This is a petition for a writ of certiorari filed by the U.S. Solicitor General on behalf of the Food and Drug Administration (FDA). 

Here are the key points:

1. The FDA denied marketing authorization for flavored e-cigarette products made by Wages and White Lion Investments (Triton Distribution) and Vapetasia LLC.

2. The U.S. Court of Appeals for the Fifth Circuit set aside the FDA's denial orders as arbitrary and capricious.

3. The FDA is now petitioning the Supreme Court to review and reverse the Fifth Circuit's decision.

4. The main issues in contention are:

• Whether the FDA unfairly surprised manufacturers by changing evidentiary standards for applications

• Whether the FDA's failure to consider marketing plans was harmless error

• Whether the FDA arbitrarily ignored distinctions between different types of e-cigarette devices

• Whether the FDA has effectively imposed a categorical ban on flavored e-cigarettes

5. The petition argues that the Fifth Circuit's decision conflicts with rulings from seven other circuit courts on similar issues.

6. The FDA contends that the Fifth Circuit's decision undermines efforts to prevent youth e-cigarette use and frustrates the goals of the Tobacco Control Act.

7. The Solicitor General is requesting that the Supreme Court grant the petition for certiorari to resolve the circuit split and address the important public health issues at stake.

This petition represents an attempt by the FDA to have the Supreme Court review and potentially overturn the Fifth Circuit's decision that was unfavorable to the agency's regulation of flavored e-cigarette products.

FDA justifies its behavior with two principal arguments. First, FDA argues that its years’ worth of regulatory guidance was not worth the paper it was printed on because it was hedged with cautious qualifiers and never guaranteed that any particular submission would be granted. Second, and most disturbingly, FDA argues that its capriciousness should be forgiven as harmless because the agency promises to deny petitioners’ applications even if we remand to make the agency follow the law.

Today we reject both propositions. As the Supreme Court recently reminded us: “If men must turn square corners when they deal with the government, it cannot be too much to expect the government to turn square corners when it deals with them.” Niz-Chavez v. Garland, 593 U.S. 155, 172 (2021). No principle is more important when considering how the unelected administrators of the Fourth Branch of Government treat the American people. And FDA’s regulatory switcheroos in this case bear no resemblance to square corners. As for the agency’s harmless-error argument, the Supreme Court recently, unanimously, and summarily rejected it. Calcutt v. FDIC, 598 U.S. 623 (2023) (per curiam). We do the same here with the expectation that FDA will give petitioners the benefit of a full and fair regulatory proceeding on remand, notwithstanding its prior promises to reject their applications no  matter what.

3rd Circuit Court of Appeals (22-3030) - October 19, 2023

The FDA here fulfilled its statutory mandate in all respects. It saw a public health crisis—youth vaping—unfolding at the sweet spot of its expertise and the core of the jurisdiction it was given in the Tobacco Control Act. It reasonably prioritized among the products at issue, and when it reached menthol-flavored ENDS and Logic’s Premarket Application, the scientific studies and market changes in the interim led it to conclude the marketing of that product was not “appropriate for the protection of the public health.” 21 U.S.C. § 387j(c)(2)(A). That was a reasoned decision, with substantial basis in fact, and thus did not run afoul of the APA or the Tobacco Control Act.

For the foregoing reasons, we will deny Logic’s petition for review.

Fontem US, LLC (22-1076 consolidated with 23-1021) - August 29, 2023

Accordingly, we deny the petition for review as to Fontem’s flavored products and grant the petition for review with respect to the unflavored products.