FDA Regulations Update: A Possible Win for Vaping Industry

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While both England and France are moving forward with supporting the use of electronic cigarettes for smoking cessation, the US is still fighting a battle against e-cigs while awaiting the final ruling of the FDA’s Deeming Regulations, and in essence, the future of the American vaping industry. As the majority of US vapers are well aware, the FDA introduced its “Deeming Regulations” for e-cigarettes back in April of 2014. These regulations were introduced to regulate vaping devices at the federal level while also categorizing them as tobacco products. The provisions of these regulations brought on quite a bit of backlash from vaping advocates and the vaping industry as a whole, which has in turn delayed the process. While nearly all e-cig manufacturers and vapers agree there should be some form of regulation for vapor products, there was one provision within the Deeming Regulations that just didn’t sit well with vapers and vaping advocates alike. This provision was the proposed predicate date.

 

E-Cig Laws: The Predicate Date for Vapor Products

FDA Regulations Update: A Possible Win for Vaping Industry

For those unfamiliar with the predicate, or grandfather, date included in the FDA’s Deeming Regulations, it is the date to be set for vapor products to be “grandfathered” in to the premarket application process, a very lengthy (and expensive) process. The FDA’s original predicate date was set as February 15, 2007, when 99% of current vapor products didn’t even exist. What this means is every single vapor product released after that date, from vaping devices to e-liquids, would be required to go through the premarket application process before being reintroduced into the market. While e-cig regulations are imminent, this predicate date would be detrimental to the vaping industry. Luckily, one congressman was bold enough to do something about it.

 

Members of Congress Show Support for Fair E-Cig Regulations

Members of Congress Show Support for Fair E-Cig Regulations

In April of 2015, Representative Tom Cole of Oklahoma introduced HR 2058 in an effort to change the predicate date for vapor products to the effective date of the FDA’s final rule on deeming regulations. Although Tom Cole does not vape, he felt compelled to create this bill after he started receiving calls and letters regarding the predicate date. Rep. Cole has stated, “It seems to me like we’re regulating out of fear instead of out of knowledge”, and went on to say, “There’s no particular logic for this date other than if you want to be punitive towards this industry, without a lot of evidence to justify that at this point.“ Soon after the bill was introduced, vaping advocacy groups opened up calls to action to support the bill by calling and sending letters in to local representatives in an effort to urge congress to change the date to help protect the vaping industry. Over the course of a year, Representative Cole’s bill picked up more than 50 cosponsors, and a similar bipartisan amendment also introduced by Rep. Tom Cole and cosponsored by Rep. Sanford Biship was included in the Agricultural and Rural Development Appropriations bill to be reviewed in 2016.

 

Those Not in Favor of the Cole/Bishop Amendment Say “No”

Those Not in Favor of HR 2058 Say “No”

The House Appropriations Committee held the Agricultural and Rural Development Appropriations bill hearing on Wednesday, April 19th. During the hearing, representatives discussed both sides of the argument on whether or not the bipartisan amendment to change the predicate date should be passed.

Those in opposition to the amendment stood up to speak against supporting this bill while using facts based on the propaganda surrounding the vaping industry. From debunked scientific claims to statements that completely contradict real scientific data, it’s quite obvious the opposing side was using the “facts” that have been circulating the media from anti-vaping campaigns and organizations. Here are a few statements made by representatives to support their opposition:

Rep Nita Lowry: “Study after study on e-cigarettes find that most e-cigarettes show a high level of formaldehyde and other cancer-causing chemicals.”

Rep Rosa DeLauro: “I don’t know how many adults would buy skittles-flavored products, fruit loop flavored products, etc.”

Rep Debbie Wasserman Schultz: “It would seem to me that the only reason this industry exists and that e-cigarettes exist, you know, it’s nice to hear that there are some who believe, although we don’t have data to attach to that, that they have been able to eliminate their addiction to cigarettes through those products, but the reality is that the purpose of this industry is to keep people addicted to nicotine.”

Also by Rep Schultz: “This product is designed to hook kids on nicotine and keep people addicted.”

