The Food and Drug Administration is threatening to pull flavored electronic cigarettes like Juul off the market if the tobacco industry doesn't do more to combat growing use of the products by children and teens.
FDA Commissioner Scott Gottlieb has said that e-cigarettes, while still harmful, may be effective for adults who want to give up cigarette smoking, which kills nearly half a million Americans each year.
It cited estimates from Public Health England that e-cigarettes are 95 percent less harmful than normal cigarettes.
The FDA said it would consider requiring brands to remove flavored products, which could be contributing to the rise in youth e-cigarette use.
In an effort to reverse that trend, the FDA on Wednesday sent letters to manufacturers of five e-cigarette brands often used by kids - Juul, Vuse, MarkTen XL, Blu and Logic - requesting that they draw up plans for limiting youth access to their products within 60 days. Yet while Big Tobacco has developed some of its own e-cigarette options and alternative products, none have been as successful as privately held Juul, which sold $1.3 billion in vape kits and nicotine pods over the 12 months ended Aug 11. Nearly 12% of high school students and 3% of middle school students reported using e-cigarettes in the prior 30 days.
Investors in Juul's competitors appeared to welcome the FDA announcement. The FDA may also limit the sale of certain flavored products, Gottlieb said.
"If young adults go online and buy 100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify", said Gottlieb.
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"Given the market's overarching concerns about Juul's impact on cigarettes, especially Marlboro, we think a potential "ban" on Juul would be positive for MO", Herzog wrote.
MarkTen's flavors, for example, include "menthol", "classic", and "summer blend", while Juul's flavors have included "fruit medley" and "creme brulee", recently shortened to "fruit" and "creme".
Gottlieb reiterated his belief that certain e-cigarette liquid flavors - including sweet ones such as mango and cucumber, popular among teenage Juul users - are particularly enticing and even marketed directly to children. The agency issued 12 warning letters to companies they declared have deceptive marketing labels on e-liquids.
"JUUL Labs will work proactively with FDA in response to its request", a company spokeswoman said Wednesday. "Appropriate flavors play an important role in helping adult smokers switch", Burns said in a statement. Shares of cigarette and e-cigarette maker Altria Group also rose more than 6 percent, while Philip Morris International shares were up 4 percent.
Although e-cigarettes can potentially help adults quit smoking regular cigarettes and other smoked tobacco products, the CDC warns they are not safe for youth, young adults, pregnant women or adults that don't use tobacco products.
"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said in an interview.
The FDA says it has issued "more than 1,300 warning letters and fines to retailers" as a result of "a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors". That initiative emerged from the agency's broader plan to regulate nicotine and tobacco, unveiled in July 2017, under the Family Smoking Prevention and Tobacco Control Act.