The MDOs for Humble Juice Co., were issued on September 15th, for the brands flavoured e-liquids with pending PMTAs. In response to this, Humble had filed a petition with the U.S. Court of Appeals for the Ninth Circuit, with the aim of having the MDOs revoked. Meanwhile, Humble received an MDO rescission letter from the FDA, stating that upon further review it identified information contained in Humble’s PMTA that requires additional evaluation such as “randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating intentions to use or likelihood of use in current smokers, current ENDS users, former tobacco users, and never users.”
The FDA’s rescission put Humble’s products back into the PMTA process
To this effect, Humble withdrew its court petition, and the FDA’s rescission automatically places the brand’s products back into the PMTA review process and provides Humble with a pathway to market its products. “FDA’s decision to rescind the MDO re-instills our faith in this challenging but science-based regulatory process,” said Humble CEO Daniel Clark. “We remain confident in and proud of our extensive PMTA submission. We are committed to working with the FDA to obtain marketing orders for the products submitted in our initial PMTAs in order to provide Humble’s adult consumers with flavor-filled and affordable e-juice long into the future.”
Recent uncovered documents revealed that PMTA reviewers have created a method to get through a backlog of millions of PMTAs, enabling them to quickly dismiss many of them without reviewing their submitted documents. A recent blog on Competitive Enterprise Institute’s website highlighted that the FDA was not expecting such a high volume of PMTA submissions. “Perhaps that explains why the FDA now seems intent on coming up with excuses to issue sweeping denials and whittle that number down to a size it can handle,” reads the blog.
The first batch of rejections came in early August 2021, when the FDA announced that it would not even review the 4.5 million applications from the same company, JD Nova, on grounds that they did not include an adequate Environmental Assessment. At the end of the same month, the agency issued marketing denial orders, or MDOs, for applications related to flavoured vaping products (55,000 from one company and 800 from another), based on the excuse that these failed to provide “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”
The agency added that such evidence, “would likely be in the form of a randomized controlled trial or longitudinal cohort study,” though it leaves room for other types of evidence “if sufficiently robust and reliable.”
A bias against flavoured products
And now, documents obtained by Filter sadly seem to confirm the above, whilst also indicating a bias towards flavoured products. The FDA had previously indicated that the threshold to be met would largely involve a balancing act between the products facilitating smoking cessation for adults whilst not being attractive to minors. The agency had also made it clear that it would likely require at least one of in order to prove the above.
However, on September 9th Mitch Zeller had stated in an update to the agency’s PMTA process, that the FDA “does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.” The agency never really expanded on what kind of other evidence that would be.
The FDA’s strategy to deal with the high volume of submitted PMTAs
Meanwhile, the uncovered memos reveal how the FDA planned to deal with the heavy volume of applications. “Office of Science has been tasked with developing a new plan to effectively manage the remaining non-tobacco flavored ENDS PMTAs not in Phase III, substantive scientific review,” reads a memorandum signed on July 9 by Matthew Holman, the director of CTP’s Office of Science.
“This task has been assigned by the Acting Commissioner given the likely impact on the marketplace on September 10, 2021 (the end of the enforcement discretion period for deemed tobacco products) and in order to take final action on as many applications as possible by September 10, 2021.”
Read Further: PR Newswire