Premarket Tobacco Product Application (PMTA) FDA explained

From the start, Brewell MFG has been worked closely with the FDA to navigate our ever-changing industry.  Since our core products have been around pre-August 8, 2016, we are here to stay!  We are also in the process of submitting our PMTA application before September 2020 to continue to provide innovative flavors and products for our adult customers.

What happens now?


All vapor products are required to have submitted the PMTA application by September 9, 2020 or be removed from the market.

Many vape brands are expected to close their doors simply due to the time, energy and financial commitments that are required to submit the PMTA.  Rest assured, BREWELL is here to stay and we have been working diligently to continue our reputation as being the best closed system device on the market.

Our plans are to re-launch some of our original flavors with FDA approval...

 

PMTA explained...

A Premarket Tobacco Product Application (PMTA) can be submitted by any person for any new tobacco product seeking an FDA marketing order, under section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health. In order to reach such a decision and to authorize marketing, FDA considers, among other things: 

  • Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
  • Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
  • Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
  • The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product. 
For more information on the FDA's overview, click here: LINK

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