According to the family smoking prevention and tobacco control act, the FDA announced as early as 2016 that all tobacco products need to apply for and obtain the pre market tobacco application authorization (PMTA) to continue to sell in the U.S. market.
Since then, the deadline for PMTA applications was postponed several times by a variety of factors until April 3, 2020, and Paul Grimm, judge of the Maryland district court, postponed the deadline until September 9, 2020.
Under the act, all tobacco products need to be approved in all respects, not only packaging, ingredients, but also adjustments in manufacturing processes and product design. This makes it very expensive to obtain PMTA authorization, which not only requires a lot of financial resources but also takes a lot of time, which makes many small atomizing enterprises unable to bear at all.
FDA has previously sent first warning letters to companies that have not yet submitted PMTA but are still selling unauthorized products.
For companies that submit applications before the deadline, the FDA will usually postpone its implementation for one year, pending review, the FDA explained in a statement released on the official website.
Last September, the FDA announced a list of companies that have not yet submitted their applications. Mitch Zeller, director of the FDA tobacco products center, announced the news on its blog, when the FDA had received about 2000 applications for atomized products and other new tobacco products. "These warning letters are the result of ongoing monitoring of violations of tobacco laws and regulations and Internet monitoring," Zeller said. We want to make clear to all tobacco manufacturers and retailers that FDA is closely following the market and will hold the company accountable for violations. "
"FDA will continue to enforce priority enforcement of companies that are not authorized to market but have not submitted their pre listing applications to the FDA for the electronic nicotine delivery system (terminals) (including e-cigarettes), including those that may lead to the use of products by adolescents.
Foreign media also had email interviews with American atomization manufacturers, reflecting some views on PMTA in the industry.
● what do you think of PMTA in general? Do you think it is fair and feasible?
Although PMTA process is complex and takes up a lot of resources, it provides a benchmark for all atomizer manufacturers, but so far, the industry has not yet met the standards. Like many other products in the atomization category, we have invested a lot of resources to build the basis for PMTA submission and continue to invest resources in PMTA processes and later market oversight. We are optimistic about the prospects for PMTA to promote industry competition, but we are aware that further transparency and enforcement efforts are still needed to optimize the expected objectives of the PMTA process.
● how do you evaluate the process itself? Is it controllable, too expensive and time consuming?
There is no doubt that the process of PMTA is complex and resource intensive. But we think it's easy to succeed. For any new process, it needs to be addressed. PMTA is no exception, and we are committed to working with FDA to simplify and improve processes where possible.
● when will you start submitting PMTA? Do all changes to the submission deadline affect you?
Since entering this category, we have been looking forward to and planning to deal with potential regulations, and our team has worked hard to carry out the necessary research and testing required by PMTA and submitted the application by the deadline.
● how does the PMTA process affect your company and operations?
I think it's important to make sure that the PMTA process has affected the entire atomization industry, from manufacturers to retailers to consumers. The atomizing liquid company that carries out PMTA process must respond positively according to the demand, so as to stay in the market for a long time. We have been committed to the development and production of high quality, adult based aerosol products that comply with FDA guidelines and applicable laws. Whether there is PMTA or not, this principle we adhere to will not change.
● is the cost of the PMTA process challenging? Is it necessary to raise the price of the product to make up for the loss?
Since entering this category, we have been anticipating and planning potential regulations. However, there are challenges to any new process. The biggest challenge we are facing today is the lack of transparency in the process and the need to impose enforcement measures on those who do not comply with FDA guidelines and applicable laws.
● do you want to share other or important views with our readers?
We are proud and confident of the atomization products produced through the PMTA process, and we hope that the products will be favored by adult consumers in the next few years. To ensure this, we will continue to work on the PMTA process and we intend to work closely with FDA as the process progresses.
The atomization industry in China is also about to be supervised. To some extent, similar to the starting point of PMTA in the United States, it is the most urgent problem to solve for the lack of standards for atomization products.
Although even the central and Guangzhou network have said that the age-old e-cigarettes are not completely harmless, compared with cigarettes, the harm is greatly reduced, but it is precisely because of the lack of standards and regulations, which makes the atomization industry grow savagely, and the good and bad are not the same. In order to avoid the unqualified fake and inferior products endangering consumers, teenagers and atomizing industry, it is necessary to supervise and control them.
Most domestic atomization enterprises, similar to those under PMTA, believe that although regulatory measures may have a great impact, they are positive for the industry in the long run.
Or that said, brave people are fearless, and enterprises who really want to do a good job of atomizing products will not fear reasonable supervision, but will actively respond to them and prepare for the arrival of new regulations.