FDA Processing 1M Applications for Synthetic Nicotine Products

SILVER SPRING, Md. — The Food and Drug Administration (FDA) is sorting through nearly 1 million applications for synthetic nicotine products, a substantial number of which were received by May 14.

The FDA's authority to regulate tobacco products that contain nicotine not made or derived from tobacco (e.g., synthetic nicotine) went into effect on April 14. With the oversight, manufacturers of synthetic nicotine products are now required to submit a premarket tobacco product application (PMTA) for those products and obtain FDA authorization to market them.

The PMTA deadline for synthetic nicotine products was May 14, 2022, as Convenience Store News reported.

According to the agency, more than 200 separate companies submitted applications. In an Aug. 3 update, Brian King, director of the FDA's Center for Tobacco Products, said FDA had issued refuse-to-accept (RTA) letters for more than 88,000 products in applications that do not meet the criteria for acceptance in the prior three-week period.

Without the required information, applications cannot proceed past the acceptance phase of the review process. The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization, he explained.

Of those applications submitted by May 14, the FDA accepted more than 350 applications, with the vast majority being for electronic cigarette or e-liquid products.

An acceptance, King said, is not a determination about the products' authorization status. The agency moves accepted applications for further review, which ensures certain criteria are met for applications to proceed forward for further evaluation, he added.

"After this further review, applications that meet the necessary criteria will enter substantive review, including consideration of the impact to the population as a whole, such as risks to youth and potential benefits to adult smokers," King said. "It is only after the substantive phase that a company may be granted a marketing order. If no marketing order is granted, it remains illegal to market the product. To date, no non-tobacco nicotine product has received a marketing granted order."

According to the new rule, after July 13, a non-tobacco nicotine product can only be legally marketed in the United States if it has received premarket authorization from FDA.

"We have been closely monitoring retailer, manufacturer, importer, and distributor compliance with the law. Similar to the application review steps, our compliance and enforcement work is a multistep process that cannot happen overnight; it takes time to ensure that any enforcement taken is supported by the available evidence with respect to the legal standards," he said.

As of Aug. 1, the agency issued 17 new warning letters to manufacturers for marketing their products without the required 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 purchasers. Companies had 15 working days to respond to the FDA's letters.