U.S. House Rep. Raja Krishnamoorthi, the Illinois Democrat who chairs a subcommittee of the House Oversight Committee that has held several hearings on vaping issues, announced today that he will lead an investigation of synthetic nicotine used in e-liquid.
Krishnamoorthi is a strong ally of the Campaign for Tobacco-Free Kids (TFK), and usually times his hearings to coincide with that group’s issue-based campaigns. The gallery at his subcommittee hearings are often filled with teenagers wearing colorful t-shirts proclaiming their affiliation with anti-vaping special interest groups like the Truth Initiative and Parents Against Vaping.
Krishnamoorthi issued a press release explaining that he has sent letters to Next Generation Labs (maker of Tobacco-Free Nicotine, or TFN) and Puff Bar, a seller of gray market disposable vapes that relaunched earlier this year, claiming to now use synthetic nicotine. Krishnamoorthi refers to Puff Bar in his statement as “the top children’s e-cigarette brand.”
In his letter to Next Generation Labs, Krishnamoorthi essentially asks the synthetic nicotine manufacturer to name names of companies falsely claiming to use synthetic nicotine when they are really using tobacco-derived nic. (NGL has made this claim without naming names.)
“We share your concern about these bad actors,” writes the congressman, “and welcome all available information about them, as the acts that you have described could violate FDA law and could also constitute unfair and deceptive acts and practices under state and federal laws.”
Because the Tobacco Control Act specifically gives the FDA authority to regulate nicotine “made or derived from tobacco,” most people believe the agency’s Center for Tobacco Products (CTP) cannot regulate products that use synthetic nicotine—at least not without serious legal challenges.
As we have explained, synthetic nicotine is about to become a major issue for anti-vaping groups. Soon after the FDA began issuing Marketing Denial Orders (MDOs) in late August to manufacturers of flavored vaping products, TFK and six allied organizations sent a letter to FDA Acting Commissioner Janet Woodcock demanding that the agency regulate synthetic nicotine as a drug.
Regulating synthetic nicotine through the drug pathway—giving the FDA Center for Drug Evaluation and Research (CDER) authority—is one possibility. Another would involve Congress amending the Tobacco Control Act to give the CTP authority over all non-therapeutic nicotine products. It is a problem CTP Director Mitch Zeller reportedly prefers Congress handle.
Rep. Krishnamoorthi, apparently completely unaware of how gray market vaping product distributors change product names and shift supply sources, threatens in his letter to Puff Bar to “put an end to your predatory practices.” It’s not the first time. Krishnamoorthi sent a hyperbolic letter to Woodcock earlier this year demanding the FDA “take all appropriate action to remove Puff Bar products from the market and to punish those responsible for putting youth at risk by ignoring FDA’s directive to stop sales.”
Ecigs and flavors saved my life. It would be fantastic if the FDA didn’t send out MDO’s to any of my favorite ejuice brands, though one can appreciate the justified villainization of Puff Bar hence synthetic nicotine by Krishnamoorthi. It’s definitely time to stock up on DIY supplies before it’s too late.
The flavored nicotine vaping industry better pray synthetic nicotine gets deemed as a tobacco product rather than a new drug. It’s far easier to get approved as a tobacco product than a new drug. Either way, looks like another loophole is about to slam shut.
If it’s deemed a tobacco product, every synthetic product will have to come off the market until after it’s authorized through the PMTA process. No manufacturer is going to bother with that. Either of those things will end the legal market for open-system synthetic nicotine products.