The Food and Drug Administration (FDA) decision earlier this month to authorise the sale of an electronic cigarette in the United States was a landmark for the vaping industry – but it may only deepen confusion about the sector’s future – writes Katherine Ellen Foley for POLITICO. An FDA statement said Vuse Solo tobacco flavoured products could benefit smokers who switched completely or with a significant reduction in cigarette consumption.
The FDA also said it had denied applications for flavoured products for failing to demonstrate that marketing them would be appropriate for the protection of public health.
More than a month after a court-ordered deadline to determine which e-cigarettes could stay on the market, FDA has yet to act on applications from some of the industry’s biggest players, including Juul.
And while the agency has denied or rejected as incomplete millions of marketing applications from small and mid-sized manufacturers, it has not said whether any type of vape flavours are acceptable, reports Politico in this 14 October 2021 article republished with permission.
In the meantime, the FDA has already rescinded its denial to one mid-sized manufacturer, after conceding that it overlooked crucial data. That could convince more firms to appeal the agency’s vaping verdicts.
E-cigarette manufacturers and anti-vaping groups alike are puzzled by the agency’s course so far. The industry is looking for a clear path forward, while public health groups argue that FDA’s actions haven’t helped reduce vaping’s appeal to teens. The agency has said only that it will review remaining vape marketing applications “expeditiously”. And it faces potential wildcards from legal challenges brought by pro- and anti-youth vaping camps.
“I think you're seeing the challenge of trying to apply new regulation to an existing industry,” said Dr Scott Gottlieb, a former FDA commissioner who spent a large portion of his tenure focused on tobacco regulation. “We’re going to get to the proper end result… This is just a challenge.”
Another former agency hand expressed confusion about the FDA’s approach. “I don’t know exactly what’s going on here,” said a former senior official in the FDA Center for Tobacco Products.
An agency spokesperson said FDA has ruled on “over 98%” of all of the new tobacco product applications it received by the 9 September deadline.
“FDA is committed to completing the review of the remaining applications as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress,” the spokesperson said.
“FDA is conducting review of many different applications concurrently and intends to continue issuing marketing decisions as review for the applications is completed.”
A long time coming
FDA’s regulation of the e-cigarette market is a long time coming. The agency finalised a rule in 2016 requiring manufacturers of tobacco products to submit premarket tobacco applications, or PMTAs, for any product introduced after February 2007. In many cases, that meant companies needed to seek permission to keep selling their existing products.
A judge later ordered companies to apply by September 2020 and FDA to issue decisions by September 2021, after anti-tobacco groups sued to speed up the regulatory process. But the agency finalised the PMTA rules for e-cigarettes this month, weeks after its mandated deadline to rule on companies’ filings.
The new rules take effect in early November. They require companies to prove that the likely benefits of their products to adult smokers outweigh the risk of enticing teens, children or other non-smokers to begin vaping. That is similar to the standard FDA had previously laid out. When it announced the final rule, FDA said that all pending applications wouldn’t be held to new standards.
To date, the agency has only authorised one vape and two tobacco-flavoured cartridges made by Vuse, a brand owned by cigarette company RJ Reynolds.
After FDA announced the decision on Tuesday 12 October, some public health experts questioned whether the items met the agency’s criteria for authorisation – particularly because they contain levels of nicotine on par with some Juul and disposable e-cigarette products, both of which have been historically popular with teenagers.
Additionally, a federal survey released last month found that more than 10% of high school students who vape named Vuse as their go-to brand.
“It’s deeply concerning that FDA seems little concerned about the abuse potential [of these products],” said Matthew Myers, president of the Campaign for Tobacco-Free Kids, which sued FDA in 2018 over the agency’s failure to require e-cigarette manufacturers to submit PMTAs in a timely manner.
“The only way Vuse [products] could be used to reduce health harms relating to tobacco are if smokers switch entirely or near-completely from smoking to using the Vuse e-cigarette instead,” Eric Lindblom, a former official at FDA's Center for Tobacco Products who is now a senior scholar at the Georgetown University Law Center, wrote in an email to POLITICO. “Any other use will increase the health harms and risks to the users.”
