Vape Perspective: 8/8/16 and PMTAs

Vape Perspective: 8/8/16 and PMTAs

Many people in the vaping industry are familiar with the date 8/8/16. This is the day the Deeming Rule went into effect, which allowed the FDA to regulate vape products. Consumers may not know the intricacies of what regulations went into effect on this day outside of the fact that the FDA now regulates vape products. In addition, the premarket tobacco application (PMTA) deadline of 5/11/20 is approaching quickly. In this post, we will cover how these regulations came to be and how it will affect the vape industry going forward.

The Deeming Rule’s Origins

The Deeming Rule’s history goes further back than 8/8/16: the Family Smoking Prevention and Tobacco Control Act (usually known as the Tobacco Control Act, or TCA) was key legislation in regulating tobacco products and has since extended to vape products. Like many laws in our society, there were lobbyists behind this law. Tobacco giant Philip Morris and the Campaign for Tobacco-Free Kids were involved in the creation of the TCA. This law easily passed Congress and then-President Barack Obama signed the TCA into law on June 22, 2009.

The FDA then created the Center for Tobacco Products (CTP) to collect user fees from tobacco companies. One interesting fact about the TCA is that it grandfathered all cigarettes that were already available, and forced any new products to undergo stricter scrutiny. At this point, cigarettes have already been a part of American society for well over a century. This sort of legislation came under fire from politicians. One politician, Sen. Mike Enzi (R-WY), called it the “Marlboro Protection Act” in a reference to Philip Morris’s role in creating the TCA.

During the time of the passage of the TCA, vaping products were already seeping into the United States. E-cig manufacturers started to file lawsuits against the FDA before the TCA was even passed, and the courts had sided with the vaping companies, granting the industry a stay of execution (at least in terms of regulation). However, the FDA was hard at work to find out how to regulate the nascent (yet rapidly growing) vape industry.

The Regulations We Know Today

By 2014, the FDA released its proposed regulations for the vape industry, which would have effectively killed the vaping industry. Some regulations included the PMTAs previously mentioned, as well as separate applications for components and parts, studies, and toxicological testing. There was also unclear guidance from the FDA, which may have led to even more confusion among vape manufacturers and retailers.

By May 2016, the final Deeming Rule was passed, with a deadline of 8/8/16. The FDA had essentially created regulations that would be difficult, namely because all components and part applications would have to show how each device would work with other components it could be combined with. If you wanted to sell an atomizer with a certain connection, you had to test the device it could be attached to and every eLiquid it could vaporize. This would lead to mountains of paperwork. According to various sources in the vaping industry, the FDA was also still unclear about guidance regarding vape products. In addition, the FDA also left the door open for flavor bans that we are seeing proposed today. As of 8/8/16, there are no new flavor profiles available on the market; all the products you see on are from existing flavor profiles that were created before that date.

One of vaping’s biggest advocates in Congress is Rep. Duncan D. Hunter (R-CA), who actually vaped during a Congressional hearing in 2016 and did so again during a committee meeting in 2017. The appointment of Scott Gottlieb to head the FDA also meant a change in the way vaping was regulated. Gottlieb himself was on the board of a vaping company called Kure, which gave new light to vaping regulations, and it seemed like he was willing to work with the industry. However, Gottlieb resigned in March 2019, and his acting successor, Norman “Ned” Sharpless, was more ambivalent towards vaping. Sharpless said about vaping in an FDA 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.

The Vapor Technology Association (VTA) said about the new 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.” Others in the industry have also hit back against the PMTA deadline. “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,” said Tony Florence, president of Vapor Stockroom LLC, a co-plaintiff with the VTA on the lawsuit against the FDA.

In light of the recent vaping bans, what do you think about these developments? Is the FDA being unfair to the vaping industry? Let us know in the comments below!

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