A joint statement from Janet Woodcock, the FDA’s Acting Commissioner of Food and Drugs, and Mitch Zeller, Director of the FDA’s Centre for Tobacco Products, said the organisation was facing the “unprecedented task of reviewing applications for over 6.5 million ‘deemed’ new tobacco products”.
In summary, the FDA has:
- Refused to accept 4.5 million applications
- Rejected 946,000 applications
- Approved 0 applications
They say they have acted on 93% of submitted PMTAs (premarket tobacco product applications), “issuing Marketing Denial Orders (MDO) for more than 946,000 flavoured ENDS products because their applications lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
Pointlessly kicking flavoured products, they added: “Flavoured ENDS products are extremely popular among youth, with over 80% of e-cigarette users ages 12 through 17 using them.”
The statement is geared around the misconception that America is suffering from a problem of teen uptake and addiction, something that has been roundly debunked. Researchers at University College London recently looked at the data and demonstrated that the USA experience of teen use is not appreciably worse than in the UK – where regular teen vapers were or are smokers and non-smoker make up an almost insignificant percentage.
The pair explain the process: “As we have said before, the burden is on the applicant to provide evidence to demonstrate that permitting the marketing of their product meets the applicable statutory standard.”
In effect, businesses are being expected to guess what the FDA will find acceptable.
They continue: “All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion. The FDA is committed to completing the review of the remaining products as quickly as possible to provide regulatory certainty and will continue to keep the public informed of our progress.
“In the meantime, products for which no application is pending, including, for example, those with a Marketing Denial Order and those for which no application was submitted, are among our highest enforcement priorities. If such products are not removed from the market, the agency intends to follow its usual enforcement practices in these circumstances and will issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond.”
The FDA has made nobody happy.
Tobacco harm reduction advocates, nicotine consumer organizations, and vape businesses are vexed by the dithering and confused approach, leaving many companies facing closure, leaving the market wide open for the tobacco industry – and, on the other hand, anti-vaping hotheads are incensed that Juul is still being allowed to trade.
The American Cancer Society Cancer Action Network slammed the decision not to make a decision on Juul: “The FDA's failure today to act on applications by JUUL, the manufacturer with the single biggest e-cigarette market share, is extremely disappointing and will allow the industry to further endanger public health and hook more kids on their highly addictive products. The FDA has had ample time to review the applications and allowing additional delays is unconscionable. There is overwhelming data to demonstrate the negative impact these kinds of flavoured products have had on public health and their role in the youth e-cigarette epidemic. The time to act is now.”
Robin Koval, president of The Truth Initiative (an organisation apparently dedicated to ignoring or hiding the truth) said: “Postponing decisions on those with the lion's share of the market further empowers the big, rich, tobacco companies to continue to grow their business and profits on the backs of young people putting millions at risk for a lifetime of nicotine addiction.”
Crank organisation Parents Against Vaping E-cigarettes (PAVE) were outraged at the Juul non-decision, while the Bloomberg-funded Campaign for Tobacco-Free Kids threatened the FDA with court action. The zealots would have only been happy with absolute prohibitions.
Over in the more equitable corner, Guy Bentley, Director of Consumer Freedom at the Reason Foundation said: “[The] FDA has created complete chaos. They've banned hundreds of thousands of products and are leaving hundreds of companies with pending applications in limbo while not approving a single product. Juul can take delays and uncertainty; your neighbourhood vape shop can't.”
Jonathan Foulds, an addiction specialist at Penn State University who has spoken at several vape conferences about research, stated: “E-cigs and other reduced harm products present a fantastic opportunity to replace cigarettes with far less dangerous products, but I’m concerned this may be the start of an overly aggressive regulation for e-cigarettes … especially compared to how we treat regular cigarettes.”
On Twitter, Foulds said it could be interpreted that the FDA are demanding a randomised controlled trial or longitudinal cohort study for every product; a proposal so ridiculous it renders description impossible.
Author of the book The Rediscovery of Tobacco, Jacob Grier called for resignations, writing: “Mitch Zeller, director of the FDA's Center for Tobacco products, should resign. He's held the position since 2013 and claimed to support harm reduction, but he's accomplished virtually nothing on cigarettes and now failed to approve a single lower risk vapor alternative.
In a statement on the FDA’s vaping actions, Attorney General Tom Miller said: “We are concerned about the impact of the FDA’s actions, particularly the unintended consequences of pulling from the market less harmful alternatives to cigarettes. We believe the best information available indicates that most youths are not getting e-cigarettes from vape shops and that a significant number of adults are using products from vape shops to move away from combustible cigarettes.
“Let’s not forget the overwhelming risk to public health: The CDC estimates the burden of tobacco use in the United States is 480,000 lives a year, all of which is due to the use of cigarettes.
“We believe in the strong, science-based regulation of alternative tobacco products, and the FDA is the best agency to undertake that task. Policy makers must strike the right balance between making accessible potentially lifesaving lower-risk nicotine products while discouraging use by those who wouldn’t smoke, especially youth.
“This quote from a recent piece by 15 former presidents of the Society for Research on Nicotine and Tobacco bears repeating: 'We believe the potential lifesaving benefits of e-cigarettes for adult smokers deserve attention equal to the risks to youths. Millions of middle-aged and older smokers are at high risk of near-future disease and death. Quitting reduces risk’.”
An article carried by Filter Magazine speaks about the FDA’s “unwavering commitment to ambiguity”, which leaves businesses guessing about the legality of continuing to sell certain products.
The American Vaping Association responded in pugilistic fashion: “[The] FDA is using an arbitrary and capricious standard to clear out companies that have challenged the market dominance of incumbent cigarette manufacturers. When smoking rates go up, not a single FDA employee will be fired. The fight is not over.”
The only clarity the FDA has provided is to firm up the notion that the USA is continuing on its downwards harm reduction trajectory and providing succour to the tobacco industry. Whether by driving vapers back to smoking or removing independent businesses from the market, the FDA is doing everything it can to promote the tobacco industry.