This will be the first part in our continuing series of posts discussing certain aspects of the FDA’s proposed deeming regulations, which were issued today.
This part focuses on the premarket review process that will be applicable to the newly deemed products — principally e-cigarettes, cigars, and pipe tobacco. The FDA contemplates that the premarket review process applicable to currently regulated tobacco products (cigarettes, smokeless tobacco and cigarette tobacco) will be equally applicable to the newly deemed products. Significantly, the statutory grandfather date of February 15, 2007 applies to the newly deemed products. This means that any product that has been introduced or changed in any way since that date will be subject to the premarket review process. This means that all or almost all e-cigarettes will be subject to premarket review.