On August 8, 2016, the US Food and Drug Administration (FDA) announced its intention to regulate vaping products as tobacco products. The announcement started the beginning of a countdown that is now just about over.
The main law that governs the tobacco industry in the United States is the Family Smoking Prevention and Tobacco Control Act, which then-president Barack Obama signed into law in 2009. The primary provision of the act that concerns the vaping industry is the fact that it froze the state of the American tobacco industry as it was in 2007. After that year, any company that wanted to release a new tobacco product would first need to go through a premarket application process requiring the maker to prove that the product deserved to be on the market because it would provide a benefit to public health without encouraging new nicotine use.
The catch is that there aren’t any vaping products in the United States that were on the market in 2007. The makers of each and every vaping product on the US market must submit premarket tobacco product applications (PMTAs) for those products, and the deadline for submitting those applications is 9th September 2020.
In just a few days, the American vaping industry will change forever.
How Does the PMTA Process Work?
As mentioned above, a PMTA must demonstrate to the FDA that a proposed new tobacco product presents a net benefit to public health and that it will not encourage new initiation of nicotine use. That’s not as easy as it sounds for three reasons.
- Because the FDA defines vaping products as tobacco products, the agency does not accept the notion that switching to vaping is quitting smoking.
- A PMTA requires an extensive battery of tests and scientific data showing the product’s health impact to users along with the impact to the general public as well as the environment. Compiling that data requires a lot of money. Estimates of the cost of compiling a PMTA typically range from $100,000-$400,000 per product. Devices, tanks, coils and every nicotine strength of every e-liquid flavour all count as distinct products and require their own applications.
- Teen vaping is a real problem in the United States, and the FDA will be looking very closely at all PMTAs to evaluate the potential for youth appeal.
For a vaping product manufacturer with a medium-to-large selection, the cost to compile PMTAs for a full product range can easily enter the millions of dollars. Nevertheless, several manufacturers have announced that their applications are ready and that they are prepared for the deadline.
What Will the PMTA Deadline Do to US Vapers?
Although many of the largest US-based e-liquid brands have announced that they intend to initiate the PMTA process, the smallest brands – such as local and regional e-liquid makers – lack the funds necessary to complete the required testing and gather data for their applications. Those companies’ products will be illegal to sell as of 9th September. Most US vaping brands that do not intend to initiate the PMTA process are planning to close permanently on that date.
A few companies, however, plan to continue doing business until the FDA forces them to close. As large as the US vaping industry is, it will probably be some time before the FDA takes any enforcement actions against companies that remain open.
In addition to the biggest e-liquid brands, many Chinese manufacturers such as SMOK, Aspire and Vaporesso have either submitted PMTAs for some of their products or have confirmed their intention to submit applications. At this time, it’s unknown exactly what devices, tanks and coils these applications will cover.
What Are the Long-Term Effects of the PMTA Deadline?
For companies that do get their applications in – as long as the products covered in the applications were already sold in the US as of August 8, 2016 – the FDA has extended a grace period of one year for continued sales while those companies’ applications are being processed. That means, unless a company’s application is denied, the company can continue selling its products until 9th September 2021 while it awaits a decision on its PMTAs.
The one-year grace period does raise some questions where hardware is concerned because most American vapers aren’t using products that were available in 2016. In fact, very few devices and tanks that were available in 2016 are even still in production. It’s unknown whether the hardware manufacturers have submitted PMTAs for products that were available in 2016 – which they can legally sell for another year after those applications are submitted – or for their current products, which were technically never legal for sale in the US in the first place.
It’s also unknown whether the FDA will take action against products that were released after 2016 but do have corresponding PMTAs submitted.
Clearly, the PMTA situation is an extremely confusing one for manufacturers and consumers alike. Vapers in the United States can take heart in the knowledge that there will definitely still be vape gear available to purchase after September. It’s uncertain exactly what will be available from a hardware standpoint, but it’s looking like most of the mainstream e-liquid brands are going through the PMTA process.
The PMTA deadline, however, will ultimately leave some vapers and small-time entrepreneurs out in the cold. From September forward, the US vaping industry will be a game for the wealthy. The smallest companies will be leaving the industry in September, and new brands will only be able to enter the industry if they submit PMTAs for their products and if those applications are approved. From now on, launching an e-liquid brand in the United States will be an extremely expensive proposition costing potentially millions of dollars.
What Will the PMTA Deadline Do to US Vape Shops?
At the time of writing, it appears that at least a dozen or so American e-liquid brands are planning to take some or all of their products through the PMTA process. When the FDA originally announced its regulations for the vaping industry, many observers felt that the price to compile even a single PMTA was so high that only the vaping brands backed by Big Tobacco would still be around on deadline day. Since then, however, the e-liquid brands that have managed to achieve wide-scale distribution in brick-and-mortar vape shops have grown rapidly and now have ample funds to spend.
Assuming the e-liquid brands that have claimed to be ready for the PMTA deadline follow through and submit their paperwork, vape shops should still be able to offer their customers plenty of variety after the PMTA deadline. That’s an enormous source of relief for small vape shop owners who previously thought they’d be looking for new work when deadline day arrived.
There is one potential issue for vape shop owners, though, and it’s the fact that the manufacturers of vaping hardware in China have been largely silent about the specific products that they intend to bring through the PMTA process. Owners of vape shops therefore have no way of knowing what they should be stocking up on now or what products will no longer be legal to sell in September. It’s likely that the distributors supplying products to those vape shops don’t know the answers to those questions either.
Many suppliers in China, meanwhile, are happy to ship any product anywhere and will not stop shipping products to the United States on deadline day. In their eyes, it’s the buyer’s responsibility to determine what’s legal and what isn’t.
The short-term forecast for vape shop owners, then, is a lot of confusion. Since there won’t be an easy way to tell whether a particular tank, coil or other accessory is legal to sell, it’s likely that most vape shop owners are planning to continue selling whatever they can get from their distributors until and unless they hear from the FDA.
What Does the PMTA Deadline Mean for Vapers in New Zealand?
Although the selection of New Zealand-made e-liquids is large and growing, we still import much of our vape juice from the United States. Brands such as Charlie Noble, Mad Hatter and Air Factory, to name a few examples, are all US-made.
In the past few months, you may have seen subtle changes in the packaging and product names of these and other American e-liquid brands. Those things are being done in preparation for the PMTA deadline, with each e-liquid company trying to refine its product range in order to present the most adult-oriented image possible.
For New Zealanders, the good news about the PMTA deadline is that you’ll still be able to buy most of the American e-liquids that you enjoy today. The biggest American vape juice brands are the ones with the widest distribution – which is why you’re able to get those products in New Zealand – and the brands with the widest distribution are the ones with the funding to go through the PMTA process.
Almost no vaping hardware is made in the United States, so the PMTA deadline won’t change anything about the devices, tanks and coils that you can buy today.
The one thing that will change in New Zealand after the PMTA deadline, though, is that you’ll no longer see new e-liquid brands and flavours coming out of the United States. Until American companies have a clearer idea of the costs and requirements for completing the PMTA process, they’ll stop developing new products.
The good news, though, is that New Zealand-made e-liquid is great and is only getting better as time goes by. The fact that we won’t be getting new flavours from the United States anymore only means that New Zealand’s vape juice brands have more room than ever with which to flex their creative muscles.