最高法院正在努力解决 FDA 拒绝批准果味电子烟的问题

华盛顿——最高法院周一调查美国食品药品监督管理局是否因公众健康问题而非法拒绝批准调味电子烟。

在口头辩论中，九名法官中的大多数似乎并不相信该机构在诉讼过程中改变了评估是否批准产品的标准，正如两家公司所主张的那样。

但法院仍有可能发现该机构的做法存在缺陷。

法院以 6 比 3 的保守派多数席位占据多数，他们往往对联邦机构的决策持怀疑态度。

但对 FDA 来说，一个积极的信号是，保守派的关键成员，大法官布雷特·卡瓦诺 (Brett Kavanaugh) 似乎同情该机构的立场。

其他保守派似乎更加持怀疑态度，他们想知道 FDA 是否未能公平地通知公司批准调味电子烟所需的证据类型。

在电子烟（vapes）充斥市场的情况下，此案使 FDA 在批准新烟草产品方面的作用受到了严格审查。

调味电子烟制造商已在全国各地提起多起诉讼，质疑 FDA 的决定。

尽管 FDA 赢得了大多数案件，但在位于新奥尔良的美国第五巡回上诉法院败诉后，它向最高法院提出上诉。

法官面临的法律问题是 FDA 是否未能正确考虑公司的请求，是否违反了名为《行政程序法》的联邦法律。

该案的重点是 Triton Distribution 和 Vapestasia 带来的挑战，Triton Distribution 为电子烟笔生产电子液体，其口味名称丰富多彩，包括 Signature Series Mom's Pistachio 和 Suicide Bunny Mother's Milk and Cookies，而 Vapestasia 已寻求对 Iced Pineapple Express、Killer Kustard Blueberry 和其他口味的批准。

美国食品药品监督管理局 (FDA) 曾多次拒绝批准调味型电子烟，称其可能构成健康风险，因为它们可能会鼓励年轻人吸烟。然而，这类产品仍然广泛存在。

这些公司因未经批准销售产品而面临潜在的民事和刑事处罚，他们表示 FDA 判断错误，认为调味电子烟可以用来帮助人们戒烟。

他们的律师辩称，FDA 在审批过程中改变了对调味电子烟的审批标准，而没有给予申请人足够的警告。

卡瓦诺反驳说，FDA 从一开始就对这一问题的立场很明确，重点关注调味电子烟产品对年轻人的危害。

他指出，根据《烟草控制法》，FDA 有权监管烟草产品，特别关注年轻人。

如果 FDA 在权衡证据之后拒绝了一项申请，“事情就到此为止了，不是吗？”卡瓦诺说。

卡瓦诺和另一位保守派法官艾米·科尼·巴雷特似乎并不认为 FDA 在此过程中有实质性的立场改变。

法院三位自由派法官也持有同样的观点。

“我想我并没有真正看到这里有什么意外或变化，”法官埃琳娜·卡根说。

她补充说，申请人非常清楚，FDA 认为调味电子烟对儿童特别有吸引力，他们需要在提交的申请中克服这种假设。

“我的意思是，FDA 的所作所为其实没什么神秘之处。你可能不同意，因为你认为，事实上，40 岁左右的人确实想吸蓝莓味电子烟，但你不能说 FDA 没有告诉你它在这方面的想法，”卡根告诉这两家公司的律师埃里克·海耶。

同样，法官凯坦吉·布朗·杰克逊 (Ketanji Brown Jackson) 表示，她对这些公司声称他们没有公平地了解该机构的立场的说法感到“困惑”。

大法官索尼娅·索托马约尔似乎也同意这一观点，称海尔的论点让她“完全困惑”。

保守党大法官克拉伦斯·托马斯 (Clarence Thomas) 是对 FDA 行为表示担忧的人之一，他将批准标准描述为“移动目标”。

其他人，包括法官尼尔·戈萨奇，怀疑该机构是否未能公平地通知申请人规则已经改变。

该机构表示，会根据每份申请的实际情况进行评估。总检察长伊丽莎白·普雷洛加尔（Elizabeth Prelogar）在法庭文件中写道，这两家公司的申请被驳回，原因是“他们未能以任何形式提供足够的证据支持其主张”。

FDA 直到 2016 年才开始监管电子烟产品，当时电子烟产品已经上市。FDA 当时表示，在企业寻求批准期间，不会采取执法行动。

随后，研究得出结论：帮助成年吸烟者戒烟的潜在好处，并不足以抵消年轻人可能面临的健康风险，因为年轻人最受非烟草味电子烟的吸引。

FDA 已经 批准了薄荷味电子烟，以及一些烟草味电子烟。

当当选总统唐纳德·特朗普开始第二任期时，FDA 将备受瞩目。特朗普已承诺改革医疗保健体系，并承诺提名疫苗怀疑论者小罗伯特·F·肯尼迪 (Robert F. Kennedy Jr.) 担任卫生与公众服务部 (HHS) 负责人，FDA 是 HHS 下属机构之一。

海耶尔告诉法官，如果他的当事人胜诉，FDA 的做法可能会发生改变，并引用了特朗普曾发表的“拯救电子烟”的言论。

WASHINGTON — The Supreme Court on Monday probed whether the Food and Drug Administration unlawfully refused to approve flavored e-cigarettes over public health concerns.

