The U.S. Food and Drug Administration (FDA) is sorting through nearly 1 million applications for synthetic nicotine products, a significant number of which were received by May 14.

The FDA's authorization to regulate tobacco products containing non-tobacco-manufactured or derived nicotine, such as synthetic nicotine, went into effect on April 14. Under supervision, manufacturers of synthetic nicotine products are now required to submit a premarket tobacco product application (PMTA) for these products and obtain FDA authorization to sell them.

According to Convenience Store News, the PMTA deadline for synthetic nicotine products is May 14, 2022.

According to the agency, more than 200 independent companies have submitted applications. In an Aug. 3 update, Brian King, director of the FDA's Center for Tobacco Products, said the FDA has issued Rejection of Acceptance (RTA) letters for more than 88,000 products whose applications did not meet previous acceptance criteria.

Without the required information, the application will not pass the acceptance stage of the review process. He explained that the RTA letter states that it is illegal to sell or distribute any new tobacco product on the U.S. market without a premarket authorization.

Of the applications filed before May 14, the FDA accepted more than 350 applications, the vast majority of which were for e-cigarettes or e-liquid products.

Acceptance is not a determination of the product's authorization status, King said. He added that the agency referred accepted applications to further review to ensure the applications met certain criteria in order to proceed with further evaluation.

“After further review, applications that meet the necessary criteria will proceed to substantive review, including consideration of the impact on the population as a whole, such as risks to adolescents and potential benefits to adult smokers,” King said. “Only after the substantive stage can a company obtain a marketing order. If a marketing order is not obtained, it is still illegal to sell the product. To date, no non-tobacco nicotine product has been licensed for marketing.”

Under the new rules, after July 13, non-tobacco nicotine products can only be legally sold in the U.S. with premarket authorization from the FDA.

“We have been closely monitoring the compliance of retailers, manufacturers, importers and distributors with the law. Similar to the application review step, our compliance and enforcement work is a multi-step process that cannot be accomplished overnight; ensuring that Any enforcement action takes time and is supported by the available evidence on legal standards," he said.

As of Aug. 1, the agency issued 17 new warning letters to manufacturers for marketing their products without the necessary premarket authorization. These manufacturers failed to submit applications for their non-tobacco nicotine products.

On July 28, the agency also issued 102 warning letters to retailers for illegally selling non-tobacco nicotine products to underage buyers. Companies have 15 business days to respond to FDA letters.

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