FDA Proposes Standards Prohibiting Menthol Cigarettes, Flavored Cigars


The FDA proposed product standards prohibiting menthol flavor in cigarettes and all flavoring in cigars as part of the Cancer Moonshot initiative.

The FDA announced proposed product standards that would prohibit using menthol flavor in cigarettes and prohibit all flavoring, other than tobacco, in cigars.

These standards come as part of the Biden administration’s reignited Cancer Moonshot initiative, which aims to reduce deaths caused by cancer by at least 50% in the next 25 years.

Tobacco smoking is the leading cause of preventable death and a leading cause of cancer in the United States, with approximately 30% of all US cancer deaths being caused by smoking.

In the press release, the FDA stated these standards can have a positive impact on public health by significantly reducing tobacco-related disease and mortality, reducing experimentation and addiction among youth, and increasing the amount of people who quit smoking.

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

As of 2019, more than 18.5 million Americans 12 years and older were actively smoking menthol cigarettes, with higher rates observed among youth, young adults, and African American and other racial minority groups.

According to published models, prohibiting menthol cigarettes is expected to reduce smoking rates by an estimated 15% and avoid between 324,000 and 654,000 smoking-related deaths within 40 years. As African Americans are disproportionately affected by this issue, prohibiting menthol flavoring in cigarettes would prevent between 92,000 and 238,000 deaths among African Americans.

On top of being an appealing flavor, menthol also interacts with nicotine in a way that enhances nicotine’s already-addictive effects and makes it harder for smokers to quit.

As stated by the FDA, the menthol product standard would:

  • reduce the appeal of cigarettes, particularly to youth and young adults, therefore decreasing the likelihood that nonsmokers would begin smoking, and
  • improve the health and reduce the risk of death among current menthol cigarette smokers by decreasing cigarette consumption and increasing likelihood of cessation.

Additionally, more than half a million American youth reportedly smoke flavored cigars, with options such as strawberry, grape, cocoa, fruit punch, and more increasing the appeal of cigars for younger people.

When finalized, standards for cigar flavoring will:

  • reduce the appeal of cigars and decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular smoking, and
  • improve public health by increasing the likelihood that people who currently smoke cigars may quit.

The press release emphasized the point that the FDA cannot and will not use enforcement against individual consumers, but rather address manufacturers, distributors, wholesalers, importers, and retailers who manufacture, distribute, or sell products that violate the standards, if they are implemented.

Americans can begin inputting comments on these proposed rules for FDA review starting May 4, 2022.

“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,” said Robert M. Califf, MD, FDA commissioner. “It is clear that these efforts will help save lives.”

Related Videos
John Hood, PhD
Kimberly Westrich, MA, chief strategy officer of the National Pharmaceutical Council
Phaedra Corso, PhD, associate vice president for research at Indiana University
Pamela J. McShane, MD, an expert on bronchiectasis
Julie Patterson, PharmD, PhD
Nancy Dreyer, MPH, PhD, FISE, chief scientific advisor to Picnic Health
Seth Berkowitz, MD, MPH, associate professor of medicine, University of North Carolina at Chapel Hill
Inma Hernandez, PharmD, PhD, professor at the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences
Dr Julie Patterson, National Pharmaceutical Council
Related Content
CH LogoCenter for Biosimilars Logo