Medical groups praise decision, but e-cigarette maker could return to U.S. market.
The U.S. Food and Drug Administration (FDA) is banning JUUL electronic cigarettes and the company’s related products.
On June 23, FDA announced marketing denial orders (MDOs) to JUUL Labs Inc. for all products currently marketed in the United States, meaning the company must stop selling and distributing the products and remove any circulating, or risk enforcement action.
The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5% and 3% and menthol flavored pods at nicotine concentrations of 5% and 3%.
Retailers should contact JUUL with any questions about products in their inventory. The FDA orders pertain to commercial distribution, importation, and retail sales and do not restrict individual consumer possession and use.
“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 M. Califf, MD, said in the administration announcement. “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 Labs’ website states the company’s mission “is to transition adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products.”
“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,” said a published statement from Joe Murillo, chief regulatory officer at Juul Labs.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health,” Murillo said. “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.”
The FDA ruling sparked praise from at least three medical groups.
The American Lung Association called it “welcomed and long overdue,” in a statement published on Twitter.
The FDA “made the right decision to end the sale of all Juul products including #menthol. They remain one of the most popular e-cigarettes among teens. Stopping these sales is an important step in ending the youth vaping epidemic,” the statement said.
The American Thoracic Society (ATS) called it “long overdue,” but said a victory against youth smoking may be short-lived because JUUL likely will seek to address the ruling or market a new product.
“Juul is one of the most popular e-cigarette products among middle and high school kids,” ATS Tobacco Action Committee vice-chair Hasmeena Kathuria, MD, said in a statement. “Their flavored products are particularly enticing to this group, who are at risk of becoming lifelong nicotine users. Removing Juul products, even temporarily, will make a small but important dent in sales to this vulnerable group.”
American Medical Association President Jack Resneck Jr. issued a statement praising the ruling and derided companies peddling e-cigarettes to youths, creating a new generation hooked on tobacco products.
“AMA policy supports banning the sale and distribution of all e-cigarette and vaping products, with the exception of those approved by the FDA for tobacco cessation purposes,” Resneck said. “Since declaring e-cigarette use and vaping an urgent public health epidemic in 2018, the AMA has pushed for more stringent policies to protect young people from the harmful effects of tobacco and nicotine use and will continue do so.”
On Twitter, some people questioned public health priorities in the United States, noting JUUL devices are banned, but cigarettes and other tobacco products remain legal for sale.
Others noted the FDA ruling on vaping was published the same day the U.S. Supreme Court struck down a New York gun law that restricted carrying concealed handguns outside the home, according to a CNN report. AMA, the American College of Physicians and other physician groups for years have pressed lawmakers for action to curb gun violence as a public health issue.
ATS described the FDA ruling as “based largely on a technical dispute over safety data, rather than JUUL’s appeal among kids,” and not based on “highly addictive levels of nicotine salts,” or long-term health effects.
FDA reviewed JUUL’s request to market the devices, documents known as premarket tobacco product applications, and found they lacked sufficient evidence to show they would be appropriate for the protection of public health.
Some of the company’s study findings raised concerns due to insufficient and conflicting data about effects including genotoxicity, or harm to genetic information within cells, and whether potentially harmful chemicals could leach form the company’s proprietary e-liquid pods, the FDA announcement said.
The FDA acknowledged the administration has not received clinical information to suggest an immediate hazard from the JUUL device or its pods. There is no way to know the potential harms from using 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 announcement linked to its resources to help smokers who want to quit.
“Quitting all tobacco products is the best possible path to good health,” it said, but the FDA also has approved other ENDS products with potential to benefit adult smokers.
The ruling about JUUL products marks the third significant FDA action on cigarettes, tobacco or electronic nicotine delivery systems in the last two months.
On June 21, the White House published plans for future regulatory actions with FDA plans to establish a maximum nicotine level to reduce the addictiveness of cigarettes.
In April, FDA proposed banning menthol cigarettes and flavored cigars to prevent youths from starting smoking and reduce tobacco-related disease and death. Menthol adds a minty taste and aroma to cigarettes, while adding flavors such as strawberry, grape, cocoa and fruit punch appeal to youths and young adults and make cigars easier to use, according to FDA.
That FDA action deals with manufacturers, distributors, wholesalers, importers and retailers who make, distribute or sell the products. FDA “cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars,” the agency announcement said.
FDA is in a public comment period until July 5 for that ban.