Key Points:
Case Outcome:
On July 23, 2025, the U.S. Fifth Circuit Court of Appeals rejected the judicial review petition filed by IVPS and its U.S. distributor ECIGRUSA, upholding the FDA’s denial of PMTAs for six open-system e-cigarette devices and components.
Core Dispute:
The FDA found that the applications lacked data from “abuse liability studies under actual use conditions,” a deficiency sufficient on its own to warrant denial. IVPS argued that enhanced warning labels could replace certain studies and questioned the transparency of FDA procedures.
FDA’s Position and Evidence:
Open-system devices, due to adjustable power and user-selected e-liquids, may lead to higher nicotine intake and increased addiction risk.
Required data comparing nicotine exposure and addiction potential against conventional cigarettes, as well as consumer perception and understanding studies.
Warning labels cannot substitute empirical research, as they cannot ensure users will comply with the warnings.
In the deficiency letter, the FDA set a 90-day deadline for submission of additional materials, making clear there would be no extensions or second deficiency letters.
IVPS’s Rebuttal and Supplementary Materials:
Proposed using enhanced warning labels to reduce addiction risk.
Argued that the FDA failed to clearly specify data requirements early in the process, which increased the burden on companies.
Court’s Judgment:
The absence of key scientific data alone was enough for the FDA to be unable to make a positive determination that the products were “appropriate for the protection of public health.”
Agreed with the FDA that labels cannot replace empirical studies.
Cited precedent in similar cases affirming the FDA’s authority to deny applications when scientific evidence is insufficient.
Found that procedural disputes were not enough to alter the ruling.
On July 23, 2025, the U.S. Court of Appeals for the Fifth Circuit issued a ruling rejecting the judicial review petition by Shenzhen IVPS Technology Co., Ltd. (IVPS) and its U.S. distributor ECIGRUSA against the U.S. Food and Drug Administration (FDA), upholding the FDA’s denial of PMTAs for six open-system e-cigarette devices and components. The court determined that the absence of core “abuse liability” research data alone justified the rejection.
Under the Family Smoking Prevention and Tobacco Control Act and the 2016 “Deeming Rule,” electronic nicotine delivery systems (ENDS) must obtain FDA authorization before being sold in the United States. Between July and September 2020, IVPS submitted PMTAs for six open-system e-cigarette devices and components. These devices allow users to choose their own e-liquids and adjust power settings. The FDA considers such features to potentially lead to higher nicotine exposure and addiction risk, warranting stricter data requirements.
FDA’s Position and Evidence
The FDA noted that open-system devices, due to adjustable power and user-selected e-liquid strength, present a significant possibility of increased nicotine intake. The agency required data, under actual use conditions and compared with conventional cigarettes, on nicotine exposure and addiction potential, in order to assess the public health impact.
The FDA also required consumer perception and understanding studies to demonstrate that warning labels could be correctly understood and would influence usage behavior. It stressed that labels cannot replace empirical research because there is no guarantee users would follow the warnings.
In a deficiency letter issued on March 29, 2023, the FDA set a 90-day deadline for submission of additional materials, noting that a second deficiency letter would generally not be issued and extensions would not be granted.
IVPS’s Rebuttals and Challenges
Label substitution proposal: IVPS proposed replacing certain abuse liability studies with enhanced warning labels, arguing this could reduce addiction risks.
Procedural challenge: The company claimed the FDA had not specified exact requirements at the start of the application, making it impossible to prepare the relevant research data in time. It also argued that the data requested exceeded original expectations and imposed additional burdens on the company.
Court’s Judgment
The court held that the lack of abuse liability study data under actual use conditions, even on its own, was sufficient to prevent the FDA from making a positive finding that the products were “appropriate for the protection of public health.”
The court agreed with the FDA that labels could not replace empirical research because there was no evidence that consumers would change their behavior due to the labels. It cited similar case precedents supporting the FDA’s authority to deny applications when scientific evidence is lacking.
The court rejected all appeals from IVPS and ECIGRUSA, upholding the FDA’s denial of the PMTAs. The judgment emphasized that the absence of scientific data was the decisive factor, and that procedural disputes were insufficient to change the outcome.
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