FDA Authorizes First Menthol E-Cigarettes

 The FDA on Friday authorized marketing of four menthol-flavored e-cigarette products even as the Biden administration continues to drag its heels on issuing a rule banning menthol-flavored tobacco cigarettes.

The authorizations are the first non-tobacco-flavored e-cigarette products to be authorized by the FDA, the agency said in a press releaseopens in a new tab or window.

"It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what's needed to successfully achieve that outcome," said Brian King, PhD, MPH, director of the FDA's Center for Tobacco Products. "This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it."

The four products are all the same brand -- NJOY -- and include the NJOY Ace Pod Menthol 2.4%, NJOY Ace Pod Menthol 5%, NJOY Daily Menthol 4.5%, and NJOY Daily Extra Menthol 6%. The Ace products are sealed, pre-filled, non-refillable pods that are used with the previously authorized Ace device, and the two authorized Daily products are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir, the FDA said.

The applications for marketing of the four products were authorized because "evidence submitted by the applicant showed that these menthol-flavored products provided a benefit for adults who smoke cigarettes relative to that of the applicant's previously authorized tobacco-flavored products -- in terms of complete switching -- that is sufficient to outweigh the risks of the product, including youth appeal," the agency said.

"We are a data-driven agency and will continue to follow the science to inform our review of premarket tobacco applications," Matthew Farrelly, PhD, director of the Office of Science in the FDA's Center for Tobacco Products, said in the press release. "Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth."

The authorization comes nearly 2 months after HHS delayed issuance of a final ruleopens in a new tab or window banning the sale of menthol-flavored tobacco cigarettes.

"This rule has garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement," HHS Secretary Xavier Becerra said in a very brief statementopens in a new tab or window posted Friday on the HHS website. "It's clear that there are still more conversations to have, and that will take significantly more time."

Feedback on the HHS announcement was very quick. "The American Lung Association is deeply dismayed that the White House continues to delay the lifesaving rules to end the sale of menthol cigarettes," Harold Wimmer, president and CEO of the association, said in a statementopens in a new tab or window. "Every day that President Biden fails to finalize these rules, he loses an incredible opportunity to reduce the death and disease associated with tobacco use. Ending the sale of menthol cigarettes would have helped eliminate the dramatic health inequities in who uses tobacco products in the United States."

The National Medical Association (NMA), which represents more than 50,000 African-American physicians, also panned the decision. "We are disappointed with the action of the Biden administration. We will continue to have Black children targeted for addiction and the health and lives of our patients ruined as long as the administration delays a total ban on menthol," Mark Mitchell, MD, MPH, chair of the association's Council on Environmental Health and Climate Change, said in a statement.

About 80% of Black smokers smoke menthol cigarettes. In 2009, the government banned 13 flavors of tobacco products from the marketplace, but left only one -- menthol -- on the market.

The NMA noted that "the CDC estimates that 40% of premature deathsopens in a new tab or window due to menthol cigarette smoking in the U.S. from 1980 to 2018 were Black Americans. Additionally, Black men have the highest ratesopens in a new tab or window of lung cancer fatalities."

One possible reason given for the delay in issuing the final rule on menthol-flavored tobacco cigarettes is that the Biden campaign may be afraid that issuing the rule could alienate Black voters at a time when Biden is seeking reelection.

But that idea could backfire, warned Michael Emanuel Smith, a Detroit resident who came to Washington, D.C. for a "menthol funeral" rallyopens in a new tab or window in January to push for issuance of the final rule. "I recently turned 18 and will be voting for the first time," he said. "I will be waiting to see if [the president] will stand up to make me free of menthol."

https://www.medpagetoday.com/publichealthpolicy/fdageneral/110770