Intended for healthcare professionals


FDA announces crackdown on e-cigarettes in bid to reduce teenage vaping

BMJ 2018; 363 doi: (Published 20 November 2018) Cite this as: BMJ 2018;363:k4908
  1. Bob Roehr
  1. Washington, DC, USA

The US Food and Drug Administration (FDA) has tabled new regulations1 that will make it harder to buy e-cigarettes, the flavoured liquids within them, and menthol versions of traditional cigarettes.

The rule change was announced on 15 November by FDA commissioner Scott Gottlieb, who said the purpose was to make nicotine products “less accessible and less appealing to children.”

The fact that nearly 90% of Americans who smoke start doing so before the age of 18 has driven the decision. Additionally, new data from the 2018 National Youth Tobacco Survey show “a 78% increase in current e-cigarette use among high school students” in the past year, Gottlieb said. The sweet flavours of vaporised products and the ease with which they can be hidden is thought to be contributing to their rising popularity.

The new regulations require that all flavoured electronic nicotine delivery systems (ENDS) products other than tobacco, mint, menthol, and flavourless versions be sold in age restricted stores such as tobacco shops. Online sales sites would need heightened age verification practices.

The rules state that placing items in a cabinet or partially hiding them would not be enough. ENDS products would effectively be banned from convenience stores, markets, and pharmacies, and largely restricted to shops that specialise in tobacco and vaping products.

Gottlieb called use of menthol “pernicious” as it “serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking.” He noted that 54% of younger smokers aged 12 to 17 use menthol cigarettes, but use declines to about a third among smokers aged over 35. About 70% of African Americans who smoke choose a menthol product.

The FDA believes it already has the legal authority to take these actions concerning e-cigarettes. But banning the use of menthol in combustible tobacco products, including cigarettes and cigars, will require new regulations, a process that the commissioner has initiated.

The administration had been signalling its intention to act in recent weeks through a series of public statements and consultations with industry.

JUUL Laboratories has become the top selling e-cigarette in the US since launching its first device in 2015, capturing over 70% of the American market. It maintains that its products are only to be used by adults trying to stop smoking.

The company acted pre-emptively two days before Gottlieb’s announcement. It stopped shipment of flavoured pods for use in its devices to over 90 000 retail outlets, shut down social media accounts, limited online purchases, and tightened age verification for sales through its website. Buyers must now provide the last four digits of their social security number as part of the process to prove they are adults.

Paraphrasing earlier remarks by Gottlieb, JUUL Laboratories president Kevin Burns said, “We want to be the “off ramp” for adult smokers to switch from cigarettes, not the “on ramp” for America’s youth to initiate nicotine use. The numbers tell us that underage use of e-cigarette products is a problem. We must solve it.”

Some have questioned whether teen vaping is the “epidemic” that Gottlieb has claimed, as the national survey of young people only asks about one time use in the past month, and does not differentiate between experimental use or use as a substitute for traditional cigarettes.

The Democrat Tom Miller, attorney general of the state of Iowa and leader of campaigns to reduce tobacco use, cited a document from Public Health England that said e-cigarettes are “at least 95% less harmful than combustibles.”

“The harm of casual use of e-cigarettes is either very small or non-existent,” and should be weighed against how restricting access to them will adversely affect those trying to wean themselves off traditional cigarettes, he said.