Master Guide to Vaping Part 10 – Regulation and Legislation
For as long as vaping has existed, it has been met with scrutiny and skepticism. While most people are capable of doing research, looking at the results of scientific studies, and making their own decisions, governing bodies have always sought to enact regulation or legislation for one reason or another. Sometimes it’s reasonable, but most of the time it is overreaching, bordering on prohibitionist. While the regulatory climate is currently at a fever pitch due the exponential growth in the popularity of e-cigarettes, advocates have been fighting for consumers’ rights to vape since at least 2009.
In early 2010, it was determined in court that e-cigarettes were not to be regulated as a drug. The FDA was intercepting e-cigarette shipments from China, claiming that they were intended to treat those with nicotine addiction. The court ended up siding with the vapor industry, saying that the FDA could no longer seize shipments, and could only exercise their authority in a similar way to tobacco products. This ruling is the main keystone of current regulation. While it didn’t declare that e-cigarettes were tobacco products in the legal sense, it meant that if vapor products were to be regulated, the FDA would need to do so differently than it does with drugs such as nicotine patches.
In the time between 2010 and May 2016, when the final deeming regulations were published, vaping advocates have been working on combating unfair local and state legislation (and supporting the sensible regulation, such as prohibiting sales to minors), correcting misinformation in the media and on social media, and keeping consumers informed. With little information about the deeming regulations in that 5-year span, there was also little to act on.
The same tired arguments could be heard time and time again, and when one was debunked, another would surface. You’ve likely heard many of these arguments against vapor products more than once:
• E-cigarettes contain toxic levels of formaldehyde.
• E-cigarettes cause cancer.
• E-cigarettes cause popcorn lung.
• E-cigarettes are creating a new generation of nicotine addicts.
• E-cigarettes cause pneumonia.
• E-cigarettes contain anti-freeze.
• E-cigarettes are harmful to bystanders and those exposed to ambient vapor.
Study after study have debunked these claims over the years, but they keep resurfacing. Let’s quickly tackle these point by point:
• E-cigarettes typically only produce harmful levels of formaldehyde when used at power levels so high that it would be rancid for anybody to vape it. It would be harsh and burnt, and anyone who has ever gotten a dry hit knows that not only is it undesirable, but virtually impossible to vape.
• Analog cigarettes cause cancer because of combustion. Organic matter is burned, which produces tar and other chemicals. It’s even been shown that spending too much time around campfires, candles, or incense increase the risk for cancer far more than e-cigarettes. Nicotine, while addictive, is not carcinogenic.
• Popcorn lung is a condition that affects the lungs. It was first discovered/contracted by popcorn factory workers, hence the name. It’s caused by the inhalation of diacetyl, a main component of butter flavoring. The same flavoring can be used in e-cigarettes. However, out of countless popcorn factory workers, only a handful have ever been diagnosed with popcorn lung. Additionally, they were exposed to diacetyl in other forms, not only vapor, and at much higher levels than an e-cigarette could ever produce. Nonetheless, e-liquid manufacturers have taken steps to either eliminate diacetyl from their e-liquids, or at least disclose whether or not certain flavors contain it so that consumers have more information when making their purchasing decisions. Studies done by Dr. Farsalinos have shown that diacetyl is an unnecessary added risk, which is why many e-liquid manufacturers have worked to eliminate it from their e-liquids.
• There is absolutely no evidence that vaping leads to smoking. While more teens than ever are vaping according to study done by the CDC, more adults are also vaping than ever before. Simultaneously, teen smoking is at an all-time low. In an ideal world, nobody would smoke or vape, but we don’t live in some sort of utopia. Given the choice between underage smoking and underage vaping, underage vaping is the lesser of 2 evils. While it certainly cannot be condoned, teen vaping also can never be completely eliminated, just as with underage drinking or smoking. It’s an unfortunate aspect that needs to be accepted given the overwhelming positive consequences of vaping in general.
• Pneumonia isn’t caused by inhaling vapor of any kind. If it were, everyone would have pneumonia since water vapor is in the air. Anyone who entered a sauna would get pneumonia. This is just a baseless attack on vaping with no basis in common sense, let alone science.
• E-cigarettes do not contain anti-freeze, but they do share an ingredient, which can sound bad out of context. Propylene glycol is a main ingredient in e-cigarettes and e-liquid flavorings. Given this information, one could make an analogous argument that food-grade flavoring contains anti-freeze, but that’s not the most egregious part of the argument. Propylene glycol in particular is used in anti-freeze precisely because it’s non-toxic. It mostly replaced ethylene glycol many years ago, which is toxic. In the case of an anti-freeze leak, propylene glycol poses far less risk to animals, pets, the environment, etc.
• A study conducted by Drexel University showed that ambient vapor posed no risk to bystanders. While it is viewed as inconsiderate to vape in close proximity to others, it’s not harmful. Ambient vapor is virtually indistinguishable from air.
