On what should have been a quiet Friday in late July, the Food and Drug Administration (FDA) revealed a number of new policies, representing arguably the most significant FDA announcement to date under the Family Smoking Prevention and Tobacco Control Act. While much of the media’s attention has focused on the component of the announcement on reducing nicotine in cigarettes to nonaddictive or “minimally addictive” levels, the overall initiative is more comprehensive, including relief on certain premarket submission deadlines for newly regulated products and reconsideration of the agency’s approach to provisional products, a category that encompasses many, if not most, tobacco products on the market today.
The July 28, 2017, announcement — composed of a prepared statement from Commissioner of Food and Drugs Scott Gottlieb, M.D., and a corresponding press release — outlined five specific policy proposals to be undertaken by FDA’s Center for Tobacco Products (CTP):
- reduce nicotine yields in cigarettes to render them “minimally” or nonaddictive
- review the role of flavored tobacco products (including menthol) and their impact on children
- extend the compliance periods for premarket submissions for newly deemed tobacco products
- consider FDA’s current approach to reviewing provisional tobacco products subject to Substantial Equivalence (SE) reports
- evaluate FDA’s regulatory approach toward premium cigars
The fourth proposal may be most significant for manufacturers of traditional tobacco products and for CTP’s operations. Since 2011, CTP has been mired in a resource-intensive review of provisional SE reports for tobacco products on the market after February 15, 2007, but before March 22, 2011, so-called “provisional products.” CTP’s “provisional product” review process has been criticized for its slow pace.1 The majority of reports are still under review, with their manufacturers awaiting agency action. The Commissioner’s directive to reconsider whether such applications should be reviewed suggests that CTP may pause its review of these products and focus its resources elsewhere, potentially addressing the risk of an abrupt “stop sale” requirement arising from a Not Substantially Equivalent order.
The freeing of resources from provisional product reviews would also give CTP the opportunity to invest more heavily in review of Premarket Tobacco Applications (PMTAs) and Modified Risk Tobacco Product Applications (MRTPAs), which hold the most promise for moving U.S. tobacco consumers away from higher-risk combustible products to new noncombustible tobacco products, such as electronic nicotine delivery systems (ENDS) and e-liquids. FDA extended its regulatory authority to ENDS products in 2016 but provided a relatively short timeline for manufacturers to submit and for CTP to review applications for products already on the market. FDA’s recent announcement extended the compliance deadlines for newly regulated combustible product submissions to August 8, 2021, and for newly regulated noncombustible product submissions to August 8, 2022. The extensions were also restated in guidance issued on Friday, August 4, 2017.
Although CTP has issued many guidance documents to clarify content requirements for all premarket submissions, Commissioner Gottlieb acknowledged the need for FDA to more thoughtfully develop criteria for its premarket reviews, particularly for technologically unique and potentially less harmful products. He committed to issuing “foundational rules” with the goal of making the review process more efficient, transparent and predictable for PMTAs and MRTPAs as well as SE reports. By undertaking rulemaking instead of issuing guidance documents, FDA would provide stakeholders with meaningful opportunities to comment on content requirements. Rulemaking would also provide a more durable framework, which industry has been requesting for many years.
The announcement also noted that FDA plans to use its authority to issue product standards to address ENDS batteries and children’s exposure to liquid nicotine.
While the details of each of these proposals remain to be seen, the Commissioner’s involvement in the announcement demonstrates that the policies have the support of leadership and are almost certainly leadership-driven. FDA’s intent to develop the majority of the proposals through separate Advanced Notices of Proposed Rulemaking (ANPRM) also indicates that the agency plans to implement these policies over a long period.