FDA Releases “Deemed New Tobacco Product Applications Lists”

Background

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 products that meet the definition of a new tobacco product must receive premarket authorization from the FDA to be legally marketed.

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 (by September 9, 2020), 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.

Generally, the submission of a premarket application and intent to commercially market a new tobacco product that has never been marketed would be considered confidential commercial information (CCI) that the FDA would not disclose.

However, the products included in the “Lists of Deemed New Tobacco Products with Timely Applications” are being treated differently because the FDA determined, based on communications with the applicants, these deemed new tobacco products are currently marketed and therefore the submission of their premarket applications could be disclosed.

Please note that FDA has not independently verified the information provided by applicants about the marketing status of their products.

In addition, the list does not include entries of products from companies that did not provide information on the current marketing status of their products to FDA so that the Agency could determine whether the existence of the application could be disclosed.

Lists of Deemed New Tobacco Products with Timely Applications

It is important to note that the lists are not comprehensive lists intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement.

Below is information that can help in understanding the lists and help determine the marketing status of a tobacco product.

Tobacco products that can be legally marketed

Tobacco products that cannot be legally marketed and risk enforcement by FDA

Tobacco products that cannot be legally marketed but, consistent with a court order, generally might remain on the market pending FDA premarket review while FDA continues to defer enforcement

Tobacco products that have been the subject of a Warning Letter

It is important to keep in mind that the lists are only one source of information. For example, retailers should discuss with their suppliers about the current status of any particular tobacco product’s application or any product’s marketing authorization

These files below include deemed new tobacco products for which a premarket application was submitted to FDA 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 lists, 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.

Deemed New Tobacco Products with Timely Applications

Lists of products for which continued marketing until September 9, 2021 may fall outside of FDA’s stated enforcement priorities
- Products with applications received through the SE and EX REQ pathways (Last updated: 04/05/21)
- Products with applications received through the PMTA pathway (Last updated: 04/05/21)
  - Note: Due to the large file sizes, the files may take several minutes to download.

Important Notes:

The lists contain deemed new tobacco products that are the subject of pending applications submitted to FDA by September 9, 2020. Products with pending applications that are included on the lists also may have been the subject of a warning letter regarding alleged violations of the Act. Check the warning letters webpage to determine if a product has been the subject of a warning letter.
For the SE and EX REQ list, products that received a negative or positive action before February 1, 2021 are not included on the list.
For the PMTA list, products that received a negative or positive action before April 5, 2021 are not included on the list. Due to the large file size, the information is broken out into 16 separate files, sorted by product type and then alphabetically by company name and then product name.
These files will be updated regularly to reflect actions taken on the applications for the products.
Due to the large amount of data in the files, minor edits and corrections may be made to these files after posting to correct any errors that occurred during FDA processing of the information provided by applicants.

*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.

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.

These lists do 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 these lists.

**FDA issued a Refuse to File (RTF) letter to JD Nova Group LLC on Aug. 9, 2021. As a result of this RTF action, the company must remove approximately 4.5 million products from the market or risk enforcement action by FDA.

This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020 deadline are still moving through the review process.

The PMTA List will be updated in the future with this RTF action. Until that time, FDA has posted the JD Nova products that were the subject of the RTF letter.

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:

redacted in accordance with applicable statutes and regulations and
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

References

_{1. Per a court ruling issued August 19, 2020, FDA will not enforce the premarket review requirement against manufacturers of “premium cigars,” as defined in that ruling, that did not submit premarket applications for these products by September 9, 2020, while this order is in effect. More information is available in FDA’s August 26 web statement.}

_{Additionally, manufacturers of deemed tobacco products that are “grandfathered” because they were commercially marketed in the United States as of Feb. 15, 2007, do not need to submit premarket applications for those products (unless the products were since modified).}

_{2. The court subsequently clarified that its order did not restrict FDA’s authority to enforce the premarket review provisions against deemed products, or categories of deemed products, during the one-year review period.}