If you’re a part of our Fog Factory HR Family then you’ve likely gotten a lot of messages from us recently.
There’s a good reason why:
The FDA has recently announced its rejection of 55,000 Premarket Tobacco Applications (PMTAs) for e-liquid products. They’ve also made it clear that they are unlikely to approve any PMTAs for e-liquid products that are any flavor other than “tobacco” before the Thursday, September 9th deadline.
The Burden of Proof
While the request for evidence of safety is well intentioned, placing the burden of proof onto the applicants puts the majority of e-liquid companies in a tough financial spot.
The evidence that the FDA is looking for is randomized controlled trials. Designing and completing just one of these trials would cost a company millions of dollars – a price that is simply unattainable for smaller, independent e-liquid companies.
This new financial burden means that the approval of PMTAs will likely only be attainable for tobacco companies and the largest independent vaping companies (i.e. Juul Labs and NJOY).
What is going to change?
We will continue to sell our current e-liquid inventory past Thursday, September 9th. However, after the 9th, we will begin to exclusively purchase products that are made with Tobacco-Free Nicotine (TFN).
The FDA’s Tobacco Control Act mandates that the agency regulates nicotine that is “derived from tobacco”. This means that TFN is not currently affected by the PMTA process, since its nicotine is not derived from tobacco, making it legal for us to continue to purchase and sell products that are made with TFN.
These new FDA regulations mean that certain brands and products may no longer be available in the near future. However, we will be replacing any product that we are forced to get rid of with a similar TFN option.
In order to maintain the same level of selection that you have grown to love, we will be converting most of our disposables, salt nicotine and regular e-liquid into TFN options.
If you don't see your favorite juice the next time you shop with us, just ask a staff member for a recommendation!
Please let us know if you have any favorite products made with TFN that we need to have on our shelves! We’d love to hear your personal favorites and recommendations!
McDonald, J. (2021, August 26). FDA Signals It Won't Authorize Flavored E-liquid PMTAs. Vaping360. https://vaping360.com/vape-news/110937/fda-signals-it-wont-authorize-flavored-e-liquid-pmtas/.
U.S. Food and Drug Administration. (2021, August 26). FDA Denies Marketing Applications for About 55,000 Flavored E-cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health. FDA. https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-applications-about-55000-flavored-e-cigarette-products-failing-provide-evidence?utm_source=CTPTwitter&utm_medium=social&utm_campaign=ctp-pmtadeadline.