The Truth About "Vitamin" Vapes and Regulatory Backlash
作者： 翠盖调味研发团队出版：广东独特风味有限公司最后更新： 十月12，2026WhatsApp与Telegram： +86 189 2926 7983电子邮件：info@cuiguai.comIn November 2021 the U.S. Food and Drug Administration moved against a small but highly visible corner of the vaping market: devices and e-liquids sold with vitamins or essential oils and marketed as wellness products. The agency issued warning letters to several companies, told them to stop making unproven health claims, and stated plainly that "no vaping products are approved by the FDA to prevent or treat any health conditions or diseases." For an industry that had spent years competing on flavour and device design, the vitamin vape episode was a hard lesson in where marketing ends and regulation begins.This article explains what "vitamin" vapes actually are, why regulators on both sides of the Atlantic pushed back so decisively, what the available science says about inhaling vitamins and essential oils, and — most importantly for suppliers and brand owners — how the backlash reshaped flavour strategy, label claims, and product development priorities. It is written for e-liquid brands, importers, and flavour buyers who need to understand both the compliance risk and the commercial opportunity that followed.简而言之：维生素和精油本身并不是问题。索赔是。味道像芒果的浓缩香料是一种香料。在监管机构看来，作为免疫增强剂出售的同一种浓缩物也是一种药物。这种区别现在影响着产品开发的每个阶段，从向风味公司提供的简报到印在十毫升瓶子上的文字。将这种差异内在化的品牌可以建立防御性的产品线。忽视这一点的品牌会承受警告信、市场暂停、海关扣留和支付处理问题的后果——这些后果往往是同时发生的，而且往往没有任何事先辩论的机会。
电子烟液风味实验室样品瓶和批次记录|翠拐
What Are "Vitamin" Vapes and How Were They Marketed?
The commercial logic was straightforward. As nicotine e-cigarettes faced tightening regulation and rising compliance costs, one segment of the market repositioned itself around benefits that had nothing to do with smoking cessation: focus, energy, immunity, relaxation, sleep quality, and hangover recovery. Product names borrowed the vocabulary of the supplement aisle, packaging mimicked vitamin bottles, and websites carried testimonials, condition-specific claims, and references to scientific-sounding concepts such as "inhalation science."The five firms that received FDA warning letters in November 2021 — Eagle Energy USA, NV Nutrition, VitaCig, Vitamin Vape, and VitaStik — illustrate the pattern precisely. Products were branded after the vitamin or the promised benefit, and the marketing copy went well beyond what a tobacco or supplement product is permitted to say. The letter to Vitamin Vape, Inc., dated 1 December 2021 and published under reference 617787, quotes website language presenting vitamin B12 as an "ideal candidate for vaporizing" and citing health information from the National Institutes of Health as support for an inhaled delivery claim.That rhetorical move — borrowing a government health authority's description of a nutrient's role in the body and attaching it to an inhalation product — is the single most common compliance failure in this category. The quoted science was accurate about vitamin B12 as a nutrient. It said nothing about whether vitamin B12 survives a heating coil or reaches the bloodstream through the lungs.
为什么吸入会改变监管问题
胶囊吞服的维生素和气雾剂吸入的维生素的监管方式不同，而且区别不是技术问题。在美国，旨在引入人体并销售以影响身体的结构或功能，或预防或治疗疾病的产品符合药物的定义。一旦附加该定义，该产品就需要根据《联邦食品、药品和化妆品法案》第 505(a) 条获得批准的新药申请——这是任何电子烟产品都尚未完成的途径。In the European Union, the equivalent boundary sits between an e-cigarette regulated under the Tobacco Products Directive and a product presented as treating or preventing disease, which falls under medicinal product legislation. Either way, the trigger is not the ingredient. It is the claim. Reformulate the same liquid and rename it "mint flavour," and the regulatory universe changes completely.
