FDA Unveils Enforcement Approach for Marketing of Vaping Products

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FDA Unveils Enforcement Approach for Marketing of Vaping Products

04/24/2018
JUUL Labs vapor products

WASHINGTON, D.C. — Several federal legislators urged the Food and Drug Administration (FDA) to step up its efforts to keep vapor products out of the hands of underage users, and now the agency is responding.

Last week, Sen. Dick Durbin (D-Ill.) and 10 other senators joined to send letters to the FDA and JUUL Labs Inc. raising concerns about youth use and JUUL vaping products.

Joining Durbin on the letter were U.S. Sens. Sherrod Brown (D-Ohio), Richard Blumenthal (D-Conn.), Chuck Schumer (D-N.Y.), Patty Murray (D-Wash.), Tom Udall (D-N.M.), Chris Van Hollen (D-Md.), Jack Reed (D-R.I.), Ed Markey (D-Mass.), Elizabeth Warren (D-Mass.), and Tim Kaine (D-Va). 

"Protecting our nation's youth from the dangers of tobacco products is among the most important responsibilities of the [FDA] — and it's an obligation I take personally," said FDA Commissioner Scott Gottlieb. "We recognize that if the FDA is to end the tragic cycle of successive generations of nicotine and tobacco addiction, we must take every opportunity to disrupt that process where it starts: youth access to and use of tobacco products."

Pointing to the agency's shift in tobacco regulation it unveiled in July, Gottlieb said while the FDA looks to lower nicotine in cigarettes and establish a foundational framework for regulating non-combustible tobacco products — like electronic cigarettes — for adults, it must also take steps to stop youth from becoming addicted to "more novel nicotine-delivery products."

To that end, the FDA announced several new actions and efforts as part of its new Youth Tobacco Prevention Plan.

FDA Actions

  • Cites 40 retailers for violations related to youth sales of JUUL e-cigarettes
  • Announces a new blitz of retailers targeting youth sale violations
  • Takes new action to examine youth appeal of JUUL
  • Takes steps to foreclose online sales of JUUL to minors

"The troubling reality is that electronic nicotine delivery systems (ENDS) such as e-cigarettes have become wildly popular with kids," the commissioner said. "We understand, by all accounts, many of them may be using products that closely resemble a USB flash drive, have high levels of nicotine and emissions that are hard to see. These characteristics may facilitate youth use, by making the products more attractive to children and teens.

He noted that several products are part of the JUUL brand, but he also called out other brands likes myblu and KandyPens.

"In some cases, our kids are trying these products and liking them without even knowing they contain nicotine. And that's a problem, because as we know the nicotine in these products can rewire an adolescent's brain, leading to years of addiction," he said.

"For this reason, the FDA must — and will — move quickly to reverse these disturbing trends, and, in particular, address the surging youth uptake of JUUL and other products," Gottlieb added.

The new enforcement and regulatory steps are:

Step One

A large-scale, undercover nationwide blitz crackdown on the sale of e-cigarettes, specifically JUUL products, to minors at both brick-and-mortar and online retailers. The blitz started April 6 has already revealed numerous violations of the law. It will continue to the end of the month.

"The illegal sale of these JUUL products to minors is concerning. In fact, just since the beginning of March, FDA compliance checks have uncovered 40 violations for illegal sales of JUUL products to youth," Gottlieb said, adding the agency has issued 40 warning letter for those violations.

"We'll hold retailers accountable for continued violations. Let me be clear to retailers. This blitz, and resulting actions, should serve as notice that we will not tolerate the sale of any tobacco products to youth," the commissioner said.

Overall, since it began retail inspections, the FDA has conducted 908,280 inspections of retail establishments that sell tobacco products, issued 70,350 warning letters to retailers for violating the law and initiated about 17,000 civil money penalty cases.

It has also issued more than 110 No-Tobacco-Sale Order Complaints, which can result in retailers being prohibited from even selling tobacco products for specified periods of time.

Step Two

The FDA contacted eBay to raise concerns over several listings for JUUL products on its website.

"We're thankful for eBay's swift action to remove the listings and voluntarily implement new measures to prevent new listings from being posted to the web retailer's site," Gottlieb said. "Our overarching goal — one we hope everyone shares — is to make sure JUUL, and any other e-cigarettes or tobacco products, aren't getting into kids' hands in the first place."

Step Three

The agency making an effort to contact manufacturers directly, and hold them accountable.

"We need to examine all the available information to understand why kids are finding these products so appealing — and address it," he added.

"That's why today, the FDA also sent an official request for information directly to JUUL Labs, requiring the company to submit important documents to better understand the reportedly high rates of youth use and the particular youth appeal of these products," Gottlieb explained.

The information requested includes:

  • Documents related to product marketing;
  • Research on the health, toxicological, behavioral or physiologic effects of the products, including youth initiation and use;
  • Whether certain product design features, ingredients or specifications appeal to different age groups; and
  • Youth-related adverse events and consumer complaints associated with the products.

The FDA also plans to issue additional letters to other manufacturers of products that raise similar concerns about youth use. Companies that do not comply with the agency's requests will be in violation of the law and subject to enforcement, according to the commissioner.

Step Four

The agency is planning additional enforcement actions focused on companies that it thinks are marketing products in ways that are misleading to kids. The FDA will provide more details in the coming weeks, according to Gottlieb.

"These actions are just the first in a series of efforts we're pursuing as part of our newly formed Youth Tobacco Prevention Plan. We will announce additional steps in the coming weeks and months," he said. "And I hope that this sends a clear message to all tobacco product manufacturers and retailers that the FDA is taking on this issue with urgency, and if kids are flocking to your product or you're illegally selling these products to kids, you're on the agency's radar."

According to Gottlieb, JUUL Labs has recognized the problem and has reached out to the FDA and other stakeholders to discuss these concerns.