By majority (10-6) opinion the United States Court of Appeal for the Fifth Circuit has determined that the Premarket Tobacco Product Marketing Application (PMTA) Marketing Denial Orders (MDOs) issued by the US FDA to Wages and White Lion Investments LLC (trading as Triton Distribution) and Vapetasia LLC should be set aside, and the PMTA applications returned for re-review by the FDA.

“The petitions for review are GRANTED, FDA’s marketing denial orders are SET ASIDE, and the matters are REMANDED to FDA” (pp.53 Fifth Circuit US Court of Appeal Opinion).

The Judgement, described elsewhere as dripping with sarcasm, hinged upon two main issues (i) that in the FDA repeatedly asked for detailed marketing plans which they subsequently ignored in their PMTA reviews and (ii) that after PMTA applications had been submitted, the FDA rejected them using a fatal-flaw approach rather than a full scientific review, solely because they failed to include long-term studies which had not previously been highlighted as essential by the FDA.

Both issues relate to concerns regarding the uptake of vaping of flavored e-cigarettes among youth. The FDA appears to have acted in a manner where failure to provide long-term studies alone was enough to trigger an MDO regardless of any marketing plan.

However, the Judgement argues that the balance between adult and youth uptake of vaping (essentially the evidence that the products are Appropriate for the Protection of the Public Health, APPH) should be considered at the same time, not in isolation. Further, by doing so the FDA had circumvented their own “notice-and-comment” rule regarding product standards and implemented a de facto ban on flavored e-cigarettes.

The basis for the Court’s determination is the legality of the FDA approach considered against four key principles of administrative law.

“(A) An agency cannot invent post hoc justifications for its decision in court and outside the administrative record. (B) An agency must provide fair notice before it deprives a citizen of property. (C) When an agency changes its position, it must display awareness of the change and explain it. And (D) even when an agency acknowledges and explains a change in its position, it cannot fault a regulated entity for relying in good faith on the previous one.” pp.18.

In failing to act in accordance with these principles, the Judgement says that the FDA acted arbitrarily and capriciously. Moreover, the Judgement describes certain of these failures as “a fortiori” i.e., clearer and more significant than the case studies upon which the principles of administrative law have been based.

The dissenting opinion of the Judges is also of interest. A particular worry is the poor understanding of the science of nicotine vaping and the willingness to accept extreme Public Health positions, some of which are not even accepted by the FDA nor submitted as case evidence. For example, in the dissenting opinion given of the Judgement, Judge Haynes et al. state,

“[t]he public health consequences are dire: Tobacco is quickly and powerfully addicting, and e-cigarettes can permanently damage developing adolescent brains, cause chronic lung diseases, and hook young users for life.” (pp.55, Fifth Circuit US Court of Appeal Opinion).

“e-cigarette usage entails myriad health risks, including lifelong addiction to e-cigarettes or traditional cigarettes, lung disease, and attention and learning deficits;” (pp.60, Fifth Circuit US Court of Appeal Opinion)

At the same time Judge Haynes et al. did not acknowledge the larger body of verified data coming from Countries where flavored vaping products are freely available.

It is a matter of conjecture to what extent this misunderstanding of the science biased the opinion of these dissenting Judges. Regardless, it is clear that several senior members of the US legal profession need education, both from the FDA and the industry, on the facts regarding nicotine vaping.

As a result of this Judgement, the PMTA process regarding flavored vaping product is frozen until the FDA decide if and how to respond to the ruling. For example, they could choose to ignore the Judgement, or take the matter to the Supreme Court, or begin a new rule-making process. None of the available options will be quick or clean.

The FDA has already indicated they will again issue MDOs against these set aside PMTA applications (pp. 3, Fifth Circuit US Court of Appeal Opinion). Therefore, Triton Distribution and Vapetasia should be working diligently to address any scientific deficiencies in their applications. Nevertheless, Triton Distribution and Vapetasia will benefit from continued marketing of their products while this further determination (and likely further litigation) is underway, particularly if these PMTAs are sent for full scientific review.

Furthermore, other manufacturers who have been in receipt of similar “fatal flaw” MDOs could now request a re- review of their PMTAs under threat of similar Court action.

Neil Sherwood, Ph.D.