乌鸦传媒

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 .

"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."

Health groups panned the move. "The FDA decision to approve menthol-flavored vapes for adults will have devastating public health consequences," Yolanda Lawson, MD, president of the National Medical Association, which represents more than 50,000 African-American physicians, said in a statement. "The use of menthol in tobacco products has been proven to be a deadly and addictive substance that disproportionately affects Black communities, particularly the youth who are at greater risk of nicotine addiction. As Black physicians, we are extremely disappointed by the FDA's decision and the continued choice of commerce over public health."

Avenel Joseph, PhD, vice president for policy at the Robert Wood Johnson Foundation, called the decision a "significant setback" and said it was the "wrong move at the wrong time."

"It's the wrong move because of the overwhelming evidence that menthol is widely appealing to and used extensively by kids," she said. "Among high school students who use e-cigarettes, nearly a quarter use menthol-flavored products. If the goal is to bring those numbers down, this decision will make achieving that goal a whole lot harder."

And it's the wrong time because HHS continues to delay issuance of a final rule banning the sale of menthol-flavored tobacco cigarettes, Joseph added. "It is inexplicable that FDA would permit the sale of additional menthol-flavored tobacco products when their own scientific agencies have documented just how dangerous and harmful they are."

HHS Secretary Xavier Becerra announced the rule delay in April, noting that, "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 ... 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, . "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."

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 due to menthol cigarette smoking in the U.S. from 1980 to 2018 were Black Americans. Additionally, Black men have the 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" rally 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."

Comment