FDA Accepts 350 Synthetic Nicotine Applications for Review

Agency receives nearly 1 million submissions for non-tobacco nicotine products
Brian King FDA
Photograph courtesy of the FDA

SILVER SPRING, Md. — The U.S. Food and Drug Administration received nearly 1 million applications for non-tobacco nicotine products, but none have received authorization yet.

New legislation enacted on March 15 clarified that the FDA could regulate tobacco products containing nicotine from any source. The law took effect on April 14. The legislation followed a growing number of companies—including manufacturers of some of the e-cigarette brands most popular with children—began using synthetic nicotine to make their products to avoid FDA regulation, the agency said.

The FDA’s Center for Tobacco Products (CTP) Director Brian King gave an update on Aug. 3 on the synthetic nicotine application review process.

“We are at an unprecedented time in the history of tobacco product regulation, which comes with both opportunities and challenges,” King said. “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. Toward that end, CTP will continue to use the best available evidence to make marketing authorization decisions and to enforce regulations that reduce the public health burden of tobacco products at the population level.”

As of July 13, a non-tobacco nicotine product can only be legally marketed in the United States if it has received premarket authorization from the FDA. The FDA is closely monitoring retailer, manufacturer, importer and distributor compliance with the law, King said. Typically, violators will first receive a warning letter.

Here are some numbers to know when it comes to synthetic nicotine:

  • More than 200 companies submitted nearly 1 million premarket applications for non-tobacco nicotine products to the FDA by May 14.
  • The FDA issued refuse-to-accept (RTA) letters for more than 88,000 products in the last three weeks for applications that do not meet the criteria for acceptance.
  • The FDA accepted more than 350 applications, the majority for e-cigarette or e-liquid products. The acceptance is not a determination about the products’ authorization status but means the application will enter further review. To date, no non-tobacco nicotine product has received a marketing granted order.
  • On Aug. 1, FDA issued 17 new warning letters to manufacturers for marketing their products without the required premarket authorization.
  • On July 28, the agency issued 102 warning letters for retailers illegally selling non-tobacco nicotine products to underage purchasers.

King said the FDA plans on including information about non-tobacco nicotine products in its regular metrics reporting. It also launched a new non-tobacco nicotine product webpage.

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