For those in the know about vaping, the FDA’s rules have been hovering above the industry like a Damocles Sword for years now. A recent court action prompted by militant prohibitionists shortened the stay of execution by two years, from 2022 to May of 2020.
All products on the market will need to submit applications to the FDA for their products or be shut down. Sounds simple enough, right?
Once you start looking into things, however it quickly becomes terrifying. First of all, each product variation counts as a separate product. If you make e-liquid in 5 different flavors, each with 3 different nicotine levels, that’s 25 unique products that must be submitted.
I’ve previously written about how expensive that’s going to be. Essentially even a small business with just one product is not going to be able to afford the cost in dollars and person-hours. Multiply that by each product and you can see now how things are going to work out.
It’s been quite a while since I talked about the subject before, and there’s been time for some companies (read Big Tobacco) to actually submit products to FDA’s approval process.
The results have not been great.
The FDA has already received 373 applications for products affected by this rule change. Of those, all but four have been deemed “non-compliant,” requiring the companies to resubmit. What’s more, the FDA disclosed that none of the remaining four applications are for electronic nicotine delivery products, but did not report further specifics. With that record, it is very likely that most small businesses’ products will not receive approval and will therefore become inaccessible to consumers, even if these businesses dump all their resources into preparing an application.
Federal Court Ruling Threatens Smaller Vape Companies’ Survival
At this point, I’m not even sure what to say. Vaping industry groups have made some inroads, but it seems like we’ll be forced into what’s sure to be a vibrant and thriving black market within a year.
