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Importing Tobacco Products
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).
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)”.
Tobacco Products for Personal Use
Importing cigarettes for personal use only may up to 200 cigarettes and 100 cigars.
Tobacco Products for Commercial Use
The importer must be in possession of a permit from the Alcohol and Tobacco Tax and Trade Bureau.
Tobacco products imported for commercial use are also subjected to Federal Excise Tax.
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 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.
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, also called E-cigarettes, personal vaporizers, e-pipes, vape pens, e- cigars, e-hookah, or vaping devices, are products that produce an aerosolized mixture containing flavored liquids and nicotine that is inhaled by the user.
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).
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.
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.
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.
Tobacco 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.
- CMT Commercially Marketed Tobacco
- ERR Entry Review Requested
- EXE Exemption from Substantial Equivalence
- HPC Harmful or Potentially Harmful Constituents
- ILS Ingredient Listings Submission-Confirmation
- PMT Premarket Tobacco Application
Affirmation of Compliance Codes
All FDA-regulated products are expected to be in compliance at the time of entry. To help expedite FDA’s review of product compliance, the entry filer can submit additional information at the time of entry, such as registration, listing, and approval numbers. This information can be submitted by using Affirmation of Compliance codes (A of C codes).
The responsible party, such as the manufacturer or importer, should be able to indicate when these affirmations should be used and supply the qualifier when required.
Working with CBPbrokers is the best way to expedite your tobacco products pass through CBP clearance.