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Deemed New Tobacco Product Applications List

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Background

Event

On June 11, 2021, from 1:00 to 3:30 p.m. EDT, join the Center for Tobacco Products (CTP) for a live, virtual meeting about the scientific review of applications received by Sept. 9, 2020. The meeting will feature a presentation from CTP Office of Science Director Matt Holman and include a question and answer session with Director Holman and additional Office of Science staff. The meeting is intended to improve public understanding of the policies and processes for tobacco product application review. The meeting is free of charge, but prior registration is required.

Register for This Event

A “new tobacco product” is any tobacco product (including those products in test markets) not commercially marketed in the United States as of February 15, 2007, or the modification of a tobacco product where the modified product was commercially marketed in the U.S. after February 15, 2007. New tobacco products may not be legally marketed in the U.S. without a tobacco product marketing order from the FDA.

On August 8, 2016, FDA’s tobacco authorities were extended to all “deemed” tobacco products (except for accessories of deemed tobacco products), such as e-cigarettes, cigars, hookah tobacco, pipe tobacco, nicotine gels and certain dissolvables. These authorities include the requirement that deemed new tobacco products must receive premarket authorization from the FDA prior to marketing.

Consistent with a court order, applications for premarket review for certain deemed new tobacco products on the market as of August 8, 2016 were required to be submitted to FDA by September 9, 2020.1 For companies that submitted timely applications, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application.

The following list can help you find the current status of a deemed new tobacco product.

List of Deemed New Tobacco Products with Timely Applications

This file includes currently marketed deemed new tobacco products on the U.S. market as of August 8, 2016, and for which a premarket application was submitted by September 9, 2020. A court order provided for a one-year period during which time such products might remain on the market pending FDA review.2  If a negative action is taken by the FDA on the application prior to September 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the below list, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.

Before posting the list, FDA verified certain product information, including their current marketing status, with companies before creating the file below. This file contains information received from companies and do not include information for companies that did not verify the marketing status of their products in response to FDA’s verification communications before the time of posting.

Deemed New Tobacco Products with Timely Applications

Important Notes:

  • Products that received a negative or positive action before February 1, 2021 are not included on the list.

  • The posted SE and EX information is complete. The PMTA information will be posted when it is compiled.

  • This file will be updated monthly to reflect actions taken on the applications for the products.

This is NOT a comprehensive list of currently marketed deemed products. The list may not contain the names of deemed tobacco products that have “grandfathered status” because they were commercially marketed in the United States as of February 15, 2007 and for which manufacturers do not need to submit premarket applications (unless the products were since modified). With respect to deemed tobacco products, FDA expects this grandfathered status to apply to many cigars, hookah tobacco, and pipe tobacco products.

In addition, per a court ruling issued August 19, 2020, FDA is currently not enforcing the premarket review requirement against manufacturers of “premium cigars,” as defined in that court’s ruling, that did not submit premarket applications for these products by the September 9 deadline. However, either before or after August 19, 2020, a manufacturer could have submitted an application for a product that is a “premium cigar” as defined in the court’s order. This list does not categorize whether a product meets this definition, and FDA did not consider whether any cigar products fell within the “premium cigar” definition used in the court order during creation of this list. As with other products, where a manufacturer did not submit an application for a “premium cigar” by September 9, 2020 or did not verify the marketing status of its product, the product would not be on this list. A company may have submitted a premarket application for a tobacco product that is relabeled or renamed by another company and then sold under that other name or label, which means the name of the second company’s product may not be included on the list. See additional information about grandfathered tobacco products below.

FDA is making this list available to the public to be transparent and increase stakeholder knowledge of these products, particularly among retailers. However, this list is only one source of information. Retailers should discuss with their suppliers about the current status of any particular tobacco product’s application and/or marketing status.

Positive Marketing Orders

Includes: Marketing Granted Order, Substantial Equivalence (SE) Orders and Exempt Orders

This section includes information on ALL TOBACCO PRODUCTS that have received a positive marketing order through one of the three application pathways and are authorized to be marketed in the U.S.

The documents posted on the pages below provide more detail about FDA’s rationale for each marketing decision.

Products that have received positive marketing orders:

Note: FDA works expeditiously to post all relevant documents for marketing orders. Before these documents are posted, they are:

  1. redacted in accordance with applicable statutes and regulations and

  2. reviewed to ensure compliance with Section 508, which requires that all website content be accessible to people with disabilities.

Because of this, relevant documents for marketing orders are usually posted several weeks after they are issued.

Grandfathered Tobacco Products

Products that were commercially marketed in the United States as of February 15, 2007, are considered grandfathered tobacco products. A grandfathered product is not a new tobacco product and does not require an application and authorization to be legally marketed. However, grandfathered tobacco products must comply with other applicable provisions under the FD&C Act.

Learn about a tobacco product’s potential grandfathered status and check FDA's standalone grandfathered submissions database, which contains information from voluntarily-submitted requests for a grandfathered status determination of a tobacco product.

Additional Information

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