In the meantime, companies that received marketing denial orders or notices of incomplete applications can choose to reapply under the new rules. And nearly a dozen firms have filed appeals against FDA’s marketing denial orders for their products.
“It’s all up in the air,” said Gregory Conley, president of the American Vaping Association. “FDA has not issued any new [marketing denial orders] since 23 September, after a month of just non-stop shuttering tobacco-derived nicotine e-cigarette businesses in America. And then it all stopped.”
The agency last week reversed a denial it had issued to Turning Point Brands, the first company to appeal a vaping decision, regarding hundreds of its e-cigarette products. FDA said it had uncovered “relevant information that was not adequately assessed” in the company’s application – including randomised, controlled trials comparing tobacco-flavoured vapes to fruit-flavoured ones, and studies assessing how smokers, vapers and non-smokers perceived or used its products.
These additional data merited FDA’s further review, the agency said, leading it to put hundreds of Turning Point Brands’ vapes back in the review process. The agency won’t punish the company for continuing to sell the products without marketing orders while it re-reviews them.
“It sounds like they didn’t review certain parts of the application,” said the former CTP official. “When I was at FDA … we had to do full reviews of everything and provide responses to everything the company had submitted. Even if there was a fatal flaw, we still had to review the entire application – which honestly felt like a waste of resources.”
The reviews then, for cigarette products, took multiple years and included several rounds of back-and-forth with the cigarette manufacturer, the official said.
“It looks like FDA isn’t doing that anymore,” the official added. “It looks like they’re giving companies one bite at the apple and then making a decision.” The official suggested this is the result of the agency’s one-year deadline to provide decisions on all the applications.
Companies are also unsure of whether their mentholated products will remain on the market. The Joe Biden administration has said that FDA will propose a policy next year to ban menthol-flavoured cigarettes.
In the meantime, the agency has told e-cigarette manufacturers that their menthol products will receive “unique considerations”, meaning it’s taking longer to review. Public health groups have an open case against FDA in northern California over its failure to regulate menthol cigarettes.
“More than half of our members have had their applications for menthols and tobaccos denied by FDA,” said Amanda Wheeler, president of the American Vapor Manufacturers Association. “The most generous interpretation is that FDA has made a sweeping clerical error in denying these products.”
Public health experts speculate that the agency wants to prevent vape users who prefer menthol from switching to cigarettes if menthol vapes are taken off shelves.
FDA “is saying, ‘Do we need menthol e-cigs on the market when we ban menthol cigarettes so menthol smokers don’t go to non-menthol cigarettes?’ I think that’s the big question FDA is sitting on,” Lindblom said.
Regardless of the reason for FDA’s denials of vapes, menthol or otherwise, outsiders fear that more companies will continue to appeal FDA’s marketing denial orders to keep selling their products.
“If their product is allowed to stay on the market, they want to drag this thing out as long as possible,” the former senior official said.
That notion angers anti-youth vaping advocates. “If these lawsuits delay implementation of FDA’s orders, it will be the quintessential example of how business has undermined and distorted the regulations designed to protect the American public,” said Myers.
He acknowledged that the agency is in a tough spot, however. “I don’t think it’s as chaotic as it appears,” Myers said. “The reality is that the vast majority of products that have been denied were flavoured products that appealed to kids for which no credible science was provided.”
And it makes sense that the agency is taking longer to review applications from larger companies, which likely have meatier applications, Myers added – especially in the face of appeals and lawsuits from other firms. But he is still frustrated that the pace of FDA’s decisions on major companies’ applications and menthol vapes is unclear and behind schedule.
Gottlieb, who has long advocated for public health restrictions on tobacco products, said that’s due in part to the difficulty FDA faces in reining in a thriving vaping industry.
“CTP has been doing a very good job, methodically walking through the various steps they need to play tape to get that proper regulatory framework in place, and that's what you see play out,” he said. “I'm sure there's a lot of people who would like to see things move more quickly.”
