For Industry

Imported Tobacco

Overview

This page provides an overview of tobacco products and the requirements that 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 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.

 

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What is a tobacco product?

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)”.

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What tobacco product requirements are verified at the time of importation?

At the time of importation, FDA will verify compliance with requirements for tobacco products (this does not apply to products subject to the deeming rule at this time) such as:

  • Labeling
  • User Fees

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How does FDA verify tobacco requirements at the time of importation?

FDA conducts label examinations of tobacco products to verify the product complies with FDA 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 an 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.

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.

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Importing Modified Risk Tobacco Products

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 an 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.

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Importing Smokeless Tobacco - Labels and Advertising Warnings

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.

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Electronic Cigarettes

FDA finalized a new rule in 2016 that extends FDA’s regulatory authority to cover all tobacco products, including electronic cigarettes (e-cigarettes).  The final rule goes 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).  FDA will conduct 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.

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Ban on Cigarettes that Contain Certain Characterizing Flavors

According to 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.

For more information review the Guidance to Industry and FDA Staff: General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2).

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User Fees 

FDA assesses and collects user fees from tobacco manufacturers and importers.  User fees provide the resources needed for 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 Fees page for more information.

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How can I determine if my tobacco product is on an import alert?

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 

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How does FDA verify compliance with the Tobacco requirements?

FDA entry reviewers are trained to verify compliance with tobacco requirements using the information provided to FDA in the importer’s entry transmission such as:

These entry declarations may be compared to information in 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. Supplying this information accurately increases the likelihood that your shipment will be processed electronically and not held for manual review because FDA’s screening tool, PREDICT , can verify the declared information against FDAs internal data systems. 

Note:  Submitting inaccurate or incomplete information may delay the review of your entry.

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Affirmation of Compliance codes 

Affirmation of Compliance (A of C) codes are three letter codes that can be provided at the time of import to facilitate FDA review.  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 further FDA entry review during 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.

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Additional Requirements for Importing Tobacco products

  • Ingredients in Tobacco Products

    At least 90 days prior to introducing a tobacco product into interstate commerce, a manufacturer or importer (or their agents), must submit a listing of all ingredients of the tobacco product. This provision also requires the manufacturer or importer (or their agents) to submit information whenever any additive, or the quantity of any additive, is changed.

    For more information please see Guidance for Industry: Listing of Ingredients in Tobacco Products
  • Importing New Tobacco Products

    FDA defines a “new tobacco product” as any tobacco product including those products in test markets that were not commercially marketed in the United States as of February 15, 2007; or any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was available in the United States after February 15, 2007.

    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.

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Contact FDA

1-877-287-1373
(9am EST-4pm EST)
Tobacco

For General Inquiries:
AskCTP@fda.hhs.gov


Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center

Building 71, Room G335
Silver Spring, MD 20993-002


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Page Last Updated: 09/14/2018
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