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12/29/2021

FDA Issues First Modified-Risk Marketing Orders for Combustible Cigarettes

The agency acts on 22nd Century Group's applications for its VLN King and VLN Menthol King.
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22nd Century Group Logo

SILVER SPRING, Md. — The Food and Drug Administration (FDA) approved 22nd Century Group's modified risk tobacco products (MRTP) applications for two cigarettes, paving the way for the products to be marketed as reduced risk.

On Dec. 23, the agency authorized the company's VLN King and VLN Menthol King combusted filtered cigarettes as modified risk products, which help reduce exposure to, and consumption of, nicotine for smokers who use them.

They are the first combusted cigarettes to be authorized as MRTPs and the second tobacco products overall to receive "exposure modification" orders, which allows them to be marketed as having a reduced level of, or presenting a reduced exposure to, a substance, according the FDA.

"Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes," said Mitch Zeller, director of the FDA's Center for Tobacco Products.

"Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death," Zeller added.

The exposure modification orders specifically authorize the manufacturer to market VLN King and VLN Menthol King with certain reduced exposure claims regarding nicotine, including:

  • 95 percent less nicotine
  • Helps reduce your nicotine consumption
  • Greatly reduces your nicotine consumption

In addition, according to the agency, Buffalo, N.Y.-based 22nd Century must include "helps you smoke less" on product labeling or advertising when using the reduced exposure claim.

The FDA also recommends that the labeling and advertising include the statement, "Nicotine is addictive. Less nicotine does NOT mean safer. All cigarettes can cause disease and death."

The manufacturer is also required to label the packages with one of four warning statements for cigarettes as required by the Federal Cigarette Labeling and Advertising Act.

In the review of 22nd Century Group's MRTP applications, the FDA evaluated data from the company and FDA testing and found that nicotine levels in tobacco and mainstream smoke of VLN cigarettes are at least 96 percent lower than the majority of marketed and market-leading conventional cigarette brands. 

22nd Century Group CEO James A. Mish said the decision was "game-changer" for the company, the tobacco industry, public health, and adult smokers.

"Having secured this FDA marketing order, we are fully prepared to launch VLN with select retail and marketing partners in our pilot markets in the U.S. within the next 90 days and in the first of several global markets by the end of the first quarter of 2022," Mish said, adding the company is also in discussions with additional retail trade, marketing and strategic partners to scale VLN sales in the United States and internationally. "We will provide additional details on strategic partners and the rollout of VLN in the coming months."