04/29/2022
FDA Proposes Rules Prohibiting Menthol Ci******es and Flavored Ci**rs
The goal is to prevent youth initiation and significantly reduce to***co-related disease and death.
By Emily Boes | April 28, 2022
FacebookTwitterPinterestLinkedIn
Proposed product standards to prohibit menthol as a characterizing flavor in ci******es and prohibit all characterizing flavors (other than to***co) in ci**rs was announced by the U.S. Food and Drug Administration (FDA). These actions have the potential to significantly reduce disease and death from combusted to***co product use, the leading cause of preventable death in the U.S., 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 to***co-related health disparities.”
These proposed product standards are based on clear science and evidence establishing the addictiveness and harm of these products and build on the Family Smoking Prevention and To***co Control Act, which prohibited all characterizing flavors (other than to***co and menthol) in ci******es in 2009. They are also a critical piece of the Administration’s reignited Cancer Moonshot to reduce the death rate from cancer by at least 50% over the next 25 years.
“The authority to adopt to***co 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, M.D. “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
Menthol is a flavor additive with a minty taste and aroma that reduces the irritation and harshness of smoking. This increases appeal and makes menthol ci******es easier to use, particularly for youth and young adults. Menthol also interacts with ni****ne in the brain to enhance ni****ne’s addictive effects. The combination of menthol’s flavor, sensory effects and interaction with ni****ne in the brain increases the likelihood that youth who start using menthol ci******es will progress to regular use. Menthol also makes it more difficult for people to quit smoking.
In 2019, there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the U.S., 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% reduction in smoking within 40 years if menthol ci******es 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 can:
• reduce the appeal of ci******es, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol ci******es would progress to regular smoking
• 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
Characterizing flavors in ci**rs, such as strawberry, grape, cocoa and fruit punch, increase appeal and make ci**rs easier to use, particularly among youth and young adults. More than a half million youth in the U.S. use flavored ci**rs, and in recent years more young people tried a cigar every day than tried a cigarette.
When finalized, this product standard can:
• reduce the appeal of ci**rs, particularly to youth and young adults, and decrease the likelihood of experimentation, development of ni****ne dependence and progression to regular use
• improve public health by increasing the likelihood that existing cigar smokers may quit
Importantly, the FDA cannot and will not enforce against individual consumers for possession or use of menthol ci******es or flavored ci**rs. If these proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who manufacture, distribute or sell such products within the U.S. 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 the FDA’s to***co 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 in a manner that may 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 provide comments 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.
