PMTA Update: FDA Review Efficiency Remains Low, Some E-Liquid Flavors May Be Allowed

Recently there have been opportunities andFDAI got in touch with people and got some information. Let's share it with everyone here.

I.CTPWhy is your work efficiency so low?

FDAThere is a serious shortage of manpower，2020years9monthsFDAReceived millions of copiesPMTAApplication, which is far beyondFDAAs expected, some customers will submit thousands of copies at a timePMTAAccording to the internal process of the application, you cannot just look at the first few applications and say yes or no, no matter how poorly or comprehensively their application materials are, even if the reviewers come up, the final conclusion must be thousands of applications. All applications are refused for review. However, they must be read according to the process. Therefore, this huge amount of data really slowed down progress.

In addition, becausePMTAThe application rules of the application for drugs are much newer than those for drugs. Many applicant units have neither a comprehensive nor thorough understanding of the regulations. Some applicants even write nonsense in order to rush to get on the bus, which results in strange application materials.The application did not followFDARecommended standard format or content, greatly increasedFDAIt is difficult for the "marking teacher" to review and improve the efficiency. The most important thing is that not onlyFDAThe leadership of our country is changing frequently, and even the staff and technicians working at the grassroots level are constantly adjusting., this makes many projects have to be replaced halfway, and even multiple substitutions occur. Newcomers need time to familiarize themselves with the process and work, resulting in even lower efficiency.

For the above reasons, even if many applications have been submitted for a long time, they have not yet been reviewed. This is the reason why many applicants have not seen any responses so far; there are also some applications even if they have the time to be reviewed, but because there are not enough technical personnel, it happens that the brand influence of the application is not strong enough, so find a non-technical reason to issue a rejection order to relieve the pressure.Whether the company files a lawsuit seriously or resubmits the application, it can delay it for a while longer. I feel like I don't bite if I have too many lice, and I don't worry if I have too many debts.But one thing is certain,FDAThe aggressive operation of the company is not only aimed at China companies, they treat everyone the same。sinceCTPnew directorBrian KingIn place,FDAThe chaos has been rectified visually. Although there is still a long way to go, it is indeed much better than at the beginning. This year is the most critical year.CTP#p#Pagination Title #e#Deeply criticized, they have already fought back in the Jedi, believing that they can clean up their internal affairs and regain their glory.

By the way, it is understood that whileFDADuring this period of "civil strife", tobacco companies in the United States have turned toFDAThe staff offered an olive branch. We know the originalCTPBoth the director and the director of the Office of Scientific Review have joined tobacco companies, but what we t know is thatFDAA large number of grassroots employees also joined various tobacco companies during this period. In this regard, the positive understanding is that theseFDAFormer employees will correctPMTATransfer operating methods and concepts to enterprises so that enterprises can better follow themFDARequirements for application and management. But at the same time, these companies in the United States have also virtually established a relationship withFDAWith a communication bridge, they will more conveniently express their demands and make it easier to revise and improve industry standards. Then gradually expand the country and Chinae-cigarette enterprisesThe "soft power" gap.

2. About multi-flavor tobacco oil

This is an unclear and sensitive topic, but everyone agrees that menthol should not be stuck, and at the same timeFDAIt is also more likely to put in more flavorssmoke oilCome out and wait for tobacco oil companies and products to passPMTAAfter that, open appliances may be approved. This is similar to my previous judgment. Next year is the U.S. election, so this year, there will definitely be a conflict between the two parties.e-cigarettesAgreement was reached on tastes, and corresponding policies were formulated. With the endorsement of these policies,FDAOnly then can we follow the rules.

Therefore, in theory, for multi-flavor tobacco oil, we still need to wait for conclusions at the policy level. However, from the general trend, there are many flavors of tobacco oil. Therefore, domestic tobacco oil companies and open e-cigarette companies should be reminded to make arrangements as soon as possible.PMTA。