FDA to review huge applications from vaping companies


Wednesday’s long-delayed deadline for e-cigarette companies to seek permission from the Food and Drug Administration to keep selling their products is launching a new era of uncertainty for the industry and a slog for regulators facing applications that can exceed 100,000 pages.To get more news about Cheap Vape Deals, you can visit urvapin official website.

Anyone who wants to sell vaping products in the United States — the hardware, flavored nicotine liquids, or pre-filled pods used in devices like Juul — must send the FDA a premarket tobacco product application, or PMTA, before midnight for electronic submissions. New tobacco products have to show a net public health benefit compared with cigarettes.

The deadline arrives several years after public alarm started to grow over youth use of e-cigarettes. National survey data released Wednesday show that about 20 percent of high school students reported vaping in the past month, after a rise to 27.5 percent in 2019. There is evidence that e-cigarette use can increase the risk of later using more harmful traditional cigarettes. And while cases of a mysterious lung illness that spread last year were mostly linked to black-market marijuana vaping, it highlighted the risks of an unregulated vaping market.

Public health experts and many lawmakers have urged the FDA to ban flavors unless manufacturers can prove they are necessary to help adult smokers quit and don’t result in youth use. But those who advocate vaping as an important tool for helping adults quit combustible cigarettes say the FDA’s process will lead to businesses closing and people seeking their preferred vaping flavors on a black market.

The FDA has a year, under a court order, to assess the companies’ data and decide which devices or flavors can be legally sold. In the meantime, the agency says it will start deciding whether applications are complete and warrant a further review. Applicants whose submissions are accepted can keep selling their existing products for a year.

The FDA first asserted jurisdiction over the products four years ago but repeatedly delayed this deadline. Some lawmakers frustrated with the FDA’s pace want swift action from the agency now.

“The FDA must clear the market of e-cigarettes that miss the application deadline or have their application denied,” said Rep. Raja Krishnamoorthi, D-Ill., who has convened hearings on e-cigarettes as chairman of the Oversight and Reform Subcommittee on Economic and Consumer Policy.

But it could be months, if not well into 2021, before the FDA makes any decisions that alter the vaping landscape or affect the trajectory of underage use.