Black Note Successfully Registers All of Its E-Liquids With the FDA
The implementation of the FDA’s e-cigarette regulations may have been delayed, but they are still a looming disaster for the industry. But there is a way through the tangle of regulatory requirements for manufacturers that are willing to spend the money and jump through all the hoops. A major deadline passed on October 12th, by which date manufacturers had to register all of their products with the FDA to get the whole process started. The good news for fans of Black Note is that we’ve successfully registered all of our e-liquids with the FDA, and everything will continue as normal for fans of our naturally-extracted tobacco e-juice.
The FDA E-Cigarette Regulations: A Primer
The FDA e-cigarette regulations have been widely-criticized as an overly burdensome and basically benefit-free exercise in bureaucracy. The short version is that every vaping product on the market will likely have to go through the pre-market tobacco application (PMTA) pathway in order to remain on the market after the regulations come into effect. This is a process that was ultimately designed to make it difficult for new “tobacco products” to come to market.
The “deeming regulations” are essentially the process of deeming e-cigarette products to be tobacco products under the law. When this happened for tobacco, the FDA instituted a “grandfather date” of the February 15th, 2007. If your product was already on the market prior to this date, or is “substantially equivalent” to a product that was on the market then, the process of gaining approval for sale is much simpler. Unfortunately for vaping companies, only very rudimentary e-cigs were on the market then, and so this pathway is closed to all modern e-cigarette products.
The only viable alternative is the PMTA approach. This isn’t ideal. Not only is the estimated cost of each application $1.3 million, it isn’t a process that was ever really intended to be successfully navigated. Among many other requirements, companies have to show that “permitting this product to be marketed would be appropriate for the protection of the public health.” (our emphasis)
The short version is that every single product – including each combination of flavor and nicotine strength – needs its own application and approval if it is going to continue to be sold. The only silver lining for the vaping industry was the recent announcement of a four-year delay, so PMTAs don’t have to be submitted until August 8th, 2022. But it’s still not looking great for the industry as a whole unless there are major changes to the proposed regulations.
The October 12th Deadline
October 12th marked one of the first big deadlines in the FDA’s e-cigarette regulation timeline. By the 12th, all vaping product manufacturers had to register all of their SKUs (Stock Keeping Units – basically a product identification code) using the FDA’s FURLS system in order to remain on the market. The deadline had previously been extended because of problems with system outages as manufacturers attempted to register their products. This is one of the first steps of a multi-step process that ends with the submission of a PMTA to continue selling vaping products.
Black Note Successfully Meets the Deadline
Black Note’s entire product range – including Quartet, Prelude, Forte, Sonata, Legato and Solo and the new line “V” Pop, Jazz, Reggae – have now all been officially registered with the FDA and will remain on sale as normal. This includes every nicotine level variation (with 0, 3, 6, 12 and 18 mg/ml of nicotine for each flavor) for every single flavor. FDA Link
For you as a vaper, the meaning of this is simple: you can continue buying and vaping Black Note e-liquids exactly as you did before. Nothing changes for our customers, so you can continue to enjoy our well-captured and realistic tobacco e-liquids completely unhindered by over-burdensome regulations.
Our E-Liquids Are Here to Stay
For everyone here at Black Note, the work is just beginning, but every hour spent working to keep our e-liquids on the market is worth it. The priority for everybody in the vaping industry should be to continue to offer a viable alternative to combusted tobacco for the smokers and vapers who depend on us. The hoops we have to jump through – and will continue to jump through as we progress through the regulations timeline – will all be worth it in the end, when we are still here providing excellent e-liquids for vapers looking for authentic-tasting tobacco e-juice.
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