FDA takes 'historic action' on youth e-cigarette epidemic



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The teenage vaping epidemic has proven itself in high schools.

(CNN) – The head of the US Food and Drug Administration, concerned about an "epidemic" of electronic cigarette consumption by teens, today announced a "historic action" against more than 1,300 retailers and five major manufacturers. access to devices in the United States.

"I use the word epidemic very carefully," said FDA Commissioner Dr. Scott Gottlieb. "E-cigarettes have become an almost ubiquitous – and dangerous – trend among teenagers. The worrying and accelerated use trajectory we see in young people and the path to addiction must stop. It's just not tolerable.

A "historic" action

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 called the action a greater coordinated coercive 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 removal of these flavored products from the marketplace."

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.

"I will be clear. The FDA will not allow a generation of young people to become nicotine addicted to allow adults to have unlimited access to these same products, "said Gottlieb.

In a statement, Juul Labs said that "appropriate flavors" play a role in adults by changing their smoking habits, but said it would work with the FDA: "We are committed to preventing the minor use of our product and solution to keep electronic cigarettes out of reach of young people.

Until the top five manufacturers respond, the FDA plans to investigate their marketing and sales practices, 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 tools of civil and criminal repression."

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 has granted extensions to new and existing vaping products, giving them until August 2022 to submit information to support the safety and 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 that time, said Gottlieb, the agency did not anticipate the teenage drinking 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. As part 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 marks this action, becoming, said Gottlieb, "the largest coordinated initiative ever against violent sales 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.

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