"I've been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends", he said.
The Minnesota Department of Health has now issued a health advisory regarding the latest evidence that early nicotine use increases the risks of addiction for youth now and later in life. "It's aimed at retail and online sales of e-cigarettes to minors".
E-cigarettes are vapor-emitting devices that have grown into a multi-billion dollar industry in the USA despite little research on their long-term effects, including whether they are helpful in helping smokers quit. They included chains such as 7-Eleven, Casey's General Store, Circle K, Cumberland Farms, Kwik Trip, Sheetz, Speedway, Tom Thumb and Wawa, as well as gas station banners like BP, Chevron, Citgo, Conoco, Exxon, Marathon, Mobil, Murphy USA, Phillips, RaceTrac, Shell, Sunoco, Texaco and Valero.
They typically contain nicotine, and sometimes flavorings like fruit, mint or chocolate.
"We're especially focused on the flavored e-cigarettes", said Gottlieb.
At that time, Gottlieb said, the agency didn't foresee the "epidemic'"of adolescent use that has become one of the plan's biggest challenges". "Hindsight, and the data that's now available to us, fully reveal these trends". Some experts were cautious about the results, however. They noted the survey did not ask specifically about Juul, a sleek, heavily-marketed e-cigarette brand that exploded onto the market and accounts for 70 percent of US sales, according to analyst estimates. The premise of such threats is that the interests of adults who might want to switch from smoking to a far less hazardous form of nicotine consumption should be sacrificed for the sake of curtailing e-cigarette use by minors, which is already illegal. But a year ago Gottlieb delayed the deadline until 2022, saying both the agency and industry needed more time to prepare.
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The head of the US Food and Drug Administration took aim Wednesday at Juul and other e-cigarette manufacturers, warning that they must show in the next two months how they'll keep the devices out of the hands of young people.
Even more significant, notices sent Wednesday morning demand that five leading e-cigarette manufacturers, including San Francisco-based Juul Labs, submit plans within 60 days detailing ways to sharply curb sales to underage consumers.
Despite the fact that they can not legally be sold to anyone under 18, e-cigarettes - hand-held vaporizers that create aerosols from liquids typically packed with nicotine and other chemicals, often including flavorings - are now the most popular tobacco product among high school students, recent federal data shows. Companies whose products are pulled from shelves will have to prove a net positive public health benefit before sales can resume. The FDA's delay on that requirement has allowed the industry to flourish with little oversight. The FDA is demanding what Gottlieb describes as "plans to immediately and substantially reverse" the "clear and present danger" of adolescent vaping. Shares of traditional cigarette maker Altria Group, which also owns the MarkTen brand, closed 6.6 percent higher, while Philip Morris International shares ended up 3.4 percent.
She said Altria could be well positioned because it has a long history of dealing with youth access to its products and has "limited/mature flavor profiles relative to Juul".
Several of the manufacturers targeted by the FDA - Juul, MarkTen, Vuse, Blu and Logic - issued statements agreeing with the need to limit access to minors and announcing their willingness to work with the FDA to reach a solution.
As part of its broader enforcement efforts, the FDA said it issued more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette products to minors. Another study found that e-cigarettes are "no more or no less" effective than nicotine patches when used to help stop smoking. Those products could include e-cigarettes, though the FDA has not given any company permission to advertise its device as a quit-smoking aid.
"I'm here to tell them today that this prior approach is over", he said.