On August 25, 2020, FirstUnion Group successfully passed the first round of PMTA audit and was officially accepted by the food and Drug Administration (FDA).
FirstUnion Group has been strictly controlling the design, manufacture, safety and other important links of products with the highest global standards.
When applying for PMTA, in order to improve the overall health level, the company needs to prepare three aspects. The first is consumer safety, which is for e-cigarette users; the second is public safety, which is for all groups; and the third is high-quality manufacturing, where it is necessary to prove to FDA that products of the same quality can be produced continuously and stably. The whole application process requires huge investment of capital, manpower and material resources, not only based on the consideration of entering the U.S. market. More importantly, the company wants to give consumers around the world a more reassuring experience.
Before entering the substantive review stage, after more than one year's endeavors, the company has completed more than 100,000 pages of application materials and evidence to support the company's claim, test data and reports to prove that the company's products are suitable for protecting public health. Meanwhile, the company expects to continue to cooperate with FDA in the next few weeks or months, and is optimistic that the PMTA process will bring market orders.
The company believes that under the new regulatory system, a fair and honest PMTA application process will be adopted to establish high standards for the industry, so as to meet the needs of the development of the whole industry. By helping customers apply for PMTA, FirstUnion Group can maintain close communication with customers.