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Vape Perspective: 08/08/16 & PMTA

September 23, 2019

Vape Perspective: 08/08/16 & PMTA

Vapers and those in the vaping industry may know about August 8, 2016. This date is important because that was when the Deeming Rule came into effect. This allowed the Food and Drug Administration (FDA) to directly regulate vaping products. However, what does that exactly mean beyond the FDA overseeing vape products? Many consumers may not know what led up to that legislation. In addition, the premarket tobacco application (PMTA) deadline is approaching on May 11, 2020. We’re going to look into the origins of these regulations and how they affected the vape industry going forward.

The Tobacco Control Act (TCA)
One might have to look to the early days of the Obama administration to find any evidence that vaping was going to be regulated. The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act, or TCA) was the first piece of legislation that was used to target vape products, although it did not originally do so. One thing to remember is that the TCA, like many other laws in our country, had lobbyists behind it. The lobbyists for the TCA were Philip Morris and the Campaign for Tobacco-Free Kids. Then-President Barack Obama signed the TCA into law on June 22, 2009. However, there were critics: Sen. Mike Enzi (R-WY) called the law the “Marlboro Protection Act” in reference to Philip Morris’s involvement in creating the law.

What was the TCA exactly? It regulated all cigarettes on the market that were introduced after the signing of the law. Existing cigarettes were already grandfathered, while new cigarettes had to undergo stricter scrutiny. The Center for Tobacco Products (CTP) was also created as a result of the CTA. E-cig manufacturers were already gaining popularity before the TCA, with some filing lawsuits against the FDA before the TCA was even passed. The courts took the side of the vaping companies, which led to the FDA backing off. However, the FDA was trying to find a way to regulate the vaping industry, which was already growing by leaps and bounds at the time.

The Current Regulations
It took until 2014 for the FDA to release its proposed regulations for the vape industry. These regulations were far-reaching and may have gone as far as to kill the vaping industry itself. The regulations were the PMTAs as previously mentioned in the article, as well as loads of paperwork for components and parts, exhaustive studies, and toxicological testing. The FDA also did not release clear guidance, which may have confused vape manufacturers and retailers. They did not know whether or not they were complying with regulations.

The final Deeming Rule passed in May 2016, with the deadline set on August 8, 2016. In addition, the FDA essentially made it far more difficult for vape manufacturers to compete in the space. All components and part applications had to show how each device would work with the other components it could be combined with. An atomizer with a certain connection had to be tested with every device it could be attached to and every eJuice it could vaporize. Given the number of eJuices and hardware out there today, that would make it extremely difficult for anyone to introduce a new product on the market. Various sources in the vaping industry still reported that there was unclear guidance from the FDA as well. The FDA also left the door open to the flavor bans you are seeing today. There are no new flavor profiles as of August 8, 2016. All the products you see on eJuices.com are existing flavor profiles created before that date.

Some advocates of vaping have appeared in Congress and other areas of politics. Rep. Duncan D. Hunter (R-CA) is one of the most open advocates for vaping. He vaped during a Congressional hearing in 2016 and vaped again during a committee meeting in 2017. Hunter is often known as “the vaping Congressman” in some circles. The former head of the FDA, Scott Gottlieb, was on the board of a vaping company, Kure, and it looked like for some time that he would be more favorable to the vape industry. Gottlieb’s resignation in March 2019 left the vaping industry in a more precarious state. His successor, Norman “Ned” Sharpless, said in a press release , “It’s clear why this topic is a complicated one with many unknowns...I considered this topic as one of the leading issues facing American public health,” he said.

Other players in the vaping industry have also taken notice. The Vapor Technology Association (VTA) spoke about the PMTA deadline back in August. “The arbitrary May 2020 PMTA deadline which the FDA is currently enforcing is simply impossible to meet for thousands of small and mid-sized vapor businesses.” Tony Florence, who also was a co-plaintiff with the VTA in the lawsuit against the FDA, also raised objections about the PMTA deadline. He said, “Our company complied with every regulation imposed by the FDA and invested in our business while waiting for the FDA to deliver on all of the promised PMTA rules, guidance, and standards. We never thought the FDA would wait so long to provide any direction and then immediately shrink the deadline so that we had no chance to stay in business.”

What are your thoughts on the latest flavor bans? Do you think the FDA and state legislatures need to investigate more before enacting these harsh bans? Let us know in the comments below!

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