WHAT IS PMTA?

5 FACTS FOR INQUIRING MINDS THAT WANT TO KNOW

If you’re in the business of vaping, you’ve heard about the PMTA. It’s a major event in the industry, which will affect e-liquid brands, distributors, and retailers. But what is it exactly? Essentially, PMTA determines what vape and tobacco products retailers can sell per FDA guidelines. Every Tobacco or Nicotine product made after Feb. 15, 2007 is required to go through this review process. We also give you the top 5 facts about PMTA to help you sort out the process.

1. The FDA has proposed a rule that would set standards for Premarket Tobacco Applications (PMTA’s) and require manufacturers to maintain records proving their Tobacco products meet all legal regulations.
2. The rule that’s been proposed would help ensure that PMTA’s contain all info needed for the FDA to decide whether a marketing order should be issued for the new product.
3. This would give the FDA detailed information regarding the physical aspects of the Tobacco product in question, including full reports and investigations that show potential risks.
4.  The rule that’s been proposed would also codify any general procedures the FDA would have to follow, even when evaluating PMTA’s. This carries over into each phase of the PMTA process.
5. PMTA’s would also then be allowed for submission in alternate formats in certain situations. This would be done to lower the burden of submitting a PMTA for modifications to a product that previously received a PMTA marketing order; or resubmitting a PMTA to address deficiencies specified in a no marketing order.