Marketing of the first low-nicotine cigarettes in the United States

Chicago is the test city for the launch of these cigarettes containing 95% with less nicotine. However, civil society actors are contesting this isolated launch and the registrations that the Food and Drug Administration (FDA) would like to grant it.

After receiving FDA approval in December 2021 to be marketed as modified risk tobacco products (MRPT), the first reduced nicotine cigarettes hit stores on April 11. They are sold under the VLN King and VLN Menthol King brands.

Produced by 22nd Century Group, an agricultural biotechnology company, the cigarettes are first available at 150 Circle K stores in Chicago, before being rolled out to the chain's 7,000 locations across 48 states.[1]This is currently a pilot phase, planned to last three to six months.

A project developed over ten years

It is by genetically modifying the roots of tobacco plants that the 22nd Century group has managed to obtain a tobacco which would contain 95% less nicotine than a classic plant, a result that its competitor Altria did not until now consider "technically feasible"[2].

This project of reduced-nicotine cigarettes, originally a New Zealand idea, has been the subject of about fifty clinical trials over a period of ten years, initiated by the company itself and conducted under the supervision of, among others, the FDA, the Centers for Disease Control and Prevention (CDC) and the American National Cancer Institute (NCI). These trials have shown that the use of reduced-nicotine cigarettes can reduce cigarette consumption by half after five months of use, that it increases the number of quit attempts and smoke-free days, and that it can reduce the compulsion and withdrawal symptoms due to tobacco.[3].

Public health associations criticize the deployment of this measure

The FDA has granted 22nd Century no fewer than 11 messages, such as "95% less nicotine" or "Strongly helps reduce your nicotine intake." However, it would like to see the words "Helps you smoke less" on the packages, which seems unacceptable to public health associations, who point out that tobacco smoke remains particularly toxic and is the cause of many diseases.

On March 9, these associations wrote a letter to the director of the FDA, Mitch Zeller, to question him on the approach, which they consider inappropriate.[4]. "The public health benefits of reduced nicotine products can only be achieved if they encompass the entire industry; they cannot be achieved through a product-by-product approach," states the letter, which considers that a general launch of these products is preferable, as provided for in the "Tobacco-Free New Zealand 2025" action plan. The associations also draw the FDA's attention to the authorization it has given to the sale of menthol cigarettes, at a time when the withdrawal of these types of flavors is particularly demanded.

Pending the outcome of these discussions, 22nd Century is already ready to invest in the South Korean market, whose government has shown interest in this initiative and has concluded an initial agreement of 1.6 billion US dollars.[5].

Keywords: reduced nicotine cigarettes, FDA, 22nd Century Group, New Zealand

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[1] Schencker L, New type of cigarette that 'helps you smoke less' debuts in Chicago stores this week, amid some controversy, Chicago Tribune, published April 13, 2022, accessed April 15, 2022.

[2] Reduced-Nicotine Cigarettes Coming to US Market Soon, Generation Without Tobacco, published January 19, 2022, consulted April 15, 2022.

[3] First Cigarette That “Helps You Smoke Less” Launches National Pilot in Chicagoland, Barron's, published April 13, 2022, accessed April 15, 2022.

[4] Request to reconsider the exposure modification orders granted to VLNTM and VLNTM Menthol very low nicotine cigarettes, Letter to FDA Director, American Lung Association website, published March 7, 2022, accessed April 15, 2022.

[5] 22nd Century Group Announces South Korea as First VLN(TM) International Market, Stockwatch, published February 28, 2022, accessed April 15, 2022.