香料出口订单监管合规文件|翠拐
监管强烈反对的细节
FDA Warning Letters and the "Wellness Vape" Enforcement Wave
On 9 November 2021 the FDA announced action to protect consumers from vaping products carrying unproven health claims. The agency described such products as illegally sold with unproven claims and potentially harmful when used. Warning letters followed to Eagle Energy USA, NV Nutrition, VitaCig, Vitamin Vape, and VitaStik, and the agency published its position in a consumer-facing notice titled "Beware of Vaping Products with Unproven Health Claims."详细说明这些信件的法律架构很重要，因为相同的结构在整个类别中重复出现。 FDA 列举了根据 FD&C 法案第 301(d) 和 505(a) 条引入未经批准的新药、错误品牌，以及（如果产品也符合烟草产品的定义）第 910 条的上市前授权要求。因此，一项健康声明可能会在一份文件中引发多项独立违规行为。
未经批准的新药、贴错标签的补充剂、未经授权的烟草产品
针对该类别使用了三种重叠的理论。第一种将产品视为未经批准的新药，因为它是在未经批准的申请的情况下以治疗或预防疾病为目的而上市的。第二种将作为膳食补充剂提供的产品视为掺假或贴错标签，因为它是通过吸入而不是摄入来提供的，超出了补充剂的预期使用途径。第三种是最常让香料供应商和品牌所有者感到惊讶的一种。Under the Deeming Rule, which became effective on 8 August 2016, the FDA extended its authority over e-cigarettes and e-liquids. Any product not on the market as of the 15 February 2007 grandfather date requires premarket authorisation — a PMTA with a marketing granted order — before it may legally be sold in the United States. That obligation applies whether or not a product contains nicotine, because the definition of a tobacco product turns on the product's intended use and its components, not on nicotine content alone. As a result, an e-liquid sold as a wellness product can simultaneously be an unapproved drug and an unauthorised tobacco product. Brand owners who assume that "nicotine-free" equals "unregulated" are the ones most exposed, which is why our guide to common flavour-related citations in FDA warning letters 值得与本文一起阅读。
雾化线圈不会温和地蒸发液体。根据功率输出、线圈电阻、灯芯饱和度和抽吸持续时间，线圈温度通常远高于溶剂基的沸点，而干燥或部分饱和的灯芯会将温度推得更高。对热敏感的微量营养素在这种环境中停留的时间只有不到一秒钟，而且许多微量营养素对这些温度非常敏感。例如，众所周知，维生素 C 在热量和氧气存在下会降解，这就是为什么食品制造商通过冷链、氮气冲洗和超量计算来保护它，而不是将其添加到热加工中。干燥形式的维生素 B12 的热稳定性相对较高，但储存片剂中的稳定性与经受重复加热循环的雾化丙二醇和甘油基质中的稳定性不同。如果没有产品特定的分析数据，没有人能够说明有多少标记剂量在线圈中幸存下来，并且在引起监管机构注意的营销中也没有提供此类数据。
沉积、生物利用度和呼吸安全信号
即使是在线圈中幸存下来的分子也面临着第二个问题：它落在哪里。粒径分布决定气溶胶是否沉积在上呼吸道、传导支气管或深肺泡区域。营养科学根据胃肠道吸收和肝脏处理的假设来确定维生素需求量和安全摄入水平，而肺部并不是替代途径。吸入物质绕过首过代谢并直接进入体循环，这改变了暴露的速度和药代动力学。这正是监管机构将吸入治疗声明视为药物声明而不是营养声明的原因。脂质载体和油溶性成分在吸入时也与类脂性肺炎风险相关，这一问题同样适用于维生素 E 醋酸酯和精油。食品级安全数据不会自动转移到吸入途径，调味品行业在这一点上很明确：评估摄入的物质并不因此评估吸入途径。
欧洲和英国框架：TPD、健康声明和药用边界
TPD 第 20 条和产品分类
在欧盟内部，含尼古丁的电子烟和补充容器受 2014/40/EU 指令第 20 条的管辖。一些成员国通过国家法律将该制度的一部分延伸到不含尼古丁的产品，这也是液体在一个首都合法而在另一个首都被禁止的原因之一。第 20 条规定了常见的限制——最大尼古丁浓度为 20 毫克/毫升、最大补充容器容量为 10 毫升、最大罐容量为 2 毫升——并要求制造商和进口商在每种产品投放市场前六个月进行通知。任何健康重新定位都会产生两个实际后果。首先，添加维生素或精油会改变必须申报的成分成分，因此重新配制的液体是新的通知，而不是修正案。其次，当营销文案描述治疗、预防或缓解某种病症时，该产品就脱离了 TPD 框架并被评估为药品。任何在欧洲运营的品牌都应该已经在追踪 UFI codes required for European poison centre notification，因为相同的成分数据支撑着这两项义务。
Regulation (EC) No 1924/2006 and the Meaning of "Health Claim"
In the European Union, nutrition and health claims made on foods fall under Regulation (EC) No 1924/2006, under which only health claims authorised in the Union list may be used, and any claim must be substantiated by generally accepted scientific evidence. Words such as "supports normal immune function" or "contributes to normal energy metabolism" are not free-form marketing language in Europe; they are authorised claim formulations with defined conditions of use. Advertising a wellness vape with equivalent wording invites both food-law and consumer-protection scrutiny, and national authorities have taken action against vaping products framed as supporting immunity, concentration, or sleep.
由于合规风险存在于声明中而不是分子中，因此香料供应商成为一个有价值的控制点。供应商准确记录浓缩物中的成分、浓度以及分类，可以保护品牌免受意外索赔蔓延的影响——技术描述符逐渐转变为面向消费者的利益声明。询问是否每个成分都有化学名称和 CAS 编号记录；浓缩物是否带有任何会触发额外标签的 CLP 分类；供应商是否会以书面形式确认该配方不支持任何治疗、免疫或疾病相关的声明；以及文档包是否包含稳定性摘要和保留示例策略。自信地回答这些问题的供应商通常是批次顺利通过海关的供应商。
U.S. Food and Drug Administration, "FDA takes action to protect consumers from vaping products with unproven health claims," 9 November 2021 — https://www.fda.gov/consumers/health-fraud-scams/fda-takes-action-protect-consumers-vaping-products-unproven-health-claims
