How is the FDA Processing PMTAs?

The U.S. Food and Drug Administration (FDA) continues to process, review, and take action on as many timely premarket tobacco product applications (PMTA) as possible before September 9, 2021. In order for a PMTA to be considered timely it must have been submitted by the September 9, 2020 deadline. The review process for PMTAs generally consists of the following steps after the initial intake of submissions:

1. Acceptance review

2. Filing Review

3. Substantive Review

The substantive review of PMTAs is generally the most time consuming and thorough of the three process steps because it involves evaluating data and other scientific information in applications. Follow up with applicants is typically required as part of substantive review. The FDA usually sends a Deficiency Letter, requesting additional information or clarification of an application, prior to reaching a final decision on a PMTA. Through Deficiency Letters PMTA applicants may provide additional information required of them by the FDA in order to conduct a thorough scientific review.

Recently, the FDA has updated the language in Deficiency Letters related to PMTAs. The new language clarifies that Deficiency Letters are sent to applicants for the sole purpose of clarifying any gaps in information which may exist in PMTAs. According to the Agency, Deficiency Letters should be viewed as a way for applicants to provide more information rather than as a list of concerns about the product detailed in the PMTA. However, it must be noted that a complete response to the Deficiency Letter does not guarantee the applicant a positive marketing order. A final decision regarding the applicant’s PMTA will only occur once the FDA has completed its scientific review. The action taken on PMTAs will depend on the applicable public health standard in the Federal Food, Drug, and Cosmetic Act (FD&C Act) after review of the totality of the information contained in the original application and subsequently requested documentation, such as a Deficiency Letter.

As a reminder, all pathways to legally market and distribute tobacco products in the U.S. are overseen by the FDA. This includes the Premarket Tobacco Product Applications (PMTA), the Substantial Equivalence (SE) Report, and Exemption to a Substantial Equivalence (SEQ) pathways. New tobacco products are evaluated based on the potential risks they present to the U.S. population as a whole. When seeking to obtain marketing authorization for any new tobacco product a PMTA may be submitted. However, other pathways may be more suitable for certain classifications of products. When a new tobacco product is found to be “substantially equivalent” to a “predicate” product it can be funneled through the SE Report pathway. In order to utilize the SE pathway a new tobacco product must demonstrate the same characteristics as the predicate product and must not raise new questions of public health. A new tobacco product may also take the SEQ pathway. This pathway is applicable when a new tobacco product is modified by altering what tobacco additives are included by addition or deletion. It is also applicable when increasing the quantity of a preexisting tobacco additive. Such products may be eligible to receive exemption from demonstrating substantial equivalence.

There are two categories in which tobacco products may be categorized, “grandfathered products” and “new tobacco products.” Grandfathered products are products which were brought to market on or before February 15, 2007. Such products are regulated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and do not require premarket authorization to be legally marketed. New tobacco products are products which were brought to market after February 15, 2007. These include any originally grandfathered products which were then modified from their original state and any products which were in test markets as of February 15, 2007.

A tobacco product marketing order must be obtained from the FDA in order to legally bring a new tobacco product to market in the U.S. Provisional SE tobacco products, or new tobacco products that were brought to market after February 15, 2007 but before march 22, 2011 with an SE Report submitted by March 22, 2011, may continue to be legally marketed unless the FDA issues an order that the new tobacco product is not substantially equivalent.

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