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FDA to review huge applications from vaping companies

FDA to review huge applications from vaping companies

2020-09-11

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.

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. 

Avalanche of applications

Part of the challenge is the sheer number of applications. The FDA last week said the market for vaping products is so large that “the likelihood of FDA reviewing all of these applications during the one-year review period is low” since the cache of applications will be “several orders of magnitude greater than anything the Agency has experienced.” 

The high number is due to the wide variety of flavors made by thousands of small vape shops. Shops that make their own liquid nicotines, also known as e-liquids, usually offer dozens if not hundreds of flavors. Those come with different nicotine strengths and volumes, adding up to thousands of distinct products that each require an application. 

That puts smaller businesses at a disadvantage compared with some of the biggest e-cigarette companies, who often have more money and expertise but fewer products requiring paperwork.

For instance, Juul Labs Inc. curtailed its flavor options after new data in 2019 showed how popular its vaping device had become among young people. Juul and others making devices that use pre-filled pods or cartridges with nicotine liquid can now sell only two flavors: tobacco and menthol. 

Juul’s flavors come in two nicotine strengths. So Juul’s submission package, including data on its device, covers just five products. It’s still 125,000 pages long, the company said in July. Juul announced in August that the FDA had accepted its package for a review. 

Reynolds American Inc., whose Vuse device is similar to Juul, announced in August that it filed a PMTA for a mixed berry flavor in addition to tobacco and menthol offerings. 

When the Trump administration ordered an end to sales of flavored cartridges and pods earlier this year, sales of liquids for devices with refillable tanks were allowed to continue. Officials argued that those types of vaping devices are commonly used by adult former cigarette smokers and less popular with kids because they are more expensive and harder to conceal. 

It’s unclear if the FDA will continue to apply the same logic, or if the small shops that make their own e-liquids will be able to generate the evidence required to get clearance. 

The standard, with companies needing to show that the products are appropriate for the protection of public health, means the FDA says it will consider a product’s likelihood of weaning current smokers off cigarettes and its likelihood of creating new nicotine users.

The FDA says it will weigh each application individually. In previous instances when a new product was authorized through a PMTA, the FDA noted that its appeal to non-tobacco users would likely be minimal.

Applicants need to submit scientific studies assessing those public health factors, as well as data showing whether there are harmful health effects for individuals from vaping. Companies like Juul have been able to conduct new studies using their products, while smaller companies are relying on published literature, like a comprehensive review by the National Academies of Sciences, Engineering and Medicine that found e-cigarettes less harmful than combustible cigarettes but said their overall public health benefit was unclear.

Some vape shops are trying the regulatory equivalent of a Hail Mary pass, in the absence of rigorous scientific data, by collecting anecdotal evidence of how their customers are former smokers in middle age, not kids. 

Char Owen, a Texas vape shop owner with a background in programming and engineering, said she developed a software application that would allow other owners like her to automate some of the paperwork to make it more feasible to file applications for hundreds of flavors. 

Owen is still pessimistic about her chances. She pointed to one of the previous PMTA authorizations, for a tobacco-heating device called iQOS, as proof that the FDA would want to see human studies that would cost millions of dollars to conduct. 

“That’s what they want to see. We’re small businesses; we can’t provide that.” Using anecdotal evidence from customers “really is our only hope,” she said. 

Michael Siegel, a public health professor at Boston University who supports vaping as a smoking alternative for adults, said he expects that big e-cigarette players will likely survive, with vape shops going by the wayside. That could lead people who want their old flavors back to seek out a black-market alternative or start making it themselves at home. 

“The irony of the whole thing is that by trying to regulate the market in this way, they are going to end up creating an unregulated market,” he said. 


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