最高法院周一就食品药品监督管理局是否有被非法拒绝出于对年轻人尼古丁上瘾的担忧，数百万支带香味的电子烟获准在美国销售。
在一个可能对公共健康产生重大影响的案件的口头辩论中，法官们努力应对烟草业的指控，即政府对新产品申请的要求不明确且不断变化，并且没有向公司提供适当的通知。
代表vape制造商Triton Distribution和Vapetasia的律师Eric Heyer认为，“FDA改变了对需要进行研究的立场”，以表明这些产品对现有吸烟者有好处，可以抵消对年轻人的风险，这两家公司正在寻求为销售电子液体开绿灯，如“果汁人吉米桃子草莓”和“冰菠萝快车”。
联邦法律要求新尼古丁产品的销售者向监管机构提供科学证据，证明这些产品能够促进公众健康，但该法规并没有明确说明什么样的证据是必要的和充分的。FDA关于如何满足这一要求的指导是本案的核心。
“他们的论点是，指南实际上是一个移动的目标，要么他们不清楚，要么你随着时间的推移改变了指南，”克拉伦斯·托马斯法官说，他似乎同情vape制造商。
“这是他们的论点，”代表FDA的拜登政府律师柯蒂斯·甘农(Curtis Gannon)回答说，“但我认为，关键是他们从法规中知道，他们需要对现有吸烟者的好处进行比较，并权衡不吸烟者和吸引年轻人的潜在成本。”
尼尔·戈鲁西法官表示，这些公司可能没有得到如何遵守法律的“公平通知”。"正当程序难道不需要通知和听证的机会吗?"他问甘农。
电子烟和vapes释放尼古丁而没有吸烟的一些有害影响，已经被人气高涨。儿童喜爱的口味，如水果、糖果、薄荷、薄荷醇和甜点，没有得到FDA的批准，在市场上是非法的。
根据疾病控制和预防中心的数据，虽然青少年中的vaping正在下降，但超过160万儿童使用这些产品。其中近90%消费非法风味品牌。
制造商承认他们的产品可能会吸引年轻人，但坚持认为“越来越多的科学证据”表明，“香料对于让成年吸烟者做出转变并远离可燃香烟至关重要。”
去年，一家联邦上诉法院站在了这些公司一边，称该机构行为武断。如果最高法院支持这一裁决，这将为有味道的尼古丁产品更广泛的营销和销售扫清道路。
法院的三名自由派法官似乎都同意政府的观点，即FDA在此过程中没有非法移动球门柱，这些公司只是缺乏获得批准的证据。
自2009年国会通过旨在限制年轻人吸烟的立法以来，政府几乎普遍拒绝了烟草公司销售加香尼古丁电子烟的请求，理由是未成年人有成瘾的风险。
FDA表示，在这种情况下，两家公司没有提供足够的证据证明他们的调味电子产品在帮助吸烟者戒烟方面的好处超过了钩住儿童的危险。
“我完全糊涂了，”大法官索尼娅·索托马约尔告诉海耶。“食品和药物管理局说，你提供的是不够的。”
凯坦吉·布朗·杰克逊法官说，她对海耶的论点感到“困惑”,因为FDA已经明确阐述了它的标准。
“我想我真的看不出这有什么令人惊讶的，或者这里有什么变化，”大法官埃琳娜·卡根说。“关于FDA在做什么，这里没有太多的神秘。你可能不同意这一点，因为你认为，事实上，40岁的人真的想做蓝莓汽蒸，但你不能说FDA没有告诉你它在这方面的想法。”
法官布雷特·卡瓦诺(Brett Kavanaugh)可能是本案中的关键一票，他对该行业关于政府酌情监管的投诉表示同情，但表示他并不认为FDA的行为不合理。
“如果该机构说(你声称的对成年吸烟者的好处)没有超过对年轻人的伤害，我们已经审查了一切，我们知道一切，当然他们知道外面的一切，那就差不多结束了，不是吗?”卡瓦诺问道。
几位法官指出，即使他们败诉，vape制造商也可以在新的申请中重新向FDA申请批准。
虽然第一届特朗普政府对营销和销售甜味和糖果味的vape采取了强硬态度，但当选总统唐纳德·特朗普在竞选期间表示，他希望“拯救”风味vape。
“我们不知道那会是什么样子，”海耶说。但是，他补充说，他的客户“等不起”
根据2023年全国青年烟草调查，近四分之一使用电子烟的高中生消费非法薄荷醇口味的品种。
乔西·夏皮罗(Josie Shapiro)是2024年无烟儿童运动的全国青年大使，她在国会面前就尼古丁成瘾的危险作证，她说非法风味的vapes在14岁时就让她上瘾了。
夏皮罗说:“我认为，通过营销任何口味的产品，如泡泡糖或任何类型的糖果，都会吸引孩子们的眼球。”。“我还在沉迷，我还在努力和自己的沉迷做斗争。老实说，美国食品和药物管理局需要监管所有的加香烟草来调味‘烟草’产品，并让它们退出市场。”
公共卫生专家认为，美国食品和药物管理局对调味尼古丁产品的限制有助于减少青少年吸烟人数，而这一数字在五年前还处于“流行”水平。
美国食品药品监督管理局诉Wages and White Lion Investments，LLC一案将在最高法院2025年6月任期结束前做出裁决。
Supreme Court divided over FDA block on kid-friendly flavored vapes
The Supreme Court on Monday was divided over whether the Food and Drug Administration hadunlawfully rejectedmillions of flavored e-cigarettes for approved sale in U.S. over concerns about nicotine addiction among young people.
