PMTA is an initialism of Pre-Market Tobacco Authorization. It is a regulation for every new or modified tobacco product manufacturer to submit their product(s) for review by FDA before they can be marketed in the United States.

The pre-market application aims to make the products safe for public consumption and health as decided by the agency from the information required and submitted by the manufacturers. The process which was passed into law in 2009 under the Family Smoking Prevention and Tobacco Control Act (TCA)

Every combination of ingredients and even flavor from a company will have to go through the PMTA approval process separately. The act affects the vaping manufacturers and the companies that produce vape components such as atomizers and drip tips.

 The initial deadline of August 2017 was unfeasible for many manufacturers and even FDA to process the avalanche of applications, necessitating multiple shifts in the deadline and finally September 2020.

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

To an observer outside the vaping industry, you would be forgiven to think the traditional cigarette manufacturers should be at the forefront of the application. Before the law was passed, the foremost cigarette manufacturers, headed by Phillip Morris, negotiated their ways out of TCA as the grandfathered tobacco products.

In essence, all tobacco products in the market before February 15, 2007, go through a less stringent approval pathway. Many new entrees find it difficult to overcome the comparatively high bar for FDA approval. Almost all vaping companies must go through the whole application process, considering the popularity of vape as a better and reliable version of e-cigarette exploded in the 2010s.

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.

To comply with the Tobacco Control Act of public health test, our scientific team performed a thorough batch testing and further periodic stability analysis of the best e liquid possible in our vape disposable. The periodic test takes up to 6 months to ensure the quality of ingredients does not change during storage. We then documented our results.

High-performance Liquid Chromatography with Diode Array Detectors. (HPLC-DAD) and Inductively Coupled Plasma Mass Spectrometry (ICP-MS) for nicotine content analysis were duly checked. Other notable analytical methods used were Gas Chromatography techniques to quantify Acetates and Ketones in nicotine, Glycol in the e-liquids, including N-butanol, furfural, and Benzyl alcohols. Our equipment and procedures are Good Manufacturing Practice (GMP) compliant and strictly adhere to CORESTA protocols.

After reviewing our application, our products, including Fumée disposable menthol vape, are categorized under the Center for Tobacco Products jurisdiction. And we are pleased to inform you that we received our PMTA acceptance letter after meeting the statutory and regulatory requirements based upon section 910. What that means is we are qualified for a substantive review process by the FDA, which is praiseworthy considering several other vape companies that got Refuse to Accept (RTA).

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.

As a consumer, you deserve to be aware of the PMTA status of the tobacco flavored vape juice and others that you are puffing. However, the FDA is bound by federal law not to publish information about such applications. It means vapes with Refuse to Accept status might still be in the market. So, how do you know your vape is found worthy of public consumption by the FDA?

At this time, you can rely on the manufacturer to take you along and inform you about their PMTA's status at every phase. Given a vape company has nothing to hide, evidence of submission and status should be displayed in stores, online and offline.