JUUL Labs Products Expelled From U.S. Market
The U.S. Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of the corporation’s products in the United States. The June 23 announcement cited the company’s inadequate safety information as a key reason for the MDOs.
An MDO is an enforcement measure that the FDA is authorized to issue that forces a company to stop selling or distributing its products in any U.S. market. According to the FDA, these orders will remove all JUUL products, including all devices and the four remaining JUUL pod products that survived the agency’s purge of flavored e-cigarette liquids.
FDA Commissioner Robert M. Califf, M.D. implied that JUUL’s removal from the market was partially influenced by the company’s appeal to youth, stating, “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.”
While the FDA does intend to pursue these MDOs with distributors, manufacturers, and retailers, the agency will not take action against any consumers. According to its announcement, possession of JUUL products has not been made unlawful and “the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products.”
This decision to expel JUUL from the market comes after multiple years of reviewing the premarket tobacco product applications of many different e-cigarette companies. According to the FDA, JUUL’s applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” In addition to finding the evidence for the benefits of JUUL to be lacking, the agency also noted that studies produced by the company featured “insufficient and conflicting data.”
Most concerning was the evidence suggesting that JUUL products have a high likelihood of damaging cellular DNA (genotoxicity) leading to cell mutations, as well as harmful chemicals in the materials leaching into the e-liquids. Due to the proprietary nature of these products, the FDA was prevented from completing a full toxicological risk assessment.
In its conclusion, the FDA stated that although they have not received clinical information that suggests that JUUL products present an immediate hazard to consumers, the issuing of MDOs removing them from the market is reflective of the agency’s determination that there is not enough information to determine they are beneficial enough to outweigh the known and unknown risks.
Acting director of the FDA’s Center for Tobacco Products, Michele Mital, stated, “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of its 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.”