SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) last gave an update on where the agency is at in the premarket tobacco product application (PMTA) review process nearly two months ago.
And while the process of reviewing PMTAs is not complete yet, there is data available that can give retailers an idea of the progress the FDA is making.
What products are authorized by the FDA ultimately will determine what convenience-store retailers can stock in their back bars and will largely affect the electronic nicotine delivery systems (ENDS) segment.
Of the fiscal year 2021 products accepted for review, 58,041 of those are ENDS, 1,986 are cigars, 500 are pipe products, 525 are waterpipe, 74 are cigarettes, 25 are roll-your-own, 12 are smokeless and 27 are categorized as “other.”
Here’s a breakdown of what we know so far. Numbers are how many products have been accepted or rejected to date and are current as of Jan. 1. The exact total number of products is still being processed. The FDA has said it will update its metrics and reporting page when more information is available.
Due to the large number of applications received and processing variability, the numbers are not exact, but generally within 95% accuracy, the FDA said.
- 59,819 accepted: Phase one in the review process is to conduct an application’s acceptance review. This ensures the product falls under the CTP’s jurisdiction and confirms the basic requirements are met. If an application is accepted, it moves onto the notification or filing phase.
- 2,767 refuse to accept: The FDA can also refuse to accept a PMTA if it contains certain deficiencies. Examples include the submission not pertaining to a tobacco product or an application not being in English or providing English translations.
- 28,127 filed: Phase two varies by application type, but all accepted PMTAs proceed through filing review, which ensures the applications contain all the items required. This includes full reports of all information concerning investigations which have been made to show the health risk of the tobacco products; full statements of the components, ingredients, additives and properties, and of the principle or principles of operation; and full descriptions of the methods used in the manufacturing and processing steps.
- 1,688 refuse to file: Those applications that do not meet the requirements in the filing phase will be the subject of a refuse to file letter.
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