Will FDA Vaping Regulations Change?

Will FDA Vaping Regulations Change?

May 1, 2017

As the majority of vapers are well aware, the FDA came down hard on the vaping industry with the implementation of its “Deeming Regulations” which claimed authority over vapor products. The regulations treat vapor products just like tobacco products without even considering their differences, nor the potential for tobacco harm reduction as we have seen in other parts of the world. The regulations also come with some burdensome costs that could destroy the vaping industry in the U.S. by August of 2018.

Politicians Fight to Save the Vaping Industry

Although there is building fear of what is to become of the vaping industry under the FDA’s control, there are U.S. politicians who do see the importance of embracing e-cigs for tobacco harm reduction, and they continue to fight for more sensible regulations. From legislation proposing to change the FDA’s predicate date to new legislation proposing the regulation of vapor products completely separate from tobacco products, there is still hope for saving the vaping industry.

The Fight to Change the Predicate Date

The Fight to Change the Predicate Date

To truly understand the most recent legislation proposing a change to the FDA’s predicate date under the Tobacco Control Act of 2009, let’s take a look at the history behind its creation.

The FDA Deeming Authority Clarification Act of 2015

Representative Tom Cole (R-OK 4th District) has been fighting for the vaping industry since 2015 when he introduced the first bill to change the FDA’s predicate date for vaping regulations: The FDA Deeming Authority Clarification Act of 2015 (H.R. 2958). Although the regulations were not finalized until 2016, it was common understanding that the FDA intended to regulate vapor products in the same manner as tobacco products; therefore, politicians in support of vaping saw the need to start proposing legislation to amend the predicate date before the regulations could take effect.

The current predicate date of February 15, 2007, was established with the passing of the Tobacco Control Act of 2009, when the FDA was given authority over tobacco products. Now that the FDA has claimed authority over vapor products, they are now categorized as tobacco products and are subject to the same regulations and predicate date – despite the fact that 99% of current vapor products didn’t even exist prior to 2007. As a result, in order for the majority of current vapor products to remain on the market, they must go through the extensive and costly Premarket Tobacco Application (PMTA) process. The FDA estimates the cost per application would be around $300,000 per product, while tobacco harm reduction experts estimate the cost per product could run into the millions.

To put this into perspective, let’s say a vape company sells just one product – a disposable electronic cigarette. The company most likely also offers quite a few nicotine strengths and flavors. Each combination of flavor and nicotine strength would be considered 1 product. So, if there are 24 flavors and 6 different nicotine strengths, that would be 144 different products, according to the FDA. So now let’s say the PMTA cost is at the FDA’s estimated $300,000 mark: that means the vape company would have to pay $300,000 multiplied by 144 (plus another $300,000 for the disposable e-cigarette itself) – that would be about $43 MILLION just to stay in business with 1 product in 24 different flavors and 6 different nicotine strengths!

So here’s the kicker: most vape companies sell way more products and flavors – some even equal up to more than a thousand. So let’s say a company needs to submit PMTAs for a thousand products, that would be a total of $300 million based on the FDA’s estimates. And, as if that isn’t bad enough, the PMTA approval is not guaranteed – that means a vape company could spend millions of dollars in PMTA applications, only to have the FDA deny their approval. Now you can see why experts estimate that if the FDA’s Deeming Regulations remain unchanged, then 99% of the vaping industry will be forced to shut down, leaving only those owned by Big Tobacco.

Now back to H.R. 2058: Although the legislation did gain bipartisan support with 77 cosponsors, it never made it past the House.

The Cole-Bishop Amendment

The Cole-Bishop Amendment

In an effort to move things along in the fight to change the predicate date, Representative Cole, along with cosponsor Representative Sanford Bishop (D-GA 2nd District), introduced a new piece of legislation referred to as the Cole-Bishop Amendment. Like H.R. 2058, the main goal of the amendment was to change the predicate date. The amendment was voted on during the Agricultural and Rural Development Appropriations bill hearing in April of 2016, and was adopted by the House Appropriations Committee by a 31-19 vote. Unfortunately, the amendment was abandoned after the election of the Trump Administration. Since the Republican Congress was given the option to avoid rushing through the budget bill at the end of the year and the legislative process requires legislation to be acted upon during one Congressional session, the bill would have to be reintroduced during the next Congressional session.

