Update on the FDA Premarket Review Process: Little Progress and Ongoing Uncertainty

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The Family Smoking Prevention and Tobacco Control Act (“TCA”) requires any new tobacco product to receive permission from the U.S. Food and Drug Administration before it can be sold This is a process known as premarket review. In passing the TCA, Congress intended to strengthen FDA’s role as a gatekeeper, preventing harmful new products from ever entering the market.

However, the premarket review process has not unfolded as Congress intended. In fact, of the thousands of electronic cigarette products out there on shelves, not one was reviewed and affirmatively authorized for sale by the agency before being sold to customers.

As a result of FDA’s delayed enforcement of premarket review, public health groups sued the FDA in 2018. The lawsuit eventually resulted in a court order directing the FDA to move forward with premarket review, imposing a timeline that requires companies to have submitted marketing applications before September 9, 2020 in order to keep their products on the market temporarily.  In addition, the court ordered that by September 9, 2021, only products that have been vetted by the FDA can continue to be legally sold.

Since that time, the FDA has provided some public updates about how the premarket review process is progressing and what it plans to do in the coming months as the September 9, 2021, deadline looms.

The FDA is currently reviewing marketing applications for new tobacco products. However, the premarket review process is not transparent. The only information we have about the status of the agency’s review comes in the form of infrequent updates from the agency itself. In February, the FDA issued a perspective piece providing a rundown of the process and status of product review. Then, in May, the agency updated its metrics and provided a list of the products for which applications have been submitted. Here are some key points about what we know so far:

  • The FDA has received applications for over six million tobacco products.1 The number of Premarket Tobacco Product Application (“PMTA”) for e-cigarettes (or ENDS) far outpaces the number of applications submitted for any other products, as depicted on this graphic created by the FDA:

Pie Chart: FY21 Products Accepted for Review

  • The applications received vary widely in terms of their format, organization, presentation of information, or number of products addressed. This is at least partially due to the fact that the FDA did not proscribe a format for applications.
  • The FDA’s list of deemed2 products that have submitted applications is available in 15 different pages of spreadsheets, which contains millions of iterations of products in different flavors, nicotine strengths, and sizes, making it difficult for public health community to effectively use the list to determine which products submitted applications and are therefore allowed to remain on the market.
  • The FDA continues to prioritize enforcement against non-tobacco or menthol-flavored e-liquid products for which it did not receive PMTAs. So far, the FDA’s enforcement efforts have been limited to sending warning letters to manufacturers selling products online (a list of the warning letters issued by the FDA is available here). The FDA has provided no information on any enforcement actions other than sending warning letters to companies, though the FDA has authority to impose monetary penalties and seize illegally marketed products.
  • The agency is prioritizing review of products that make up most of the current market share, assuming that this will have the “greatest public health impact most quickly.” This undoubtedly includes JUUL and other products that are most popular among youth.
  • There are four phases of application review: (1) Acceptance, (2) Notification or Filing; (3) Substantive Review; (4) Action. So, far, the FDA has “accepted” PMTA applications for over six million products and “filed” 138,508 PMTA applications.
  • Phase 3, substantive review, is still in the beginning stages. The FDA states it has reviewed information for “hundreds” out of the millions of products at this point.
  • There is an exceptionally low likelihood that the FDA will make a determination on all the PMTAs by September 9, 2021, and the agency publicly represents that it intends to remove products from the market that have not received authorization by the September 9 deadline.
  • The FDA has a “metrics and reporting” page that it intends to periodically update (last updated June 17, 2021). That page contains basic information and graphics about the progress of the review process.
  • Though no products that submitted PMTAs have received marketing orders yet, marketing orders will be available on this page once they are issued.

 

The PMTA review process has overwhelmed the FDA for several reasons. By its own admission, the FDA failed to design a uniform application process. That caused initial delays in processing applications. The FDA is unlikely to complete its review of the backlog of applications by September 9, 2021 which should result in millions of products being removed from stores. The Public Health Law Center will continue to monitor developments and update information on this process as it unfolds.

On August 9, 2021, the FDA refused to grant marketing orders for approximately 4.5 million new tobacco products submitted by JD Nova. This is significant because the FDA had received a total of 6.5 million applications by the September 9,2020 deadline. Now the company must remove approximately 4.5 million products from the market or risk enforcement action by FDA.

 


1 In fact, one firm submitted a single submission covering four million products.

2 The TCA authorizes the FDA to assert regulatory authority over any products derived from tobacco and intended for human consumption, which it did in 2016 through the deeming rule. In that rule, the agency asserted regulatory authority over cigars, e-cigarettes, hookah, and other tobacco products.