The Biden administration is set to order JUUL e-cigarettes off the U.S. market after years of scrutiny around company marketing practices and fears its products fueled the youth vaping crisis.
The Food and Drug Administration’s looming decision to issue a marketing denial order, first reported Wednesday in The Wall Street Journal, comes after a two-year review of JUUL and is part of a one-two punch by regulators against the smoking industry.
Regulators on Tuesday proposed reducing the level of nicotine in combustible cigarettes to non-addictive levels, leading some to charge the rules will be self-defeating, as President Biden tries to cut rates of smoking-related cancer and disease.
Critics said nicotine limits will be so drastic that they amount to a prohibition on cigarettes — even as the administration removes less harmful vape products from JUUL.
“The FDA is directly hampering its stated strategy by limiting the number of alternatives to current smokers,” said Guy Bentley, director of consumer freedom at the Reason Foundation, a libertarian think tank.
JUUL, which did not respond to a request for comment, faced intense scrutiny after lawmakers and regulators pointed to its products as the main driver of youth vaping in recent years. Critics said JUUL’s 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.
Mr. Bentley pointed to federal surveys that found regular youth vaping, defined as one or more puffs in the last 30 days, was down to 11.3% of high school students in 2021 from 27.5% in 2019.
Yet FDA Commissioner Robert M. Califf is under immense pressure from Sen. Richard J. Durbin, Illinois Democrat, and other lawmakers who say the agency has failed to protect kids. Mr. Durbin said 750,000 kids had initiated the use of e-cigarettes over the last nine months.
“It’s time for Commissioner Califf to do his job to protect our children or step aside,” Mr. Durbin said Wednesday.
The White House declined to get ahead of an official announcement from the FDA on moves to banish JUUL vapes.
“I would refer you to the FDA. I don’t have anything for you,” White House press secretary Karine Jean-Pierre said.
Former Food and Drug Commissioner Scott Gottlieb, who served from 2017 to 2019 in the Trump administration, weighed in on The Journal report by tweeting that JUUL was the “fulcrum of the youth vaping crisis; it was driven by their product and marketing practices.”
“FDA is right to be circumspect. Electronic devices offer [the] opportunity for adult smokers to transition off combustible products but must be conceived, marketed by responsible actors,” he wrote.
Dr. Gottlieb also 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.
Now, the FDA is moving forward with the plan. Regulators said while nicotine isn’t what causes cancer and disease, it is the ingredient that gets people hooked on harmful cigarettes. Roughly 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.
“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.
Congress granted the FDA the authority to regulate cigarettes in 2009. Regulators cannot ban cigarettes outright but have room to place limits on them.
Mr. Bentley said while the FDA did not outline the extent of the nicotine reduction, existing studies suggest it could be up to 95%. He said that is tantamount to a ban and not what Congress intended.
“It’s technically tobacco you can set on fire and inhale, but if you slashed the alcohol content of bourbon by 95% to 96%, I don’t think anyone would realistically call it bourbon,” he said.
Conversely, 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.”
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.”
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.
“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,” the company said. “Today marks the start of a long-term process, which must be science-based and account for potentially serious unintended consequences.”
Another major company, ITG Brands, said the FDA’s proposed product standard likely won’t be released until May so “it is premature to comment on potential company or industry impact.”
At least one member of the industry is thrilled, however.
22nd Century Group, which is selling a cigarette with 95% less nicotine content in the Chicago area, praised the move since it got a jump start in offering cigarettes that should comply with the final rule.
“We are delighted by today’s announcement from the Biden Administration, which is great news for adults who smoke and for 22nd Century Group,” said John Miller, president of 22nd Century’s tobacco programs. “We are excited to pilot sales of the first and only cigarette designed specifically not to create and sustain addiction, but to instead reduce the hold of cigarette addiction on adult smokers.”