The U.S. Food and Drug Administration (FDA) drew criticism from anti-smoking advocates for authorizing 22nd Century Group to market two cigarette products as modified risk tobacco products (MRTPs). VLN King and VLN Menthol King are the same in design as traditional cigarettes — and pose similar health risks — but they have around 95 percent less nicotine than conventional cigarettes. The “VLN” stands for “very low nicotine.”

A MRTP is a product intended to “reduce exposure to, and consumption of, nicotine for smokers who use them,” according to the FDA. VLN King and VLN Menthol King are the first combusted cigarettes to receive this designation. In 2019, the FDA authorized eight smokeless tobacco products as MRTPs for the first time.

The MRTP authorization allows manufacturers to make claims about reduced nicotine exposure in their advertising and product packaging. The products are still required to have the same warning statements as other cigarettes.

In a statement, American Cancer Society Cancer Action Network (ACS CAN) President Lisa Lacasse called the decision a “step backwards for the protection of public health.”

Smoking and Lung Cancer Risk

Smoking is one of the top risk factors for lung cancer. Between 80 percent and 90 percent of lung cancer deaths in the United States are associated with cigarette smoking. Quitting smoking can reduce the risk of developing lung cancer.

“Our mission is to find ways to stop tobacco-related disease and death,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said about the authorization. “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.”

Opposition To Modified Risk Tobacco Products

Anti-smoking and cancer advocates objected to the authorization to market the VLN King products as MRTPs. In 2020, the American Academy of Pediatrics, ACS CAN, the American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and the Truth Initiative submitted a joint written statement urging the FDA to reject the VLN King application.

“​​Cigarettes with lower nicotine levels are not harmless,” the organizations wrote in the statement. “Nicotine is the primary addictive agent in cigarettes and is not benign. While [VLN content (VLNC)] cigarettes may be less addictive, the overwhelming health consequences of smoking come from the more than 7,000 chemicals and 69 cancer-causing agents produced from combusted cigarettes. It is for this reason that VLNC cigarettes remain harmful; indeed deadly.”

Smoking Cessation Claims

Anti-smoking advocates also challenged the assertion that MRTPs will reduce smoking. In their 2020 statements, the public health groups noted that consumers were confused by claims from the VLN products. They further noted that, in some cases, consumers perceived them as nicotine replacement therapy (NRT) instead of low-nicotine cigarettes. This misconception could “​​prolong cigarette smoking among those seeking cessation products like NRT,” they wrote.

“In a remarkable and disturbing decision against public health today, the FDA approved two combustible tobacco products, despite insufficient evidence that adults who currently smoke would actually decrease their smoking using these products or that youth will not use them,” Lacasse stated.

Menthol Opposition

The public health groups urged against the marketing authorization of menthol cigarette products as MRTPs in 2020. The FDA took steps in April 2021 to advance rules that would ban menthol cigarettes. The organization noted in the Dec. 23 release its commitment to the ban. The menthol ban is intended to reduce smoking initiation among young people and to help reduce smoking among communities of color and other groups that are more likely to use menthol cigarettes.

“Menthol, other candy- and fruit-flavored tobacco products have long been a key part of the tobacco industry’s strategy to entice our youth into a potential lifetime of addiction,” Lacasse stated. “FDA should be prohibiting flavors in all tobacco products, including menthol in cigarettes.”