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.
The regulations contemplate that all three pathways — exemption from substantial equivalence(“SE”), substantial equivalence and premarket tobacco application (“PMTA”) — could work for the newly deemed products. Exemption from SE applications must be submitted within 12 months of the regulations’ effective date, SE applications must be submitted within 18 months and PMTAs must be submitted within 24 months. Significantly, if the FDA does not grant a particular application within 12 months, the product can not longer be marketed (although the FDA reserves discretion to delay enforcement on a case-by-case basis). This represents a dramatic departure from existing practice and from the proposed regulations. This limited compliance period effectively places the burden of regulatory inertia on the industry. It is hard to imagine the FDA acting on these applications within a year, given the fact that some currently pending applications have been pending for more than five years without any substantive review.
It is also not clear whether the SE pathway will be available for electronic cigarettes. Given the dearth of viable predicate products to which these products would be compared as part of the SE process, the FDA appears to contemplate that a PMTA may be the exclusive premarket review pathway for electronic cigarettes. Conservative estimates are that this pathway would cost at least $1,000,000 per product, and as much as $10,000,000.
Finally, August 8, 2016 is the magic date for premarket review. Products newly-introduced or changed after that date must obtain FDA approval before they can be sold. Products introduced or changed before then (and assuming they are not grandfathered) can be marketed unless and until the FDA rejects the application, or the one-year compliance period expires.