The U.S. Food and Drug Administration denied authorization for JUUL Labs to market all of its products in the U.S., according to a June 23 FDA news release.
The company must stop selling and distributing its products and those currently on the U.S. market must be removed or risk enforcement action, according to the FDA.
JUUL Labs is an American electronic cigarette company that makes the JUUL e-cigarette, which atomizes nicotine salts derived from tobacco supplied by one-time use cartridges.
"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., in the release. "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."
ADA President Cesar R. Sabates, D.D.S., supported the FDA's action.
"E-cigarette use is a serious public health issue, particularly among adolescents and young adults," he said. "Banning these products is a step toward protecting millions from their potential harms. All tobacco products pose risks to oral health and overall health, and the FDA should be lauded for its evidence-based public health protections and for taking action on vaping and flavored tobacco products."
In the release, Michele Mital, acting director of the FDA's Center for Tobacco Products, said that 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. "As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards," she said. "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."
According to the Associated Press, "JUUL launched in 2015 and within two years rocketed to the top of the vaping market. JUUL, which is partially owned by tobacco giant Altria, still accounts for nearly 50% of the U.S. e-cigarette market."
While the oral health effects of vaping are not fully studied, there is some evidence that vaping increases the likelihood that tobacco users will not be able to quit, according to the ADA Council on Scientific Affairs.
The 2020 ADA House of Delegates adopted an interim Board policy calling for a total ban on all vaping products that aren't approved by the Food and Drug Administration for tobacco cessation purposes.
According to the policy, "dentists should be fully aware of the oral and maxillofacial health risks that are causally associated with tobacco use, including higher rates of tooth decay, receding gums, periodontal disease, mucosal lesions, bone damage, tooth loss, jaw bone loss and more."
In addition to the policy, the ADA House of Delegates in September 2019 passed a resolution stipulating that the word "vaping" and any other alternative nicotine delivery systems be added to the existing ADA policy focused on tobacco use prevention, research and regulation.
"E-cigarette use by adolescents is a dangerous problem," said Shailee Gupta, D.D.S., chair of the ADA Council on Advocacy for Access and Prevention. "The FDA has taken a major step in the direction of Health Equity by ordering JUUL products, such as vaping devices, to be removed from the U.S. market. These types of products are heavily marketed to underserved and at-risk populations as a flavored option to combustible tobacco products. A real danger to oral health is probable in the age groups that purchase these devices. The FDA should protect young adults through science-based public health actions by guarding against the harm from unregulated products."
The United States Court of Appeals for the District of Columbia issued a temporary stay on June 24, sought by JUUL, that will allow it to keep its e-cigarettes on the market pending further court review, according to The New York Times.