Top Takeaways:

• Fifth Circuit affirms FDA’s denial of the PMTA for the Suorin Air open-system device, ruling the agency acted reasonably—not arbitrarily or capriciously—in weighing public‑health risks and benefits.
• FDA’s single deficiency-letter policy upheld: the court found that the agency’s choice to issue only one deficiency letter, rather than multiple rounds, was justified and communicated in advance.
• Change‑in‑position and deficiency‑letter criticisms rejected: the court concluded that FDA’s actions did not surprise the applicant, and its rejection of Youme’s proposed mitigation measures (e.g., recommending only lower‑concentration e-liquids) was based on legitimate concerns about consumer comprehension and abuse liability.

A federal appeals court has affirmed the U.S. Food and Drug Administration’s denial of marketing authorization for the Suorin Air, an open‑system vaping device marketed by Shenzhen Youme Information Technology Co., Ltd.

The Fifth Circuit’s judgment, issued on July 23, 2025, rejected the Chinese manufacturer’s petition for review, concluding the FDA’s decision was both “reasonable and well-explained” under the Tobacco Control Act.

At the core of the case was Youme’s premarket tobacco product application (PMTA) for the refillable Suorin Air device. After a preliminary review in July 2022, the FDA issued a deficiency letter in March 2023, citing insufficient evidence—particularly related to abuse liability, or the product’s potential to promote continued use and nicotine dependence.

Youme responded only partially and sought an extension, which the FDA declined to grant. In January 2024, the FDA formally denied the application, stating Youme failed to demonstrate that the product would be “appropriate for the protection of the public health.”

On appeal, Youme (joined by a Texas retailer, Vape-E-Way, to establish venue in the Fifth Circuit) challenged the denial on several grounds:

• They argued the FDA failed to properly weigh risks versus benefits, as required under the Family Smoking Prevention and Tobacco Control Act.
• They claimed a violation of the change‑in‑position doctrine, asserting the FDA shifted standards without fair notice.
• They also took issue with the deficiency letter process, contending that the FDA’s critique of Youme’s proposed mitigation (e.g., recommending lower‑strength e-liquid use) was unfair.

The Fifth Circuit, which has been favorable to the vaping industry, dismissed all of the arguments. The court found the FDA had indeed provided a coherent rationale: its focus on abuse liability was relevant and tied to the statutory public‑health evaluation. The agency’s decision to issue only one deficiency letter was not arbitrary; FDA had explicitly announced that practice in June 2021, giving applicants notice of the process.

And FDA’s concern that consumers might not understand or follow instructions limiting e-liquid choice was neither novel nor unreasonable.

The decision aligns with a broader trend: courts continue to defer to FDA’s judgment when its reasoning is transparent and grounded in statutory mandates. It also echoes the Supreme Court’s unanimous ruling in April 2025 upholding FDA’s denial of PMTAs in the Triton/Wages & White Lion case—again, on the grounds that the agency had not engaged in a “surprise switch.”