Even with vapers and advocates trying to get correct information out there, misconceptions are still rampant. Believe it or not, public perception of vaping is important. Not only that, but legislation has been crafted based on misinformation or even simply doubt as to the safety of vaping.
In the vacuum left by the lack of federal regulation, local and state legislatures began enacting policies to restrict where people could vape, tax vape gear and e-liquid, and restrict sales to minors. The intensity of these laws varies across the country from reasonable, to ridiculous, to unconstitutional. Indiana in particular recently had a policy overturned that put the majority of e-liquid manufacturers out of business, although not before the damage was already done. Not only can unreasonable regulation affect public health, but also the economy by putting companies out of business and people out of work.
As of May 2016, the FDA deeming regulation has started to come into effect. The original document is 499 pages long, but the main points of it are clear. When attempting to comply with FDA regulations, there are 3 avenues that a tobacco product can take: substantial equivalence (SE), substantial equivalence exemption, and premarket tobacco application (PMTA). SE must prove that a new or modified tobacco product is basically the same (substantially equivalent) to a product that was available on the market before 2007. Substantial equivalence exemption still requires a product to be on the market before February 2007, but that product must have not been altered in any significant way. PMTA is the only path relevant to vaping, which is a new product, and legally a tobacco product as of May 10, 2016. Unfortunately, the PMTA process is prohibitively expensive and time-consuming, resulting in a de-facto ban on 99% of vapor products.
To put this in perspective, let’s say a company carries 300 unique products in terms of hardware. That includes batteries, mods, atomizers, tanks, kits, and even cotton and wire. These all are now considered tobacco products since they’re to be used in the context of vaping. In addition, said company also has 50 e-liquid flavors available in 3 bottle sizes, 5 nicotine strengths, and 3 PG/VG ratios. Each variation of e-liquid sold counts as a separate product, and requires a separate application. Between hardware and e-liquid, this company must submit 2550 applications. There may be ways to combine different bottle sizes or nicotine strengths into a single application, but it’s all very vague as to what companies will actually be allowed to do. For each e-liquid PMTA, extensive toxicology and population studies must be done, the latter of which could take years to gather acceptable data. Many vapor companies are relatively small, yet have the largest burden to bear when it comes to weathering the storm of regulation.
Consider a tobacco company that has recently started selling disposables. They offer 2 flavors and 2 nicotine strengths for a total of 4 products. Not only do they only need to submit 4 applications, but the e-cigarettes they manufacture are generally much more straightforward. Additionally, they have hundreds of millions, if not billions of dollars to spend on these applications, more experience dealing with the government, and more manpower.
All this culminates in an obvious end result. If left unchecked, the FDA deeming regulations will put nearly every vape company out of business, remove nearly every quality product from the market, and leave only Big Tobacco and cigalikes standing. It will likely also create a black market. Chinese companies that manufacture vapor products will still have incentive to create new products to sell in other markets, which means they will eventually end up in the US somehow. The scarcity of vapor products and the increased prices will also likely cause vapers to turn, or return, to smoking.
This is why advocacy is so important. Anyone who vapes or cares about public health and the agencies in place that are supposed to safeguard it should take interest and take action. As it stands, the FDA expects the industry to adhere to standards far stricter than those imposed on tobacco cigarettes, and feels the responsibility of consumer choice is too much for the average person. The consequences of the current regulations seem to make no sense, and it’s up to each person to make it known, loud and clear, that there are concerns. Vaping has science on its side, and with a reasonable approach, an effective society and government should be able to come up with fair and sensible regulations for vaping.
The best thing for the average person to do is to follow CASAA and Not Blowing Smoke, two advocacy groups that consistently provide good information and ways to take action. While vendors like Madvapes are working to comply with regulation, advocacy groups and consumers are pursuing every avenue to try and get new legislation in place to mitigate the damage that the FDA deeming regulations will do. Madvapes is currently meeting with congressmen as well as the FDA in person in order to present our case for changing the current regulations, but the combined voice of consumers can be just as loud. Even though some companies have already fallen victim to the regulations (most notably the legendary Provape, makers of the ProVari), it’s not too late for everyone to do their parts and take action!
Currently, the most important thing is to contact your representatives and voice your support of HR 1136. With the current regulation, any “tobacco” product introduced to the market after February 2007 must have an application submitted through the previously mentioned PMTA process. HR 1136 aims to change this date, which would allow products currently on the market to stay on the market without needing PMTA approval. This isn’t a catch-all solution, but it’s an excellent start towards changing the FDA deeming regulations.
The more people that are active in advocacy, the more effective it is. I encourage you to keep up to date with the latest developments, follow CASAA and Not Blowing Smoke and respond to any and all of their Calls to Action, and voice your support of HR 1136. Vaping is likely to be around for a long time to come, but it’s up to each of us to determine whether it will be a dangerous, expensive, and illegal black market or an affordable, legitimate, and life-changing industry.