During oral arguments in a case that could have a significant impact on public health, the justices grappled with tobacco industry claims that the government had given unclear and shifting requirements for new product applications and failed to provide proper notice to the companies.
"FDA switched its position on what studies were required" to show that the products have benefits to existing smokers that offset risks to youth, argued Eric Heyer, the attorney representing vape manufacturers Triton Distribution and Vapetasia, which are seeking a green light to market e-liquids such as “Jimmy the Juice Man Peachy Strawberry” and “Iced Pineapple Express.”
Federal law requires sellers of new nicotine products to provide regulators with scientific evidence to show that the products would promote public health, but the statute does not spell out specifically what evidence is necessary and sufficient. The FDA's guidance on how to meet that requirement is at the center of the case.
"Their argument is that the guidance were actually a moving target, that either they weren't clear or you changed the guidance as time went on," said Justice Clarence Thomas, who appeared sympathetic to vape manufacturers.
"That is their argument," replied Biden administration lawyer Curtis Gannon, representing the FDA, adding, "But I think that the key point is that they knew from the statute that they needed to be making this comparison about what the benefits were with respect to existing smokers and weighing that against the potential costs with respect to nonsmokers and attracting youth."
Justice Neil Gorusch suggested that the companies might not have been given "fair notice" of how they could comply with the law. "Wouldn't due process require an opportunity for notice and a hearing?" he asked Gannon.
E-cigarettes and vapes, which deliver nicotine without some of the harmful effects of smoking, have beenbooming in popularity. Kid-friendly flavors, such as fruit, candy, mint, menthol and desserts, are not approved by the FDA and are on the market illegally.
While vaping among youth is declining, more than 1.6 million children use the products, according to the Centers for Disease Control and Prevention. Nearly 90% of them consume illicit flavored brands.
Manufacturers have acknowledged that their products may appeal to youth but insist that a “growing body of scientific evidence” shows that “flavors are crucial to getting adult smokers to make the switch and stay away from combustible cigarettes.”
A federal appeals court sided with the companies last year, saying the agency had acted arbitrarily. If the Supreme Court upholds that ruling, it could clear the way for broader marketing and sale of flavored nicotine products.
The Court's three liberal justices all seemed to share the government's view that FDA did not illegally move the goal posts during the process and that the companies simply lacked the evidence to win approval.
Since 2009, when Congress passed legislation aimed at curbing tobacco use among young people, the government has almost universally denied tobacco company requests to sell flavored nicotine e-liquids, citing risks of addiction among minors.
The FDA said the two companies in this case provided insufficient evidence that the benefits of their flavored e-products in helping tobacco smokers quit exceed the dangers of hooking children.
"I'm so totally confused," Justice Sonia Sotomayor told Heyer. "What [FDA] said is what you provided wasn't sufficient."
Justice Ketanji Brown Jackson said she was "baffled" by Heyer's argument because the FDA had explicitly articulated its standard.
"I guess I'm not really seeing what the surprise is here, or what the change is here," said Justice Elena Kagan. "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."
Justice Brett Kavanaugh, who could be a critical vote in the case, signaled sympathy to the industry's complaint about discretionary government regulation but suggested he wasn't convinced FDA had acted unreasonably.
"If the agency says [your claims of benefits to adult smokers] that doesn't outweigh the harm to youth, we've reviewed everything, we're aware of everything, of course they're aware of everything that's out there, that's kind of the end of it, isn't it?" Kavanaugh asked.
Even if they lose the case, several justices noted, the vape manufacturers could reapply for approval with the FDA in a new application.
While the first Trump administration had taken a hard line against the marketing and sale of sweet and candy-flavored vapes, president-elect Donald Trump said during the campaign that he wants to "save" flavored vapes.
"We don't know exactly what that's going to look like," said Heyer. But, he added, that his clients "can't afford to wait that out."
Nearly a quarter of high school students who use e-cigarettes consume illicit menthol-flavored varieties, according to the 2023 National Youth Tobacco Survey.
Josie Shapiro, the 2024 national youth ambassador for the Campaign for Tobacco-Free Kids who testified before Congress on the dangers of nicotine addiction, said illicit flavored vapes hooked her at age 14.
“I think that by marketing any sort of flavored product as bubble gum or any of the genres of candy, it's going to catch the eyes of children,” Shapiro said. “I'm still addicted, and I'm still trying to fight my addiction. Honestly, the FDA needs to regulate all flavored tobaccos to flavor ‘tobacco’ products and get them off the market.”
Public health experts have credited the FDA’s restrictions on flavored nicotine products with helping to drive down the number of teenagers who vape gradually from an “epidemic” level just five years ago.
The case, Food and Drug Administration v. Wages and White Lion Investments, LLC, will be decided before the end of the Supreme Court’s term in June 2025.
