FDA Commits to Evidence-Based Action to Save Lives and Prevent Future Generations of Smokers
- For immediate release:
Today, the United States Food and Drug Administration announced that it is committed to advancing two standards for tobacco products to dramatically reduce illness and death from the use of burnt tobacco products. , the leading cause of preventable death in the U.S. The FDA is working to publish proposed product standards in the next year, to ban menthol as a characterizing flavor in cigarettes, and to ban all characterizing flavors (including menthol ) in cigars; the power to adopt product standards is one of the most powerful tobacco regulatory tools that Congress has given to the agency. This decision is based on clear science and evidence establishing the addiction and harms of these products and builds on important past actions that banned other flavored cigarettes in 2009.
âBanning menthol – the last flavor allowed – in cigarettes and banning all flavors in cigars will help save lives, especially among those disproportionately affected by these deadly products. Through these actions, the FDA will help dramatically reduce youth initiation, increase the odds of smoking cessation among current smokers, and address health disparities among communities of color, low-income populations, and individuals. LGBTQ +, who are all much more likely to use these tobacco products, “said Acting FDA Commissioner Janet Woodcock, MD.” Together, these actions represent powerful, science-based approaches that will have extraordinary impact on public health. Armed with solid scientific evidence and with the full support of Administration, we believe these actions will set us on a path to ending tobacco-related illness and death in the United States â
The agency is taking urgent action to reduce tobacco addiction and reduce the number of deaths. There is strong evidence that a ban on menthol will help people quit smoking. Studies show that menthol increases the attractiveness of tobacco and facilitates progression to regular smoking, especially in youth and young adults. Menthol masks the unpleasant flavors and harshness of tobacco products, making them easier to use. Tobacco products containing menthol can also be more addictive and more difficult to stop by enhancing the effects of nicotine. A study suggests that a ban on menthol cigarettes in the United States would lead to an additional 923,000 smokers quitting, including 230,000 African Americans in the first 13 to 17 months after a ban goes into effect. One earlier study projected that about 633,000 deaths would be prevented, of which about 237,000 deaths were averted for African Americans.
âFor too long, certain populations, including African Americans, have been targeted and disproportionately affected by smoking. Despite the tremendous strides we’ve made in getting people to quit smoking over the past 55 years, these strides haven’t been experienced by everyone in the same way, âsaid Mitch Zeller, JD, Director of FDA Center for Tobacco Products. âThese flavor standards would reduce the initiation and use of cigarettes and cigars, reduce health disparities and promote health equity by addressing a large and disparate source of harm. Taken together, these policies will help save lives and improve public health in our country as we tackle the leading cause of preventable disease and death.
If implemented, the FDA’s enforcement of any ban on menthol cigarettes and all flavored cigars will only affect manufacturers, distributors, wholesalers, importers, and retailers. The FDA cannot and will not argue against the possession or use by individual consumers of menthol cigarettes or any tobacco product. The FDA will ensure that no illegal tobacco products reach the market.
These actions are an important opportunity to achieve significant and significant gains in public health and to advance health equity. The FDA is working quickly on both issues, and the next step will be for the agency to publish the proposed rules in the Federal Register, which will allow for public comment.
The agency also recognizes the importance of ensuring broad and equitable access to all tools and resources that can help currently addicted smokers who seek to quit, including those who smoke menthol cigarettes and who would be affected by these measures. public health. The FDA will work with partners from other federal agencies to make sure support is there for those trying to quit. Smokers interested in quitting today should visit smokefree.gov or call 1-800-QUIT-NOW to learn more about withdrawal services available in their state.
The FDA also remains focused on its regulatory oversight of electronic cigarettes and other electronic nicotine delivery systems (ENDS). The Center for Tobacco Products recently provided an update on its ongoing pre-market review work for ENDS and other tobacco product applications, and issued warning letters to manufacturers and retailers of ENDS products who continue to sell products illegally in the market. The FDA has also made a significant investment in a public education campaign on multimedia electronic cigarettes. The campaign targets nearly 10.7 million young people between the ages of 12 and 17 who have used or are ready to try e-cigarettes, and highlights information on the potential risks of e-cigarette use.
Context of today’s actions
Menthol Product Standard
Today, the FDA granted a citizen petition asking the agency to continue developing rules to ban menthol in cigarettes, affirming its commitment to providing such a product standard.
The Tobacco Control Act (TCA) of 2009 did not include menthol in its ban on characterizing flavors in cigarettes, leaving menthol cigarettes as the only burnt flavored cigarettes still marketed in the U.S. The law ordered the FDA to further examine the issue of menthol in cigarettes.
Since then, the FDA has sought input from an independent advisory committee, as required by the TCA, and has further demonstrated its interest by publishing advance notice of proposed regulations, undertake an independent evaluation and support broader research efforts – all to better understand the differences between menthol and non-menthol cigarettes and the impact of menthol on the health of the population.
In the United States, it is estimated that there are currently nearly 18.6 million smokers of menthol cigarettes. But the use of menthol cigarettes among smokers is not uniform: of all black smokers, nearly 85% smoke menthol cigarettes, compared to 30% of white smokers who smoke menthol. Additionally, among youth, from 2011 to 2018, declines in menthol cigarette consumption were seen among non-Hispanic white youth, but not among black or non-Hispanic youth.
Cigar flavored product standard
After the 2009 legal ban on flavors in cigarettes other than menthol, the use of flavored cigars increased significantly, suggesting that the public health objectives of the flavored cigarette ban may have been undermined by the continued availability of these flavored cigars.
Mass-produced flavored cigars and cigarillos are burnt tobacco products that can look a lot like cigarettes, pose many of the same public health concerns, and are disproportionately popular among young people and other populations. In 2020, black non-Hispanic high school students reported smoking cigars in the past 30 days at levels twice as high as their white counterparts.
Almost 74% of 12 to 17 year olds who consume cigars say they smoke cigars because they have flavors they like. Among young people who have tried a cigar, 68% of cigarillo users and 56% of filtered cigar users say their first cigar was a flavored product. In addition, in 2020, more young people tried a cigar every day than tried a cigarette.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.