This article was updated on 11 May 2020
What this article covers:
- The FDA is in the process of finalising mandatory regulations for manufacturers of vaping products if they want to sell their products on the US market.
- The number of documents that industry professionals will have to submit to get marketing authorisation is overwhelming.
- It will not be financially viable for most small manufacturers or producers to provide the information needed.
- These new regulations, which should have come into effect in 2021, will now apply as of 09 September 2022, following a decision by a judge in Maryland, USA.
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):
- Launching any new vaping product on the market without a successful Premarket Tobacco Application (PMTA). What is crucial here is that the slightest change in the composition of an e-liquid, in the power of a built-in battery in a box, or even the size of an e-liquid bottle now means that the product is considered to be new. This prevents even the tiniest modification to any existing product since the “new model” will be considered to be a new product in its own right, and therefore prohibited.
- Selling any vaping product to someone under the age of 18. But that’s not all. All customers under the age of 27 must show ID or they will be refused the sale.
- Handling any vaping product that’s about to be sold. As Gregory Conley, president of the American Vaping Association explains, any decent salesperson in a vape shop regularly helps customers with their devices. By that, he means that a salesperson might show someone how to make a coil, screw on an atomizer correctly, fill their clearomizer without spilling the liquid, and more. As far as the FDA is concerned, these little gestures, which are intended to help and inform customers, are considered “manufacturing“. And that makes them strictly prohibited.
- Offering free samples. When it comes to free samples, the FDA isn’t just prohibiting manufacturers from sending out a few here and there. The Agency is also prohibiting all vape shops from offering any free samples of e-liquid at all. That means customers will be obliged to pay a “tax” that entitles them to try a product before they decide to buy it.
- Making claims about the modified risks of vaping. As everyone knows, the British Department of Health considers vaping to be at least 95% less harmful than smoking. This claim (like all similar claims) has been strictly prohibited since 08 August 2016.
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.
How can they continue to sell vaping products in the USA?
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:
- All companies that “manufacture, prepare, compose, or process” vaping products, including those that “repackage or otherwise modify the container, packaging or labelling” must register with the FDA. They have to renew their registration annually.
- All businesses must submit a list of every product they sell, including its labels and any related advertising. They must update that list twice a year, in June and December.
- All manufacturers must submit a full list of the ingredients they use in their product, and state the quantity, brand, and any sub-brands.
- They must submit detailed documentation on “the health, toxicological, behavioural or physiological effects” of all of their products, the constituents, ingredients, additives and components.
- No product is authorised to use words such as “soft, light, or weak” in its name, description, or anywhere else.
- All vaping product packaging must display health warnings that occupy at least 30% of the packaging surface area on each side.
- All labels must show the names and addresses of the manufacturer, packaging company or distributor. The packaging must display the “percentage of tobacco” used in the product and a statement that product is only authorised for sale in the USA.
- Any vaping product that any manufacturer might want to launch must first have been authorised by the FDA via a PMTA.
As if that weren’t enough, the FDA is also drafting new regulations to determine “good manufacturing practices for vaping products“.
What exactly is a PMTA?
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.
Which products does this apply to?
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.
How do you get a PMTA?
Let’s get down to the nitty gritty: what do manufacturers need to do to file a marketing authorisation application with the FDA?
- First, they must be able to “demonstrate […] that permitting the marketing of the new tobacco product(s) would be appropriate for the protection of public health“.
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.
- Manufacturers must also provide “a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product”.
- The chemical and physical identity and quantities of aerosol emissions under “the range of operating conditions (e.g., various temperature, voltage, wattage settings)” and “use patterns […] within which consumers are likely to use the new tobacco product.”
- Various scientific studies which shed light on the probabilities of current non-users “initiating or reinitiating tobacco use by using the new tobacco product”.
- Other research indicating the likelihood that users of the product “will adopt the new tobacco product and then switch to other tobacco products that may present higher levels of risk, such as cigarettes“.
- The likelihood of consumers who use the product in combination with other tobacco products “switching to the product instead of ceasing tobacco product use or using an FDA-approved tobacco cessation product.”
- A risk assessment “in case of dependence” on the product.
- An assessment of the “user topography (how individual users consume the product, e.g., the number of puffs, puff duration, puff intensity, duration of use), the frequency with which consumers use the product, and the trends by which users consume the product over time”.
- A full description of the “methods, facilities and controls used for, the manufacture, processing, and, when relevant, and packaging of such tobacco product” (more on this below).
- Samples of the product and its components or ingredients.
- Sample labels that will be used for the product.
That’s a lot to take in. Ready? Then let’s carry on.
But that’s just the start
Manufacturers must also include a “full statement of the properties” of the product. This statement must include the following information:
- A description “of the product dimensions and the overall construction of the product (using a diagram or schematic drawing that clearly depicts the finished product and its components with dimensions, operating parameters, and materials).”
- A description of “all design features of the product, specifying the explicit range of or the nominal values of the design features as well as the design tolerance, where appropriate“.
- “A quantitative description of the performance specifications”.
- A description of “the product container closure system“. The description should include information on how the container closure system protects and preserves the product, such as from damage during transport, environmental contaminants, leaching, and migration of container closure system constituents into the products.
- Information on the product’s “stability“. This information should include the established shelf life of the product and changes in pH and constituents (including HPHC and other toxic chemicals) over the lifespan of the product, such as the factors that determine the shelf life (e.g., volume of e-liquid, power supply, atomizer, coil); how stability is affected by the storage conditions, such as moisture and temperature, and “full reports of all stability testing; and how the product’s performance may significantly decline […] over the product’s lifetime.”
- Assessment “of product design hazards that could be expected to result in illness or injury from normal use and foreseeable misuse of the product”.
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.
Everything must be in writing and explained
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:
- The manufacturing and production operations at each facility, including a description of the facilities and all production stages.
- How they implement the “supervision of management and training of employees”.
- The manufacturing process and product design testing, including a risk analysis that details the correlation between product design attributes and public health risks, and any identified risk mitigation measures that have been taken.
- Operations related to identifying and monitoring suppliers and the products they supply (in particular, quality control and incoming goods inspections for materials).
- The validation and verification procedures used to ensure that the new tobacco product meets specifications, including any voluntary standards to which their product conforms.
- The test methods and procedures conducted before the new tobacco product is released for sale and distributed in the United States, including information on test parameters such as the concentration of the standard solution, and a description of acceptance procedures with a log and acceptance criteria.
- How the “handling of complaints, non-conforming products and processes and corrective and preventive measures” is managed.
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.
The studies used
But that’s not all! The studies we’ve mentioned above – which are mandatory under the PMTA framework – must include certain very specific details:
- A description of the purpose of the study.
- A description of the study design (or hypothesis tested).
- A description of any statistical analysis plan, including how the data were collected and analysed.
- A brief description of the results and conclusions (positive, negative or inconclusive).
- Copies of all study protocols and modifications that were used in the study.
- Copies of all of the researcher’s instructions.
- The statistical analysis plan, including a detailed description of the statistical analyses used (i.e. all variables, confounding factors, subgroup analyses and any modifications).
- A list of the sites where the study was conducted, including contact details and physical addresses.
- Line or study data, comprising an analysable dataset of individual observations for each participant.
- A list of all participants in the study, along with their role and the dates their role in the study started and ended.
- A complete signed report on the conclusions.
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.
How do you submit a PMTA?
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.
When is the PMTA due to come into force?
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.
The end of vaping in the USA?
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?
