- User Fees
- Tobacco Product Review and Evaluation Requirements
- Tobacco Product Site Tours Program
- Final Rule for Cigarette Packages and Advertisements
- Industry Submissions
The Food and Drug Administration has issued a final rule requiring domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act. This information is currently collected by the U.S. Department of Agriculture (USDA) and provided to FDA, but beginning October 2014, when the USDA program sunsets, manufacturers and importers will have to submit this information to FDA instead. FDA will use a similar submission process and the method of assessing user fees currently used by the USDA. The final rule applies to domestic manufacturers and importers of four classes of tobacco products – cigarettes, snuff, chewing tobacco, and roll-your-own tobacco.
New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product was both commercially marketed after February 15, 2007 but before March 22, 2011 and a Substantial Equivalence Report was submitted by March 22, 2011, then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.
- More information about Substantial Equivalence
- Guidance for Industry and FDA Staff – Demonstrating Substantial Equivalence for Tobacco Products (Section 905(j)) (PDF)
- Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
- Webinars on Substantial Equivalence
Exemption from Substantial Equivalence
A tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence if certain conditions are met.
- More information on Exemption from Substantial Equivalence
- Final Rule: Tobacco Products, Exemptions From Substantial Equivalence Requirements
Premarket Tobacco Products
To market a new tobacco product, you may submit a Premarket Tobacco Application under Section 910 of the Food, Drug, and Cosmetic Act. Before marketing your product in the United States, you must receive written notification from FDA permitting the marketing of the new tobacco product.
- More information on Premarket Tobacco Products
- Draft Guidance for Industry Applications for Premarket Review of New Tobacco Products
Modified Risk Tobacco Product Applications
A modified risk tobacco product (MRTP) is a tobacco product that is sold or distributed for use to reduce harm and the risk of tobacco-related disease associated with commercially marketed tobacco products. You can legally market a modified risk tobacco product only after FDA issues an order permitting its marketing (Section 911(g)).
- More information on Modified Risk Tobacco Products
- Draft Guidance for Industry: Modified Risk Tobacco Products Applications
Harmful and Potentially Harmful Constituents in Tobacco Products
Harmful and potentially harmful constituents (HPHCs) are chemicals or chemical compounds in a tobacco product or tobacco smoke that cause, or could cause, harm to smokers or non-smokers. The Family Smoking Prevention and Tobacco Control Act requires tobacco product manufacturers and importers to report quantities of HPHCs found in tobacco products or tobacco smoke by brand and sub-brand.
- More information on reporting HPHCs
- Draft Guidance for Industry: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug and Cosmetic Act. (PDF)
- Guidance for Industry and FDA Staff: “Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act
Tobacco Product Site Tours Program
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Science is announcing an invitation for participation in its Site Tours Program. This program is intended to give CTP staff an opportunity to visit facilities involved in the growing, processing, or manufacturing of tobacco or currently regulated tobacco products (i.e., cigarettes, roll-your-own, and smokeless tobacco). These visits are intended to provide CTP staff with the opportunity to gain a better understanding of the tobacco industry and its operations and are not intended as regulatory inspections or facility visits for the purposes of developing Tobacco Product Manufacturing Practice regulations. The purpose of this notice is to alert parties interested in participating in the Site Tours Program to submit requests to CTP.
On June 22, 2011 FDA issued a final rule requiring cigarette packs and advertisements to contain both a health warning statement and a graphic element illustrating the negative health effects of smoking.
Light, Low, Mild or Similar Descriptors
As of July 22, 2010, Manufacturers cannot distribute tobacco products with labeling, or advertising contains the descriptors “light,” “low,” or “mild,” or any similar descriptor.
- Guidance for Industry and FDA Staff: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products
- Letter to Tobacco Manufacturers on Tobacco Products Labeled or Advertised with the Descriptors “Light,” “Low,” “Mild,” or Similar Descriptors
Smokeless Tobacco Product Warning Labels
New warning labels must begin to rotate in advertising for smokeless tobacco products beginning on June 22, 2010, and must be distributed and displayed on the packaging of smokeless tobacco products manufactured on or after June 22, 2010. Starting July 22, 2010, manufacturers may not distribute any smokeless tobacco product unless its packaging complies with the new warning requirements.
- Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products
Tobacco product manufacturers or importers are required to submit certain information to the FDA including:
Tobacco Health Document Submission
Section 904(a)(4) of the act requires each tobacco product manufacturer or importer, or agent thereof, to submit all documents developed after June 22, 2009 “that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.”
- Guidance for Industry: Tobacco Health Document Submission
- Form 3743
- Technical Working Specifications
Establishment Registration and Product Listing
Under section 905 of the act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.
- Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
- Electronic Registration and Product Listing: Step-by-Step Instructions
Listing of Ingredients in Tobacco Products
Section 904 of the act requires each tobacco product manufacturer or importer, or agent thereof, to submit a listing of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of each regulated tobacco product by brand and by quantity in each brand and subbrand.
Reporting of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Section 904(a)(3) of the Act requires each tobacco product manufacturer or importer, or agent thereof, to report quantities of harmful and potentially harmful constituents (HPHC) for tobacco products by brand and subbrand.
- Draft Guidance for Industry: Reporting of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
For electronic submission of such information, FDA utilizes the eSubmitter tool and the Electronic Submissions Gateway (ESG) for Listing of Ingredients, Tobacco Health Document Submissions, and Reporting of Harmful and Potentially Harmful Constituents. The FDA Unified Registration and Listing Systems (FURLS) is utilized for Establishment Registration and Product Listing.
- The FDA’s eSubmitter tool is designed to facilitate efficient and secure electronic submission of this information and provides automatic acknowledgement of FDA receipt with attached data from FDA to facilitate future submissions. Instructions , video tutorials and helpdesk assistance (firstname.lastname@example.org or 1-877-CTP-1373 (are available. The instructions also address information regarding obtaining a DUNS number.
- The FDA's Electronic Submissions Gateway (ESG) enables the secure submission of regulatory information for review. The ESG authenticates and validates electronic submissions and routes it to the appropriate Center. Please see the ESG checklist to register as a trading partner and obtain an ESG "WebTrader" account. For any ESG-related support, please visit the ESG website or call 1-877-CTP-1373 , or email at email@example.com for preparation/registration/policy-related questions) or ESGHelpDesk@fda.hhs.gov (for technical issues with submissions).
- The FDA Unified Registration and Listing Systems (FURLS) allows you to submit and view online. To create and account go to https://www.access.fda.gov/oaa/logonFlow.htm.
- FDA strongly encourages electronic submission. Alternatively, you may use Form FDA 3741 (PDF) for Establishment Registration and Product Listing, Form FDA 3742 (PDF) for Listing of Ingredients in Tobacco Products, and Form 3743 for Tobacco Health Document Submissions. Persons with disabilities having problems accessing the above pdf file may call 301-796-9241 for assistance.
For regulatory questions regarding sections 904 and 905 of the act, email TobaccoIndustryQuestions@fda.hhs.gov. Regulatory Submissions can be mailed to:
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
FDA is unable to accept regulatory submissions by electronic mail.