What The US President Needs To Do

Clive Bates has produced a report, titled Fixing the broken and lawless American tobacco and nicotine market, that aims to provide analysis and a framework to support the reform of federal tobacco and nicotine market regulation.

Clive says that this is currently, “one of the most chaotic and conspicuous failures of the federal government and Food and Drug Administration.”

He explains that the Food and Drug Administration [FDA] has produced “a chaotic, lawless mess” through its failure to put adequate regulations in place to control the tobacco and vape markets. By omitting to take sensible action, Bates argues that the environment surrounding the harm reduction tool has become “harmful to people and legitimate businesses”. 

To date, the FDA has only approved a mere 34 vape products from the hundreds of thousands of products were part of applications for permission to be sold (PMTA) in the United States – a ludicrous situation when placed against the background of tobacco products, of which there are “over 3,800 cigarette varieties are available”.

Consequently, Clive states, “over 90% of vape sales in the US are unauthorised products, and the majority are illicit disposables, mainly from China.” The FDA might have set out to restrict the sale and availability of single-use products, but it has effectively given up control over them.

Not only preventing the sale of perfectly decent products that were already on the market, the FDA has erected a barrier to entry for new products that may conform to its requirements because the application process can now cost up to a claimed £80 million and take multiple years for the process to be concluded. Given how products rapidly develop and change, this is clearly a ridiculous situation – they would be out of date before they hit the shelves.

Clive says the FDA has to allow “at least 4,000 more vape products onto the market”, drastically reduce the cost of the prohibitively expensive application process, and to slash the amount of time it takes to process a PMTA application by a radical amount.

To bring about this change, Clive suggests:

• Split the assessment of the “appropriate for the protection of public health” standard between pre-market product-specific screening and post-market evaluation of population impacts, given the latter are impossible to know in advance.
• Apply efficient pre-market screening of vape products for safety relative to cigarettes and appropriate labelling, marketing and branding, then allow the products onto the market.
• Conduct extensive independent market surveillance for all products and populations.
• Assess and address any adverse behavioural or population effects once they emerge and take proportionate corrective or enforcement action, including product withdrawals..

After that, Clive argues that the FDA needs to then move to focus on “a standards-based approach” in the longer term.

“Regulation of nicotine needs to move to a risk management philosophy as the ‘appropriate for the protection of public health’ standard will begin to make little sense as cigarette use declines further. We don’t use APPH to regulate beer or wine, but these industries are regulated by a wide range of standards and obligations for public health and consumer protection,” he states.

The benefits of Clive’s approach:

• Improved health
• Provide positive choices 
• Protect young people from unregulated products 
• Support law-abiding American small and medium businesses
• Radically improve federal bureaucracy efficiency, reducing costs 
• Combat criminal networks 

Is the 47^th President up to the task? Time will tell.

References:

• Fixing the broken and lawless American tobacco and nicotine market - https://clivebates.com/documents/FixingThePMTAJan2025.pdf

Photo Credit:

• America images created using AI

Dave Cross

Journalist at POTV

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Dave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous start-ups to develop content for their websites.