The Food and Drug Administration (FDA) noted earlier this year that its proposed very low nicotine regulation could be published by this fall. While a comment period and review would follow, if the regulation were to go into effect, it would prohibit the sale of almost all cigarettes currently on the market.
In July of 2017, the FDA announced a new comprehensive plan for tobacco and nicotine regulation.
While the plan focuses on youth tobacco prevention efforts and public education campaigns about e-cigarettes and smoking cessation, the plan also includes a provision to propose a new product standard to set a maximum level of nicotine in cigarettes and other combustible tobacco products.
A “product standard” is a power that Congress granted to the FDA in the 2009 Federal Tobacco Control Act to reduce or eliminate an ingredient in a tobacco product or a constituent in tobacco smoke. Under the FDA’s comprehensive nicotine plan, the FDA plans to propose minimizing the amount of nicotine in cigarettes and possibly other combustible products.
Essentially, this plan will involve lowering nicotine in these tobacco products to what the agency refers to as a minimal or non-addictive level. This proposal has also become known as the very low nicotine standard. One of the goals of this plan is to reduce the likelihood that future generations become addicted to nicotine. Another goal is to make it easier for smokers to quit using combustible tobacco products.
Currently, cigarette nicotine levels range from approximately 7.5 milligrams of nicotine up to 13.5 milligrams of nicotine per cigarette. At this time, the FDA has not stated the maximum level of nicotine per cigarette or other combustible product that the product standard would allow. From a timing perspective, the FDA announced in the Federal Unified Agenda and Regulatory Plan that was issued in January of 2023 that the proposed very low nicotine regulation could be published by October of 2023.
In the event that the proposed regulation is published, federal law requires that the FDA provide a period of time for the industry and the public to submit comments in response to the nicotine level product standard. Then, the FDA is required to review all the comments and make any changes that it deems appropriate to the product standard regulation.
In addition, the FDA would need to have the White House Office of Management and Budget review and approve proceeding with the proposed product standard before it is finalized because the regulation would have a significant impact on the U.S. economy. Only then can the FDA finalize the regulation and set a date for the regulation to go into effect.
A major reduction in the level of nicotine permitted in cigarettes would prohibit the sale of almost all cigarettes that are currently available on the market.
That is the case because the FDA has authorized the sale of only two very low nicotine cigarettes that are manufactured by 22nd Century Group — VLN King and VLN Menthol King, which have approximately 95% less nicotine than an average cigarette. A very low nicotine requirement would result in manufacturers having to use a tobacco plant that has been engineered to produce a very low level of nicotine in the tobacco plant itself.
It is important to note that reducing the level of nicotine in cigarettes and other combustible tobacco products does not mean that such products are safe or safer. This is the case because removing most of the nicotine from cigarettes and other combustible tobacco products does not remove the other constituents in the smoke.
As the FDA states on the agency’s website, nicotine is an addictive chemical found in the tobacco plant and is therefore present in all tobacco products. However, nicotine is not what makes tobacco use harmful. Rather, it is the other chemicals in tobacco and tobacco smoke — not nicotine — that cause health consequences in tobacco users.
Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATO’s mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco segment in a responsible manner.