This article was updated on 11 May 2020

Since 08 August 2016, all vaping products have been classed as tobacco products in the US. Regardless of whether a product is a personal vaporizer or even an e-liquid, any vaping-related product will be subject to the constraints imposed by the Family Smoking Prevention and Tobacco Control Act.

What does this actually mean?

If vaping products are considered to be tobacco products, that will impose several restrictions on industry manufacturers. So, in theory, the following things have been prohibited since 08 August 2016 in the USA (but we will come back to this later):

On top of all of these bans, more minor bans (for customers at least) have also come into effect. It is now forbidden to sell any vaping product from a vending machine if it is anywhere a minor could access it. Manufacturers must also comply with new regulations on product labelling.

Of course, because vaping is legal in the US, the FDA is allowing manufacturers to continue operating in this sector, as long as they follow certain rules. The upshot is that all industry professionals must comply with the FDA’s long list of requirements. Here they are:

As if that weren’t enough, the FDA is also drafting new regulations to determine “good manufacturing practices for vaping products“.

On top of the many obligations the US vaping industry now has to comply with, the worst thing has to be the Premarket Tobacco Application. We’ve already mentioned it a couple of times, but haven’t explained it.

So what exactly is it?

A PMTA is a marketing authorisation application – all vape manufacturers have to get one if they want to launch a new product. However, as you’ll see, obtaining authorisation is very difficult. The FDA may take up to 180 days to respond once the application has been filed correctly (the period starts again at 0 every time the PMTA is not correctly filed). And every new product has to get this authorisation. If a manufacturer wants to sell 30 products, they have to submit and successfully file 30 PMTAs.

Basically, this applies to all vaping products except a few “accessories“, as long as they aren’t “intended or reasonably likely to affect or modify the performance, composition, constituents or characteristics” of a vaping product subject to a PMTA. So that makes all vaping products subject to getting a PMTA, except perhaps drip-tips or similar small accessories.

The FDA states that the PMTA covers:

“the components and parts of vaping products, but not their related accessories. i.e. pods, cigalikes, boxes, atomizers, clearomizers, drippers, e-liquids, batteries, chip sets, flavourings, etc.”.

And, more generally, according to Section 101 of the Tobacco Control Act – Amendment of Federal Food, Drug, and Cosmetic Act (FDCA):

“Any product manufactured or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product“.

The Agency specifies in the guide that since the vaping market is growing and changing constantly, this list will be regularly updated.

Let’s get down to the nitty gritty: what do manufacturers need to do to file a marketing authorisation application with the FDA?

To do this, the FDA asks manufacturers to “provide a full assessment of the toxicological effects” of the product (the finished product and all of its components) on its users and on non-users. Of course, once it’s read all of the documents submitted by the manufacturer, the US regulatory body will perform its own tests to “determine whether the use of the product will have an adverse effect on the health of users and non-users.” It will also assess “all of the potential benefits and risks of the information in the PMTA to determine whether the product should be marketed“.

To do so, the FDA reserves the right to rely on “other valid scientific evidence if it is considered sufficient to assess the product“.

The manufacturer must also provide “full reports of all information, published or known (…)  concerning investigations which have been made to show the health risks of the tobacco product and whether the tobacco products present less risk than other tobacco products”.

In short, manufacturers have to provide all the information on the effects of their product on the health of its users and non-users. The FDA will then check this for itself, and is free to choose which studies to base its decision on. In other words, if the FDA chooses to use an anti-vaping study, all of the manufacturer’s efforts will have been wasted.

That’s a lot to take in. Ready? Then let’s carry on.

