"If you don't think this is an epidemic, one, look at the number of stores that are opening up. Two, drive around a high school and just see the number of kids that are doing this. ...for the FDA this is a big, big deal. As a parent, do your kids do this? Do you think it's safe and, ultimately, do you support the decision by the FDA to say, 'Look, you've got to crack down on this. We have to prevent kids and young people under 18 from getting involved in and being able to buy these products.'" - Steve Scaffidi
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Concerned with an "epidemic" surge in teen use of e-cigarettes, the head of the U.S. Food and Drug Administration announced today a "historic action" against more than 1,300 retailers and five major manufacturers for their roles in perpetuating youth access to the devices in the U.S.
"I use the word epidemic with great care," said FDA Commissioner Dr. Scott Gottlieb. "E-cigs have become an almost ubiquitous -- and dangerous -- trend among teens. The disturbing and accelerating trajectory of use we're seeing in youth, and the resulting path to addiction, must end. It's simply not tolerable."
A 'historic' action
Gottlieb announced the agency sent 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors under the age of 18, and issued 131 fines to stores that continued to violate the restrictions on sales to minors.
Gottlieb called the action the largest coordinated enforcement effort in the agency's history.
Juul and four other manufacturers, which Gottlieb said control 97 percent of the market, are now required to provide plans to mitigate youth sales within 60 days or face potential criminal or civil action.
Gottlieb warned action may require companies to change their sales and marketing practices; stop distributing products to retailers who sell to kids; and remove "some or all of their flavored e-cig products from the market."
"We're especially focused on the flavored e-cigarettes," said Gottlieb. "And we're seriously considering a policy change that would lead to the immediate removal of these flavored products from the market."
Gottlieb said the FDA recognized the impact this might have on adults trying to stop smoking, but said that emerging research on how flavored products encourage excessive use by young people shows action must be taken.
"I'll be clear. The FDA won't tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products," Gottlieb said.
In a statement, Juul Labs said "appropriate flavors" play a role in adults changing their smoking habits, but said it would work with the FDA: "We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people."
While waiting for the five major manufacturers to respond, the FDA plans to investigate their marketing and sales practices, with possible "boots on the ground inspections," Gottlieb said.
The agency will also be increasing federal enforcement actions on e-cig sales to minors in convenience stores and other retail sites, Gottlieb said, and would look closely at a practice called "straw purchases," in which adults visit web-based stores and buy in bulk to resell to minors.
"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. If manufacturers aren't willing to do the research, he said, the FDA will do it for them, with appropriate consequences.
"Let me be clear: Everything is on the table," said Gottlieb. "This includes the resources of our civil and criminal enforcement tools."
A change of plan
Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes. Instead, the agency gave extensions to new and existing vaping products, giving them until August 2022 to submit information to support their products' safety and efficacy as switching devices.
The agency said it allowed the extra time to strike an appropriate balance between regulation and encouraging the development of innovative tobacco products that may help older smokers quit.
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.
"Today we can see that this epidemic of addiction was emerging when we first announced our plan last summer," said Gottlieb. "Hindsight, and the data now available to us, reveal these trends."
In April the agency launched a Youth Tobacco Prevention Plan, designed to address some of the known public health risks, such as flavors, that contribute to adolescent use of e-cigarettes.
Shortly after the launch, the FDA cracked down on e-liquids marketed to resemble kid-friendly foods like juice boxes, candy and cookies. As part of today's action, the agency sent an additional 12 warning letters to another 12 companies that continue to sell the products.
The FDA also targeted Juul retailers this spring, issuing 56 warning letters and six civil monetary penalties. Today's effort notches up that action, becoming, said Gottlieb, the "largest ever coordinated initiative against violative sales in the history of the FDA."
The agency said it plans to unveil a new e-cigarette public education campaign targeted to youth next week, and will soon announce wider access to new nicotine replacement therapies to help more adult smokers quit cigarettes.