For the past 15 years, any discussion of the public health impact of e-cigarettes has been subject to a caveat. Even though millions of people in the US they use them regularly, the devices have never been approved by the US Food and Drug Administration (FDA).
That could change next week as the multi-billion dollar steam industry nears judgment day. The FDA is due to decide by September 9 whether and how e-cigarette companies – including market leader Juul Labs – can continue to sell their products in the United States.
Anti-vaping advocates and public health groups have already urged the FDA to reject Juul’s application for approval, citing his popularity with teenagers. “Juul has fueled the e-cigarette epidemic among young people and is still number 1 among young people,” the anti-smoking group Campaign for Tobacco-Free Kids tweeted on August 31, “@FDATobacco has to take them off the market – and the same goes for other flavored, nicotine-rich e-cigarettes.”
On the other hand, vape industry officials and pro-vaping researchers warn that adult smokers could return to deadly traditional tobacco cigarettes if the FDA clears the popular e-cigarette market. “To date, the unique focus of US policy on vaping reduction in adolescents may have reduced the potential contribution of vaping to reducing smoking in adults,” 15 former presidents of the Society for Research on Nicotine and Tobacco wrote in a recent release American Journal of Public Health items.
The FDA is in the middle of this tug of war – and the fate of the US e-cigarette industry is at stake.
For those who haven’t paid much attention to the steam industry, this moment can feel like it came out of nowhere. E-cigarettes have been sold in the US since 2007. Why is the FDA acting now?
The agency was given the power to regulate tobacco products in 2009 when then-President Obama signed the law Family Smoking Prevention and Tobacco Control Act. However, at the time, e-cigarettes were not very popular and were exempt from FDA regulatory requirements. The agency didn’t finalize a rule until 2016 to regulate vaping devices that heat and atomize nicotine e-liquids and hopefully represent a less dangerous version of a traditional cigarette. At that point, the agency informed companies with products already on the market that they would have to retrospectively compile Tobacco Products Premarket Applications (PMTAs) to ask for permission to resell in the United States
After numerous changes, the final deadline for these applications has been set for September 9, 2020. The FDA is scheduled to complete its review by September 9 this year. The Agency has said It may not meet that deadline for every 2 million applications it analyzes, but it does prioritize decisions for big brands like Juul and Vuse, the tobacco company RJ Reynolds’ e-cigarette.
The FDA’s decisions will technically depend on whether each e-cigarette product under consideration is “suitable for the protection of public health” – the Agency standard to assess whether it is having a net positive or negative effect on the country’s public health. It is critical that the agency assess the potential impact of each product on the entire US population, not just adult smokers.
I published earlier this year a book on Juul’s rise to dominance in the e-cigarette industry. In it, I shared how Juul has been widely blamed for luring underage users into addictive nicotine with the sleek design of its device, fruity flavors that have since been discontinued, and early viral marketing. It now appears that for Juul and other similar companies, the FDA is playing off potential adult smoker benefits (fewer carcinogens, a way to quit cigarettes) against teenage and recreational consumer appeal.
Juul has repeatedly denied that it is deliberately targeting teenagers, saying that its product is for adult smokers only. In 2019 – apparently in anticipation of FDA action – Juul stopped selling all flavors except menthol and tobacco. That year it also introduced a new age verification system in retail stores and ceased almost all US advertising. “While millions of adult smokers have switched to our cigarette products, we will only be trusted to offer adult smokers alternatives if we continue to combat underage consumption, respect the central role of our regulator, and build on our shared commitment to science and evidence . “” Said a Juul spokesman in a statement.
There are data that support both sides of the debate. A study funded and conducted by Juulpeer-reviewed and published in the journal Nicotine and Tobacco Research in May 2021 found that of 8,800 adult smokers in North America who consumed Juul, nearly 40% had quit smoking completely six months later. And while company-sponsored research can be biased, some independent researchers support e-cigarette use as well. A peer-reviewed research report dated April 2021 of 56 previous studies found that e-cigarettes may be better at helping smokers quit cigarettes than existing therapies on the market, such as nicotine patches or chewing gum.
However, it noted that more research is needed on the long-term effects of vaping. Some research has linked e-cigarette use to lung damage, although the data suggests the risk is lower than that of smoking traditional cigarettes. Lots of e-cigarette aerosols too contain toxins this can damage the heart, albeit in smaller amounts than conventional tobacco smoke.
Then there are the unmistakable youth steam numbers. From 2020, about 20% of US high school students said they had vaped in the last month, and mostly chose products like Juuls, which use pre-filled e-liquid cartridges. That’s actually less than the 27.5% who said so in 2019 – possibly a reflection of pandemic isolation and stricter regulations on e-cigarettes, among other things. In 2019 the Trump administration did behaved the minimum age for selling tobacco products to 21 years and in 2020, forbidden the sale of e-liquid cartridges in all flavors except menthol and tobacco unless they receive FDA approval.
The FDA has remained silent about its thoughts on Juul’s application, which covers the Juul device and its menthol- and tobacco-flavored e-liquids. However, it is FDA has already denied applications which cover 55,000+ flavored vapor products, saying their manufacturers have not presented enough evidence to prove they offer net public health benefits. At first glance, that seems like a bad sign for Juul – proof that the FDA is ready and willing to refuse marketing contracts to e-cigarette companies.
That may be true, but it has also long been expected that many smaller vaping brands would fail the PMTA process, which requires a huge amount of research and can easily cost more than $ 1 million for brands with multiple products and flavors. Large, well-staffed companies with large research budgets like Juul and tobacco companies that make their own e-cigarette products are better placed to meet this high standard. That, of course, presupposes that the FDA is willing to overlook its role in a vaping trend among teenagers that it has often referred to as an “epidemic.”
Companies that have already been rejected by the FDA have been quick to look for workarounds since filter previously reported. Vapor Salon, one of the FDA rejected brands, wrote on Facebook that it plans to use synthetic nicotine instead of nicotine from tobacco to avoid government regulation. (If nicotine is lab-made and not made from real tobacco, it’s technically not a tobacco product, Vapor Salon and others argue.) And enjoy it, “Vapor Salon wrote in the mail.
Even if other e-cigarette companies pass the PMTA process, their tango with the FDA won’t be over. Agency approval may include sales or distribution restrictions, and it can be revoked if companies fail to comply with FDA manufacturing and marketing standards – or if the agency decides that the product no longer protects public health.
While the details remain to be seen, the bottom line is: The steam industry’s honeymoon is over. Now its rocky relationship with the FDA is being tested.
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