The PMTA deadline for the American vaping industry is upon us. In less than a month, every vaping product presently on the market will need to be pulled if it doesn’t have a premarket application on file with the FDA. Based on that, it’s fair to expect that your vape shop will have significantly fewer products to sell after September. At this point, the question you should be asking yourself is this: Will your vape shop survive after September, or is this the time to start thinking about winding down your operations? It’s a big decision, and this article will present a few points for you to consider.
Many E-Liquid Brands Are Ready for the PMTA Deadline
The biggest problem with the vaping regulations in the United States is that the PMTA process is a legal hurdle far too large for any small business to overcome. Estimates vary widely as to how much it costs to compile a PMTA, but almost everyone agrees that the cost of a single PMTA is in excess of $100,000. Every nicotine strength and every VG/PG ratio of every e-liquid flavor counts as a separate product that requires its own PMTA. That’s a lot of money for a company with a modest flavor selection, and it’s a virtually impossible sum for a company that makes vape juice to order. It’s safe to say, in fact, that the era of making e-liquid to order is over in the United States.
To gain acceptance, a PMTA must prove to the FDA that a product will benefit public health. Although it seems likely that e-liquids should be able to make it through the PMTA process, there’s no guarantee of that because no vaping product has gained FDA approval yet. So, the long-term future of the vaping industry past 2021 is still very uncertain.
In the near term, though, the future might not be as bleak as you think.
When the FDA first announced its regulations for the vaping industry in 2016, many e-liquid companies cried foul, saying there was no way for a small business to scrape together the kind of funding necessary to submit PMTAs for even a handful of products. The regulations, they complained, made it impossible for any company without financial backing from Big Tobacco to succeed.
While there’s no denying that the PMTA requirements are onerous for small businesses, the fact is that, since 2016, the biggest companies in the vaping industry have continued to grow rapidly and actually do have the funding necessary to submit PMTAs for at least their most popular products. The fact is that the most successful e-liquid brands aren’t small businesses anymore. Some of the brands that have submitted – or have said they are ready to submit – PMTAs include Charlie’s Chalk Dust, Virgin Vapor and Savage.
What Will Happen to E-Liquid in September?
As the deadline approaches, it’s very probable that many more companies will come forward to say that they have submitted their applications. Many e-liquid brands have likely kept quiet about their PMTA plans up to this point to avoid tipping their hands to their competitors.
So, what happens next?
It’s going to take a very, very long time for the FDA to process all of the applications that the agency will receive between now and September. The agency has always been slow to act on premarket applications, and with the current COVID-19 pandemic, the process is likely to be even slower. With that in mind, a grace period will apply to any product with a PMTA submitted.
To qualify for the grace period, the product must have already been on the market when the FDA originally announced its vaping regulations in 2016. If the product was on the market at that time, it can remain on the market for an additional year after September pending FDA review of the product’s PMTA. Since it’s unlikely that the FDA will even process applications within a year, it’s possible that the grace period will ultimately be extended.
Products that weren’t on the market in 2016 don’t qualify for the grace period and technically aren’t allowed to be on the market at all without marketing orders from the FDA. So far, the FDA has selectively enforced that rule, and new products have continued to enter the market since 2016 largely without repercussions.
In September, every vaping product that doesn’t have a PMTA on file with the FDA will need to be pulled from store shelves – which brings us to our next topic.
How Are Vape Shops Approaching the PMTA Deadline?
Vape shop owners, for the most part, aren’t really talking about how they plan to handle the PMTA deadline. Since the FDA has changed the deadline so many times, it’s difficult to believe that September is really going to be it – and for the vape shop owners who do believe the deadline is real, there isn’t much of an incentive to tell customers that the products they’re buying might be going away soon.
So, it’s likely that most vape shop owners are taking a wait-and-see approach to the PMTA deadline. It’s even possible that many vape shops are going to continue selling the same products they’ve always sold until the FDA tells them not to. It’s going to be difficult for most vape shop owners to tell which products are legal anyway, with most manufacturers remaining tight-lipped about their PMTA plans.
Alternate Revenue Streams Can Save Your Vape Shop
At this time, it looks like most of the biggest e-liquid brands will have their PMTAs submitted on time for the September deadline. If that ends up being the case, you’ll be able to continue selling most of the e-liquids that you already sell for at least another year pending FDA review of those applications. You should, however, think of the current legal happenings in the vaping industry as a serious call to action. You can’t rely on vaping products as your only revenue stream when the legal status of those products is so uncertain. CBD, kratom and dry herb vaping products can all be viable sources of income for a vape shop. You should add whatever makes sense for your customer base.
Jason Artman is the owner and author of eCig One. A professional freelance writer and SEO consultant with more than a decade of experience, Jason works with vaping companies around the world to increase their targeted web traffic and improve their revenue.