Tobacco Products
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Tobacco Product Review and Evaluation Pathways
FDA has created a new section on our website to provide information about the criteria for review and evaluation of new and modified risk tobacco products, before they are marketed, to determine their impact on public health. FDA created the Tobacco Product Review and Evaluation content to provide:
- Centralized information on the three pathways to legally market new tobacco products;
- An interactive tool to provide greater understanding about which pathway may be appropriate for a new tobacco product; and
- Information on how to legally market a tobacco product with an explicit or implicit modified risk claim.
Visit the Tobacco Product Review and Evaluation page to learn more.
Tobacco Product Manufacturing Facility Visits
The Tobacco Product Manufacturing Facility Visits program is intended to give FDA staff an opportunity to:
- visit facilities involved in the manufacturing of tobacco products, including any related laboratory testing,
- observe the manufacturing operations of the tobacco industry – from the receipt of raw materials to the distribution of finished products, and
- learn about the manufacturing practices and processes unique to regulated tobacco products and their facilities.
These tours are educational in nature and are not intended to include or replace official FDA inspections of facilities.
Participate in the Program!
If you are interested in participating in this program, please submit a request for participation via the Federal Register Notice Docket No. FDA-2012-N-0853.
Final Rule: Substantial Equivalence Exemption
On July 1, 2011, FDA issued a final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Food, Drug, & Cosmetic Act. Exemptions from demonstrating substantial equivalence are limited to modifications of additive levels.
Cigarette Health Warnings
On June 21, 2011, FDA issued the regulation that will require cigarette health warnings on packaging and advertisements. There are different requirements and compliance dates based on whether you are a tobacco product manufacturer, retailer, importer, or distributor.
Cigarette Health Warnings: What Small Businesses Need to Know
Sale and Distribution
Who is covered, or impacted, by the Youth Access and Advertising regulations?
The regulations apply to manufacturers, distributors, importers, retailers, and others who sell cigarettes and/or smokeless tobacco.
- Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
- Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
- Draft Guidance for FDA and Tobacco Retailers: Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers
- FAQs
Registration and Product Listing
Rotational Warning Plans
Low, Light and Mild or Similar Descriptors
Listing of Ingredients in Tobacco Products
Final Guidance for Industry: Listing of Ingredients in Tobacco Products
Tobacco Health Document Submission
- Guidance for Industry: Tobacco Health Document Submission
- Form 3743 (PDF)
- Technical Working Specifications
