On March 27, it was reported that When the U.S. Court of Appeals for the Fifth Circuit granted RJ Reynolds Vapor Co. (RJRV) a stay of the Food and Drug Administration's rejection of its 150-page Premarket Tobacco Product Application (PMTA) In its application for menthol Vuse, the judges indicated that the court believes RJRV is likely to prevail on the merits when full review is heard.

Clive Bates, a Counterfactual expert on tobacco harm reduction, said the substantive decision was based on three main arguments, as outlined by the judge who granted the stay. The order states:

Specifically, RJRV shows that FDA failed to properly consider the company's legitimate reliance on its needs for longitudinal research and marketing programs; Failure to consider evidence, particularly that younger users dislike mint-flavored e-cigarettes; And enacted a de facto rule banning all non-tobacco flavored e-cigarettes without following APA's notice and comment requirements.

The three main arguments argued by the court are summarized below:

The FDA changed its decision criteria after the application.

1. Legitimate trust interests.

"FDA did not reasonably consider the legitimate reliance interests of RJRV before changing its position on the type of comparative research and marketing program that is essential to compliance and complete PMTA."

Failed to take full account of Reynolds's argument.

2. Relevant factors are not considered.

The FDA did not adequately address evidence from RJRV that both adult and young smokers who switched to menthol Vuse received substantial health benefits, and that popularity among young adults overall remained low. For example, RJRV's app contains research showing that switching from smoking to menthol Vuse Vibe significantly reduces toxic exposure in a way similar to quitting smoking.

RJRV also submitted evidence of the low popularity of ENDS among young people compared to other flavours.

Bates said at least some of the court's arguments troubled Brian King, the newly appointed director of the FDA's Center for Tobacco Products (CTP).

Then in July 2022, a new CTP director appeared and told OS that the treatment method of menthol ENDS should be the same as that of other flavored ENDS, that is, products can be found suitable for protecting public health only when the evidence shows that the benefits of menthol ENDS are greater than those of tobacco flavored ENDS. The latter is less risky for young people. king then changed its location.

The FDA has been implementing de facto standards for tobacco products (flavor bans) without using the rulemaking process, public comment, etc.

3. Tobacco Product Standards

RJRV cited evidence that the FDA has effectively banned all non-tobacco flavored e-cigarettes under its new secret enhanced evidence standard without any notice or opportunity for public comment to those affected. There is no question that the TCA requires the FDA to follow the notice and comment rulemaking process before setting standards for tobacco products. 8 21 USC § 387g(c) -- (d). Similarly, it is clear that banning all e-cigarettes except tobacco-flavored e-cigarettes would constitute a tobacco product standard.

Bates explained that the court justified its assertion that the FDA was enforcing the de facto standard under the so-called fatal defect memorandum. This is a fast-track decision making system that states that applications for non-tobacco flavored products must be supported by controlled trials or longitudinal studies showing a smoking cessation or switching advantage over tobacco flavored products. Otherwise, they will be automatically rejected.

We conclude that the higher standard of proof for the fatal flaw memorandum has all the hallmarks of a substantive rule. First, the memorandum makes it mandatory for applications to include the required type of research, and is therefore binding. Second, the way it is applied suggests that it is binding; In fact, numerous subsequent denial orders referred to the same flaws identified as "fatal" in the memo. Third, it removes the previous discretion of FDA reviewers to consider individual PMtas solely on their merits, requiring instead a cursory boxed review.

Finally, it affects the rights of thousands of applicants for PMTA who have been rejected. It is not a close call.

Bates said the third point raised by the court could be very serious for the FDA, and is not at stake, as the court suggests. "The tobacco product standards under TCA s.907 mean that the onus is on the FDA to demonstrate that its de facto standards are appropriate to protect public health - such as considering the impact of closing all vape shops, possible for adults or young people who smoke, unintended consequences, illegal trade, etc." "Bates explained. "It would move the analysis from a single applicant (PMTA) to system-wide impacts (product standards) - in my opinion, the FDA would find that difficult or impossible to meet."

Taking all factors into account, the court weighed its decision to grant a stay based on four criteria, as outlined by Bates:

Our judgement is guided by sound legal principles, having taken into account four factors: (1) whether the applicant for a stay has demonstrated strongly that he is likely to succeed on the merits; (2) whether the applicant will suffer irreparable harm during his absence; (3) whether the issuance of the suspension will seriously harm other parties who have an interest in the proceedings; (4) Where the public interest lies.

Bates said the first of the four criteria reflected the court's view of the merits discussed in the three substantive arguments. In point four: (4) Where the public interest lies, the court attaches great importance to "the supreme public importance for federal agencies to comply with the law" and states that:

In short, there is usually no public interest in the perpetuation of illegal institutional behavior. And there is no evidence that Congress's policy choices included exemptions from mandatory federal administrative procedures.

The court has not set a date for the completion of the full review.