On September 9, 2021 US Eastern time, Mitch Zeller, director of FDA CTP, released the "opinion" report "on the progress of tobacco product audit and relevant mandatory measures".
People in the industry have been looking forward to this report for a long time, and many enterprises even hope to use this report to determine the company's future development strategy. However, as we predicted before, FDA has not given substantive information at this high-profile moment, such as whether it will cut out the products that have not applied for PMTA in the current market, and whether it will approve which products or enterprises PMTA listing; whether to restrict taste, etc.
FDA gives opinions on the issues of concern to everyone in the form of "opinions" by reviewing and taking the display data as the objective basis. The report mainly includes the following two aspects.
Current audit progress
As of September 2021, FDA has completed the preliminary acceptance of all applications before September 9, 2020, accepted 6.5 million PMTA applications for ends products, and issued more than 200000 RTA (rejected).
As of September 8, 90% of PMTA applications had been accepted for filing, and of course, a large number of RTFS had been issued. On August 9, FDA issued RTFS to 4.5 million pmtas of a company.
On August 26, FDA issued the first MDO (refusal of marketing approval), including 55000 PMTA applications, and the main products are multi flavor tobacco oil. So far, FDA has issued 132 MDOs, covering 946000 multi flavor tobacco oil products.
To date, FDA has responded to 93% of PMTA applications.
Since January 2021, FDA has issued 170 warning letters, including 17 million ends products.
If an enterprise receives a warning letter, it shall give a treatment plan in accordance with laws and regulations (usually off the shelf) within 15 working days. In case of violation, it will be subject to court injunction, confiscation, fine and other corresponding penalties.
A small part of the 6.5 million applications are still under review. FDA will continue to review after September 9, 2021 and issue corresponding processing results.
Based on the current situation, it is impossible for FDA to warn or clean up all non-conforming products in the market, but FDA will use institutional resources to warn and clean up non-conforming products or products in the market that have not submitted PMTA application before September 9, 2020.
Multi flavor products are still the focus of FDA law enforcement. The national tobacco product survey report of the United States shows that young people use tobacco flavor less than other flavors.
The above is the main information of this report. In addition, we also find some descriptions worthy of our consideration from between the lines of the report:
1. With regard to multi flavor tobacco oil and related closed products, FDA does not give a final judgment in this report, but emphasizes again that FDA will fully consider the submitted scientific basis in the audit, so as to judge whether the risk of multi flavor to young people is lower than that to adult smokers. If the proof in this regard is insufficient or unreliable, FDA will issue MDO. This can Therefore, multi flavor is not prohibited, but how to make PMTA of multi flavor e-cigarette products will be the focus of our research.
2. FDA emphasized at the beginning that "there is no safe tobacco product", whether it has obtained the marketing license or not, which shows that FDA's basic attitude towards tobacco products is strict and continuous.
3. Since September 9, 2020, FDA has still received 1 million PMTA applications, and FDA will continue to review the applications submitted one after another. Therefore, no matter domestic and foreign e-cigarette enterprises can submit new PMTA applications at any time, FDA will review and accept them in accordance with regulatory requirements, and the PMTA access system will not change, everything is just the beginning.
Based on the above statements, although this report did not meet everyone's expectations, it is the best answer we expected FDA to give. From this report, we can see FDA's ideas and actions to be taken. Therefore, Ziyuan reminds you that whether you are an enterprise that has operated PMTA or an enterprise that hesitates to declare PMTA, you should declare PMTA as soon as possible. For the overall layout An international market will be forward-looking!
We have reason to believe that FDA will introduce some new regulations and news one after another. We will interpret them in detail one by one in the follow-up. Please keep your attention.