On September 20, 2019, the Food and Drug Administration announced that it will issue a proposed rule governing the process for premarket tobacco applications, including for electronic nicotine delivery systems. The rule (when finalized) would establish binding procedures for PMTAs, as opposed to the current non-binding procedures reflected in FDA guidance.
The rule will establish specific requirements for the content and format of PMTAs, amendments and supplementation of PMTAs, the PMTA review process (including filing and acceptance review and communications with FDA), record retention and post-marketing requirements. Although the proposed rule is largely consistent with existing guidance and procedures for PMTAs, there are some important exceptions. Although the proposed rule will not be finalized for some time, PMTA applicants should consider the proposed rule in preparing their submissions. Comments are due on November 25, 2019.
The proposed PMTA rule comes on the heels of President Trump’s announcement that he intends to “ban” flavored ENDS, other than tobacco, but including mint and menthol. While it will be important to examine the text of the policy when it is formally announced (apparently within a few weeks), it appears that the intent is to promptly initiate enforcement action against all flavored ENDS (other than tobacco) that lack FDA marketing authorization. Since no ENDS currently have FDA marketing authorization, suppliers of flavored ENDS have strong incentives to advance their premarket review programs and to submit credible PMTAs as soon as possible. The question then will be how quickly the FDA can process these submissions. It is reasonable to assume that the review process will take at least a year.
The issuance of the proposed PMTA rule may be in response to industry criticism that the agency has yet to issue “foundational rules” governing the PMTA process. When then-FDA Commissioner Scott Gottlieb announced in July 2017 a “comprehensive plan” for nicotine regulation, he extended the ENDS PMTA deadline to 2022 and indicated that the FDA would promptly issue foundational rules governing the process. Now that the FDA has threatened to advance the PMTA deadline (with a federal judge ordering the FDA to do so by at least May 2020), the FDA has been subject to criticism for failing to issue PMTA rules more than two years after promising to do so. The recent announcement of the proposed PMTA rule could be FDA’s effort to quell this criticism, although this rule probably will not be finalized until at least mid-2020.