FDA delays decision on fate of e-cigarette giant Juul amid ongoing crackdown on vaping products
- The FDA on Thursday denied marketing applications for more than 946,000 flavored products for failing to provide evidence they appropriately protected public health.
- A 2020 CDC report found more than 3 million high school students and 550,000 middle school students reported using e-cigarettes.
The U.S. Food and Drug Administration on Thursday banned the sale of hundreds of thousands of vaping and electronic cigarette products, but delayed its decision on the industry's leading company, Juul.
The agency faced a court deadline to issue decisions on marketing applications from the vaping giant and hundreds of other companies after anti-tobacco groups successfully sued the agency to speed up its review. Regulators previously said they would prioritize Juul and a handful of other key players, but none were included in the agency's announcement.
“We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications, which is key to advancing harm reduction and earning a license to operate," Juul said in a statement sent to USA TODAY. "We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.“
Many opponents of vaping are encouraged by the FDA's progress in taking regulatory action against millions of vaping products, but say it's not enough.
"We very concerned that they did not prioritize and complete the reviews of the companies with over 75% of the e-cigarette market as they promised to do, especially category leader Juul who started the e-cigarette epidemic in the first place followed by Vuse, blu and NJOY, who round out the top brands," said Robin Koval, CEO and president of Truth Initiative, a public health nonprofit.
Others, however, say scrutiny is an important part of the regulatory process.
“(The FDA) is doing this the right way,” said Dr. Theodore Wagener, director of the Center for Tobacco Research and co-leader of the Cancer Control Program at the Ohio State University Comprehensive Cancer Center. “Their slow walk of these things is a measured approach where they’re trying to review what the manufacturers supply while also recalling the science and having a longer-term view of what the science continues to suggest.”
E-cigarette companies were required to submit a Premarket Tobacco Product Application (PMTA) this time last year for the FDA to evaluate whether their products are “appropriate for the protection of public health,” safe for current smokers and not appealing to non-smokers.
The agency received more than 6.5 million tobacco products from over 500 companies, and, in the last year, took action on over 90% of the total timely-submitted applications.
"We are committed to working as quickly as possible to transition the current marketplace for deemed new tobacco products to one in which all products available for sale have undergone a careful, science-based review by the FDA and met the statutory standard," acting FDA Commissioner Dr. Janet Woodcock and Mitch Zeller, director of the FDA's Center for Tobacco Products, said in a joint statement to USA TODAY. "Continuing to take appropriate regulatory actions to protect the public, especially youth, from the harms of tobacco products remains one of the agency's highest priorities."
Since January, the agency issued more than 170 warning letters to firms selling e-cigarettes that did not send their PMTA in time, including Visible Vapors LLC, which had over 15 million products on the market.
The agency on Thursday denied marketing applications for more than 946,000 flavored products for failing to provide evidence they appropriately protected public health.
Wagener says it's unlikely the FDA will pull all Juul products from the market, but their continued sale may come with limitations including where products are sold and how they're advertised.
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Earlier this year, the agency banned fruit- and mint-flavored products used in e-cigarettes and vaping devices, targeting products widely used by teens and children. Juul reduced all its inventory to only tobacco- and menthol-flavored products and pulled all marketing in an attempt to diminish its appeal to youth.
But other companies found a way to escape regulatory oversight. Puff Bar, an e-cigarette maker popular among teens, claims its synthetic nicotine product is not derived from tobacco and, therefore, cannot be regulated by the FDA’s Center for Tobacco Products. The company continues to sell kid-friendly flavors on its website such as strawberry banana, blue razz, mango peach, and guava ice.
“There are companies that have already received their discontinued order from the FDA that are looking into synthetic nicotine,” Wagener said. “It’s like squeezing the balloon on one end and water fills up on the other side.”
Puff Bar has not responded to USA TODAY’s request for comment.
E-cigarettes and vaping products have been a subject of controversy since they were introduced to the U.S. in 2006.
An explosive uptake of e-cigarettes among adolescents and young adults caused an uproar among parents, educators, and health experts, who say companies purposefully targeted this demographic to profit off youth addiction.
A 2020 report published by the Centers for Disease Control and Prevention found more than 3 million high school students and 550,000 middle school students reported using e-cigarettes.
“The use of any tobacco product by youths is unsafe, including electronic cigarettes,” study authors said. “Most e-cigarettes contain nicotine, which is highly addictive, can harm the developing adolescent brain, and can increase risk for future addiction to other drugs.”
However, data shows e-cigarettes are more successful than other nicotine products to help smokers quit cigarettes.
A 2019 study published by the New England Journal of Medicine found e-cigarettes were nearly twice as more effective for quitting than nicotine-replacement products such as the patch, gum, lozenge, nasal spray, inhalator, mouth spray, mouth strip, and microtabs.
“They replace the nicotine addiction from a very much dirty nicotine delivery device – the cigarette – to a much less dirty nicotine delivery device – the e-cigarette,” Wagener said. “The research is suggesting that (e-cigarettes) will over time benefit public health, but right now, manufacturers have to find a way to prevent youth uptake and take it on the nose a little bit with marketing and flavors.”
While e-cigarettes have the potential to help people stop smoking traditional cigarettes, he said most are dual users. According to the Truth Initiative, nearly 55% of e-cigarette users also smoked cigarettes among adults in 2016.
Cigarettes are more harmful than e-cigarettes, Wagener said, and the only way e-cigarettes fit into a public health strategy is marketing them as a tool to help adults stop smoking.
“Perceptions of e-cigarettes have changed over the last years where a lot of adults are now confused about what is more harmful,” he said. “Any amount of sustained dual use is not helpful at all… E-cigarettes must be marketed as a cigarette alternative.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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