Whilst the trends and regulations in the US and by their FDA can echo here in the UK and Europe, it is interesting to see how the regulatory process evolves and how small vape companies and eliquid producers can future proof their business and application and get ahead of potential upcoming TPD regulations.
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.
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.
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 comprehensive reviews 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.
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.
Vvapour have been established as one of the vape industries longest running providers of quality eliqiuds, merchandise and information since 2011, and trading since 2012. We can help anyone from seasoned vapers, to those starting out and wanting to kick the habit of traditional smoking. The company CEO created Vvapour primarily to help people stop smoking following the death of a close, rather than as a profit building business. Get in touch for any information and advice o anything vape related. Either email us on:
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0121 794 2043
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