The FDA takes aim at menthol and other tobacco flavorings

The U.S. Food and Drug Administration this week announced plans to stem the increase in young Americans’ use of tobacco and its primary psychoactive agent, nicotine.

The object of Food and Drug Commissioner Scott Gottlieb’s ire was flavorings – those minty, sweet, nutty or even salty flavors that cigarette and e-cigarette manufacturers add to their products to make them more enticing.

The prime market for those flavors, Gottlieb said, is no secret: While less than one-third of adults over 35 smoke menthol cigarettes, they are the choice of 54 percent of children too young to buy cigarettes legally but acknowledge that they smoke anyway.

3.6 million high school and middle school students surveyed in 2018 said they used e-cigarettes in the past 30 days – a 78 percent increase since 2017 that Gottlieb blamed on the enticement of flavorings like cola, chocolate, bubble gum and coffee latte. And menthol, a flavoring derived from peppermint oil.

“These data shock my conscience,” Gottlieb said.

He said he would exercise a stronger regulatory hand over the use of flavorings in e-cigarettes and to crack down on retailers that sell tobacco products to minors.

He also opened a new front in the tobacco war with a proposal to ban the use of menthol entirely in all products that are burned or smoked. That includes cigarettes, cigars and pipe tobacco.

All of which raises some questions:

CAN HE DO THAT?

It’s not entirely clear that the FDA has the power to ban menthol in cigarettes.

The 2009 Family Smoking Prevention and Tobacco Control Act gives the agency the authority to establish tobacco product standards “where appropriate for the protection of the public health,” including “provisions respecting the construction, components, ingredients, additives.”

By all appearances, that would allow the FDA to prohibit the use of certain flavorings, including menthol. The 2009 law went ahead and did just that, banning the use of “characterizing flavors” in cigarettes – those used to give a product a distinctive taste and marketing appeal.

But it made an exception in the case of menthol.

WHAT ABOUT MENTHOL IN E-CIGARETTES?

Unanticipated by the Tobacco Control Act, the delivery of nicotine by electronically heated dispensers – vaping – became a multibillion-dollar industry in which flavorings, including menthol, have flourished.

The FDA has asserted its authority to regulate e-cigarettes and their flavorings. That claim is contested but FDA Commissioner Scott Gottlieb testifies at an hearing on Capitol Hill in October in Washington D.C.

hasn’t been struck down by the courts.

Gottlieb said this week that while he’s ready to ban menthol as a flavor enhancer in smoked products, he wants to keep it available for e-cigarettes because many older users like it and he doesn’t want them to go back to smoking menthols.

Gottlieb said he wants to concentrate on kid-oriented

flavorings. But he warned that if he sees more evidence that menthol is luring uninitiated kids to ecigarettes, he would revisit the possibility of restricting it there too.

Congressional legislation may be necessary if the FDA is to ban menthol or restrict the use of flavorings in e-cigarettes. Alternatively, the FDA could

simply act, get sued and let the courts decide whether and how much it authority it has to take such actions.

The process will take years to work out, said Will Woodlee, a partner with the law firm Kleinfeld, Kaplan & Becker LLC, which has represented tobacco and e-cigarette companies in their dealings with the FDA.