FDA Gives Update on Synthetic Nicotine Review, Enforcement

A non-tobacco nicotine product can only be legally marketed if it has an FDA premarket authorization.

August 05, 2022

E-Cigarette Cartridges

ALEXANDRIA, Va.—The Food and Drug Administration (FDA) provided an update on the review and enforcement of non-tobacco nicotine products.

Brian King, the director for the FDA’s Center for Tobacco Products, wrote in a letter, that the FDA has been “working diligently to process non-tobacco nicotine product premarket applications and prepare them for the review process—day in and day out—since we were granted the authority to do so by Congress.”

In March, legislation was passed that gave the FDA authority to regulate synthetic nicotine products and required any manufacturers of synthetic nicotine that wanted to market their products to submit a premarket tobacco application (PMTA) by May 14, 2022, and obtain FDA authorization to stay on the market after July 13, 2022.

The FDA said it received nearly one million PMTAs from more than 200 separate companies. The agency has been making “significant progress” on the application, and in the past three weeks, it has issued refuse-to-accept (RTA) letters for more than 88,000 products in applications that do not meet the criteria for acceptance. The FDA has also accepted over 350 applications, with the vast majority being for e-cigarette or e-liquid products. However, the FDA’s acceptance is not a determination about the products’ authorization status.

“Accepted applications then enter further review, which ensures certain criteria are met for applications to proceed forward for further evaluation,” wrote King. “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,” wrote King.

King notes this important information for retailers in his letter:

“After July 13, 2022, a non-tobacco nicotine product can only be legally marketed in the United States if it has received premarket authorization from FDA. This means that it is illegal for a retailer or distributor to sell or distribute a non-tobacco nicotine product that is not subject to a marketing granted order (MGO) from FDA. Without this MGO, a product is in violation of the law and its manufacturer, retailer, or distributor may be subject to FDA enforcement.”

On August 1, the FDA 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.

The FDA requests that firms that receive warning letters respond to the agency within a specified time period, typically 15 working days, and provide an explanation of the steps they will take to address any violations and their plan for maintaining compliance with the law.

“Failure to address any violations will lead to further action, as appropriate,” wrote King.

“We are at an unprecedented time in the history of tobacco product regulation, which comes with both opportunities and challenges. It is critical that we seize upon these opportunities and work to mitigate the challenges through the regulatory authorities afforded to us, which now include non-tobacco nicotine products,” wrote King.