What Does PMTA's Mean For Us?
The deeming regulation’s ambiguous language and confusing references to various regulations, coupled with conflicting information passed along during FDA’s teleconference last week has left the vaping industry and vapers questioning the future of e-liquids and e-cigarettes in the U.S.
The FDA's revised compliance policy for premarket review is intended to balance the public health concerns, while allowing the Agency to more efficiently manage the flow of incoming applications, and encourage high-quality premarket submissions from applicants.
According to FDA, the Agency established staggered “compliance periods” for e-liquids and e-cigs to enable FDA to balance concerns regarding the extended availability of newly deemed vaping products without scientific review, to address concerns regarding flavored tobacco products' appeal to youth, and to consider emerging evidence that some adults “may potentially use certain flavored tobacco products to transition away from combusted tobacco use.”
The deadline schedule is based on the expected complexity of the applications to be submitted, followed by continued compliance periods for FDA review such that enforcement discretion will end twelve months after each initial compliance period.