FDA Cites ‘Epidemic’ Of E-Cigarette Teen Use
By Sarah Owermohole • Politico.com
he FDA launched its boldest move yet to combat vaping by teens and avoid a new generation of nicotine addicts, threatening to pull flavored e-cigarettes from five manufacturers if the companies don't submit plans to curb the use of their products.
The agency gave e-cigarette maker Juul and four other companies 60 days to submit plans or face regulatory consequences.
Commissioner Scott Gottlieb said he's reevaluating a decision last summer to delay moves to regulate e-cigarettes until 2022, citing an "epidemic of youth use that I believe is before us."
“Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends, or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications," Gottlieb said in a statement.
The warning marked one of the most sweeping moves to curb smoking in years and comes as e-cigarettes sales have skyrocketed. Hundreds of varieties of flavored products populate the market, according to a recent CDC report that noted teen use surged 900 percent from 2011 to 2015. Some states such as California — one of nine that has instituted an e-cigarette tax — have seen use by youths slide in recent years.
The FDA this summer issued 1,300 warning letters and fines to e-cigarette retailers in its largest coordination enforcement effort yet, officials said today.
The “undercover blitz” targeted retailers nationwide that sold Juul and other e-cigarette products to minors. The other companies handed a 60-day warning were Vuse, MarkTen, Blu and Logic. The five together represent more than 97 percent of the current market for e-cigarettes, Gottlieb said.
Spokespersons for Juul and Blu said they will work proactively with the FDA and that preventing youth use of their products is a priority. The other companies didn't immediately respond.
Seventeen e-cigarette makers, distributors and retailers in August stopped marketing products with kid-friendly labels after the FDA issued warning letters in May.
A group of public health and consumer advocacy organizations, including the Campaign for Tobacco-Free Kids and the Truth Initiative, in March sued the FDA for delaying the regulations, calling the agency’s plan “arbitrary and capricious.”
The e-cigarette industry would be hard-pressed to respond if the FDA pushed up its deadline for reviewing products, said Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials.
Mike Hogan, who represents the Smoke Free Alternatives Trade Association, a group of vapor manufacturers and retailers, said most of the companies currently can't afford submit their products for review because it would cost about $1 million. Making them do so now would knock more than 98 percent of manufacturers out of the market, he added.
Hogan said that the industry is mulling a proposal to attach radio-frequency ID labels to vapor products, allowing regulators to track them from the manufacturing stage through retail sales. It's also considering lobbying to make e-cigarette marketing to youths illegal, which would put the onus on law enforcement, parents and kids.
While the FDA weighs its options, states have have taken the lead on other e-cigarette controls, sometimes at a halting pace. Nine states now tax vapor products in some form, which ASTHO's Plescia noted can be an effective way of restricting youth consumption. Yet out of 10 taxation proposals in the 2018 legislative season, only New Jersey's 10-cent per fluid milliliter of liquid nicotine levy has passed.
Twenty-seven states require child-resistant packaging for vapor products, while 23 states have passed legislation to register e-cigarette retailers. New York's legislature passed a bill for vendor registration in November 2017 that was later vetoed by Gov. Andrew Cuomo.
In the most aggressive action yet, San Francisco this June voted in a landslide for a sweeping ban of flavored vapor products, menthol cigarettes, flavored hookah tobacco and infused cigars.
"Ultimately what you hope for is federal legislation that sets the bar for everyone," Plescia said.
The FDA shouldn't let the nascent industry police itself, said Robin Koval, president and CEO of The Truth Initiative, a group established with states' funding in the wake of the tobacco industry's Master Settlement Agreement. "We know through a long history that this is an industry that cannot regulate itself."
In his speech, Gottlieb said that "the FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products.”
Yet many are concerned about whether a crackdown could drive consumers to traditional cigarettes. Tobacco companies' stocks surged Wednesday on the news of the crackdown.