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FDA CTP Announces Update to Provisional Substantial Equivalence Review Process

April 10, 2018

EAS Consulting Group would like to bring to your attention an FDA Center for Tobacco Products announcement regarding updates to the Provisional Substantial Equivalence review process. Substantial equivalence (SE) is the most commonly used pathway by which tobacco products may obtain premarket authorization. Whether SE reports were submitted Provisionally, (products introduced into commercial distribution between February 15, 2007, and March 22, 2011) or are now submitted Regularly (SE Reports received after March 22, 2011), manufacturers must demonstrate that their new products have the same characteristics as a predicate product, or that any differences do not cause the new tobacco product to raise different questions of public health.

Since this program’s inception, FDA has received a huge number of applications, creating a significant backlog in the review and decision-making. Specifically, the agency received more than 3,600 Provisional applications, of which it has resolved approximately 1,000, including orders of Not Substantially Equivalent (NSE) status, a Refuse to Accept status or the applications were withdrawn. In addition, FDA has also received more than 2,500 Regular submissions, resolving 93% of them to date. The review process for Regular SE submissions has been without a backlog since March 2014.

Over the years the agency has gained efficiencies in the SE review process and intends to apply that knowledge to expedite the remaining applications in Provisional status, triaging those 1,000 applications determined to have the greatest potential to raise different questions of public health and removing from review the approximately 1,500 Provisional SE Reports determined less likely to do so.

In the cases where a product is being removed from the Provisional review, the legal marketing status remains unchanged and the product cannot be used as a predicate for a new SE application. FDA will monitor for criteria that would cause the product to return to the review queue including:

  • The provisional SE product is also the subject of another pending application
  • New information suggests that the provisional SE product is more likely to have the potential to raise different questions of public health than previously determined
  • FDA has reason to believe that the provisional tobacco product was not introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to March 22, 2011.

The agency has listed those products which are now removed from Provisional status on their website as well as a cumulative list of Provisional SE Reports since the program’s inception.

As you know, EAS Consulting Group offers a wide range of services to the tobacco industry, including assistance with preparation for tobacco GMPs, implementing quality systems, registration and listing assistance and more. Please view our industry services sheet should you wish to learn more.