Manufacturers must also include a “full statement of the properties” of the product. This statement must include the following information:

The FDA also recommends that manufacturers provide analyses for the following constituents, if their product(s) include these. This isn’t mandatory, but we bet that if the Agency recommends it, they want to know about it:

acetaldehyde, acetyl propionyl, acrolein, acrylonitrile, benzene, benzyl acetate, butyraldehyde, cadmium, chromium, crotonaldehyde, diacetyl, diethylene glycol, ethyl acetate, ethyl acetoacetate, ethylene glycol, formaldehyde, acetamutsoil, glycerol, glycerol, glycerol, acetoacetate, acetamutol, glycerol, formaldehyde, acetamutsoyl acetate lead, menthol, methyl acetate, n-butanol, nickel, nicotine from any source, propionic acid, propylene glycol, propylene oxide and toluene.

Manufacturers must also submit information including the “full description of the methods used for the manufacture, processing and, where applicable, packaging and installation of the product, as well as the facilities and controls used for this purpose.”

Nothing could be simpler! All the manufacturer needs to provide is:

You can imagine how the various organizations that specialise in writing these documents are really cashing in. How, then, is a “simple little” modder or juice maker expected to finance all of this?  Hundreds of pages. According to the FDA, the cost of a PMTA ranges from $117,000 to $400,000 per product. Some experts have revised this cost upwards, and estimate it at several million dollars.

But that’s not all! The studies we’ve mentioned above – which are mandatory under the PMTA framework – must include certain very specific details:

This data must be provided a “in SAS-transport file in XPT format, created by a procedure that allows the files to be readily read by JMP software“. And this is just for one type of study. They also want additional data for non-clinical studies.

And since the number of studies and other mandatory reports is huge, the cost very quickly becomes huge too. What is more, these costs mount far too quickly for most small brands to cope – they have a fraction of the money big firms do.

All of this makes getting the PMTA required to sell a vaping product in the USA very difficult, if not impossible, from the outset. Especially for smaller companies.

To date, only one product appears to have passed these new regulatory tests. The IQOS by Philip Morris International is a heated tobacco device that the Swiss tobacco company has already poured several hundred million dollars into.

PMTAs must be sent electronically or by post.

If the documents contain confidential data (which is mandatory, because e.g. e-liquid applications must list all of the ingredients and their quantities), the manufacturer must send a “censored” version, as well as a “clear” version, clearly marking which parts are confidential. But that’s not all. Manufacturers must also explain why they consider such information to be subject to commercial secrecy.

Of course, all of these documents must be sent in English. If they’ve been translated, they must all be accompanied by “certification that the translation into English is accurate”. Again, the cost of having hundreds of pages of documents translated and then checked afterwards quickly becomes prohibitive.

Initially, the PMTA was to supposed be mandatory from 2017.

However, the FDA realised at the time that neither it nor the vaping industry was ready to apply it, so they postponed the deadline by several years. They finally decided to make it mandatory in 2022.

A few months ago, when he resigned, the former Commissioner of the American health agency decided to bring it forward by one year to 2021.

But he didn’t count on the legal action taken last year by several health associations against the FDA.

They won their case just a month ago after accusing the Food & Drug Administration of being so late to introduce the PMTA (which was originally supposed to be introduced in 2017), that it “amounts to an abdication of its statutory responsibilities“.

The health bodies that won the legal battle then asked that the PMTA be brought in within 4 months, in 2019.

As for the FDA, they wanted a delay “of at least 10 months.”

So the judge had to determine the new date from which the PMTA would be mandatory. According to their verdict, it should have come into force on 12 May 2020.

While all of this may seem complicated (even impossible) for small manufacturers, rest assured, the FDA has thought of everything. It has drafted a 50-page document (in PDF format) for the industry describing its “recommendations” on how to correctly file a PMTA.

In case you’re wondering why the title of this article is “Law likely to kill off independent vaping in the USA on its way”, it’s simply because – despite its obligations – the FDA has so far utterly failed to follow any of the rules above. This explains why the vaping market in the USA is still doing relatively well.

However, as the agency noted in its recent press release, it has just finalised its “guidelines for manufacturers submitting new applications for tobacco products via a PMTA.”

Yes, the PMTA is on its way. This time it seems it’s here to stay. But so should all of the other FDA regulations that have been ignored until now.

Will American vaping even survive?

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