The Senate confirmed Dr. Robert Califf as FDA commissioner Tuesday afternoon by a 50-46 vote. Califf’s nomination, first considered a sure thing, was in doubt almost to the end because of the nominee’s industry ties, questions over his handling of the opioid crisis, and opposition from anti-abortion conservatives.
Califf has been generally antagonistic toward vaping as a consumer product. He was at the FDA helm in 2016 when the agency rolled out the Deeming Rule, which gave the FDA authority over e-cigarettes and other tobacco-free nicotine products.
One of the new commissioner’s first tasks will be working with Health and Human Services Secretary Xavier Becerra to find a replacement for retiring Center for Tobacco Products Director Mitch Zeller.
Califf will also have to solve the FDA’s vaping regulation mess. After issuing Marketing Denial Orders (MDOs) to hundreds of manufacturers for hundreds of thousands of flavored products, the agency has been challenged in court by more than 30 companies who say the FDA denied their Premarket Tobacco Applications (PMTAs) based on a standard that was not in place when applications were submitted. The agency has so far authorized just one vaping product—a primitive, underpowered “cigalike” device.
Jim McDonald – Vaping360 – 2022-02-15.