The FDA's decision to order Juul e-cigarette products off the U.S. market opens a new and grinding battle in the push to revamp the government’s rules for smoking and vaping.
The big picture: With parallel efforts to cap nicotine in cigarettes and ban menthol cigarettes and flavored cigars, the Biden administration is pursuing a broad tobacco agenda not seen since the Clinton administration.
Yes, but: It could be a drawn-out and costly fight. Hours after the FDA issued its marketing denial order on Thursday, Juul said it would seek a stay and was exploring a possible appeal.
- The tobacco lobby, e-cigarette makers and libertarian-leaning groups are digging in, portraying e-cigarettes as an effective cessation tool to wean adult smokers off cigarettes.
- "The agency is hellbent on rigging the process to fulfill its prohibitionist agenda," said Amanda Wheeler, president of the American Vapor Manufacturers Association.
Go deeper: The FDA on Thursday said Juul's marketing application didn't have enough evidence to show the sale of the company's products would be appropriate for the protection of public health.
- FDA commissioner Robert Califf also said Juul products may have played a "disproportionate role in the rise in youth vaping."
- Public health groups like the American Heart Association said the decision marks a dramatic step to discourage youth smoking.
- The popularity of the company's products led a new generation of teens to get hooked on smoking, driven by fruit and mint-flavored cartridges that fit in small vaping devices, research in the journal Pediatrics showed.
- The burst in youth vaping led the FDA to ban most flavored cartridges products in a bid to cut off an alternative nicotine source.
The road ahead: The FDA has authorized 23 e-cigarette products and continues to work through a slew of pending applications.
- These include numerous bottled vaping liquids sold to adults in different flavors and nicotine strengths, per the Washington Post.
- The agency has rejected applications for close to 1 million products, but last October granted tobacco giant R.J. Reynolds permission to sell three of its Vuse vaping products.
The bottom line: Anti-tobacco advocates say Thursday's decision didn't address the continued role of flavored e-cigarettes, including menthol-flavored products, in sustaining youth e-cigarette use.
- "These remain critical issues requiring FDA to deny marketing applications for all flavored e-cigarettes, including all menthol-flavored products and the flavored disposable products like Puff Bar that have become so popular with kids," said Matthew Myers, president Campaign for Tobacco-Free Kids.
- But the decision still could ease some pressure on the agency from Democrats in Congress, who had accused the FDA of moving too slowly and giving big tobacco companies a free pass.
