The FDA issued this morning its long-awaited deeming regulations, which will subject all tobacco products (including e-cigarettes, cigars and pipe tobacco) to the FDA’s regulatory authority. We are currently digesting the regulations and will be posting a series of blog entries regarding various aspects.
Our initial impression is that, notwithstanding the flood of comments regarding the proposed regulations, the final regulations are not markedly different. Significantly, the FDA rejected the so-called “Option 2” that would have exempted a defined category of premium cigars from regulation. Under the final rule, all cigars will be regulated.
The FDA also rejected calls to shift the so-called “grandfather” date for purposes of premarket review to the effective date of the regulations. Although shifting the grandfather date would have been reasonable and defensible, the decision is not surprising given that the FDA has repeatedly (and incorrectly) stated that shifting the grandfather date would “emasculate” its authority over the newly-deemed products, including e-cigarettes.
We will continue to report on other impressions.