E-cigarette Market Chills: PMTA Guidance, Claims Enforcement Sought
Executive Summary
Guidance on keeping electronic cigarettes available comes a month after medical organizations and public health advocacy groups asked agency to investigate alleged smoking cessation claims by leading e-cigarette firm. Guidance maintains explanation FDA stated in 2016 draft guidance that approval of a Premarket Tobacco Product Application depends on showing a tobacco or nicotine product has some smoking cessation-like utility.
The US Food and Drug Administration's final guidance on keeping electronic cigarettes available comes a month after medical organizations and public health advocacy groups asked the agency to investigate alleged smoking cessation claims by a leading e-cigarette firm.
The guidance published June 11 includes an explanation on potentially applying for approval as a smoking cessation product, a designation that Juul Inc. does not have even though the American Academy of Pediatrics, American Cancer Society Cancer Action Network and other organizations say it is making those claims frequently in print, broadcast and digital advertising.
Additionally, the guidance maintains the explanation the FDA stated in its 2016 draft guidance that approval of a Premarket Tobacco Product Application depends on showing a tobacco or nicotine product has some smoking cessation-like utility. That is, PMTA approval for an e-cigarette or other electric nicotine delivery systems partly swings on showing that use of a product will not be indefinite and does not lead to using combustible or other forms of tobacco.
However, even though ENDS apparently show strong results for helping smokers quit combustible tobacco use, the vape product industry's chances for PMTA approvals appear slim.
'Unmistakably, A Smoking Cessation Claim'
In a May 9 letter to the FDA, the American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative joined AAP and the Cancer Society in detailing Juul's alleged violations of the agency's requirement for pre-market approval for smoking cessation claims. The groups also say the firm has a history of targeting young consumers with its marketing and by previously offering flavored liquid nicotine.
"After JUUL came under intense public scrutiny and criticism for this youth-directed social media marketing, the company changed its marketing strategy to make it appear to be targeted only at adult smokers. A central theme of its recent and current message is that smokers should 'Make the switch' from cigarettes to JUUL," stated the groups.
A Juul print ad communicates the message that the average cigarette smoker goes through a pattern of quitting and then relapsing, an idea is conveyed by the repetition of the phrase “Quit. Start smoking again” followed by the word “Switch” and the statement, “The average smoker tries to quit 30 times. Make the switch.”
"The ad clearly communicates the message that by switching to JUUL, the smoker can achieve what he/she had previously been unable to achieve: quitting smoking. It is, unmistakably, a smoking cessation claim for JUUL," according to the letter.
The San Francisco-based TV and online ads include testimonial statements about needing "to find an alternative” and “You don’t have to do that” indicate the intended use of Juul is to enable smokers to switch to Juul and no longer smoke cigarettes for health reasons, the groups state.
“Make the switch,” the groups argue, "is a message establishing that the intended use of JUUL now is for smoking cessation, a clear therapeutic purpose, making the advertised products drugs, devices, or combination products that must be approved prior to sale."
Other ads do not use “Make the switch” or otherwise refer to “switching” but suggest an intended use to derive health benefits from quitting smoking with statements including “The alternative for adult smokers” and “I think it’s an amazing invention … I don’t know how we lived without that.”
"The double-entendre conveys a therapeutic message: using JUUL as a smoking alternative will save your life," the groups tell the FDA.
They "urge FDA to launch a full-scale investigation of all aspects of JUUL’s advertising and marketing to determine the scope of its statutory violations and to take strong enforcement action to sanction the company and bring these violations to an end."
Vape Products' Days Numbered?
Meanwhile, the FDA's final guidance could bring an end to much of the ENDS industry, says Gregory Conley, president of the American Vaping Association, a nonprofit group that lobbies for consumer access to the products.
Under a 2016 final rule that expanded the FDA's tobacco industry oversight to cigars and pipe tobacco in addition to ENDS and other novel products, firms marketing products introduced to the US following the rule's publication must by August 2021 submit PMTAs to keep those products available. (Also see "E-cigarettes' Future Generates Questions, Not Their Efficacy For Smoking Cessation" - HBW Insight, 6 May, 2019.)
The guidance likely will make compliance unattainable for the majority of ENDS firms, including retailers as well as manufacturers. Research the FDA requests to support PMTAs are not within reach of most firms that are providing products that hundreds of tobacco smokers switch to using daily, Conley said in an interview.
"It signals that unless you're a company potentially with tens of millions of dollars … you don't stand a chance of remaining on the market," he said.
The option the FDA notes in the guidance for submitting new drug applications for marketing an ENDS as nicotine replacement therapy isn't appealing or sensible for vaping product firms, Conley says. One reason is that the NRT product market isn't a growth area, and another is that the FDA's Center for Tobacco Products already has approved a nicotine product because it is a better alternative to using combustible tobacco.
"Switching from combustible tobacco is why, for example, FDA approved IQOS. There's no reduced nicotine, down to zero option there. They just said it was for the protection of public health," Conley said.
The FDA on April 30 authorized a PMTA by Philip Morris Products S.A. for the IQOS “Tobacco Heating System” line with marketing restrictions to prevent youth access and exposure. Like vaping products, IQOS products are electronic devices, but they heat tobacco-filled sticks wrapped in paper, rather than liquid nicotine.
While marketing IQOS is deemed "appropriate for the protection of the public health" with its PMTA approval, its designation as a modified risk tobacco product remains pending in a separate applications that the company also submitted for these products to market them with claims of reduced exposure or reduced risk.
Vaping product marketers, on the other hand, offer liquids with no nicotine, allowing users to continue vaping without inhaling nicotine. "The most success for smoking cessation with vaping products is for people who make the change and continue using them," Conley said.
And flavored nicotine is preferred by most users who switched to vape products from smoking tobacco. But due to its popularity with teenagers, FDA wants flavored nicotine marketing to end and approval of PMTAs for flavored products is unlikely. (Also see "Smoking Cessation Indication For E-Cigarettes Could Fade Under Cloud Of Nicotine Packaged For Children" - HBW Insight, 1 May, 2018.)
"It will be extremely difficult for flavored products to gain approval. It is very hard to predict what the FDA will do, but certainly it seems that tobacco-flavored products will have a much easier time," Conley said.