Bryan Haynes of the Troutman Sanders Tobacco Team participated in a panel discussion entitled “How Innovation is Changing the Vape Category” at the Tobacco Plus Expo on February 12. A video of the panel discussion can be found here.
In reality, the FDA’s requirements for electronic nicotine delivery systems (“ENDS”) under the Deeming Regulations make it very difficult for companies to innovate. Any new product, or any product that has changed in any way since 2007, must first receive FDA marketing authorization before it can lawfully be sold. For ENDS, that pathway is generally considered to be a Premarket Tobacco Application (“PMTA”). Based on the recommendations in the FDA’s guidance for ENDS PMTAs, the suggested scientific studies can take years to complete, with ultimate approval taking a year or more. So if companies want to lawfully innovate, they must commit substantial resources and be prepared to wait.
At the panel discussed, one issue is the FDA’s failure to take enforcement action against companies that have introduced new products without marketing authorization. There appear to be numerous products in the market that have been introduced since August 8, 2016 (the cut-off date for introducing new ENDS without approval), yet the FDA appears to have targeted only a few of them. Haynes suggested that the FDA commit greater resources toward enforcing premarket review requirements because there is little point in having these requirements if they are not enforced.