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 In this section:

                Importing FDA Regulated Products

Importing FDA Regulated Products

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                        Importing COVID-19 Supplies Home
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          Import Program – Food and Drug Administration (FDA)
          Importing FDA Regulated Products
          Importing Tobacco ProductsImporting FDA Regulated Products Importing Tobacco Products
  
  	
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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 May 2016, FDA published a final rule extending its tobacco product authority to all tobacco products (except for accessories of deemed tobacco products). This rule (the Deeming Rule) became effective on August 8, 2016 and extended the FDA’s jurisdiction to include products like electronic nicotine delivery systems (ENDS), pipe tobacco, cigars, hookah (waterpipe) tobacco, and e-liquids containing nicotine.

All tobacco products, including deemed products, that meet the definition of a “new tobacco product” are subject to the premarket requirements in section 910 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In January 2020, FDA issued the “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization” guidance for industry.  This guidance document describes the FDA’s intent to prioritize enforcement for the lack of marketing authorization against certain ENDs products that are offered for sale in the United States regardless of whether a premarket application for such product has been submitted or when it was submitted.

For more information visit our Tobacco Products page.

Overview

	What is a tobacco product?
		What tobacco product requirements are verified at the time of importation?
		How does the FDA verify tobacco requirements at the time of importation?
	Importing Modified Risk Tobacco Products
	Importing Smokeless Tobacco - Labeling and Warning Statement Requirements
	Electronic Nicotine Delivery System (ENDS)
	Premarket Authorization Requirements
	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?
	General Labeling Requirements
	Nicotine Warning
	Affirmation of Compliance codes
	Additional Requirements for Importing Tobacco products
	Tobacco Health Documents**What is a tobacco product?**

The term “tobacco product” means “any product made or derived from tobacco, or containing nicotine from any source, 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)”.

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

At the time of importation, the FDA will verify compliance with requirements for tobacco products such as:

Market Authorization
	Labeling
	User Fees**How does the FDA verify tobacco requirements at the time of importation?**

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:

General labeling requirements
	Nicotine warning
	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
	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**General Labeling Requirements**

General labeling requirements include:

Name and place of business of the tobacco product manufacturer, packer, or distributor;
	An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; and
	The statement “Sale only allowed in the United States” on labels, packages, and shipping containers.**Nicotine Warning**

If the tobacco product contains nicotine, the labeling needs to state, “WARNING: This product contains nicotine. Nicotine is an addictive chemical.”

If the tobacco product does not contain nicotine, the labeling needs to state, “This product is made from tobacco.”

**Importing Modified Risk Tobacco Products**

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.

**Importing Smokeless Tobacco - Labeling and Warning Statement Requirements**

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.

**Electronic Nicotine Delivery System (ENDS)**

The FDA finalized a rule in 2016 that extends the FDA’s regulatory authority to cover all tobacco products, including ENDS. The final rule went into effect on August 8, 2016.    ENDS 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).   Visit our Vaporizers, E-Cigarettes, and other Electronic Nicotine Delivery Systems (ENDS) page for more information.

Refer to the Guidance for Industry (GFI), titled Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.

Resource for Customs brokers/filers: Information for successfully filing entries of Electronic Nicotine Delivery System (ENDS) Products

**Premarket Authorization Requirements**

On May 10, 2016, FDA issued a final rule deeming all products that meet the definition of a tobacco product, except accessories of deemed products, to be subject to FDA’s tobacco product authority. These deemed new tobacco products are required to obtain premarket authorization under Section 910 of the FD&C Act. Deemed new tobacco products that remain on the market without marketing authorization are marketed unlawfully in contravention of the Tobacco Control Act.

For more information on the Premarket Authorization requirements, including current enforcement priorities of the agency for ENDS and other deemed products, please refer to the following Guidance for Industry: Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.

**Ban on Cigarettes that Contain Certain Characterizing Flavors**

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.

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).

**User Fees**

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.

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

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.  ****

**How does the FDA verify compliance with the tobacco requirements?**

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 codes**

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.

**Additional Requirements for Importing Tobacco products**

**Importing New Tobacco Products**
	The 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.
	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.

Useful Links
	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
	Frequently Asked Questions – Electronic Nicotine Delivery Systems (ENDS) Import Requirements
	**NEW!**Information for successfully filing entries of Electronic Nicotine Delivery System (ENDS) Products



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**Tobacco**

For General Inquiries

AskCTP@fda.hhs.gov



Center for Tobacco Products

Food and Drug Administration

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Building 71, Room G335

Silver Spring, MD 20993-002



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                                                                                  Content current as of:
      09/20/2022Importing FDA Regulated Products

          
                        Importing Animal and Veterinary Products
          Importing Biologics and CBER Regulated Products
          Importing Cosmetics
          Importing Human Drugs
          Importing Human Foods
          Importing Medical Devices
          Importing Radiation-Emitting Electronic Products
          Importing Tobacco Products


                        Importing COVID-19 Supplies
 
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