Tobacco-Free Vapes to Linger on Shelves as FDA Grasps New Power
By Celine Castronuovo, Bloomberg Law
April 22- Many unauthorized, tobacco-free nicotine products could stay on the market past a summer deadline as the FDA grapples with its new power to regulate them and an influx of marketing applications.
A government spending package for fiscal 2022 gave the Food and Drug Administration the authority to regulate synthetic nicotine, closing a loophole that popular e-cigarette companies like Puff Bar had used to skirt federal oversight. The law marked a win for health advocacy groups that have long called for the FDA to take action against teen-friendly flavors of vaping products.
But attorneys who counsel tobacco and vaping companies say Congress set unrealistic deadlines for manufacturers to submit premarket applications and for the FDA to review them. Companies have until May 14 to apply, and all existing products that haven’t won authorization must come off the market by July 13 under the law.
“We’re talking about an agency that is already suffering from extremely limited resources, which are progressively being dedicated to the thousands” of pending applications from Juul and other producers of tobacco-based e-cigarettes, said Ben Haas, a partner at Latham & Watkins LLP’s Healthcare and Life Sciences Practice.
“I don’t think there’s any realistic scenario in which FDA is able to resolve fully and finally” applications “for synthetic nicotine products by July with a full scientific review,” he said.
The agency previously only had regulatory authority over products derived directly from the tobacco plant. The FDA is still conducting reviews of applications from Juul Labs Inc. and other vaping companies past a September 2021 court-imposed deadline, after it previously extended its regulatory authority to e-cigarettes.
The FDA has so far opted to prioritize enforcement against youth-appealing products and those that didn’t submit applications, and it has yet to act on products with pending applications. Attorneys say the agency is likely to apply that approach to synthetic nicotine, allowing companies to continue selling their products as they await FDA review.
More than a quarter of middle and high school e-cigarette users reported using Puff Bar as their usual brand, according to a survey from the Centers for Disease Control and Prevention. Puff Bar didn’t respond to multiple requests for comment.
Attorneys who specialize in tobacco regulations say it’s unlikely that synthetic nicotine companies and the FDA will be able to meet the deadlines set by Congress, citing the amount of work that goes into the application submission and review process.
Premarket tobacco authorization applications “typically require multiple studies that pretty much all of which last more than 60 days,” said Stacy Ehrlich, a partner at Kleinfeld Kaplan & Becker LLP who counsels tobacco manufacturing groups.
“If they didn’t start working on their” application “prior to the enactment of this legislation, it’s going to be very difficult to put together a fulsome” application by May 14, she said.
Haas said it is also unlikely that the public will hear from the FDA about each of the timely submitted synthetic nicotine product applications by this summer. For tobacco products, the FDA typically does an initial review to make sure a company’s application is complete—a process that Haas said usually happens within a month or two of a company filing the application. The agency then decides whether to refuse an application, or move it forward for a substantive review.
The FDA hasn’t specified how long it anticipates it will need to review applications for synthetic nicotine products. In any premarket tobacco product application review, the FDA examines information from a manufacturer on its product’s potential risks and benefits to the U.S. population as a whole. The agency also looks at whether the product would help discourage use of more harmful tobacco products, and if there’s any risk that current non-tobacco users will start using the product.
Attorneys say the FDA could decide to not penalize or take enforcement action against products with pending applications after the July deadline, essentially allowing them to stay on the market for an indefinite amount of time.
“If you look at what FDA has done for products that are still pending past the September 2021 date,” the FDA “has not taken enforcement action against any of the products that are covered by still pending” applications, Ehrlich said. “They may take a similar approach here” with synthetic nicotine products.
Haas said the FDA will likely allow some products with timely submitted applications to remain on the market until FDA announces its decisions. Meanwhile, the agency could still engage in “targeted enforcement against synthetic nicotine manufacturers,” of products similar enough to previously rejected tobacco-based e-cigarette products.
For any unauthorized tobacco products that continue to be sold, marketed, or distributed, the FDA could issue warning letters, injunctions, or initiate product seizures, an FDA spokesperson said. The agency could also assess civil money penalties or no-tobacco sale orders to any retailers selling unauthorized products, the spokesperson added.
Rigorous Health Standard
Public health advocacy groups say they don’t think many synthetic nicotine products, especially the ones most popular among youth, will be able to meet the FDA’s health standard for authorization.
“The vast majority of synthetic nicotine products come in flavors that FDA has recognized pose a particular problem to youth use,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. Nearly 85% of youth e-cigarette users reported using flavored products in 2021, with the most popular flavors including candy and desserts, according to the CDC’s National Youth Tobacco Survey.
Another factor working against vapor companies is that some have explicitly admitted to switching to synthetic nicotine to avoid FDA regulations.
VaporSalon, for example, announced in an August 2021 Facebook post that it was “switching” to “tobacco free nicotine” after its tobacco products received marketing denial orders from the FDA. The Texas-based retailer said the “main purpose” for the change was “to be outside of the FDA’s regulations.”
Myers said his organization hopes the FDA is “prepared to move swiftly” regarding synthetic nicotine.
“If FDA exercises the authority given to it, this should dramatically reduce youth use of e-cigarette products,” he said.