Juul Labs is reportedly working on a next-generation e-cigarette that can tell if the user is 21 years old, as e-cigarette manufacturers scramble to submit their products for authorization ahead of FDA's May 12 deadline.
The Trump administration over the past year has taken steps to curb youth use of e-cigarettes.
In December 2019, President Trump signed into law a bill that raised the legal age to purchase tobacco products in the United States from 18 to 21. FDA the following month issued new guidance that orders companies to stop manufacturing, distributing, and selling flavored e-cigarettes that have become popular among U.S. youth.
The policy, which took effect Feb. 6, prohibits companies from selling unauthorized cartridge-based e-cigarettes with fruit, candy, mint, and dessert flavors. The policy does not apply to menthol and tobacco-flavored e-cigarette cartridges. The new policy also doesn't apply to open-tank vaping systems and disposable flavored e-cigarette pods.
Under the guidance, manufacturers of all electronic nicotine delivery systems, including products exempt from the ban, are required to submit applications for sales authorization to FDA by May 12.
FDA said it will authorize certain products for sale under the ban if a company can prove the product "meets the applicable standard set forth by Congress, including considering how the marketing of the product may affect youth initiation and use." Companies also must show that the products can benefit the population and help adults quit smoking.
Manufacturers look to keep vaping products on the market
As the deadline for product applications approaches, vaping companies are scrambling to submit their products to FDA for authorization.
For instance, a Juul official told the Wall Street Journal that the company is finalizing FDA authorization applications for existing e-cigarette devices in two flavors, menthol and Virginia Tobacco.
The company also plans to submit more than 250,000 pages of scientific research, marketing materials, and an explanation of the company's efforts to reduce illegal sales to minors.
A company spokesperson said the application is "designed to provide FDA with the science and evidence needed to assess the role our products can play moving smokers away from cigarettes, while combating underage use."
In addition, the application will include a proposal for a new device that can verify whether the user is at least 21 years old, a person familiar with the matter told the Journal. The new device would be locked when purchased and would require the user to verify he or she is at least 21 years old before it can be used. According to the Journal, Juul has similar products on the market in Canada and the United Kingdom. Those products require users to connect the device to a mobile app and submit a photo and government identification.
A person familiar with the product told the Journal the final application for the new device could be ready by May, or the company may submit an additional application before 2021.
Vaping device manufacturers Reynolds American and NJOY Holdings, meanwhile, plan to submit applications for fruit- and dessert-flavored products that were pulled from the market under FDA's ban.
Tony Abboud, executive director of the Vapor Technology Association, said he expects fewer applications from smaller vape manufacturers because the cost of each application can range between $117,000 and $466,000.
Given the cost, some small manufacturers are considering filing applications for a single product, while others are changing their products entirely, according to the Washington Post (Maloney, Wall Street Journal, 2/24; McGinley, Washington Post, 2/24; Stolberg, New York Times, 2/28).