Sorry vape gods, the FDA announced today that the popular e-cigarette Juul will be banned from the American market.
After a report earlier this week from the Wall Street Journal indicated that the decision was imminent, the Food and Drug Administration has made the ban official. Juul is a popular e-cigarette that features a sleek black device that uses flavored “pods” to deliver nicotine to users. The FDA’s order confirms that the company can no longer sell the device or four specific pods, which are:
- Virginia tobacco flavored pods at nicotine concentrations of 5.0%,
- Virginia tobacco flavored pods at nicotine concentrations of 3.0%,
- Menthol flavored pods at nicotine concentrations of 5.0%, and
- Menthol flavored pods at nicotine concentrations of 3.0%.
Juul previously carried several “fun” pod flavors like mango, cucumber, and mint, but the FDA banned all pod flavors except tobacco and menthol from sale in January 2020 citing data that these more approachable flavors encouraged minors to use the product.
“The [FDA] 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,” said FDA Commissioner Robert M. Califf in a press release.
Tobacco companies have to submit a premarket tobacco product application—or PMTA—to the FDA before the company can legally market their product in the United States. The FDA says that after reviewing Juul’s PMTA, the agency was skeptical of the product’s impact on public health as the company allegedly did not provide the FDA with enough information on its toxicological effects. “In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data,” the FDA wrote.
““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,” said Joe Murillo, Chief Regulatory Officer of Juul Labs, in a statement emailed to Gizmodo. Murillo claims that the company “appropriately characterized the toxicological profile of JUUL products” in their applications to the FDA. “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.”
The Centers for Disease Control and Prevention says that 99% of the e-cigarettes on the market contain nicotine, and it remains to be seen which of Juul’s competitors will fill the void of one the nation’s most popular e-cigarettes. Meanwhile, reports earlier this week also indicated that the Biden administration has become interested in reducing the amount of nicotine in traditional cigarettes.
Brace yourself for a lot of Americans being in a very bad mood.
Update 1:55PM: This story was updated to include comment from Juul Labs.