The e-liquid PMTA application submitted by Boulder to the FDA (U.S. Food and Drug Administration) passed the preliminary review on November 12, 2020 and entered the next stage.
The FDA has assigned STN review codes to all SKUs submitted by Boulder, and one of the e-liquid review codes is PM0001472.
On September 8, US Eastern Time, Boulder formally submitted a PMTA application with e-liquid as the core to the US FDA. There are a total of 9 SKUs, of which 6 are e-liquids. For this application, Boulder has been preparing for nearly 4 years, countless experiments and hundreds of thousands of pages of application materials, and cost more than 100 million yuan.
The PMTA’s application requirements for e-liquid and the profound details of the certification are extremely demanding and complicated, similar to the first and second phases of trials before the launch of prescription drugs or vaccines. It has high requirements for the quality of products and the technical capabilities of enterprises.
PMTA is an approval method and standard for e-cigarettes and vape juice issued by the FDA. Manufacturers who applied for PMTA before September 9, 2020, can continue to legally sell in the US market unless they receive a delisting notice from the FDA. Companies that apply after September 9, 2020, must obtain a letter of approval from the FDA before they can be listed. It is generally believed that it is unlikely that an e-liquid product that attempts to apply for PMTA after September 9 will be approved by the FDA.
Although the requirements are strict, for Boulder, in the past few years, Boulder has stored a large number of e-liquid research and development technology and talents in two laboratories in the United States and China, and the technical reserves are very sufficient. Since 2017, Boulder’s two major laboratories in the United States and China have begun to improve and develop formulas, processes, and ingredients in accordance with FDA requirements. Before submitting the PMTA application, Boulder has conducted sufficient research and experiments on the addictiveness and attractiveness of toxicity, ingredients and release objects, population experiments, and FDA Phase I and Phase II experiments.
Boulder’s successful passing of the first round of PMTA review is not only an affirmation of Boulder’s past work, but also a great encouragement to Boulder itself.
According to public information query, Boulder is the only Chinese-funded enterprise in the world that has applied for PMTA of e-liquid.