The FDA's Center for Tobacco Products (CTP) was reportedly planning to submit a PMTA application for electronic cigarette e-liquids. According to an exclusive report by Alex Norcia in Filter, the CTP's Office of Science submitted a memo outlining plans to expedite the review process for e-liquid.
A memorandum titled "ENDS Open E-Liquid PMTAs Review Bundling and Bracketing Approach for Review of ENDS Open E-Liquid PMTAs" outlines a method for grouping electronic cigarette products based on flavor characteristics to expedite the PMTA review process. This approach utilizes the "Flavor Wheel," which was first mentioned in a 2019 paper by a group of Dutch scientists. FDA scientific reviewers evaluate multiple products from a single manufacturer and draw conclusions that apply to similar products instead of assessing each individual product separately.
The plan aimed to save time for FDA review officers, but it also acknowledged that the agency believed certain bottled e-cigarette liquids would be authorized at the time.
The memorandum was signed by the former Director of the Office of Science, Matthew Holman, who recently left the FDA to work for tobacco company, Philip Morris International. The memo was obtained from the FDA through a Freedom of Information Act (FOIA) request made by Filter.
The proposed "bundling" system for PMTA review aims to make the work of CTP easier, but its creators also anticipate that it will "increase the likelihood of reviewing more tobacco products and receiving marketing orders before the compliance period ends". The compliance period refers to the year following review. The PMTA submission deadline is September 9, 2020, during which time products submitted can be sold without FDA enforcement oversight.
The fact remains that the FDA has not authorized a single open-system electronic cigarette product, not even tobacco or unflavored ones. Instead, the FDA has implemented a review system aimed at rejecting all flavored products through the PMTA process, unless manufacturers submit expensive and time-consuming research to prove that their products "provide enough benefit to adult smokers to overcome the risks posed to young people.
Without randomized controlled trials or longitudinal studies, the FDA (based on limited evidence) has assumed that non-tobacco flavored products are "not appropriate for protecting public health" and issued marketing denial orders (MDOs). The US Food and Drug Administration has rejected applications for millions of products from hundreds of manufacturers and has been sued by dozens of small companies.
A company challenging the FDA in federal court may have effectively utilized the "bundling and bracketing" memo – assuming they saw it before the case ruling. This suggests that the CTP intended to authorize some open-system products (although not necessarily flavoring products), but instead, FDA officials rejected the idea and supported the agency's established template for rejecting systems.
A memo has been created by CTP scientific reviewers for the Product Science Division and Nonclinical Science Branch outlining a plan to randomly select up to 24 unique flavored products from a company's PMTA and compare the reviewers' conclusions to other products included in the same application. The memorandum explains that there are no restrictions on the maximum number of tobacco products in each PMTA and conclusions can be drawn accordingly.
Of course, manufacturers are not allowed to make assumptions about their own products based on information submitted for similar products. This would be a shortcut that saves time and effort, only allowing diligent CTP reviewers. However, the existence of the "bundling and bracketing" memorandum itself shows that the FDA recognizes that requiring every (very similar) product to undergo the same testing is foolish, as these tests would likely yield identical results in a particular company's product line.
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