The FDA today denied Juul Labs' premarket tobacco product applications and ordered all products removed from shelves nationwide, ending a 2-year review.
The US Food and Drug Administration (FDA) this morning denied Juul Labs Inc the ability to market its Juul electronic nicotine delivery system (ENDS) and 4 types of JULLpods, the device companion cartridges filled with a nicotine-containing e-liquid formulation.
The company must discontinue sales and distribution of the products and any currently available on the US market must be removed, pending enforcement action, according to an FDA statement.
The agency’s marketing denial orders (MDO) follow by one day the FDA-announced plans for a proposed product standard that would prescribe a maximum nicotine level to help reduce the addictive nature of cigarettes and other tobacco products.
“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, M.D. “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 decision follows FDA’s nearly 2-year review of Juul Labs’ premarket tobacco product applications (PMTAs) which the agency determined lacked sufficient evidence to demonstrate that marketing of the product is appropriate for the protection of public health. FDA specifically noted insufficient data regarding the products’ toxicologic profile including inadequate and conflicting data on genotoxicity and on potentially harmful chemicals leaching from the company’s proprietary e-liquid pods. Discrepancies and something else have not been adequately addressed, says the FDA, precluding the agency from completing a full assessment of the products in company’s PMTAs.
The FDA cites additional unknown hazards including potential harms from using other third-party e-liquid pods with the JUUL device or using JUULpods with a non-JUUL device.
In late 2019, Juul halted US sales of several JUULpod flavors in response to widespread criticism from regulators, lawmakers, and state attorneys general that the product specifically targeted minors.
In September 2020, the FDA required all US ENDS manufacturers to remove their products from the market or submit them to the agency for review. Of primary interest was any scientific evidence that a product would assist smokers in efforts to quit and whether product benefits to smokers outweighed health damage to new users, and particularly teens.
In 2021, the FDA rejected such applications for nearly 950 000 flavored e-cigarettes and related products, citing the lure of the products to underage youth. At that time, the agency delayed its decision on Juul.
“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 states that it does not have the authority to enforce action against individual consumers for possession or use of Juul products and that today’s action focuses on importation, distribution, and sales.
RESOURCE NOTE: There are many resources to help smokers who want to quit. Some current JUUL users who will not have access to JUUL products following this action or current smokers who want to transition away from cigarettes and cigars may decide to switch to other ENDS products that have been reviewed and authorized by the FDA based on their potential to benefit adult smokers.