The move comes 11 years after the agency's menthol report.
SILVER SPRING, Md. — After a long and winding road, the Food and Drug Administration (FDA) is taking action against menthol.
On April 28, the FDA proposed two product standards, one to prohibit menthol as a characterizing flavor in cigarettes and the other to prohibit all characterizing flavors (other than tobacco) in cigars.
"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."
According to the agency, the 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 Tobacco Control Act, which prohibited all characterizing flavors — other than tobacco and menthol — in cigarettes in 2009.
They are also a piece of the Biden Administration's reignited Cancer Moonshot to reduce the death rate from cancer by at least 50 percent over the next 25 years, it 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," said FDA Commissioner Robert M. Califf. "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."
If finalized and implemented, the FDA's enforcement will only address manufacturers, distributors, wholesalers, importers and retailers, and not adult tobacco consumers who possess or use the flavored products.
The agency will begin taking public comments on the proposed rules on May 4. It will also hold public listening sessions on June 13 and 15 for individuals, communities, and organizations to share their perspectives with the FDA.
The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.
A Decade-Plus in the Making
The proposal comes one year, or 11 years, in the making — depending on how you look at it.
On April 29, 2021 the agency said it was taking steps to ban menthol as a characterizing flavor in cigarettes, and ban all characterizing flavors — including menthol — in cigars within the next year.
At the time, the FDA noted there was "strong evidence" that a menthol ban will help tobacco users quit. It pointed to studies that show menthol increases the appeal of tobacco and can lead to regular smoking, particularly among youth and young adults.
For example, one study suggests that banning menthol cigarettes in the United States would lead an additional 923,000 smokers to quit, including 230,000 African Americans in the first 13 to 17 months after a ban goes into effect, the agency said.
The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA regulatory control over tobacco and any deemed tobacco products. Among its first actions was to remove flavored cigarettes, excluding menthol, from the market.
Almost from the beginning there have has been a question mark around menthol — with many wondering if a menthol ban was a matter of when, not if.
In a March 2011 report, the FDA's Tobacco Product Scientific Advisory Committee (TPSAC), recommended removing menthol cigarettes from the market to benefit public health. However, after several tobacco companies challenged the make-up of the TPSAC, and three years after U.S. District Court Judge Richard Leon in Washington, D.C., barred the agency from using the report ordered the FDA to reconstitute the tobacco panel, as Convenience Store News previously reported.
The agency did not made any moves on the issue since that July 2014 ruling. However, the FDA had until April 29, 2021 to respond in court to a citizens' petition to ban menthol by disclosing whether the agency intends to pursue such a policy.
Playing Regulatory Catchup
In the 11 years since the initial report, it can be argued that state and local officials across the United States got tired of waiting for the FDA to make a decision on menthol and took matters into their own regulatory hands.
In June 2017, the San Francisco Board of Supervisors, which has joint jurisdiction over the city and the county, unanimously approved an ordinance prohibiting the sale of all flavored tobacco products, including menthol cigarettes.
The vote faced opposition and the issue was eventually brought to the voters the following year, when more than two-thirds of voters cast ballots in favor of Proposition E, which prohibited tobacco retailers from selling flavored tobacco products, during the June 5, 2018 election.
During the same timeframe, Minneapolis lawmakers passed a measure to ban the sale of menthol cigarettes at convenience stores. On Aug. 4, 2017, the Minneapolis City approved a restriction limiting sales of all flavored tobaccos — including menthol, mint and wintergreen — to adults-only tobacco shops and liquor stores. The new restrictions took effect on Aug. 1, 2018.
Since then, many municipalities have taken up the issue of flavored tobacco product bans, some including menthol, and in November 2019, Massachusetts Gov. Charlie Baker signed a flavored tobacco product ban, including menthol, into law. His signature made Massachusetts the first in the country to enact a ban statewide. The ban went into effect on June 1, 2020.
Across the country, a similar ban in California will be put the issue to the voters this November.