FDA permits marketing of e-cigarette products, marking first authorisation of its kind by the agency
Press release published on 12 October 2021.
Today, the US Food and Drug Administration announced it has authorised the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorised by the FDA through the Premarket Tobacco Product Application (PMTA) pathway.
The FDA issued marketing granted orders to RJ Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavoured e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.
As the RJR Vapor Company submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today’s authorisation allows these products to be legally sold in the US.
“Today’s authorisations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavoured products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products.
“We must remain vigilant with this authorisation and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorisation.”
Under the PMTA pathway, manufacturers must demonstrate to the agency that, among other things, marketing of the new tobacco product would be appropriate for the protection of the public health.
These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only the authorised products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes.
The toxicological assessment also found the authorised products’ aerosols are significantly less toxic than combusted cigarettes based on available data comparisons and results of nonclinical studies.
Additionally, the FDA considered the risks and benefits to the population as a whole, including users and non-users of tobacco products, and importantly, youth. This included review of available data on the likelihood of use of the product by young people.
For these products, the FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided the applicant follows post-marketing requirements aimed at reducing youth exposure and access to the products.
Today, the FDA also issued 10 marketing denial orders (MDOs) for flavoured ENDS products submitted under the Vuse Solo brand by RJR. Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavoured products. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce.
Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory. The agency is still evaluating the company’s application for menthol-flavoured products under the Vuse Solo brand.
The FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found approximately 10% of high school students who currently used e-cigarettes named Vuse as their usual brand. The agency takes these data very seriously and considered risks to youth when reviewing these products.
The evidence also indicated that, compared to users of non-tobacco flavoured ENDS products, young people are less likely to start using tobacco-flavoured ENDS products and then switch to higher-risk products, such as combusted cigarettes. The data also suggest that most youth and young adults who use ENDS begin with flavours such as fruit, candy or mint, and not tobacco flavours.
These data reinforce the FDA’s decision to authorise the tobacco-flavoured products because these products are less appealing to youth and authorising these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.
Additionally, today’s authorisation imposes strict marketing restrictions on the company, including digital advertising restrictions as well as radio and television advertising restrictions, to greatly reduce the potential for youth exposure to tobacco advertising for these products.
RJR Vapor Company is also required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, ongoing and completed consumer research studies, advertising, marketing plans, sales data, information on current and new users, manufacturing changes and adverse experiences.
The FDA may suspend or withdraw a marketing order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product is no longer “appropriate for the protection of the public health”, such as if there is a significant increase in youth initiation.
While today’s action permits the tobacco products to be sold in the US, it does not mean these products are safe or “FDA approved”. All tobacco products are harmful and addictive and those who do not use tobacco products should not start.
Applications for many ENDS and other new deemed tobacco products on the market as of 8 August 2016 were required to be submitted to FDA by 9 September 2020. The agency has taken action on over 98% of the applications submitted by that deadline.
This includes issuing MDOs for more than one million flavoured ENDS products that lacked sufficient evidence that the benefit to adult smokers who used the flavour products would overcome the public health concern posed by the well-documented and considerable appeal of the products to youth.
Recently, FDA posted a sample MDO decision summary. This sample does not reflect the decision rationale for each MDO action taken by the FDA.
The agency will continue to issue decisions on applications, as appropriate, and is committed to working to transition the current marketplace to one in which all ENDS products available for sale have demonstrated that marketing of the product is “appropriate for the protection of the public health.”
Politico story – Confusion clouds FDA’s approach to e-cigarettes (Open access)
See also from the MedicalBrief archives
FDA approvals of e-cigarettes must be based on evidence, not politics
FDA delays Juul e-cigarettes’ decision but culls almost a million products
Global tobacco control ‘hugely outdated’ – Dr Kgosi Letlape
WHO versus Public Health England over e-cigarettes
Tobacco harm reduction – The lesser of two evils
Profound problem of misinformation for public health and tobacco harm reduction