采购产品尼古丁，烟草，降低风险产品(RRP)， 结束 & 和测试

As an accredited reduced-risk product (RRP) testing lab with e-liquid 和 tobacco chemical testing facilities, im体育APP has the scientific expertise 和 in-depth knowledge of the FDA premarket tobacco application (PMTA) regulatory pathway to help demonstrate the quality of your nicotine 和 tobacco products, 同时驾驭不断变化的监管格局. This includes RRPs such as 电子尼古丁传送系统(结束) 和替代尼古丁输送系统(ANDS).

The FDA initiated planned requirements for e-liquid 和 tobacco chemicals testing in May 2016, 2019年6月, the Agency released updated guidance for PMTA submissions. The FDA requires premarket tobacco product applications (PMTAs) must be submitted for every flavor 和 nicotine strength, with supporting pre-clinical 和 clinical safety data for 电子尼古丁传送系统(结束) to demonstrate the new tobacco product is “appropriate for the protection of public health”. These regulation 和 label requirements apply to manufacturers of new or newly deemed finished tobacco products that were on the market as of August 8, 2016. As an FDA-registered 和 inspected independent testing lab, GMP-Compliant, DEA-Licensed, 和符合glp标准的化学分析合作伙伴, our team has decades of experience supporting successful regulatory filings 和 submissions with the FDA 和 other regulatory agencies.

Our expert team has access to a 范围 of specialized instruments to fulfill both routine 和 challenging testing 和 analytical requirements. Eliminate surprises or delays that could keep your reduced-risk products from the market, 包括e-liquids, 电子尼古丁传送系统(结束), 下一代产品(NGP), 和替代尼古丁输送系统(ANDS), 包括袋, 牙龈, 含片, 以及种类繁多的无烟烟草制品. Finding the right nicotine 和 tobacco chemicals testing lab for such an extensive regulatory submission can seem overwhelming. A partnership with im体育APP is not just about compliance; our consultative teams of industry 和 regulatory experts will work to provide you with peace of mind now 和 in the future. 作为一个有经验的人, 值得信赖的, 和 nimble partner with years of scientific 和 regulatory experience, we will help you to navigate the dynamic 和 uncertain e-liquids 和 nicotine industry 和 evolving regulatory l和scape carefully 和 successfully.

电子液体和电子烟产品的测试过程

●      将制定定制的测试和监管计划, 全面考虑产品, 口味, 时机, 市场野心

●      Seven replicates on three batches of product will be performed for each analysis, 按照FDA的要求

●      Analytical methods can be transferred-in or developed 和 validated for accuracy, 精度, 线性, 范围, 鲁棒性, 和 limit of detection 和 limit of quantitation (LOD/LOQ)

●      A determination can be made as to whether any new chemical entities are created through the heating 和 vaporization process

●      A suite of state-of-the-art instrumentation 和 analytical techniques will be utilized, 包括LC / MS, 质/女士, 核磁共振, 高效液相色谱法, 摘要利用, 和 GC / MS

PMTA报告

●      所有源数据, 认证, 以及测试验证信息, as well as a complete description of the aerosol generating methodology used (PMTA guidance, p.24)将提供

●      Required in vitro toxicology 和 clinical safety data required by the FDA will be prepared

●      A tobacco product master file (TPMF) will be created (confidential filing with the FDA in relation to a product that may be used in manufacturing, 比如香精包装. The product’s safety 和 chemistry data can be incorporated into a PMTA by reference, with permission; FDA preferred)

im体育APP优势

im体育APP provides all levels of service related to custom analysis 和 testing protocols for our customers, including large manufacturers 和 established tobacco companies, mid-size manufacturers 和 distributors of specialty ingredients, 和小规模的“妈妈” & “Pop”尼古丁/烟草电子烟液制造商. Our goal is to apply our scientific 和 regulatory expertise to help bring safe 和 high-quality nicotine-containing vape, e-liquid, 结束, alternative nicotine delivery system 和 next generation products to the market. Confidently navigate the PMTA 和 evolving nicotine product regulatory l和scape 和 demonstrate the quality 和 purity of your products with im体育APP by your side.

To learn more about our nicotine 和 PMTA testing services, or to speak with one of our experts, im体育APP 今天.