This page provides an overview of tobacco products and the requirements that the FDA verifies/enforces at the time they are imported or offered for import into the United States.
Tobacco products imported or offered for import into the United States must comply with all the applicable requirements of the FDA’s laws and regulations. The FDA's Center for Tobacco Products (CTP) carries out the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
In 2016, the FDA finalized a rule - Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act – which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.
This final rule is in effect, as of August 8, 2016. Requirements for these tobacco products are being implemented over a period of time. For more information, review the Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers and Distributors of Deemed Tobacco Products.
For more information visit our Tobacco Products page.
- Importing Modified Risk Tobacco Products
- Importing Smokeless Tobacco - Labels and Advertising Warnings
- Electronic Cigarettes
- Ban on Cigarettes that Contain Certain Characterizing Flavors
- User Fees
- How can I determine if my tobacco product is on an import alert?
- How does the FDA verify compliance with the tobacco requirements?
- Affirmation of Compliance codes
- Additional Requirements for Importing Tobacco products
The term “tobacco product” means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)”.
At the time of importation, the FDA will verify compliance with requirements for tobacco products such as:
- User Fees
Note: This does not apply to products subject to the deeming rule at this time.
The FDA conducts label examinations of tobacco products to verify the product complies with the FDA's laws and regulations. A tobacco product’s label, labeling, or advertising will be reviewed for the following:
- Modified risk descriptors such as “low,” “mild,” or “light,” or any similar descriptor and the product does not have a FDA order in effect
- Advertising warnings for smokeless tobacco
- E-cigarette labeling for therapeutic purposes
- An artificial or natural flavor (other than tobacco or menthol) or an herb or spice that is a characterizing flavor of the tobacco product or tobacco smoke
The FDA reviews the import alert database to determine if the manufacturer or product is subject to detention without physical exam (DWPE). For example, import alert 98-03 Detention without Physical Examination of Smokeless Tobacco Products without Required Warning label lists smokeless tobacco products that did not contain one of four required textual warnings in English. See Importing Smokeless Tobacco - Labels and Advertising Warnings section below for more information on the required textual warnings.
The FDA defines a “modified risk tobacco product” as any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
As of July 22, 2010, manufacturers or importers of finished tobacco products may not introduce into interstate commerce any tobacco product for which the label, labeling, or advertising contains the descriptors “low, ” “mild,” or “light,” or any similar descriptor without a FDA order in effect.
For more information visit the Modified Risk Tobacco Products webpage and Guidance for Industry and FDA Staff: Use of “Light,” “Mild,” “Low,” or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products.
The FDA prohibits the importation and advertising of imported smokeless tobacco products within the United States unless the product package and advertising bears one of four textual warning statements that must appear on smokeless tobacco advertising. For more information review the Draft Guidance for Industry - Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products.
The FDA finalized a rule in 2016 that extends the FDA’s regulatory authority to cover all tobacco products, including electronic cigarettes (e-cigarettes). The final rule went into effect on August 8, 2016. E-cigarettes that are marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the Center for Drug Evaluation and Research (CDER). The FDA conducts label examinations to determine if e-cigarettes are being marketed for therapeutic purposes. Visit our Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS) page for more information.
According to the FDA’s laws and regulations, cigarettes or any component parts (including the tobacco, filter, or paper) shall not contain an artificial or natural flavor (other than tobacco or menthol) or an herb or spice that is a characterizing flavor of the tobacco product or tobacco smoke.
The FDA assesses and collects user fees from tobacco manufacturers and importers. User fees provide the resources needed for the FDA to build a national tobacco product regulation framework to reduce the impact of tobacco use on the nation’s health. Import alert 98-05, Detention without Physical Examination of Regulated Tobacco Products, for Non-Payment of User Fee lists importers who have failed to pay a user fee.
Visit the Tobacco User Fees page for more information.
The FDA provides a list of import alerts by industry. To view the list of import alerts related to tobacco products visit the import alert for tobacco products page.
The FDA entry reviewers are trained to verify compliance with tobacco requirements using the information provided to the FDA in the importer’s entry transmission such as:
- Declared manufacturer
- Declared importer/consignee
- Product description
- Affirmations of Compliance (A of C)
These entry declarations may be compared to information in the FDA’s internal database. The reviewer uses these internal databases to determine if the product is subject to DWPE.
The submission of correct and accurate entry data along with the relevant A of C codes will help expedite the entry review process. Submitting accurate information increases the likelihood that your shipment will be processed electronically and not held for manual review because the FDA’s screening tool, PREDICT, can verify the declared information against the FDA's internal data systems.
Note: Submitting inaccurate or incomplete information may delay the review of your entry.
Affirmation of Compliance (A of C) codes are three letter codes that can be provided at the time of import to facilitate the FDA's review. The FDA uses A of C codes to assist in verifying that your product meets the appropriate requirements. Providing the correct A of C codes reduces the likelihood that your shipment will be held for additional FDA entry review during the FDA’s import screening process. Submission of A of C codes is only mandatory in some instances and is not required for all scenarios. Submitting voluntary A of C codes in addition to all mandatory A of C codes may expedite initial screening and review of your entry.
For information on affirmation of compliance codes refer to the “Affirmation Of Compliance References” at the bottom of the affirmation of compliance codes page.
For more information please see Guidance for Industry: Tobacco Health Document Submission
For more information please see Guidance for Industry: Listing of Ingredients in Tobacco Products
The FDA requires a premarket order for a new tobacco product prior to its introduction and distribution in the United States. For more information on submitting an Application for Premarket Review of a New Tobacco Product.
- FDA ACE External Outreach Presentation-Tobacco
- Automated Commercial Environment/International Trade Data System (ACE/ITDS)
- Importing and Exporting Tobacco Products
- Tobacco Letters to Industry
- Labeling Tobacco Products
- Advertising & Promotion of Tobacco Products
- Tobacco Products, Ingredients & Components
- Recognize Tobacco in its Many Forms