The Food and Drug Administration is poised to order JUUL e-cigarettes off the U.S. market after years of scrutiny over company marketing practices and fears its products fueled the youth vaping crisis, according to a report in the Wall Street Journal.
The FDA could announce the move as soon as Wednesday after a nearly two-year review of the company, the newspaper reported.
JUUL faced intense scrutiny after lawmakers and regulators pointed to its products as the main driver of youth vaping in recent years. Critics said its trendy pods were easy to conceal from parents and teachers.
The company withdrew its fruit-flavored products but the FDA continued to review its tobacco and menthol flavored e-cigs.
Proponents of e-cigs say they help adult smokers wean off more harmful cigarettes but JUUL’s role in the youth market made it a key target.
“JUUL was fulcrum of the youth vaping crisis; it was driven by their product and marketing practices,” former FDA Commissioner Scott Gottlieb said. “FDA is right to be circumspect. Electronic devices offer opportunity for adult smokers to transition off combustible products but must be conceived, marketed by responsible actors.”
FDA action to remove the products would be the Biden administration’s second move in as many days to confront the tobacco and smoking industry.
On Tuesday, the agency proposed a rule that would set a maximum amount of nicotine in cigarettes in a bid to reduce their addictive properties.
The FDA said 480,000 people die prematurely from a smoking-attributed disease each year, making tobacco use the leading cause of preventable disease and death in the U.S.
Regulators said while nicotine isn’t what causes cancer and disease, it is the ingredient that gets people hooked on harmful cigarettes.
“Because tobacco-related harms primarily result from addiction to products that repeatedly expose users to toxins, FDA would take this action to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit,” the proposed regulation said.
The FDA also said reducing nicotine levels would decrease the number of people who pick up the habit.
“Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit,” FDA Commissioner Robert M. Califf said.
Congress granted the FDA the authority to regulate cigarettes in 2009. Regulators cannot ban cigarettes outright but have room to place limits on them.
Dr. Gottlieb floated a plan in 2017 to limit nicotine in combustible cigarettes but it didn’t gain enough traction in the Trump administration before the commissioner departed in 2019.
The Campaign for Tobacco-Free Kids praised the nicotine proposal but said it won’t amount to much unless the administration acts swiftly and boldly.
“Given the enormous public health benefits and the millions of lives that would be saved, the administration and the FDA should move as quickly as possible to turn this plan into reality,” the campaign said. “For this proposal to have maximum impact, the FDA should require a reduction in nicotine levels in all combustible tobacco products, not just cigarettes, to prevent switching to other harmful products.”
Yet regulators must gather public input before issuing a final rule, so the action could take a year or more.
Opponents of the move are likely to argue adult smokers will need less harmful alternatives, such as e-cigarettes, or say the nicotine reduction is a de facto ban that will upend the industry, eliminate jobs and force smokers onto the black market.
“It may yield some public health benefit and, of course, the less people smoking cigarettes the better. But it will force smokers who do not abstain or who can’t quit into a dangerous and unregulated market,” said Mazen Saleh, policy director of integrated harm reduction at the R Street Institute, a Washington-based think tank.
“In the absence of reduced-risk nicotine alternatives — they will turn to illicit markets and cigars,” he said. “To make matters worse, the FDA has rejected reduced-risk nicotine alternatives and has banned other classes of products, such as menthols, entirely. This is more indicative of full-scale prohibition, and it is nothing new. The U.S. has a long history of unsuccessfully attempting to regulate human behaviors.”
He said a more effective policy would include education about smoking, enforcement of age requirements for purchases, smoking-cessation support and improved access to reduced-risk products.
“The proposal from the Biden administration is none of those things,” Mr. Saleh said.
Altria, a large producer of cigarettes and related products, said the FDA should be focused on offering less harmful products than upending regular cigarettes. It also signaled it is digging in for a long regulatory process.
“We believe tobacco harm reduction is a better path forward. The focus should be less on taking products away from adult smokers and more on providing them a robust marketplace of reduced harm FDA-authorized smoke-free products. Today marks the start of a long-term process, which must be science-based and account for potentially serious unintended consequences.”
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