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                Products, Guidance & Regulations

Products, Guidance & Regulations

                        Submit Comments on Tobacco Regulatory Activities
          Tobacco Products-Related Citizen Petitions
          Importing and Exporting
          Tobacco Product Standards


                        Market and Distribute a Tobacco Product
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          Tobacco Products
          Products, Guidance & Regulations
          Importing and ExportingProducts, Guidance & Regulations Importing and Exporting
  
  	
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**Importers and exporters play an important role in protecting the public from the harms of tobacco products.**

Tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

How and When Do I Comply with FDA's Rules to Import Tobacco?

Importers of finished tobacco products may be distributors, tobacco product manufacturers or both. Importers who do not own or operate a domestic establishment engaged in the manufacture, preparation, compounding or processing of a tobacco product are not required to register their establishment or provide product listing. However, they must comply with all other applicabletobacco product manufacturer requirements.

If you do **not**comply with the requirements, your imported tobacco products are subject to refusal of admission, under section 801 of the FD&C Act.

Reporting through Automated Commercial Environment

Automated Commercial Environment (ACE) is the primary system through which the trade community reports its imports and exports.

For all FDA regulated products, importers are **required** to submit the following data elements through ACE:

Country of Production
	FDA Product Code
	Intended Use Code
	Email and phone number for importer of record
	Brand name of product
	Brand name is not required if the product is investigational or for further manufacturing
	For additional information on ACE requirements for FDA regulated products, please refer to the FDA Supplemental GuidePersonal Use

The FD&C Act does **not** exempt tobacco products imported for personal use from applicable requirements for tobacco product imports.

More Information

You can also learn more about the importation process in the FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions.

If you have questions about importing a specific tobacco product, please contact the FDA district into which your product will be imported.

Exporters

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You do not need to report to FDA in order to export a tobacco product outside of the U.S. However, tobacco products intended for export may be deemed to be adulterated or misbranded unless the product is:

in accordance with the specifications of the foreign purchaser,
	not in conflict with the laws of the country to which it is intended for export,
	labeled on the outside of the shipping package that it is intended for export, and
	not sold or offered for sale in domestic commerce.In addition, there are recordkeeping requirements related to exported tobacco products.  Notification and recordkeeping requirements for tobacco products exported under Section 801 of the FD&C Act are provided in 21 CFR 101.1.

FDA reports to Congress on the export of tobacco products that do not conform to U.S. tobacco product standards, per the Tobacco Control Act. Currently, there are no documented instances of the export of tobacco products that do not conform to current U.S. tobacco product standards.

Additional Resources

Compliance, Enforcement and Training
	Guidances

                                                                                  Content current as of:
      09/20/2022
              
              
Regulated Product(s)
		 TobaccoProducts, Guidance & Regulations

          
                        Submit Comments on Tobacco Regulatory Activities
          Tobacco Products-Related Citizen Petitions
          Importing and Exporting
          Tobacco Product Standards


                        Market and Distribute a Tobacco Product
          Advertising and Promotion
          Labeling and Warning Statements for Tobacco Products
          Products, Ingredients & Components
          Rules, Regulations and Guidance
 
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