The FDA commissioner just launched a crackdown on e-cigs like Juul as he prepares to leave office

The FDA proposed restricting sales of e-cigarettes and some cigars in a big anti-smoking push.

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The FDA proposed restricting sales of e-cigarettes and some cigars in a big anti-smoking push.
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Eduardo Munoz/Reuters

  • On Wednesday, federal regulators proposed broad new limits on sales of flavored varieties of e-cigarettes like the Juul.
  • The move comes just a week after FDA chief Scott Gottlieb announced he was stepping down from his post after just under two years in the job.
  • Gottlieb told Business Insider in an interview that he wanted to enact the rules before he leaves his position in a few weeks.
  • Gottlieb has been a vocal critic of e-cigarette startups such as Juul, which he has repeatedly slammed for targeting young people.

On the heels of news of his prompt departure as chief of the Food and Drug Administration, FDA commissioner Scott Gottlieb announced a plan on Wednesday to crack down on flavored vaping products.

In accordance with the new plans, the FDA will focus on curbing the sale of any flavored e-cigarettes sold at the following locations:

  • Places where “minors are able to enter at any time,” such as gas stations, pharmacies, and convenience stores
  • Stores and websites that previously were found to be selling to minors
  • Websites that don’t limit the quantity that a customer can purchase at one time
  • Websites that don’t use independent age-verification software.

Once the policy – which is currently in the draft-stage – is finalized, flavored options sold at these locations could be pulled from the market. Companies like Juul that want their flavored varieties to be available in these locations will have to submit applications for their products to the FDA by the summer of 2021, a year earlier than the previous policy suggested.

The move revisits a policy that Gottlieb first outlined at the start of his time at FDA which allowed flavored e-cigarette products like the Juul to be sold without federal oversight through 2022.

The agency will revoke those plans and replace them with a new policy that could drastically limit the sale of flavored e-cigarette varieties like mango from manufacturers like Juul.

“Ultimately, we expect these steps designed to address flavors and protect youth will dramatically limit the ability of kids to access tobacco products we know are both appealing and addicting,” FDA Commissioner Scott Gottlieb said in a statement.

“Our pledge to reduce youth use of e-cigarettes is deeply rooted and has broad support within the Trump Administration,” he added. “Nobody wants to see children becoming addicted to nicotine.”

Like the steps the FDA outlined in the fall, the latest proposal doesn’t apply to tobacco, mint, or menthol-flavored e-cigarettes. The new proposal also includes restrictions on flavored cigars, including mint and menthol flavors, out of concern that teens might switch from e-cigarettes to those products. The proposal is open for comment for 30 days. Once it is finalized, the FDA will start enforcing it 30 days later.

The moves come on the heels of Gottlieb’s sudden announcement last week that he would resign, after just under two years on the job. Advocates had worried that the anti-smoking push might falter without Gottlieb at the helm of the FDA.

‘Most scientists believe flavorings are used to target teenagers’

Flavors have been at the center of the debate over vaping.

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Flavors have been at the center of the debate over vaping.
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California Department of Public Health

Gottlieb has been a harsh critic of Juul, an e-cigarette startup that is now partially owned by Marlboro maker Altria, and has said he believes the company’s sleek devices and sweet flavors helped drive the recent surge in teen vaping. Juul currently represents 80% of the e-cig market, according to Nielsen data. The company’s 6-month launch campaign – which anti-tobacco groups and public health researchers have called irresponsible – featured images of young models and included parties and promotional events.

Juul banned retail sales of its fruit, creme, mango and cucumber flavors last fall, just before the FDA announced its intention to crack down on flavored e-cigarettes. The flavors are still available online, where customers have to verify that they are 21 or over.

The start-up said in a statement on Wednesday that it is “committed to reducing youth usage while preserving our opportunity to eliminate combustible cigarettes, the number one cause of preventable death in the world.”

“We support category-wide action including the responsible, restricted sale of flavored products and will review today’s draft guidance as we continue to work with FDA, state Attorneys General, local municipalities, and community organizations as a transparent and responsible partner in combating underage use,” the statement said.

Still, the new FDA proposal could pose a particular threat to Juul because it allows the FDA to remove any e-cigarettes targeting young people or that will likely promote vaping among the age group, Jefferies analyst Owen Bennett said.

“This to us, could raise a risk of all pod products being removed, and especially raises the risk for Juu,” Bennett said.

The FDA is also having the makers of many flavored e-cigarettes put in applications that show their products meet a public health standard by mid-2021.

That’s a year earlier than the deadline the agency had previously given e-cigarette manufacturers, and Gottlieb described it as an “important change.” The regulator plans on taking enforcement action against the companies that haven’t submitted those applications by the deadline, according to the new proposal.

Both the American Cancer Society Cancer Action Network and the Campaign for Tobacco-Free Kids described the new measures as falling short, even as they said that Gottlieb and the FDA deserve credit for focusing on youth use of these products.

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, called for faster and more forceful action from the regulator, and criticized the latest step for not focusing on Juul specifically or applying to menthol and mint e-cigarette flavors.

“With Juul and other mint- and menthol e-cigarettes still widely available, it is doubtful the FDA’s new policy will stem the tide of youth e-cigarette use,” Myers said.

Flavors have been at the epicenter of much of the debate around young people and e-cigarettes, leading the city of San Francisco to ban flavored e-cigarettes (and menthol cigarettes) last summer.

Experts say sweet, fruity, and even candy-like e-cigarette varieties are designed to hook teens on nicotine. In young people, nicotine appears to blunt emotional control as well as decision-making and impulse-regulation skills

Gottlieb and others believe those sweet flavors are partially responsible for the troubling 78% rise in e-cigarette use outlined in data published by the Centers for Disease Control last November. The report analyzed teen e-cig use between 2017 and 2018. Gottlieb has also said he believes the increase has been driven largely by Juul, although their devices do not come in packages that resemble things like candy or hot sauce, like hundreds of other e-cigarettes do.

Read more: San Francisco has passed a sweeping ban that should scare the $23 billion vaping industry

“Most scientists believe flavorings are used to target teenagers into becoming users,” Ana Rule, a professor of environmental health and engineering at Johns Hopkins University who was an author of a recent study on e-cigs and teens, told Business Insider last summer.

The FDA also considered changing its approach to hookah products, another type of tobacco product that many young people use, the new guidance document said. Ultimately, though, the regulator wasn’t sure how getting rid of flavors might affect use of hookah products, and the products are also not as easy as e-cigarettes to use in places like schools.