Vapor Manufacturers Identify Potential FDA Regulatory Loophole

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One of those companies has indicated it sees a potential loophole that could allow it to move forward, though it will be costly–Tobacco Free Nicotine (TFN). Currently, TFN is not regulated by the FDA and with the lack of tobacco, some believe products made with TFN could enable vapor and e-cigarette products to continue to remain in the market without being subject to FDA review and approval.

Here’s what one of those companies that received a MDO, Vapor Salon, posted on Aug. 26, 2021 on Facebook:

“Vapor Salon is switching to Tobacco Free Nicotine on Friday, 8/27/2021. It is still nicotine, however, just made in a lab and does not use any tobacco whatsoever. The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement which takes full effect on Sept. 9, 2021 with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to-date.

“The only real downside to switching to TFN is that it costs a HELL of a lot more. Quadruple to be exact. And for this reason, anything above 6 mg will have an upcharge. I apologize in advance for this but it is what we have to do to stay in business. It looks like the up-charge will be about 0.25 cents per each mL of nicotine. So, for 30mL, 9mg would be 25 cents more, 12mg would be 50 cents more. For 60mL, 9mg would be 50 cents more. For 120, 9mg would be $1 more, etc. We hope this is not too much of a burden on you; and we hope we can continue to be your go-to vapor carrier for many years to come!

“Oh, and a huge upside to TFN: we can make your e-liquid however you like. Strawberry cinnamon watermelon? Sure. Jackfruit with apple? Sure. You’ll be able to create flavors, however you like, again.” [read more here]

According to reporting from other media sources including FilterMag, other vapor manufacturers are also considering making the switch to synthetic nicotine as a way to circumvent the FDA and its Deeming Rule and PMTA requirements. There has been no indication when, if and how the FDA will regulate synthetic nicotine and those products that use it.