Interpretation of Logic's e-cigarette's PMTA acquisition: factory quality management has become a top priority, and FDA's implementation or acceleration
The FDA issued an announcement stating that three products of Imperial Tobacco Logic have passed the PMTA, becoming the second e-cigarette brand after RJR to pass the PMTA. In addition, a few things were officially announced, so let's interpret them.
1. What does Logic's approval mean?
So far, only two Chinese e-cigarette factories have received FDA inspections from the United States. I believe everyone knows who it is. Its subsidiary factory is specially designed for Logic. The last time the FDA came to inspect the factory was in January 2020. Just before the outbreak of the new crown epidemic, CTP's factory inspection team has never been to China since then. The previous article speculated that after the FDA will inspect other Chinese e-cigarette factories, comprehensively evaluate the quality level of Chinese e-cigarette factories, formulate corresponding e-cigarette quality standards, and then issue certificates to Logic and other manufacturers in China. FDA issued a certificate before coming to China! On the one hand, it can be seen how much pressure the FDA is under, and they may not be able to bear it; on the other hand, we can also understand that the FDA preliminarily determined that the two OEM factories meet the FDA's quality management requirements for electronic cigarette factories, and Use this as a reference standard to perform factory inspections on other factories.
It is no exaggeration to say that these two factories have been repeatedly subjected to "internal audit torture" by Imperial Tobacco, and they are considered top-notch in the industry in terms of software and hardware, quality system and personnel quality. If this is the standard, there is no doubt that the factory system The difficulty of this piece increases sharply. You must know that the FDA review of the application materials is only half of the PMTA certification work, and the other half is in the factory.
The factory quality management system has always been the top priority of manufacturing enterprises. The management method of the e-cigarette industry, which was once oriented on production capacity and efficiency, will inevitably transform rapidly under the dual pressure of Sino-US policies. Otherwise, it will lose its reliance. fundamentals of survival.
2. The FDA has begun to play hard!
To date, the FDA has received more than 6.7 million PMTA applications, and the FDA has reviewed and responded to 99 percent of those applications. Response methods include: approve, reject, suspend, continue reviewing, or add information, etc. In other words, the FDA is about to clear its head and return to normal!
The FDA stated that it has issued MDO rejections to more than 1 million applications and asked them to withdraw from the U.S. market. This action and subsequent supervision will be faster and faster. The US FDA's decree has always been like this. It was very slow at the beginning, because there was a lot of consideration and the foundation was laid firmly, but the more it went, the faster it went. This is my experience of operating the US FDA certification for 20 years. Therefore, companies that are still hesitating to do PMTA hurry up! It is very likely that it is still happy to ship today, and it will be banned tomorrow!
I have repeatedly emphasized that the time for the FDA to fully and strictly implement the PMTA may be in the first quarter of next year, but judging from today's announcement, this time may be earlier. It depends on when the FDA will come to China to inspect the factory! As long as he comes, a group of companies and products will pass, and then the PMTA will be fully implemented! !
3. There is little chance of approval of multiple flavors in a closed
Logic's original application also included several fruit flavors and menthol, but in this approval, only tobacco flavors have passed PMTA, other flavors have received MDO, and the FDA emphasized that menthol and other flavors are still under review. Therefore, we have reason to believe that for closed e-cigarettes, tobacco and menthol flavors are not too suspenseful to pass PMTA, but for other fruit flavors, the risk is great! Combined with the speeches of FDA Commissioner Robert M. Califf and CTP Director Mitch Zeller, in order to protect young people, the benefits of multi-flavor to adults are not enough to resist the risk of inducing minors, unless the applicant can provide strong evidence to Prove it.
And this proof cannot be proved by one company or one or two products. Therefore, for closed-type electronic cigarettes, I think the possibility of the characteristic flavor being approved in the short term (three to five years) is zero. After that, with the support of global big data or other factors, it may change! We will wait and see.
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