• November 13, 2024

Rumors swirl around FDA reg change

Early Tuesday afternoon the rumors started. The U.S. FDA was changing the deeming date. While being true in a sense, it wasn’t quite what was expected. Today’s announcement will be almost meaningless to the vapor industry.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, has said that the FDA considered a number of factors in developing the rule and “believes our approach is reasonable and balanced.”
Mitch Zeller, director of the FDA’s Center for Tobacco
Products, has said that the FDA considered a number
of factors in developing the rule and “believes our
approach is reasonable and balanced.”

The FDA will publish a rule change today, Sept. 16, that will address how it “refuses to accept” premarket tobacco applications (PMTA).

The rule change does matter to many, though. Changing its direct final rule regarding procedures for refusing to accept PMTA will undoubtedly give those (mostly tobacco) companies much-needed time to comply with an onerous regulation that isn’t far off for the vapor industry.

This change does give hope, however, that the FDA is susceptible to public outcry, according to many vapor industry experts.

The US FDA statement can be found below:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-27456.pdf