早上把FDA上vuse solo、logic和myblu的核准文章又扫了一遍,批准和否决的主要原因(见下文)总结一下就是FDA认为vuse和logic的产品利大于弊,减害作用大于对青少年的潜在危害,同时重要的一点是申报材料里有充足的证据支撑。而这正好是本次myblu被否决的原因,缺乏数据支撑(申请材料问题),同时产品外观、品质、缺乏稳定性(设计和代工厂实力问题)。
以上是台面上的问题,主观性和可操作性很大,下面我来揣摩一下台面下的问题:
1.去年电话会上严谨的小思管理层被问及vuse薄荷醇口味能否通过PTMA,表现出反常的笃定,一笑置之甚至有点多余问的赶脚,只说了一句类似要相信英美烟草的实力和运作能力的话(原话记不清了)。看过美剧的朋友们应该明白,光鲜背后全是利益博弈,一切皆为利来,皆为利往。
2.从FDA的角度考虑,否决了绝大多数小品牌以后,也需要牺牲一个大品牌来证明自己不是资本的狗腿子,老大老二惹不起,就拿老四开刀吧。今天fda文章里的这句话“Please note that FDA has not independently verified the information provided by applicants about the marketing status of their products ”挺有意思,特意强调一下来自证公平公正。
最后我摘抄了几段FDA网站上的原话及网址,供参考。
VUSE SOLO:
The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.(网页链接)
LOGIC:
The FDA authorized these tobacco-flavored ENDS products because, among several key considerations, the data submitted by the company and the available evidence show that marketing these products may help addicted adult smokers transition away from combusted cigarettes and reduce their risk of exposure to harmful and potentially harmful toxins compared to combusted cigarettes. At the same time, the data showed there was low risk for non-users, including youth, to use the products. The risk was also low for non-users, including youth, to progress to regular use of the products.(网页链接)
MyBLU:
Based on the information provided in the applications submitted by Fontem US, LLC for these myblu products and the available evidence, the applications lacked sufficient evidence regarding design features, manufacturing, and stability. Additionally, the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth.(网页链接)