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Bantam: FDA still needs to increase enforcement and transparency of PMTA

2021/03/05|Knowledge

A few days ago, foreign e-cigarettes media conducted an exclusive interview with Bantam, an American electronic liquid manufacturer, on issues related to PMTA, aiming to let more businesses and users know about PMTA.

Bantam: FDA still needs to increase enforcement and transparency of PMTA

Bantam is a manufacturer of hand-made perfumes that are produced from scratch using only high-quality ingredients. The brand adheres to its own standards of quality and transparency, and in fact they use a system: SENTRI ℠ tracking and tracking system, where people can enter the batch number of the electronic liquid bottle to check the quality of the content.

In 2016, FDA announced that according to the revised family smoking prevention and tobacco control act, all tobacco products (including safer nicotine substitutes without tobacco) need to apply for and obtain pre marketing tobacco use authorization (PMTA) to remain in the U.S. market.

In the past few years, the deadline for this application has been moved back and forth many times until April 3, 2020, and judge Paul Grimm of the United States District Court for the Maryland District moved the deadline to September 9, 2020.

According to the tobacco law, all tobacco products need to be authorized in all aspects, including packaging, manufacturing process and product design adjustment. This makes authorization very expensive and time-consuming, leading to bankruptcy or insurmountable debt of many small e-cigarette enterprises.

In an email interview with Bantam spokesman Anthony Dillon, vaping post tried to understand how the brand approached and was influenced by the PMTA process. The following is the full text of the interview:

Vapingpost: what's your general view of PMTA? Do you think it's fair and feasible?

Dillon: Although the PMTA process is complex and resource intensive, it provides a benchmark for all manufacturers of electronic liquids, which the industry lacks so far. Like many other e-liquids categories, we have invested a lot of resources to create the basis for our PMTA submission and continue to invest in PMTA process and aftermarket monitoring resources. We are optimistic about the future of PMTA and believe that PMTA will provide a level playing field for the industry; however, we recognize that FDA still needs to increase transparency and enforcement efforts to optimize the expected purpose of the PMTA process.

Vapingpost: How did you discover this process? Is it controllable? See? Too much time?

Dillon: there is no doubt that the PMTA process is complex and resource intensive; however, we believe that Bantam is fully capable of success. There are many problems to be solved in any new process. PMTA is no exception. We are committed to working with FDA to simplify and improve the process as much as possible.

Vapingpost: when did Bantam start applying? Is it affected by the change of submission deadline?

Dillon: since entering this category, we have been predicting and planning potential regulations, and our team has worked hard to carry out the necessary research and testing required by the PMTA and submitted the application before the deadline.

Vapingpost: how does the PMTA process affect your company and operations?

Dillon: I think it's important to make sure that the PMTA process has affected the entire E-liquid industry - from manufacturers to retailers and consumers. E-liquid companies that have gone through the PMTA process must develop according to their needs in order to stay in the market for a long time. Bantam has been committed to the development and production of high-quality electronic liquid products for adults in accordance with FDA guidelines and applicable laws. That goal has not changed.

Vapingpost: is it challenging to cover the cost of the PMTA process? Do you have to raise the price of the product in order to make up for the loss?

Dillon: since entering this category, we have been predicting and planning potential regulations. However, any new process can bring challenges. At present, our biggest challenge is due to the lack of transparency in the process and the need to take enforcement measures against those who do not comply with FDA guidelines and applicable laws.

Vapingpost: do you have any comments or points you would like to share with our readers?

Dillon: we are proud and confident of the electronic liquid products obtained through the PMTA process, and we look forward to Bantam's products being loved by adult consumers in the next few years. To help ensure this, we remain committed to the PMTA process and intend to work closely with FDA as the process progresses.


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