The Cole-Biship Amendment was expected to be attached to the FY17 Omnibus Budget, with the deadline for voting set for midnight on May 5, 2017; however, house Democrats released the FY17 Omnibus Appropriations Act press release early Monday morning which states:

The Omnibus does not include a House provision allowing thousands of unregulated tobacco products to escape full FDA review. The House provision would have exempted e-cigarettes, little cigars, cigarillos, hookah, cigars and other products from the Tobacco Control Act’s pre-market review requirement, allowing products to escape regulations and requirements that Congress enacted to protect the public health from the nation’s leading preventable cause of death.

This is very unfortunate for the industry and for the consumers who have come to rely on the vapor products they have been using for years. If the FDA’s grandfather date remains unchanged, vape companies must submit the costly PMTA’s for all of their products by August 8, 2018.

The FDA Deeming Authority Clarification Act of 2017

Luckily for the vaping industry, Representatives Cole and Bishop also proposed stand-alone legislation for changing the predicate date. Enter H.R. 1136: The FDA Deeming Authority Clarification Act of 2017. Similar to the abandoned Cole-Bishop Amendment, H.R. 1136 would move the FDA’s predicate date to the effective date of the Deeming Regulations of August 8, 2016. While this would allow vapor products introduced to the market after February 15, 2007, to remain on the market without PMTA approval, innovation in the vaping industry will remain stifled, as any new products introduced after August 8, 2016, would be required to obtain PMTA approval. Still, the passing of H.R. 1136 is vital for the vaping industry to keep current products on the market after August 8, 2018. You can show your support for H.R. 1136 by sending an email to your elected officials via the form provided on CASAA’s website.

The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017

Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017

Like Representatives Tom Cole and Sanford Bishop, Representative Duncan Hunter (R-CA 50th District) has also been fighting for the vaping industry and the idea that e-cigs should be used for tobacco harm reduction. One of the most notable moments of Rep. Hunter showing his support for vaping was during a Capitol Hill hearing in February of 2016. In an effort to protest a proposed ban on vaping inflight, Rep. Hunter took a puff from an e-cigarette and proceeded to explain to other House members what vaping is and how it differs from traditional tobacco cigarettes. Unfortunately, the ban still passed by a 33-26 vote and vaping on airplanes has been prohibited ever since.

On April 27, 2017, Rep. Hunter introduced The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017 (H.R. 2194). This piece of legislation would be a serious game changer for the FDA and the vaping industry: it would remove vapor products from the category of tobacco products to be regulated separately as an alternative to tobacco – something that all tobacco harm reduction experts have agreed should have been considered by the FDA in the first place. The legislation would also require the FDA to rename its center for tobacco products to “The Center for Tobacco Products and Tobacco Harm Reduction”, and would require the organization to adopt safety standards for e-liquids and vaping devices established by the American E-Liquid Manufacturing Standards Association (AEMSA) and the American National Standards Institute (ANSI), which would go into effect one year after the enactment of the legislation. There are quite a few other provisions within this piece of legislation, all of which would be beneficial to the vaping industry and tobacco harm reduction in general. Tobacco Harm Reduction expert Dr. Michael Siegel provides a great breakdown and explanation of this new legislation on his blog titled “The Rest of the Story”.

To show your support for this game-changing legislation, you can sign the petition available on change.org.

What’s Next for the Vaping Industry in the US?

While there is no guarantee that any piece of legislation will change the FDA’s Deeming Regulations for vapor products, it seems certain that we can rest assured there are politicians on our side, along with other parts of the world that have finally embraced vaping. All we can do is hope for the best and take every opportunity to voice our opinions to our members of Congress to ensure they have the best interests for public health.