During the oral argument, a majority of the nine justices appeared unconvinced that the agency had changed its standard for evaluating whether to approval products in the middle of the proceeding, as two companies argue.

But it is still possible the court could find fault in the agency's approach.

The court has a 6-3 conservative majority that is often skeptical of federal agency decision-making.

But in a positive sign for the FDA, a key member of the conservative wing, Justice Brett Kavanaugh, seemed sympathetic to the agency's position.

Other conservatives seemed more skeptical, wondering if the FDA had failed to give companies fair notice of what kind of evidence it required to approve flavored vapes.

The case puts the FDA's role in approving new tobacco products under the microscope at a time when e-cigarettes, or vapes, have flooded the market.

Makers of flavored vapes have brought various cases around the country challenging FDA decisions.

Although the FDA won most of those cases, it appealed to the Supreme Court after it lost one of them in the New Orleans-based 5th U.S. Circuit Court of Appeals.

The legal issue before the justices is whether the FDA failed to correctly consider the companies’ requests, in violation of a federal law called the Administrative Procedure Act.

The case focuses on challenges brought by Triton Distribution, which makes e-liquids for vape pens with colorfully named flavors, including Signature Series Mom’s Pistachio and Suicide Bunny Mother’s Milk and Cookies, and Vapestasia, which has sought approval for Iced Pineapple Express, Killer Kustard Blueberry and other flavors.

The FDA has repeatedly declined to approve flavored vapes, saying they might pose a health risk because they could encourage young people to use tobacco. The products nevertheless remain widely available.

The companies, which face potential civil and criminal penalties for marketing products without approval, say the FDA got it wrong, arguing that flavored vapes can be used to help people stop smoking.

Their lawyers argue that the FDA changed its standard for considering flavored vapes in the middle of the process without giving applicants adequate warning.

Kavanaugh pushed back, saying the FDA's position on the issue was clear from the outset, with a focus on the harm to young people of flavored vape products.

He noted that under the Tobacco Control Act, the FDA has the power to regulate tobacco products, with a special focus on young people.

If, after weighing the evidence, the FDA rejects an application, "it's kind of the end of it, isn't it?" Kavanaugh said.

Kavanaugh and another conservative justice, Amy Coney Barrett, did not seem to think the FDA had meaningfully changed its position during the process.

It was a view shared by the court's three liberal justices.

"I guess I'm not really seeing what the surprise is here or what the change is here," Justice Elena Kagan said.

She added that applicants know very well that the FDA believes that flavored vapes are especially appealing to children and that they would need to overcome that presumption in their submissions.

"I mean, there's just not a lot of mystery here about what FDA was doing. You might disagree with that, because you think that, in fact, the world of 40-year-olds really wants to do blueberry vaping, but you can't say that FDA hasn't told you all about what it's thinking in this respect," Kagan told the companies' lawyer, Eric Heyer.

Likewise, Justice Ketanji Brown Jackson said she was "baffled" by the companies' argument that they did not have fair notice of the agency's position.

Justice Sonia Sotomayor seemed to share that view, saying she was "so totally confused" by the arguments made by Heyer.

Conservative Justice Clarence Thomas was among those who expressed concern about the FDA's actions, characterizing the standard for approval as a "moving target."

Others, including Justice Neil Gorsuch, wondered whether the agency had failed to give applicants fair notice that the rules had changed.

The agency says it evaluates each application on its merits. The two companies' applications were rejected because "they failed to support their claims with sufficient evidence in any form," Solicitor General Elizabeth Prelogar wrote in court papers.

The FDA began regulating vape products only in 2016, after they were already on the market. The FDA said at the time that it would not take enforcement actions while companies sought approval.

It subsequently concluded that the potential benefits of helping adult smokers quit do not outweigh the potential health risks to young people, who are most attracted to non-tobacco flavored vapes.

The FDA has approved menthol-flavored e-cigarettes, as well as some that are tobacco-flavored.

The agency will have a high profile when President-elect Donald Trump takes office for his second term. Trump has pledged to shake up the health care system, pledging to nominate vaccine skeptic Robert F. Kennedy Jr. to run the Department of Health and Human Services, of which the FDA is part.

Heyer told the justices that if his clients win the case, there could be a change in the FDA's approach, citing comments Trump has made that he would "save vaping."