We’re now past the FDA’s finalized guidelines, and people are still vaping. Although some vape industry professionals ran around like Chicken Little proclaiming the sky is falling, the industry is still going strong.
But it’s not all roses and butterflies. There have been some bumps along the way, especially for manufacturers of both e-cigarette hardware (known to the FDA as Electronic Nicotine Delivery Systems, or ENDS) and vape juice.
Meanwhile all of the hoopla disrupted our business a little bit, and Lemon Pound Cake was rushed to the market faster than we were prepared for with less of a marketing push. Marketing, it turns out, is at the heart of the FDA’s regulations.
Here’s what happened and what lies ahead for manufacturers in the vape industry.
The FDA issued a wide-blanket regulation of all e-cigarette hardware, software, and components, including (but not limited to) cartomizers, batteries, tanks, and drip tips. What this means is you can’t import, manufacture, package, label, advertise, sell, promote, or distribute e-cigarette hardware without complying to certain FDA regulations.
This means electronics and software manufacturers are considered to be making tobacco products, even though their products contain no actual tobacco. Establishments selling tobaccos products must register with the FDA and pay the appropriate fees to risk penalties, including serious fines and jail time.
Most vape equipment, tanks, and ejuice is considered a “new tobacco product” by the FDA, which means you’ll need to fill out applications to market them. A new tobacco product is considered any product not commercially marketed in the United States as of February 15, 2007.
If your product was commercially marketed after Feb 15, 2007, but before March 22, 2011 and a Substantial Equivalence form was submitted in that timeframe, you can continue marketing your product unless the FDA specifically prohibits it.
The FDA considers manufacturers to be anyone who mixes eliquids, makes or modifies any vaping device, or even imports tobacco products. So if your smoke shop or vape business is importing vape equipment, you’ll be regulated as both a manufacturer and retailer.
Vape and smoke shops that make their own in-house e-juice may find it more prudent not to do so, but it also limits how involved vape and smoke shop owners can be with helping their customers. When I first started vaping, I hated rebuilding my drip system and would often find it easier to just bring it in to the shop, but that’s not going to be as easy anymore, thanks to the FDA.
In many of the newer vape shops staff knowledgably assist customers with building and setting up vape equipment. In the next few years, we may find special seals created to discourage product testing before purchase. This could become a big problem for the vape industry.
One of the separating factors between vape and smokes shops is the expertise of the staff. When I walk into a vape shop, I know these people all vape, so I can trust their opinions better than if I were looking for pipe tobacco in a smoke shop where the employees may prefer cigars, cigarettes, or hookahs.
While the FDA gets all the heat from the industry, a lot of localities have already started cracking down on the vape industry. Smaller ejuice manufacturers in Indiana, for example, have been forced out of the market by a stringent approval process, despite having spent upwards of $70,000 to comply.
Even in California, where cannabis laws are the loosest in the nation, there’s been rampant bans on vaping in public places. However, we’re so used to following strict laws here that it really isn’t a big deal that the FDA is regulating the industry. California already has stricter manufacturing laws in place in just about every other industry.
Anyone familiar with the FDA knows labelling is everything. In fact, label changes are the bulk of the new guidelines. Vape hardware and ejuice will now have the same warnings that are already on cigarettes, chew, and other tobacco products.
The big tobacco companies have in a way helped the vape industry by appealing part of the FDA’s new regulations that consider a tobacco product “new” when packaging and labelling are changed. This is a key to avoiding the Substantial Equivalence pre-market approval process that is associated with all the high costs murmured about in the industry.
Because of the high costs of FDA compliance, the price of e-cigarettes and ejuice is going to rise over the next couple of years. While this may sound like a good thing for manufacturers, margins are still tight, and it could be a year or longer before application costs are recouped.
Small batch juice and startup mod manufacturers are going to find a high barrier to entry moving forward, but established brands shouldn’t have any issues with new requirements.
Although the vaping industry is now regulated, it’s not the end of the world. We’re still hard at work developing new flavors while refining the processes used to create all the Vape Chemist flavors you know and love, like Philippine Mango and Vietnamese Iced Coffee.
The FDA isn’t stopping us and you shouldn’t let them stop you either. If your favorite flavor from another brand is discontinued, let us know, and we’ll do what we can to help out.
Brian Penny is a former business analyst at Bank of America turned whistleblower, consultant, troll doctor, and writer. He’s featured on The Huffington Post, Mainstreet, Lifehack, Money Side of Life, Gaiam, HardcoreDroid, and more.