 

e-cig survey

As you can see, the infamous e-cig formaldehyde study is still rearing its ugly head, despite the fact that the study results were formally debunked. Even more shocking was the statement that there is no data supporting the “belief” that electronic cigarettes are helping smokers give up tobacco. But what really gets me personally is the continued claim that e-cig flavors target children. To the representative who thinks no adult would be interested in candy or cereal flavored e-liquid: I am an adult. I still eat candy. I still eat cereal. And it was a FLAVORED e-liquid that finally convinced me to put down the cigarettes after a 13-year smoking habit. I no longer crave the taste of tobacco and I am not interested in tobacco-flavored e-cigs, but you don’t have to take my word for it—just take a look at the results of the largest e-cig survey to date, and you will see just how wrong you are. Just because your circle of friends does not eat Skittles or indulge in a bowl of Fruit Loops, that does not mean there are no adults in this world who actually enjoy sweet flavors.

e-cig survey

And to the representative who claims there is no evidence to support that e-cigs are being used for successful smoking cessation: First of all, the data is there—you are either not bothering to look for it or are choosing to ignore it. My guess is it’s the latter of the two, because if you do a simple Internet search for “e-cigs helping smokers quit in England”, you’ll see that an entire country has accepted the fact that electronic cigarettes are playing a huge role in smoking cessation. After you get caught up on that, check out the CDC’s most recent National Health Survey and you will see the significant decline in smoking rates falls right in line with the growth of the vaping industry–even the CDC director admitted e-cigarettes are beneficial for smoking cessation. You can also read page after page of testimonials from former smokers and family members of smokers who attribute e-cigs to their smoking cessation. So, if you’re going to be a true representative for our country, you should probably take some time to learn a little more about us before making a blanket claim based on your own personal opinion.

Related: Smoking Rates Decline As E-Cig Use Increases

Anyway, please excuse my rant, although I’m sure some of you reading this now get just as heated when you see nonvapers making claims that completely contradict your personal experiences in making the switch to e-cigs. Luckily, there are some representatives who care to hear what the public has to say.

 

Those in Favor of the Cole/Bishop Amendment Say “Aye”

Those in Favor of HR 2058 Say “Aye”

Now, let’s take a look at the supporting side of the Cole/Bishop Amendment. Representatives for the amendment took a more logical approach in explaining why the bill should be adopted, while referencing Public Health England’s Evidence-Based Review on e-cigs more than once. Here’s what some of the supporting representatives had to say:

 

Rep Tom Cole: “The FDA is effectively making it more difficult to bring a vapor product into the market than a cigarette.”

Rep Hal Rogers: “Let’s support those who are looking for less harmful alternatives to smoking.”

Rep Andy Harris MD: “I’ve met so many people who have benefitted by access to a vaping product rather than tobacco.”

Rep Sanford Bishop: “Many vapor products play an important role in harm reduction.”

 

Now that’s better: representatives who are actually paying attention to all sides of the argument and basing their decisions on evidence, rather than personal opinions. One representative even admitted to opposing the amendment the year before, but he now believes the other provisions included in the FDA’s proposal should be the primary focus and lengthy premarket application processes would take away from that. I’m sure we all agree there does need to be some form of regulations for e-cigarettes, but overregulating will cause more harm than good as it would not only prevent smokers from moving to what evidence continues to suggest is a safe alternative to smoking, but would also put thousands of hardworking Americans out of business. It is disheartening to see that the FDA has not even considered what overly strict regulations could do to the economy.

 

House Appropriations Committee Moves to Change Predicate Date

Here comes the good news: the House Appropriations Committee adopted the Cole/Bishop Amendment by a 31-19 vote. But, here comes the so-so news: Although the amendment was adopted by the committee, it still must go through a few more steps of the legislative process, from the House floor to the Senate, then on to the president. Additionally, Tom Cole’s HR 2058, which is actually a separate piece of legislation in relation to the Cole/Bishop Amendment adopted by the House, has yet to reach the House Committee; therefore, calls to action to support HR 2058 are still being encouraged.

So, what does this mean for the vaping industry? It means we’re not quite out of the woods just yet; however, the 31-19 vote has gotten us one step closer.