FDA Announces Plans for Proposed Rule on Very Low Nicotine

The agency seeks to establish a maximum level of nicotine in cigarettes.

June 22, 2022

Cigarettes and Nicotine Gum

ALEXANDRIA, Va.—The Biden Administration has published plans for future potential regulatory actions, including a proposed standard by the Food and Drug Administration (FDA) that would establish a maximum nicotine level in cigarettes and certain other combusted tobacco products. The administration said the goal is to reduce youth use, addiction and death.

“Nicotine is powerfully addictive,” said FDA Commissioner Robert M. Califf, M.D. “Making cigarettes and other combusted tobacco products minimally addictive or non-addictive would help save lives.”

Califf said that the U.S. Surgeon General has reported that 87% of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age.

“Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit,” he said.

Reducing nicotine has been a topic of discussion within the FDA since the 1990s. In 2009, the Family Smoking Prevention and Tobacco Control Act authorized the FDA to mandate such a change—with the stipulation that the policy be based on scientific evidence, a caveat that slowed the process for years.

Cigarette manufacturers can reduce nicotine by altering the blend of tobacco leaves or use different types of paper or filters. Nicotine can also be stripped from the leaf in the manufacturing process.

NACS has expressed concerns that a standard on very low nicotine would push current users to seek out illicit sources for the products. Tobacco companies say that forced reduction of nicotine would cause people to smoke more, not less, and would expand the illicit market for cigarettes.

The FDA also said that it remains focused on its regulatory oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS). So far, the agency has made decisions on about 99% of the nearly 6.7 million products for which applications were received by the Sept. 9, 2020, deadline, including issuing marketing denial orders for more than one million ENDS products. The FDA has also issued warning letters to ENDS product manufacturers and retailers who continue to sell products that are illegally on the market.

The FDA recently released two proposed tobacco product standards: One bans menthol as a characterizing flavor in cigarettes, and the second bans all characterizing flavors, including menthol, in cigars.

The menthol market accounts for roughly 34% of cigarette sales, and flavored cigars account for 51% of cigar sales. Given the existing market and current user base, NACS believes a ban on these products will push sales to the illicit market, which undermines the efforts of responsible retailers and poses a greater risk to communities. The rulemaking process includes a comment period in which the agency will consider input from the public before finalizing the rule.

“History has proven that prohibition of a legal product that has an established user base doesn’t work and has negative consequences for our communities,” stated Anna Blom, NACS director of government relations. “Unfortunately, many current users of these products will seek out illicit sources who don’t check IDs and who sell counterfeit products smuggled into the country.”

NACS will be filing comments on behalf of the industry, but the FDA also needs to hear from individual retailers. Here’s how to help stop the FDA menthol ban and file comments by August 2.