The CTP Science Office was expected to issue e-liquid authorizations once
The FDA Center for Tobacco Products (CTP) once expected to approve bottled e-liquids from manufacturers who had submitted Premarket Tobacco Applications (PMTAs). The FDA Tobacco Center’s Office of Science submitted a memo outlining a plan to expedite the review of e-liquids. based on an exclusive story by Alex Norcia in Filter.
The memo, titled “Bundling and Bracketing Approach for Review of ENDS Open E-liquid PMTAs,” described a process to accelerate the scientific review of PMTAs for e-liquids by grouping products based on characterizing flavors using a “flavor wheel” that was first published in a paper from 2019 by a group of Dutch scientists. FDA’s scientific reviewers could have reviewed multiple products from a single manufacturer and then applied their conclusions to additional products included in that company’s PMTA.
The plan was intended as a time-saver for the FDA’s scientific reviewers, but it also confirmed the agency’s belief at the time that some bottled e-liquids would be approved.
The memo was signed by then-Director of the Office of Science Matthew Holman, who recently left the FDA to work for tobacco company Philip Morris International. Filter obtained the memo from the FDA through a Freedom of Information Act (FOIA) request. (The full memo can be read in the Filter article.)
— American Vapor Manufacturers (@VaporAmerican) August 10, 2022
The proposed “bundling and bracketing” system for PMTA reviews was intended to make the CTP’s job easier, but its author also said it would “increase the likelihood that more tobacco products would be reviewed and receive marketing engagements before the end of the compliance period.” ” (“Compliance Period” referred to the one-year period after the PMTA submission deadline of September 9, 2020, during which submitted products could be sold without threat of FDA enforcement.)
“In essence,” Norcia writes, “CTP appears to have envisioned a few years ago that an expedited process would efficiently produce a large number of marketing denials and approvals for open-system vapes and e-liquids.” System are devices that can be refilled with bottled e-liquid and the bottled e-liquid itself.
As it turns out, the FDA still hasn’t approved a single open-system product, not even tobacco-flavored or non-tobacco-flavored products. Instead, the agency chose to implement a review system designed to reject PMTAs for all flavored products without review — unless the manufacturers submitted expensive and time-consuming studies to prove their products “proved a sufficient benefit for… adult smokers who overcome the risk associated with youth.”
With no randomized controlled trials or longitudinal cohort studies, the agency assumed (based on scant evidence) that non-tobacco flavored products were not “appropriate to protect public health” and issued denial marketing orders (MDOs). The FDA denied applications for millions of products submitted by hundreds of manufacturers and has been taken to court by dozens of small companies.
Once again, internal memos from the FDA have surfaced outlining their shadowy review process. Conveniently, this document appears after the appeals have been heard. Apparently, the process was rigged against small businesses from the start. What other shady secrets will be discovered? https://t.co/KoMq9fO1DM
— Amanda Wheeler (@amandawheeler32) August 10, 2022
The companies challenging the FDA in federal courts might have put the bundling and stapling memo to good use — if they had seen it before their cases were decided. At the very least, it shows that the CTP had envisioned approving some open-system products (although not necessarily flavored products), but instead someone at the FDA scrapped the idea in favor of the boilerplate denial system that the authority has agreed.
The memo set out a plan for CTP scientific reviewers from the Division of Product Science and the Division of Nonclinical Science to randomly select products with up to 24 signature flavors from a single company’s PMTA and then the reviewers’ conclusions on others therein included products transfer the same application. The author of the memo said there was “no limit to the maximum number of tobacco products per PMTA for which the conclusions can be bridged.”
Manufacturers were, of course, not allowed to make assumptions about their own products based on information about other similar submitted products. This would have been a time and labor saving shortcut granted only to diligent CTP reviewers. But the mere existence of the “bundling and bracketing” memo shows that the FDA has realized the folly of their requirement that every (very similar) product be subjected to identical tests that, in all likelihood, produce exactly the same results across a product line certain company would show.