Vapes Without FDA Approval Could Stay on Sale Long Past Deadline

Jan. 3, 2020, 10:16 AM

Consumers are likely to be kept in the dark through much of the year on whether certain vaping products now on store shelves will be banned from sale thanks to dangerous marketing tactics.

The FDA has already taken steps to curb vaping among teens by banning the manufacture, distribution, and sale of cartridge-based fruit or mint-flavored e-cigarettes, which are popular among young people. But all menthol and tobacco-flavored vapes still are fair game while the agency determines if any flavor of e-cigarette is justifiable. Despite the Jan. 2 flavored e-cigarette ban, vape shops can still sell fruity flavors in liquid form that can be loaded into “open-tank” vape products.

The Food and Drug Administration won’t disclose any information about companies applying to sell e-cigarettes until it makes a final decision, a process that could take up to a year. And even then, information considered trade secrets won’t ever be publicly available, attorneys say, casting a veil of secrecy on a process meant to improve Americans’ health.

Companies like JUUL Labs Inc. have until May to submit applications to the FDA and convince agency officials that their products and sales tactics won’t hurt the public’s health. The products can only stay on the market if the agency signs off on the marketing.

The agency wants to have those reviews finished within six months of receiving them, but attorneys expect that process to take longer, and a judge says the FDA has up to a year to review applications. The agency will disclose which products it ultimately authorizes after the process is over. Until then, consumers and retailers won’t know whether the product they’re using is being considered for the FDA green light.

The expected delays and opacity come at a time that teen vaping has been dubbed an “epidemic” by health officials, with marketing practices suspected of playing a major role in why kids decide to vape. Congressional leaders have been requesting marketing information from top-players like JUUL, which they accuse of using social media and other marketing tools to target kids.

In 2016, almost seven in 10 American kids said they saw ads for e-cigarettes in stores, on the web, on TV, or in magazines and newspapers, the Centers for Disease Control and Prevention found. Meanwhile the number of kids and teens who used e-cigarettes between 2017 and 2018 went up by 1.5 million.

In November 2018, JUUL closed down its Facebook and Instagram presences following a push by the FDA to cut back on underage vaping.

Companies are being encouraged to address youth vaping in their market applications, by answering whether marketing “would increase or decrease the likelihood that those who don’t use tobacco products, including youth and young adults, will start using them,” the agency wrote in September.

That’s where the future of fruity vape flavors is coming into question. FDA research shows fruity flavors and mint are very popular among high-schoolers, which promoted calls to ban flavored vaping products altogether. The agency released its flavor restrictions Jan. 2, saying it will take enforcement action against pod-based e-cigarettes with flavors besides tobacco or menthol.

Fruity Flavors

Some companies like JUUL have preemptively stopped selling fruity flavors, but whether they’ll try to get marketing authority for them is unclear.

A JUUL spokeswoman told Bloomberg Law the marketing application process is “the best way to assess the positive role that flavored products can play in helping adult smokers move away from combustible cigarettes, while also addressing youth use.” She wouldn’t specify whether JUUL intends to include flavors in its application, but said the company is “confident in the content and quality of materials we will submit with our application” by the May 2020 deadline.

And the FDA says that flavored vaping products will still be considered in the marketing application process, but it’s unclear whether any such products will clear the bar set by the agency. “The FDA has already accepted and begun review of several pre-market applications for flavored ENDS products,” the agency said in a statement Jan. 2. “If a company can demonstrate to the FDA that a specific product meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use, then the FDA could authorize that product for sale.”

Overall, the identities of companies that met the deadline, the status of any of their applications, and the evidence companies are citing to show their products are beneficial will all be under wraps unless the company itself discloses it, FDA spokesman Michael Felberbaum told Bloomberg Law.

Some have already. In October, Reynolds American Inc. said it was applying for FDA authorization for its Vuse electronic cigarette.

Beyond those types of company announcements, “there’s not really a lot available for the general public,” said Eric Heyer, a partner at the law firm Thompson Hine that has had clients in the e-cigarette industry.

The FDA issued the e-cigarette marketing proposed rule in September and it then reopened the comment period in November. The May 2020 filing deadline won’t change because it’s mandated by a judge.

Delays Expected

The FDA doesn’t “start” the clock for the review process until it decides whether it needs samples of the products, drawing out the timeline. The agency might stop the clock if it has to ask the manufacturer clarifying questions. It’s also not clear how many vape producers will apply for authorization and how thinly stretched agency officials will be.

The application fee will be around $117,000 to around $466,000, a lot for a small vape company. That creates some uncertainty for how many applications there will be.

Ultimately, attorneys say they don’t expect the FDA to penalize companies if they’re trying their best to meet deadlines but can’t because of agency bureaucracy. And if retailers sell products past the May 2020 deadline that haven’t gotten FDA authorization, they shouldn’t face any fines.

“There’s no way for them to know,” Stacy Ehrlich, partner at Kleinfeld, Kaplan & Becker said. “The FDA could go in and remove products from the shelf and that retailer would have to have recourse from the manufacturer to get covered for losing the products.”

Michael Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. Bloomberg Law is operated by entities controlled by Michael Bloomberg.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Bernie Kohn at bkohn@bloomberglaw.com; Fawn Johnson at fjohnson@bloomberglaw.com

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