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By Maria Montecristo

The US Food and Drug Administration announced the proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. These actions can significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the US, by reducing youth experimentation and addiction and increasing the number of smokers that quit.

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

Smoking is a leading cause of cancer and death from cancer, with approximately 30 percent of all cancer deaths in the United States caused by tobacco use. These proposed product standards are based on precise science and evidence establishing the addictiveness and harm of these products and build on the Family Smoking Prevention and Tobacco Control Act, which prohibited all characterizing flavors (other than tobacco and menthol) in cigarettes in 2009. These strategies are crucial to the Administration’s reinvigorated Cancer Moonshot goal of cutting death rates by at least half by the year 25.

“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, “said FDA Commissioner Robert M. Califf, MD” Through the rulemaking 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 would have significant public health impact

Menthol is an additive that has a minty flavor and reduces the irritation and harshness of smoking. Youth and young adults, in particular, find menthol cigarettes more appealing and easier to use. In addition, menthol interacts with nicotine in the brain to enhance nicotine’s addictive properties. Youth who start smoking menthol cigarettes are much more likely to progress to regular use by combining the flavor, sensory effects, and interaction with nicotine in the brain. It also makes quitting smoking difficult.

In 2019, there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the US, with particularly high rates of use by youth, young adults, and African American and other racial and ethnic groups. Published modeling studies have estimated a 15 percent reduction in smoking within 40 years if menthol cigarettes were no longer available in the United States. These studies 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.

When finalized, the proposed menthol product standard will:

  • 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 standards would reduce youth risk

Characterizing flavors in cigars, such as strawberry, grape, cocoa, and fruit punch, increase the appeal and make cigars easier to use, particularly among youth and young adults. More than a half-million youth in the US use flavored cigars, and in recent years more young people tried a cigar every day than tried a cigarette.

When finalized, this product standard will:

  • reduce the appeal of cigars, particularly to youth and young adults, and decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular use; and
  • Improve public health by increasing the likelihood that existing cigar smokers may quit.

Notably, the FDA cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If these proposed rules are finalized and implemented. In that case, FDA enforcement will only address manufacturers, distributors, wholesalers, importers, and retailers who manufacture, distribute, or sell such products within the US that are not in compliance with applicable requirements. These proposed regulations do not include a prohibition on individual consumer possession or use.

State and local law enforcement agencies do not independently enforce the Federal Food, Drug and Cosmetic Act and do not, and cannot, take enforcement actions against any violation of FDA’s tobacco authorities, including its regulations, on the FDA’s behalf. However, the agency recognizes concerns related to how state and local law enforcement may enforce their own laws to impact equity and community safety, particularly for underserved and underrepresented communities. The FDA is seeking comment on, among other things, how it can best make clear the respective roles of the agency and state and local law enforcement, as well as policy considerations related to the potential racial and social justice implications of the proposed product standards.

Beginning May 4, 2022, the public can comment on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities. The listening sessions are another opportunity for individuals, communities, and organizations to share their perspectives with the FDA and will be recorded and submitted to the dockets.

The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.

The agency also recognizes the importance of ensuring broad and equitable access to all the tools and resources that can help smokers quit. The FDA and HHS are working with federal partners to make sure the support is there for those who are trying to quit, especially in underserved communities. Many insurance plans cover tobacco cessation services, like medication and counseling, without any out-of-pocket cost. Smokers interested in quitting today should visit or call 1-800-QUIT-NOW to learn about cessation services available in their state.

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