“Today,” wrote the FDA last year, “the U.S. Food and Drug Administration issued warning letters notifying ten companies, including Cool Clouds Distribution Inc. (doing business as Puff Bar), to remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization.”(1)
Defining what a Puff Bar product is turns out to be quite difficult, as explained by Jim McDonald at Vaping360(2). Products are made by a number of Chinese manufacturers: “The better question is if there has ever been a legitimate Puff Bar.”
The FDA told Cool Clouds Distribution Inc. that the products had to go because, “under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.”(3)
In a move that has spurred the FDA into immediate action, and caused worry among consumer advocates that it could reflect poorly on vaping in general, PuffBars are back.(4)
The distributor picked up on the phrase “they are made or derived from tobacco” and addressed it by using tobacco-free nicotine – synthetic nicotine.
What is synthetic nicotine?
Synthetic nicotine is chemically identical to pure nicotine obtained from tobacco leaves but has been manufactured using chemical compounds in a scientific laboratory. It is identical in its properties and use to tobacco-derived nicotine.
The PuffBar website now proudly proclaims: “This product contains tobacco free nicotine.”
“As a demonstrated pledge to premium quality, Puffs nicotine-based products are created with tobacco-free nicotine. Our nicotine-based products are crafted from a patented manufacturing process, not from tobacco. The result? A virtually tasteless, odorless [sic] nicotine without the residual impurities of tobacco-derived nicotine. This dramatically improves flavor [sic] while still maintaining the same satisfaction smokers are seeking from their nicotine.”
It continues: “PuffBar products are not intended to diagnose, treat, cure, or prevent any disease, condition, or disorder and are not smoking cessation or nicotine replacement therapy products. The FDA has not reviewed these products, nor has it evaluated their safety or any of the statements made regarding these products.”
It's a move redolent of the growth of the shortfill market at home which came about following the restriction on bottle capacity and nicotine concentration, and the demand for testing and certification for sale, in the EU’s Tobacco Products Directive.
As the FDA announced it had launched an immediate investigation, it was reported that the owner of Cool Clouds Distribution Inc. said he has sold the distribution rights to DS Technology Licensing LLC, a Chinese manufacturer.
Then, a lawyer representing DS Technology told the Wall Street Journal, “it no longer owned the brand, had stopped exporting Puff Bar products to the U.S. and had no knowledge of the new products.”(5)
Eyes will be watching what happens in the States next as Europe presses forward with the next iteration of the Tobacco Products Directive. It is believed that the EU will push to places harsher restrictions on vape products and classify them as tobacco products. This may not be the last time we hear about synthetic nicotine.
- FDA Shutting Down The Vape Industry - https://www.planetofthevapes.co.uk/news/vaping-news/2020-08-06_fda-shutting-down-the-vape-industry.html
- Puff Bar: A Preview of the Post-PMTA Vaping Industry - https://vaping360.com/vape-news/104174/puff-bar-a-preview-of-the-post-pmta-vaping-industry/
- Warning letter - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cool-clouds-distribution-inc-dba-puff-bar-608526-07202020
- Puff Bar - https://puffbar.com/
- Puff Bar Defies FDA Crackdown on Fruity E-Cigarettes by Ditching the Tobacco - https://www.wsj.com/articles/puff-bar-defies-fda-crackdown-on-fruity-e-cigarettes-by-ditching-the-tobacco-11614681003