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FDA releases proposed rules limiting US sales of e-cigarettes, flavored cigars

The U.S. Food and Drug Administration on March 13 formally proposed previously announced rules limiting the sale of most flavored e-cigarettes and cigars and speeding up the deadline for e-cigarette manufacturers to submit their products for full agency review as regulators warned they could pull products from shelves that do not meet the new guidelines.

"The epidemic-level rise in youth e-cigarette use has prompted a series of escalating actions by the FDA in both enforcement and public education. It has also required us to take a critical look at our policies and regulatory priorities," outgoing FDA Commissioner Scott Gottlieb said in a March 13 statement announcing the proposed guidance.

Under the proposed rules, the FDA could pull e-cigarettes from the market that are not sold in specialty vape shops, online or age-restricted sections of other retailers. The new restrictions would apply to flavored products other than tobacco, menthol and mint and include devices made by Juul Labs Inc., Imperial Brands PLC, British American Tobacco PLC, Japan Tobacco Inc. and other companies who sell e-cigarettes, which generally heat a nicotine-infused liquid to produce a flavored vapor.

Online sellers who do not limit how many e-cigarettes or liquid refill pods a person can buy will also face enforcement, according to the draft guidance.

The FDA also wants to move up a previous deadline for e-cigarette manufacturers to submit their products for agency review, according to the proposed rules.

Under current rules, manufacturers who introduced their products on the market after Feb. 15, 2007, and before Aug. 8, 2016, have until Aug. 8, 2022, to apply for FDA review. The new guidance moves the deadline up by a year to Aug. 8, 2021.

Gottlieb, who is stepping down from his post at the FDA in April, first proposed rules limiting e-cigarette sales in November 2018 after announcing a crackdown on e-cigarettes to curb what regulators have said is increasing use by minors. The FDA is accepting comments on the draft guidance for 30 days and will implement the rules 30 days after the final guidance is crafted.

The FDA also proposed new rules for flavored cigars on March 13, including the agency's intent to move ahead with a total ban on cigar flavors. Gottlieb also warned that existing mint, menthol or other flavors of cigars that lack marketing authorization could be pulled from the market. Manufacturers would then have to apply for FDA authorization to sell those cigars.

"Youth continue to use these dangerous combusted tobacco products due, in part, to the availability and appeal of fruit and other flavors. And research shows that, compared to adults 25 or older who smoke cigars, a higher proportion of youth use flavored cigars," Gottlieb said in the statement.

Juul, Imperial Brands, British American Tobacco and Japan Tobacco did not immediately return messages from S&P Global Market Intelligence seeking comment on the proposed e-cigarette rules. Juul, however, stopped selling most of its flavored e-cigarettes at retailers following the FDA's initial crackdown in September 2018.

U.K.-based Imperial Brands, meanwhile, raised the age limit for online sales of its e-cigarettes to 21. The company in November 2018 also announced plans to explore connected devices with possible child locks and limits based on a device's location.

Altria Group Inc. also dropped its e-cigarette line in response to declining sales and tighter regulations. The FDA previously called on the company and other e-cigarette manufacturers to help address rising teen use, and Gottlieb renewed scrutiny of Altria following a $12.8 billion investment in Juul.