2020年6月17日，E-Alternative Solutions（EAS）已向美国食品和药物管理局（FDA）提交了烟草产品上市申请（PMTAs），以寻求对其Leap和Leap Go蒸气产品组合进行市场营销和销售的授权。
EAS总裁兼首席执行官JaCOPo D'Alessandris说：“我们很高兴迈出重要的一步，以表明我们对蒸气行业的承诺，零售商和成年吸烟者正在寻求用我们的Leap和Leap Go蒸气产品替代可燃卷烟。” 。
“在EAS，我们始终坚持高标准，为成年消费者提供他们可以信赖的产品，并始终遵循道德营销实践。我们对PMTA的强大优势充满信心，并要感谢我们的合规性和研究团队开发并提供了详尽的意见书。”
EAS认为，PMTA支持Leap和Leap Go蒸气产品适合保护公众健康的主张。“Leap和Leap Go总共提交了75,000页以上的PMTA，这是几个月的辛勤工作和调查的结果，其中包括对产品随时间推移的稳定性进行评估、毒理学配方审查、毒理学测试、对滥用责任的评估，标签理解研究和行为研究。”该公司在一份声明中写道。
此外，EAS对与健康影响、行为因素和毒理学终点有关的蒸气产品进行了广泛的文献综述。同时，针对Leap和Leap Go产品的许多潜在风险领域进行了严格的风险评估。
“我们的PMTA提交的材料对Leap和Leap Go产品进行了强有力的分析，这将使FDA认同这些产品适用于保护公众健康。”EAS的克里斯·霍华德（Chris Howard）说。“PMTA流程设定了很高的标准，并使公司承担责任，确保蒸气产品制造商遵守规则并真诚行事。展望未来，与FDA的强有力合作将有助于为蒸气行业和成人消费者建立一个美好的未来。”
EAS Requests Marketing Authorization For Leap Brand
June 17, 2020
E-Alternative Solutions (EAS) has submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA) seeking authorization for the marketing and sale of its portfolio of Leap and Leap Go vapor products.
“We are pleased to take this important step in demonstrating our commitment to the vapor industry, retailers and adult smokers seeking an alternative to combustible cigarette smoking with our Leap and Leap Go vapor products,” said Jacopo D’Alessandris, president and CEO of EAS.
“At EAS, we have always held ourselves to high standards, from supplying adult consumers with products they can trust to consistently following ethical marketing practices. We are confident in the strong merits of our PMTAs and want to thank our compliance and research teams for developing and delivering thorough submissions.”
According to EAS, the PMTAs plays support the proposition that Leap and Leap Go vapor products are appropriate for the protection of public health. “The collective 75,000-plus-page PMTA submissions for Leap and Leap Go are the result of months of hard work and inveSTIGation that included an assessment of the stability of the products over time, toxicological formula reviews, toxicology testing, an assessment of abuse liability, label comprehension studies and behavioral studies,” the company wrote in a statement.
In addition, EAS undertook an extensive review of available literature on vapor products related to health effects, behavioral factors and toxicological end points. Further, an exacting risk assessment was conducted across many areas of potential risk for Leap and Leap Go products.
“Our PMTA submissions provide a robust analysis of the Leap and Leap Go products that will enable [the] FDA to conclude these products are appropriate for the protection of public health,” said Chris Howard, vice president, general counsel and chief compliance officer at EAS. “The PMTA process sets a high bar and holds companies accountable, ensuring vapor product manufacturers follow the rules and act in good faith. Looking ahead, a robust collaboration with [the] FDA will help build a strong future for both the vapor industry and adult consumers.”
