Vitamin Air is so novel, it could get FDA's attention for misbranding as a supplement and being an unapproved new drug. Sparq says it's not an electronic cigarette because there's no nicotine in formulations it offers in products that resemble early-edition e-cigarettes. But it is a dietary supplement because each one is a mixture of vitamins, minerals and supplements plus natural flavors and glycerin so the formulations heat into vapor that is inhaled, the firm says.

Commissioner Gottlieb highlights the first of two draft guidances US FDA will publish on developing "novel, inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs, similar to current" OTC  nicotine replacement therapies. FDA has had a contentious history with manufacturers of electronic nicotine devices, but officials have said the products are eligible for review as NRTs through the NDA process.