FDA Takes Action On The Youth e-cigarette Epidemic

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The head of the US Food and Drug Administration announced 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 US after major concerns have been raised with an “epidemic” surge in teen use of e-cigarettes.

“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 A ‘historic’ action.”

Gottlieb said that 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 referred to the action the largest coordinated enforcement effort in the agency’s history.

Juul and 4 other manufacturers, which Gottlieb said control 97% of the market, now have to provide plans to mitigate youth sales within 60 days or face potential criminal or civil action.

Gottlieb warned action may require companies to amend their sales and marketing practices; which means they have to 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 that the FDA recognized the impact which this may have on adults who are 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.

Juul Labs said in a statement that “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 5 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 as well as 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.”

“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.”

The agency said that it plans to unveil a new e-cigarette public education campaign which will be targeted to youth, and will soon announce wider access to new nicotine replacement therapies to help more adult smokers quit cigarettes.