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"I use the word outbreak with great care," said FDA Commissioner Dr. Scott Gottlieb. "E-cigarettes have become an almost ubiquitous – and dangerous – trend among teens, and the worrying and accelerated trajectory we see in youth, and the path to addiction, must stop. not tolerable. "
Gottlieb announced that the agency had sent 1,100 warning letters to stores for the illegal sale of electronic cigarettes to minors under the age of 18 and 131 fines for stores that continued to violate restrictions on sales to minors.
Gottlieb described the action as historic and said it was the most important coordination effort in the agency's history.
Juul and four other manufacturers, which Gottlieb said they controlled 97% of the market, are now required to provide plans to reduce youth sales within 60 days or to face criminal or civil proceedings.
Gottlieb warned that the action could force companies to change their marketing and business practices; stop distributing products to retailers selling to children; and remove "all or part of their flavored e-cig products from the market".
"We are particularly focused on flavored electronic cigarettes," Gottlieb said. "And we are seriously considering a policy change that would lead to the immediate elimination of these flavored products from the market."
Gottlieb said the FDA has recognized the impact this could have on adults trying to quit, but said emerging research on how flavored products encourage the use by young people show that action needs to be taken.
"Clearly, the FDA will not allow a generation of young people to become nicotine addicted to allow adults to have unrestricted access to these same products," Gottlieb said.
Several of the FDA's targeted manufacturers – Juul, MarkTen, Vuse, Blu and Logic – have issued statements recognizing the need to limit access to minors and announcing their willingness to work with the FDA to find a solution.
Juul Labs, who controls about 70% of the market, said in his statement that "the right flavors" play a role in changing smoking habits among adults, but added that they "were committed to prevent the minor use of our product, and we want to be part of the solution to keep electronic cigarettes out of reach of young people. "
The Vapor Technology Association, which represents more than 600 manufacturers and distributors of vaping, also supports limiting teen access, adding that new FDA shares are "venturing into dangerous territory."
In a statement, VTA Executive Director Tony Abboud asked, "Does the FDA really want millions of Americans to start smoking cigarettes again?"
During the 60-day waiting period, the FDA plans to investigate the sales and marketing practices of the five companies, with possible "field inspections," Gottlieb said.
The agency will also increase federal enforcement of sales of electronic cigarettes to minors in convenience stores and other retail locations, Gottlieb said, and will closely examine a practice called "straw shopping." ". in bulk to resell to minors.
"If young adults go online and buy 100 units of a product for sale to teens, this activity should be easy to identify for a product manufacturer," Gottlieb said. If the manufacturers are not willing to do the research, the FDA will do it for them, with the appropriate consequences.
"Let me be clear: everything is on the table," Gottlieb said. "This includes the resources of our civil and criminal law enforcement tools."
"Need to go further"
While applauding the FDA for today 's actions, some said the agency should step up its efforts to protect the country' s youth from the dangers of spraying.
"We need to go further," said Michael Bloomberg, the billionaire philanthropist who has worked for years to reduce smoking.
"The FDA should immediately take steps to regulate flavored electronic cigarettes, instead of waiting until 2022, as it plans to do," Bloomberg said in a statement.
Dr. Barbara McAneny, of the American Medical Association, also said that the FDA could do a lot more, promising that the association "would continue to advocate for tighter policies."
A change of plan
Last year, the FDA announced that it would delay regulations that could have put an end to sales of many electronic cigarettes. Instead, the agency granted extensions to new and existing vaping products, giving them until August 2022 to submit information to support safety and security. efficiency of their products as switching devices.
The agency said it was allowing additional time to strike a proper balance between regulation and encouraging the development of innovative tobacco products that could help older smokers quit smoking.
At the time, the Gottlieb agency did not predict the teenage epidemic that has become one of the biggest challenges of the plan.
"Today, we can see that this addictive epidemic has emerged when we announced our plan last summer," Gottlieb said. "The setback and the data we have now reveal these trends."
In April, the agency launched a youth smoking prevention plan designed to address some of the known public health risks, such as flavors, that contribute to teens' consumption of electronic cigarettes. .
Shortly after the launch, the FDA cracked down on e-liquids marketed to look like child-friendly foods like juice boxes, candies and cookies. In the course of today 's action, the agency sent 12 additional warning letters to 12 other 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 culminates in this action, becoming, Gottlieb said, "the largest coordinated anti-sales initiative ever in the history of the FDA."
The agency plans to unveil a new e-cigarette public education campaign next week and will soon announce wider access to new nicotine replacement therapies to help more adult smokers. stop smoking.
Roni Selig from CNN contributed to this report.
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