FDA bans Juul's vapes, pods citing 'conflicting' data on potentially harmful chemicals

  • In Business
  • 2022-06-23 18:04:42Z

The U.S. Food and Drug Administration on Thursday announced a nationwide ban on the sale and marketing of Juul Labs Inc. vaping and e-cigarette products.

The federal agency cited "insufficient and conflicting" data in Juul's application to continue selling non-fruit-flavored products. The company must cease marketing and sales of the Juul vaping device and four types of liquid pods: Virginia tobacco flavored and menthol flavored pods with nicotine levels of 5% and 3%.

The agency said retailers should contact Juul with question about products they have on shelves or in their inventory. The sales and marketing ban does not restrict consumer possession or use of the popular devices; the agency does not enforce consumer use of vaping or other tobacco products.

The FDA has reviewed marketing applications from Juul and hundreds of other companies amid calls from anti-tobacco groups to crack down on products that led to a surge in youth vaping in the past decade. But advocates of these nicotine-delivering devices say they can help adult smokers kick the habit of smoking cigarettes or using other tobacco products.

►Why did the FDA ban Juul?: What to know about the latest response to vaping concerns

The agency said Juul's application to continue selling its products lacked evidence that the chemicals used would be "appropriate for the protection of public health." While the FDA said it has not received clinical information suggesting a hazard from using Juul's vaping device or liquid pods, the agency determined there is not enough evidence to "assess the potential toxicological risks of using the JUUL products."

Also unknown are potential harms from mixing Juul's device or liquid pods with other manufacturer's vaping products, the agency said.

"Today's action is further progress on the FDA's commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards," FDA Commissioner Robert M. Califf said in a statement.

Joe Murillo, Juul Labs chief regulatory officer, said the company believes it provided enough evidence to meet the FDA's standards.

"We respectfully disagree with the FDA's findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency," he said.

The San Francisco-based company intends to seek a stay and is "exploring all of our options under the FDA's regulations and the law," Murillo said. "We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide."

In 2020, the FDA required all e-cigarette and vaping companies to submit applications to continue marketing products. The agency also banned fruit- and mint-flavored juice pods used in e-cigarettes and vaping products, a ban that did not apply to menthol and tobacco-flavored products.

In September, the FDA banned the sale of hundreds of thousands of vaping and electronic cigarette products but did not rule on Juul, which came under fire for its appeal to youth vapers.

The FDA's removal of Juul products, rejecting the company's application to continue selling its vaping device and menthol- and tobacco-flavored pods, is "long overdue," said Erika Sward, the American Lung Association's national assistant vice president of advocacy.

"Juul is largely responsible for the youth vaping epidemic," Sward said. "No company and no product that has such blatant disregard for the health of our children and public health should be allowed to remain on the market."

John Banzhaf III, a George Washington University professor of public interest law who has long sought tougher regulation of vaping devices, said Juul's marketing to kids likely influenced FDA's ban.

Juul's "promotion was directed to kids, and I think that's one of the reasons that the FDA went after them first," Banzhaf said. "This is really the opening gun. Eventually they will go after all, or virtually all, e-cigarettes."

Ken Alltucker is on Twitter at @kalltucker, or can be emailed at alltuck@usatoday.com.

This article originally appeared on USA TODAY: Juul banned by FDA from selling pods, vapes due to 'conflicting' data


More Related News

FDA won
FDA won't require lengthy clinical trials for COVID-19 boosters

Future COVID-19 vaccine boosters won't have to go through a traditional, lengthy clinical trial process to attain emergency use authorization in the U.S., according to a report in Reuters. An agency official, speaking to the publication today, said that the U.S. Food and Drug Administration (FDA) will instead rely on data from trials on shots developed earlier in the pandemic to combat specific virus variants as well as manufacturing data in considering whether to clear boosters for administration. Preclinical animal study and safety data might also be used, the official said.

FDA will not require clinical trial data to authorize redesigned COVID boosters -official
FDA will not require clinical trial data to authorize redesigned COVID boosters -official
  • US
  • 2022-06-30 20:49:07Z

The U.S. Food and Drug Administration will not require companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 Omicron subvariants in order to authorize those shots, a top FDA official said on Thursday. Dr. Peter Marks, head of the agency's Center for Biologics Evaluation and Research, told Reuters the agency will rely on data from clinical trials vaccine makers have run on shots designed to combat the BA.1 Omicron variant, as well as manufacturing data, for emergency use authorization submissions before the fall. The FDA on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall...

FDA asks COVID-19 vaccine makers to update boosters to target new Omicron variants
FDA asks COVID-19 vaccine makers to update boosters to target new Omicron variants

The BA.4 and BA.5 strains now account for over half of infections in the US, according to the CDC.

FDA recommends inclusion of BA.4, BA.5 subvariants in COVID boosters
FDA recommends inclusion of BA.4, BA.5 subvariants in COVID boosters
  • US
  • 2022-06-30 14:18:56Z

The FDA said it has not advised manufacturers to change the vaccine for the primary vaccination series, saying the coming year will be "a transitional period...

Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid
Pfizer asks for formal U.S. approval of oral COVID treatment Paxlovid
  • US
  • 2022-06-30 10:48:42Z

Pfizer said it submitted a New Drug Application for Paxlovid to the Food and Drug Administration for the treatment of COVID-19 in vaccinated and unvaccinated...

Leave a Comment

Your email address will not be published. Required fields are marked with *

Cancel reply


  • Tech Holding
    (2022-06-24 08:05:09Z)

    The FDA said that Juul's application didn't have enough information on the toxicological profile of its products. It also said that the lack of information and conflicting information, such as the fact that potentially harmful chemicals could be leaching from its liquid pods, were cause for concern.


Top News: Business