CNN

FDA Takes ‘Historic Action’ On Youth E-Cigarette ‘Epidemic’

Sep 13, 2018, 1:03 AM | Updated: Jun 7, 2022, 4:01 pm
The teen vaping epidemic has made its mark in high schools....
The teen vaping epidemic has made its mark in high schools.

(CNN) — Concerned with an “epidemic” surge in teen use of e-cigarettes, the head of the US 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 US.

“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 “historic” and said it was the largest coordinated enforcement effort in the agency’s history.

Juul and four other manufacturers, which Gottlieb said control 97% 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.

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.

Juul Labs, which controls about 70% of the market, said in its statement that “appropriate flavors” play a role in adults changing their smoking habits, but added that they “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.”

The Vapor Technology Association, which says it represents over 600 vaping manufacturers and distributors, also supports limiting teen access, but added that the new actions by the FDA ventured “into dangerous territory” by not being in the best interest of public health.

In a statement, VTA Executive Director Tony Abboud asked: “Does FDA really want millions of Americans to return to smoking cigarettes?”

During the 60-day waiting period, the FDA plans to investigate the five companies’ 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.”

‘Need to go further’

While applauding the FDA for today’s actions, some said the agency should increase its efforts to protect the nation’s youth from the dangers of vaping.

“We need to go further,” said Michael Bloomberg, the billionaire philanthropist who has worked for years to reduce tobacco use.

“The FDA should immediately move to regulate flavored e-cigarettes, instead of waiting until 2022, as it is currently planning to do,” Bloomberg said in a statement.

The American Medical Association’s Dr. Barbara McAneny also said the FDA could do much more, pledging that the association would “continue to advocate for more stringent policies.”

U.S. Senate Democratic Whip Dick Durbin and Republican Sen. Lisa Murkowski also asked the FDA to end delays. In a statement, they called for support for their bipartisan legislation, introduced in July, which would ban flavored cigars and place stringent controls on e-juice flavorings.

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.

The-CNN-Wire
™ & © 2018 Cable News Network, Inc., a Time Warner Company. All rights reserved.

KSL 5 TV Live

Top Stories

CNN

Six-year-old Mason Stonehouse was playing on his dad’s phone before bedtime and spent about $1,00...
CNN

Michigan six-year-old orders $1,000 worth of food on Grubhub

A six-year-old as playing on his dad's phone before bedtime and spent about $1,000 on Grubhub orders.
1 day ago
A man accused of kidnapping and torturing a woman in southwest Oregon knew his victim before the at...
Lucy Kafanov, Elizabeth Wolfe and Jeremy Harlan

Man accused of severely beating, kidnapping Oregon woman knew his victim, police say

A man accused of kidnapping and torturing a woman in southwest Oregon knew his victim before the attack, police tell CNN, as the week-long search for the suspect continues.
2 days ago
Artic weather leads to canceled flights...
Lilit Marcus, CNN

More than 1,800 flights canceled Tuesday, hundreds more on Wednesday

More than 1,800 flights were canceled and many more were delayed on Tuesday as a brutal ice storm continued to hit parts of the South and central United States, bringing a second day of transport problems.
2 days ago
This photo provided by the Dallas Zoo shows an emperor tamarins that lives at the zoo. Two monkeys ...
Andi Babineau and Elizabeth Wolfe

After monkeys stolen and animals enclosures cut open, Dallas Zoo releases photo of suspect

For the fourth time this month, the Dallas Zoo finds tampering with their animals and their enclosures, including one dead bird.
2 days ago
Showy highway in Texas...
Aya Elamroussi and Dakin Andone, CNN

Millions across the South and central US brace for ice storm

A winter storm bringing the triple threat of ice, sleet and snow Tuesday to parts of the South and central US has prompted officials to close roads and schools as they urge people to avoid traveling in dangerous conditions.
2 days ago
DALLAS, TX - JUNE 07:  A general view of the skyline of downtown Dallas, Texas as the American Airl...
KELSY MITTAUER

Arrest made in sex trafficking of teen girl who disappeared at Mavs game

Nine months after a Texas girl was sex trafficked after disappearing from a Mavericks game, an arrest has been made.
3 days ago

Sponsored Articles

vintage photo of lighting showroom featuring chandeliers, lamps, wall lights and mirrors...
Lighting Design

History of Lighting Design | Over 25 Years of Providing Utah With the Latest Trends and Styles

Read about the history of Lighting Design, a family-owned and operated business that paved the way for the lighting industry in Utah.
Fiber Optical cables connected to an optic ports and Network cables connected to ethernet ports...
Brian Huston, CE and Anthony Perkins, BICSI

Why Every Business Needs a Structured Cabling System

A structured cabling system benefits businesses by giving you faster processing speeds and making your network more efficient and reliable.
notebook with password notes highlighted...
PC Laptops

How to Create Strong Passwords You Can Actually Remember

Learn how you can create strong passwords that are actually easy to remember! In a short time you can create new ones in seconds.
house with for rent sign posted...
Chase Harrington, president and COO of Entrata

Top 5 Reasons You May Want to Consider Apartment Life Over Owning a Home

There are many benefits of renting that can be overshadowed by the allure of buying a home. Here are five reasons why renting might be right for you.
Festive kitchen in Christmas decorations. Christmas dining room....
Lighting Design

6 Holiday Decor Trends to Try in 2022

We've rounded out the top 6 holiday decor trends for 2022 so you can be ahead of the game before you start shopping. 
Happy diverse college or university students are having fun on their graduation day...
BYU MBA at the Marriott School of Business

How to Choose What MBA Program is Right for You: Take this Quiz Before You Apply!

Wondering what MBA program is right for you? Take this quiz before you apply to see if it will help you meet your goals.
FDA Takes ‘Historic Action’ On Youth E-Cigarette ‘Epidemic’