FDA Bans JUUL E-Cigarettes From The United States Market

JUUL must stop selling and distributing e-cigarettes in the United States including those currently on the market, the U.S. Food and Drug Administration said on Thursday.

The restrictions apply to the JUUL device and four types of JUULpods — Virginia tobacco-flavored pods at nicotine concentrations of 5 percent and 3 percent and menthol-flavored pods at nicotine concentrations of 5 percent and 3 percent.

JUUL, founded in 2015, vaped new life into the e-cigarette market with its youth-focused media campaigns. In 2018, the company generated $1 billion in revenue and the tobacco giant Altria bought a 35-percent stake in the company.

“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,” said FDA Commissioner Robert M. Califf. “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 FDA found that JUUL’s applications for marketing a new tobacco product lacked details about the toxicological profile of the products. Some of the company’s studies raised concerns due to insufficient or conflicting data, including about the genotoxicity — the property of chemical agents that damage genetic information and cause mutations, which may lead to cancer — and other harmful chemicals leaching from the JUULpods.

The FDA concluded from the applications that they could not ensure the products were appropriate for the protection of public health.

The FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods. However, they have determined that there is insufficient evidence to assess the public health risks of using JUUL products.

The FDA also pointed out that they do not know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

The FDA’s orders only apply to the commercial distribution, importation, and retails sales of JUUL products, and do not restrict individual consumer possession or use.

JUUL was headquartered in San Francisco until 2020, when it moved to Washington, D.C. As the FDA cracks down on JUUL’s products in the US, officials are concerned that the company plans to flood international markets with its products.