WHITE OAK, Md. — The FDA on Thursday ordered e-cigarette maker JUUL to take all of its products off the market, citing “insufficient evidence” that public health would be protected if the company’s products stayed on the market.
“After reviewing the company’s premarket tobacco product applications, the FDA determined that the 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,” the agency said in a press release. “In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data — including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods — that have not been adequately addressed, and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.”
The order applies to the JUUL device and four types of JUULpods: Virginia tobacco-flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol-flavored pods at nicotine concentrations of 5.0% and 3.0%. As a result of the order, “the company must stop selling and distributing these products,” the FDA said. “In addition, those currently on the U.S. market must be removed, or risk enforcement action.” The agency added, however, that the stop-marketing orders “only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use — the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any 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,” FDA Commissioner Robert Califf, MD, said 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.”
JUUL said it would fight the FDA’s move. “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,” Joe Murillo, chief regulatory officer at JUUL Labs, said in a statement. “We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator. 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.”
HHS Secretary Xavier Becerra praised the FDA’s move. “This action by FDA reflects the agency’s steadfast commitment to carefully evaluating the science to ensure that only those products meeting its rigorous public health standards are granted marketing authorization,” he said in a statement. “FDA has taken the proper steps to protect the health of all Americans.”
Rep. Frank Pallone (D-N.J.), chairman of the House Energy & Commerce Committee, agreed. “I applaud FDA for following the science and taking this decisive stance to protect our nation’s public health by taking these dangerous products off the market,” he said in a statement. “While I have long held concerns that JUUL used enticing flavors and slick marketing to get young people hooked on their products, these new revelations that JUUL’s pods are leaching dangerous chemicals is deeply alarming. There is no question that FDA did the right thing today.”
Nancy Brown, CEO of the American Heart Association (AHA), applauded the decision in a statement but urged the FDA “to take swift and severe enforcement action if the company defies the order.” She also said the agency should “issue decisions on all remaining premarket tobacco applications as soon as possible, as we are long past the court-ordered September 9, 2021 deadline for the agency to rule on the applications.”
That latter comment refers to the outcome of a 2018 lawsuit filed by seven public health and medical groups — including the AHA — and five individual pediatricians. The suit challenged an FDA decision to delay a requirement that manufacturers of e-cigarettes and certain other tobacco products demonstrate to the FDA that their products are “appropriate for the protection of the public health.” The judge agreed that the FDA illegally extended its deadline for implementing the requirement until August 2022, and set the September 2021 deadline instead.
Source: MedicalNewsToday.com
