Despite those findings, the FDA stopped short Tuesday of proposing specific restrictions or a ban on menthol, instead saying it would solicit public input for the next two months before deciding how to proceed. That probably means that any potential regulations remain months, if not years, from becoming reality.
The issue of menthol in cigarettes has long been controversial, in part because menthol cigarettes overwhelmingly are favored by African Americans and teenagers. Sales of them account for about a quarter of the U.S. cigarette market. But about 80 percent of black smokers prefer menthol, as do nearly half of all young smokers.
When Congress gave the FDA power to regulate tobacco in 2009, lawmakers banned candy-, fruit- and spice-flavored cigarettes, saying manufacturers had used such products to lure young smokers into addiction. But the law exempted menthol, instead instructing the FDA to study the issue to determine whether restricting or banning menthol would benefit public health.
In 2010, an FDA advisory panel made up of doctors, scientists and public-health experts convened to weigh that question. The next year, the group issued a 250-page report saying that menthol made it easier to get hooked and more difficult to quit smoking. The group concluded that “removal of menthol cigarettes from the marketplace would benefit the public health in the United States.”
Meanwhile, the tobacco industry steadfastly defended its use of menthol, saying it is no more harmful than any other type of tobacco.
Cigarette maker Philip Morris USA submitted its own report to the FDA, asserting that its scientific review had shown that restricting the use of menthol in cigarettes was “neither necessary or justified.” Another report, backed by R.J. Reynolds Tobacco and Lorillard Tobacco, maker of Newport, the country’s most prevalent brand of menthol cigarettes, warned of grave unintended consequences if the government banned menthol.
“The evidence unequivocally shows that the result would be a dramatically larger illegal cigarette market than currently exists,” it said. “As a result, there also would be severe negative impacts on public health, including exposure of smokers to more harmful contraband cigarettes, increased access of youth to tobacco, increased criminal activity particularly in urban communities, reduced government revenues and loss of jobs.”
Until Tuesday, the FDA had taken no public action on the topic for more than two years. Given the long wait, some tobacco-control advocates said the decision to seek more input was too timid even as they called the FDA’s findings a step in the right direction.
“There is a real public-health cost to this delay,” said Stanton Glantz, director of the Center for Tobacco Control Research and Education at the University of California at San Francisco. “But better late than never.
“If FDA proceeds logically based on these conclusions, they’re going to have to ban menthol,” he added.
Former FDA commissioner David Kessler, who has long favored tough government regulation of tobacco, praised the agency’s action. “This is about creating an administrative record, based on science, that is going to be sustainable when it’s subject to scrutiny,” he said. “I think the agency is doing a credible, methodical job.”
Mitch Zeller, the head of the FDA’s Center for Tobacco Products, told reporters that there is “no holdup” in trying to settle the menthol issue. He said the agency merely wants to have a solid scientific basis for whatever regulations it might eventually pursue. “As a regulatory agency, we can only go as far as the regulatory science will take us,” he said.
“The bottom line is, we need more information,” he added.
In a statement Tuesday, Lorillard chief executive Murray Kessler said he was “encouraged” by the FDA’s vow to rely on sound science, which he said would show that his company’s primary product shouldn’t face any more scrutiny than other cigarettes.
“It is Lorillard’s long-held belief,” he said, “that the best available science demonstrates that menthol cigarettes have the same health effects as non-menthol cigarettes and should be treated no differently.”