By Willie McKinney, Ph.D., D.A.B.T.
Potential implications of FDA’s October 7, 2021 rescission of its Marketing Denial Order (MDO) issued to Turning Point Brands (TPB)
McKinney Regulatory Science Advisors would like to share our thoughts on the potential implications of FDA’s October 7, 2021 rescission of its Marketing Denial Order (MDO) issued to Turning Point Brands (TPB).
While the situation is still unclear, this action may indicate a sea change that can affect your current or future applications, even if they’ve been denied or have received a deficiency letter.
As you may know, FDA recently sent out MDOs to a broad swath of applicants, mostly small and midsize manufacturers of noncombustible nicotine products such as e-liquids. This followed a year of confusion over FDA’s requirements for behavioral research that could support “appropriate for the protection of public health” (APPH) determinations. FDA had been under pressure from the federal courts to review PMTAs by early September 2021 but had been overwhelmed by the number of applications it had received.
On September 14, 2021, a week after receiving the MDO, TPB petitioned the federal court to review the MDO, claiming that it was “arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.” Among the reasons for such claims was that FDA had been unclear and even contradictory in its guidance on what would be acceptable as evidence that a product met the standards for APPH.
On October 7, 2021, FDA rescinded its MDO to TPB, claiming that it had “found relevant information that was not completely assessed.”
There is also language that “your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.” A careful reader will note that the FDA does not specify that TPB conducted all these studies itself. The language would apply equally to, for example, new surveys by TPB that allowed them to bridge to randomized trials published in the research literature. That would also be in keeping with all the FDA’s previous guidance.
With that rescission, TPB’s products have been placed back into FDA’s review process.
So, what does this mean? Companies that submitted behavioral research that follows the guidelines and addresses their specific products, but recently received MDOs, may be able to get a reprieve: have their PMTAs placed back in the review queue and resume sales of their products while they wait.
This may also apply to companies that submitted detailed plans to the FDA for new behavior studies based on the October 2020 TPPI guidance (that guidance was affirmed in FDA’s Final Rule). Appealing an MDO by citing the TPB rescission letter is not pro forma; it should be strategic and customized to your company’s PMTA and available research data.