The vaping industry has been a major boon, both to public health and to former smokers across the world who have switched to an alternative that most doctors agree appears significantly less harmful than tobacco. In the United States, thousands of vape shops like E-Cigarette Empire have opened, and those vape shops employ tens of thousands of people. An entire economy has been created that previously didn’t exist at all.
Though the vaping industry has grown rapidly, it has existed until now in an essentially unregulated state. Products that were already on the market when the FDA announced its regulations have been allowed to remain on the market pending FDA review of those products. Although no new products are allowed to come out without FDA review, that still leaves plenty of existing products available for people to buy – for now. The reckoning is coming soon, however, and things are likely to become very different for vape shop owners in just a few short months.
What is your vape shop doing to prepare for the FDA PMTA deadline in May 2020? In this article, we’ll explain the situation and describe the one thing that you can do to ensure that the new FDA vaping regulations don’t put your shop out of business.
Why Should I Worry About the FDA Vaping Regulations?
When the FDA announced its intention to regulate vaping products, the agency did so by deeming vaping products to be tobacco products. If vaping products meet the legal definition of tobacco products, that means the Family Smoking Prevention and Tobacco Control Act applies to those products – and according to that law, no new tobacco product after 2007 can enter the market without first being approved by the FDA. To gain approval for a new product, the maker of that product must submit a pre-market tobacco product application (PMTA) demonstrating that the product will not entice new nicotine users and that it represents a net benefit to public health.
Getting through the PMTA process is so difficult – and so expensive – that some people have nicknamed the Tobacco Control Act the “Marlboro Protection Act” because it reduces the chance of any other company ever launching a new cigarette brand in the United States to almost zero. Although the Tobacco Control Act has existed for more than a decade, only one product – Swedish Match snus – has gone through the process successfully and received FDA approval. Swedish Match received approval to market its products by demonstrating that those products are significantly less harmful than cigarettes.
The Tobacco Control Act matters to companies in the vaping industry because, although vaping did exist in 2007, no product that was on the market at that time still exists today. Whether anyone owns the legal rights to those early products and can bring them back to the market is unclear. Even if a company could bring those products back to the market, they would work extremely poorly by modern standards and would not be popular today.
In short, every vaping product on the market today is a “new tobacco product” being marketed without FDA authorization. To remain on the market, all vaping products must have PMTAs on file with the FDA by the application deadline.
The deadline is May 2020.
Wasn’t the PMTA Deadline Supposed to be in 2022?
If you don’t follow the regulatory news closely because you aren’t a manufacturer of vaping products, you might be confused about the PMTA deadline. Former FDA commissioner Scott Gottlieb extended the application deadline for vaping products – which was originally August 2018 – to August 2022 because he recognized the fact that e-cigarettes were helping smokers quit and that vaping products were providing a benefit to public health.
Unfortunately, youth-oriented marketing of some vaping products encouraged millions of teens to take up vaping, and recent survey results suggest that more than 27 percent of high school students now vape. Public health officials and concerned parents are extremely angry about the fact that vaping has potentially caused millions of kids to become nicotine addicts, and a federal court ultimately ruled that the FDA must begin regulating vaping products immediately.
Will Any Vaping Products Still Be Legal in May 2020?
The vaping industry will still exist in some form in May 2020, but it may not be a form that you’ll recognize. So far, only one vaping product manufacturer – R.J. Reynolds, the maker of Vuse – has submitted a PMTA. Pending FDA review, Vuse will still be legal to sell in May. It’s likely that all other vaping products with backing from the tobacco industry will have PMTAs on file by May as well.
For smaller vaping product manufacturers, however, the PMTA process will be substantially more difficult to complete due to the expense involved. The FDA has attempted to make the process easier by creating a database that companies can use to gather preexisting research for their applications, but it’ll still be expensive. Many of the smallest companies in the industry will go out of business in May.
What Should I Do to Prepare for the PMTA Deadline if I Own a Vape Shop?
If you own a vape shop, the best thing that you can do for your business is to start diversifying your revenue streams right now. It’s great if you’re passionate about vaping, but vaping products alone will not keep your company afloat once the PMTA deadline arrives.
These are some of the products that you should consider adding to your shop’s selection before the deadline.
● Closed-system e-cigarettes – especially disposable e-cigarettes – that contain no nicotine should be legal to sell even without PMTAs because those products can’t be used with nicotine and therefore don’t meet the legal definition of tobacco products.
● Closed-system e-cigarettes using only synthetic nicotine may not meet the legal definition of tobacco products, but it’s unknown whether any manufacturer in the vaping industry has ever attempted to put that doctrine into practice.
● Herbal products such as CBD and kratom are potentially extremely profitable and are not yet regulated by the FDA.
● Products related to dry herb vaping are not FDA regulated and are completely legal to sell. It’s even possible to vaporize tobacco in a dry herb vaporizer.
Ironically, many vape shops have discovered important new revenue streams by selling tobacco products such as roll-your-own tobacco and supplies.