FDA Issues Proposed Product Standards for Tobacco Products

The FDA's latest proposed product standards would ban menthol cigarettes and all characterizing flavors in cigars other than tobacco.

FDA | Proposed Product Standards for Mentho Cigarettes and Flavored Cigars

The U.S. Food and Drug Administration (FDA) is making moves that could drastically change the tobacco industry and products many consumers use. Today, the FDA announced its proposed product standards that would prohibit menthol as a characterizing flavor in cigarettes and would also prohibit all characterizing flavors–other than tobacco–in cigars.

In a press release, the FDA stated that these proposed product standards are based on clear science and evidence establishing the addictiveness and harm of these products. These regulatory actions also build on the Family Smoking Prevention and Tobacco Control Act, which banned all characterizing flavors in cigarettes, with the exception of tobacco and menthol, back in 2009. The moves also fit within the Biden Administration’s aim to reduce the death rate from cancer by at least 50 percent over the next 25 years. Tobacco use is oftentimes named as a leading cause of cancer and death from cancer and approximately 30 percent of all cancer deaths in the U.S. are caused by smoking.

In a press release, Health and Human Services Secretary Xavier Becerra commented: “The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit. Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities.”

Robert Califf, M.D., FDA commissioner, added: “The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives. Through the rule-making process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”

Menthol Product Standard
When speaking of menthol, the FDA described it as an addictive flavor with a “… minty taste and aroma that reduces the irritation and harshness of smoking. This increases appeal and makes menthol cigarettes easier to use, particularly for youth and young adults. Menthol also interacts with nicotine in the brain to enhance nicotine’s addictive effects. The combination of menthol’s flavor, sensory effects and interaction with nicotine in the brain increases the likelihood that youth who start using menthol cigarettes will progress to regular use. Menthol also makes it more difficult for people to quit smoking.”

The FDA cited a 2019 stat that showed that more than 18.5 million menthol cigarette smokers were 12 and older in the U.S. It also stated that many menthol cigarette smokers were youth, young adults, and African American, among other racial and ethnic groups. The FDA estimates that there could be a 15 percent reduction in smoking within 40 years if menthol cigarettes were no longer available in the U.S. They also estimate that “324,000 to 654,000 smoking attributable deaths overall (92,000 to 238,000 among African Americans) would be avoided over the course of 40 years.”

The finalized proposed menthol product standard would:

  • reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
  • improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.

Flavored Cigar Product Standard
Since it first proposed banning menthol cigarettes, the FDA has oftentimes made a link between menthol cigarettes and flavored cigars, arguing that flavored cigar products are a gateway to nicotine addiction and also are linked to an increase in tobacco use. The FDA argues that characterizing flavors in cigars–such as strawberry, grape, cocoa, and fruit punch–may make cigars easier to use and more appealing to youth and young adults.