Tuesday, March 5, 2024

First PMTA Awarded To Big Tobacco


The FDA has announced the first PMTA awarded has gone to Big Tobacco for the Vuse Solo kit.

Back in October 2019 the kit was the first to seek FDA approval submitting over 150,000 pages of data it says had taken years to collate.

First PMTA Awarded To Big Tobacco

I covered this in detail: The First Premarket Tobacco Application Is Filed And It’s From Big Tobacco – and said at the time the company looked likely to win approval.

However the upshot is at the time of writing, only the tobacco flavoured pods are deemed safe for sale in the USA.

The FDA says:

The FDA issued marketing granted orders to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored 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 authorization allows these products to be legally sold in the U.S.

Which of course begs the question, if a kit like the Vuse Solo can be deemed “appropriate for the protection of public health” – then why not all the others, or at least pod kits of a similar ilk?

A question that I doubt will be answered anytime soon…though the FDA does appear to accept vaping is considerably safer than smoking…but only if the documentation is up to scratch.

The FDA adds:

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 authorized products were exposed to fewer harmful and potentially harmful constituents (HPHCs) from aerosols compared to users of combusted cigarettes.

Like I said, they almost admit vaping is safer than smoking – but only certain brands and products…crazy!

First PMTA Awarded To Big Tobacco – Vuse Solo

The Vuse Solo is owned by Reynolds American Inc. specifically R.J. Reynolds (RJR) Vapor Company.

That’s a subsidiary of multi-national corporation British American Tobacco and makers of the iconic Camel lit cigarettes.

First PMTA Awarded vuse solo pmta approved
only tobacco flavours allowed at this time

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products said:

Today’s authorizations 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-flavored 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.

We must remain vigilant with this authorization 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 authorization.

With the first PMTA awarded to Big Tobacco, the FDA is literally acting as the financial buffer between Big Pharma and Tobacco products – and of course filling both organization’s coffers.

I wrote recently that on the very day the FDA had thrown ‘proper‘ vape companies under the bus, it was promoting Big Pharma patches and gums on social meadia…

In the article: FDA Pushes Nicotine Patches the Same Day It ‘Bans’ 800 Flavoured Vapes – I suggested this showed the ‘incestuous‘ links between the FDA and Big Pharma, and by approving the Vuse Solo, you can add Big Tobacco to that three-way.

We haven’t reviewed the Vuse Solo, however it was the vape brand formally known as Vype and we’ve reviewed a few of those products.

None of which really ticked the good vape kit products boxes, with lack of flavour being the main bone of contention.

If I’m honest pretty much all of the Big Tobacco owned/linked vape kits have been no where near the standard expected these days – compared to those from ‘proper‘ vape companies.

It’s almost as if the FDA is setting out its stall to push people back to smoking…


It goes without saying the anti-vape brigade are furious at the Vuse Solo being given the green light.

vuse solo e-cig PMTA

Erika Sward, national assistant vice president for advocacy at the American Lung Association, told the New York Times:

This throws young people under the bus…

Hardly…but hey enjoy your soundbite.

Gregory Conley, President of the American Vaping Association had mixed feelings tweeting:

For a decade, I have waited for the day that a vaping product would receive a PMTA from @FDATobacco
Today, that day finally came.
Pretty underwhelming for it to be for a tobacco-flavored Vuse Solo and follow six weeks of over one million products being banned.

US based vape reviewer Grimm Green tweeted:

So it turns out #Vaping IS appropriate for the protection of public health.

Let’s get this ball rolling and really save some adult smokers lives.

#FlavorsMatter and you know it.

As for me..?

My reaction is a bit like Greg’s.

I’m sad that a sub standard Big Tobacco backed vape product has been given the go ahead – but I’m slightly optimistic it might pave the way for better kits from so called Big Vape to be in with a squeak of approval.

I’m not holding my breath, and the worry of none of the Vuse flavoured pods passing the PMTA test certainly suggests NO flavours except tobacco and some menthols may get through the process…expect a whole raft of law suits soon.

Now we wait to see if JUUL gets the green light…trust me that WILL put the cat amongst the pigeons lol.

So…what are your thoughts on the First PMTA Awarded to Big Tobacco?

Have you used the Vuse Solo?

If so…how was it?

Please let me know your thoughts and opinions in the comments below.

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