Key Points:
- Plaintiffs: Shenzhen Youme Information Technology Co., Ltd. & U.S. distributor Frendz Trading, Inc. (Vape-E-Way)
- Defendant: U.S. Food and Drug Administration (FDA)
- Product: “Suorin Air” open-system e-cigarette device
Youme’s Claims:
- FDA ignored the potential health benefits of e-cigarettes as cigarette alternatives.
- Denial was unjustified—FDA failed to fully weigh the product’s benefits and rejected it solely due to “data gaps.”
- Review process was unfair—FDA shifted from multiple deficiency letters to a single-letter policy, depriving the company of the chance to submit key supplemental evidence.
FDA’s Response:
- Abuse liability assessment is central to protecting public health.
- The single deficiency letter policy was publicly announced in June 2021 to manage a backlog of 27 million applications, including 6.5 million submitted before September 2020.
- Testing requirements were not a new policy but a reasonable case-specific application of existing standards.
Court’s Reasoning:
- FDA considered potential benefits but could not confirm a net public health benefit without the missing risk data.
- The single-letter policy was lawful and announced in advance; Youme had no legitimate reliance interest.
- FDA’s refusal to accept supplemental data complied with internal rules, and the case did not meet criteria for exceptions.
On July 23, 2025, the U.S. Court of Appeals for the Fifth Circuit issued a ruling in the case of Shenzhen Youme Information Technology Company, Limited (“Youme”) and its U.S. distributor Frendz Trading, Inc. (doing business as Vape-E-Way) versus the U.S. Food and Drug Administration (FDA), formally rejecting the plaintiffs’ appeal. The court upheld the FDA’s decision to maintain a marketing denial order (MDO) on Youme’s “Suorin Air” e-cigarette product.
The core of the ruling is that the court found Youme failed to provide sufficient scientific evidence to prove its product was “appropriate for the protection of public health,” particularly in assessing potential risks to youth and other non-smoker populations.
Youme’s Position: FDA Ignored Benefits and Acted Unfairly
In its lawsuit, Youme argued that the FDA’s decision was “arbitrary and capricious,” citing two main points:
The FDA did not fully weigh the potential health benefits of its product as an alternative to traditional cigarettes for adult smokers, and instead rejected it solely because of “gaps” in the data.
The company claimed the FDA abruptly changed its review process from multiple rounds of deficiency letters to a “single deficiency letter” policy, depriving it of the opportunity to submit key supplementary materials—violating procedural fairness.
FDA’s Response: Data Gaps Made Risk Assessment Impossible
The FDA told the court that its primary duty is to assess the net impact of a product on “the population as a whole.”
For the “Suorin Air,” an open-system device allowing users to add their own e-liquids, the FDA’s main concern was that Youme failed to provide key scientific research data to evaluate the product’s “abuse liability” (i.e., addiction risk) when paired with the wide variety of high-nicotine e-liquids available on the market.
The FDA emphasized that this missing data made it impossible to properly assess the product’s overall risks—especially its potential appeal to youth—and therefore impossible to meaningfully weigh those risks against claimed benefits.
Regarding the procedural issue, the FDA explained that in June 2021, facing a backlog of 27 million applications (including 6.5 million submitted before September 2020), it changed to the single deficiency letter policy, publicly notifying the industry two years prior.
Court Ruling: Insufficient Evidence, Deference to FDA’s Scientific Judgment
After reviewing the case, the Fifth Circuit fully adopted the FDA’s arguments.
The court noted that under the Administrative Procedure Act, it must give substantial deference to the scientific judgments of expert agencies such as the FDA.
It found that the FDA’s decision-making process was reasonable, and that the agency had clearly explained why “abuse liability” data was essential to its public health risk assessment. Under the Tobacco Control Act, if an applicant fails to “demonstrate” that its product is appropriate for the protection of public health, the FDA is required to deny the application.
The court ruled that Youme had not met its statutory burden of proof and that the FDA’s denial was “reasonable and well explained.” Accordingly, it rejected the plaintiffs’ appeal in full and upheld the sales ban.
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