The Food and Drug Administration ordered JUUL Labs Inc. to stop selling and distributing its e-cigarette products in the United States on Thursday.
FDA Commissioner Robert M. Califf stated in a press release:
“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.”
He added, “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products, and many have played a disproportionate role in the rise in youth vaping.”
The ban applies only to JUUL products.
All e-cigarette manufacturers were required to present data demonstrating their products met public health standards established by the FDA. JUUL allegedly failed to do so.
The FDA claimed that JUUL provided “insufficient and conflicting data … regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods … [precluding] the FDA from completing a full toxicological risk assessment.”
NJOY Holdings Inc. and Reynolds American Inc., JUUL’s chief competitors, submitted their data almost two years ago and had gotten the go-ahead from the FDA to maintain their operations.
Investors anticipated the FDA’s decision and sold off shares of the publicly-traded tobacco company Altria Group, which purchased 35% of JUUL shares. JUUL is still a privately-traded company.
Altria Group’s stock price fell roughly 9% on Wednesday, recovering a fraction by the end of close the following day.
JUUL responded in a press release on Thursday, stating:
“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.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health.'”
The press release went on to say that the company plans on appealing the decision and “engaging with [its] regulator.”