PMTA or Premarket Tobacco Product Application refers to the process of registering new tobacco products with the government and proving that they’re up to code. A PMTA must be submitted to and approved by the FDA before any tobacco products, whether it’s a flavored vape or new dip, can be marketed within the U.S.

Yes! Fumée is up to date and compliant with federal and state regulations.

In 2007, the U.S. federal government began requiring makers of new tobacco products to submit information and samples of their wares to prove they adhere to all federal guidelines and are safe for public use before those products could purchase advertising or market themselves. In theory this applies to all tobacco products, but in practice most traditional products likes cigarettes and cigars do not have to submit PMTAs because they were on the market before 2007 and are not considered “new products.”

The rule was later updated to require all e-cigarette companies submit and PMTA by July 2019 to be sold – not just marketed – in the U.S. However, the Covid-19 pandemic pushed that deadline back to September 2020, during which time a severe backlog of cases has slowed the process down. The FDA has until Sept. 9, 2021, to decided which new products will remain on shelves, and what will happen to the others.

The administrative review ensures that the product falls under the Center for Tobacco Products jurisdiction and confirm that the stature and regulation requirements of the application are met based upon Section 910 of the FD&C Act and the criteria set forth in S.1105.10. 

To complete a PTMA, companies submit statements of component, ingredients, additives, and properties of their product, a writeup of their principles of operation, and a description of how the product is manufactured. In many cases, clinical trials are also required.

To comply with FDA policy, Fumee also performs batch testing and stability analysis on its product line. As part of our tests, our scientific team checks for:

• Accurate nicotine content using High Performance Liquid Chromatography with Diode Array Detectors (HPLC-DAD)

• Metals in the nicotine product through inductively coupled plasma mass spectrometry (ICP-MS)

• Quantification of Acetates and Ketones in the nicotine products through Gas Chromatography Mass Spectrometry

• Quantification of Glycol in the e-liquids through Gas Chromatography Flame Ionization Detectors

• Quantification of N-butanol, furfural, and Benzyl alcohols

And those are just some of the tests we run! Most importantly, we use laboratory-grade equipment and procedures that follow the CORESTA protocols and GMP conditions.

We have also put together an environmental assessment that documents our manufacturing, supply chain, and disposal processes to determine the impact our company has on the environment and processes to reduce e-waste to the environment.

Because every new tobacco product, including new vape flavors and liquid nicotine products, moves through the same bureaucracy, the process can be time consuming. But the final result — an accepted PTMA — signals to buyers that the product is safe for consumption and has been thoroughly vetted.