeeping Requirements” published in the Federal Register on September 25, 2019.
- Designated consultation representatives should receive an email or letter with call details. If you have not received the call details and are interested in participating, please contact David Oliveira at CTP-TribalLiaison@fda.hhs.gov.
- A transcript of the consultation will be added to the docket for the proposed rule (Docket No. FDA-2019-N-2854). An instant replay of the call will be available for 30 days beginning approximately 1 hour after the call ends.
On this page:
- Federally-Recognized Tribes: Working with CTP
- Manufacturers on Tribal Lands
- Retailers on Tribal Lands
- Traditional (Ceremonial) Tobacco Use
- Contact CTP
FDA's Center for Tobacco Products (CTP) understands the importance of collaboration and consultation, as appropriate, with federally-recognized tribal governments, per FDA Tribal Consultation Policy and Executive Order 13715, on the implementation and enforcement of the Tobacco Control Act and related regulations. CTP respects tribal sovereignty and honors the government-to-government relationship we have with federally-recognized American Indian and Alaska Native tribes.
American Indian and Alaska Native population has the highest prevalence of cigarette smoking (about 29%) compared to any other population group in the United States.1 We appreciate that many tribal governments have been working actively to reduce tobacco use within their tribes and to prevent smoking and other tobacco use among tribal youth. Through a collaborative partnership, we can protect the health of Native communities, including youth, by ensuring compliance with the Tobacco Control Act.
We maintain contact with Tribal stakeholders, including Tribal government leaders, Tribal health leaders, public health professionals, and other relevant federal agencies, by various methods:
- Engaging in formal and informal consultations
- Holding face-to-face meetings
- Disseminating "Dear Tribal Leader" letters
- Communicating through presentations, webinars, and email updates
- Participating in quarterly calls among tribal stakeholders
- Arranging meet-and-greets
- Participating in listening sessions
- Hiring tribal policy analysts with special expertise to serve as liaisons
- Awarding retail inspection contracts to tribes to conduct retail inspections within tribal jurisdictions
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import any "tobacco product," then you are considered a tobacco product "manufacturer" and must comply with FDA's tobacco regulations for manufacturers, as applicable.
FDA inspects establishments engaged in the manufacture, compounding, or processing of regulated tobacco products to determine a manufacturer's compliance with FDA regulations.
Retailers on tribal lands must comply with all applicable federal laws and regulations for retailers.
Retail Inspections on Tribal Lands
FDA inspects tobacco retailers to determine a retailer's compliance with FDA regulations.
FDA is authorized to award tobacco retail inspection contracts to States, Tribes, Territories, and third parties to conduct retail inspections. FDA has awarded contracts within Tribal jurisdictions to help enforce Tobacco Control Act regulations within those jurisdictions. FDA may also use its own personnel to conduct retailer inspections.
The Tobacco Control Act specifically prohibits FDA from contracting with any state to exercise enforcement authority under the Tobacco Control Act in Indian Country without the express written consent from the tribe involved.
- Current Tobacco Retail Inspection Contracts
- Webinar: Tobacco Retail Inspection Contracts for Tribes (2014)
- Pre-proposal Conference for Tribal Retailer Inspection Contracts, April 16, 2015
- Protect Our Future: Prevent Tobacco Sales to Minors
- Compliance Training Webinars
The FDA does not regulate the use of traditional (ceremonial) tobacco. The FDA understands and respects the use of traditional tobacco by Native tribes.
We invite tribes to engage in a collaborative and respectful government‐to‐government approach to the implementation and enforcement of the Tobacco Control Act and its regulations.
- Eshael Johnson, Stakeholder Relations Director
- General Resources for Manufacturers, Compliance, etc.
- Disputes? Conflicts? Not Sure Who To Contact? Contact our Ombudsman:
- Call: 1-877-CTP-1373
- Write: Center for Tobacco Products Food and Drug Administration
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002
- FDA Tribal Affairs
- Fact Sheet: The Center for Tobacco Products and Native Communities
- Family Smoking Prevention and Tobacco Control Act
- Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
- Compliance, Enforcement, and Training
- Rules, Regulations and Guidance
1. Centers for Disease Control and Prevention (CDC). Current cigarette smoking among adults – United States, 2005-2014. Morbidity and Mortality Weekly Report. 2015; 64(44):1233-1240.