The American E-Liquid Manufacturing Standards Association (AEMSA) is the first and only manufacturers’ trade association completely dedicated to creating responsible and sustainable standards for the safe manufacturing of e-liquids used in e-vapor products (aka electronic cigarettes). AEMSA is an all-volunteer organization, formed by American manufacturers of e-liquids, to promote safety and responsibility through self-regulation.
We had two great interviews with both Schell Hammel, AEMSA vice president, which ran last month, and Scott Eley, president. Part 2 focuses on Eley's thoughts, which he said are important to be distinguished from the position of AEMSA. Areas where he mentions AEMSA can be directly construed as an AEMSA position, but his personal opinion is not the same as an AEMSA position.
Let's talk about the flavor bans sweeping the nation. San Francisco of course was huge, but I am definitely seeing a bump in alerts that are growing in terms of other jurisdictions looking to ban flavors. Can you talk about how dangerous this is in terms of harm reduction?
My personal view on this: The Tobacco Control industrial complex is very large, and very profitable. Prohibitionists, for example, the tobacco control extremists, continue to trap the conversation in the laughably ineffective policy of prohibition. It didn’t work for alcohol. It didn’t work for cannabis. Public health officials are rightfully concerned with the opioid crisis. Clearly taking things off the market doesn’t stop their use. In fact, it makes them even more uncontrollable. Not to mention the side effects of an unregulated and black market.
Organized crime in this country is widely attributed as a direct side effect of alcohol prohibition in the 1920. Cannabis prohibition resulted in a complete ban on medical research. We are just now seeing FDA approve pharmaceuticals based on compounds in cannabis, albeit synthetic.
It’s obvious to everyone that adults like flavors. In, 2009, I ended my 4-pack a day addiction overnight because I realized that I could replace cigarettes with something equally satisfying, and better tasting. Back then I was vaping on, now antique, devices; the same types of devices that FDA would have us return to. I used grape, watermelon, caramel, and mint flavored e-liquid. I am an adult. I like those flavors. It worked for me. I can’t say the same about my attempts of going cold turkey, patches, gums, or even if my only choice for e-liquid was tobacco flavored.
The Continuum of Risk, often talked about by FDA Commission Scott Gottlieb and FDA Center for Tobacco Products Direct Mitch Zeller, is often over looked when a jurisdiction like San Francisco discusses a flavor ban. They are either unwilling or unable to understand that everything comes with an associated risk. If your goal is to reduce harm, then you should focus on the most harmful product, reduce that as much as possible, then go to the next most harmful. Isn’t that common sense? I suspect that it isn’t that they are “unable” to understand that; it’s that they are unwilling to understand that. How else can you ignore data, science, and truth unless you are driven by an idealistic agenda and a lust for power and control?
Moving a cigarette smoker to vaping is a substantial reduction in risk. Should that smoke quit altogether? Of course. But in the alternative, switching smokers to vaping is a huge victory for public health. Flavors only help in that transition. For me, it was grape, watermelon, caramel, and mint flavors. If my only option was tobacco flavors, I highly doubt that vaping would have been a success for me. It would have been another in a long line of unsuccessful attempts to quit combustible tobacco.
What do you say to those who want to ban flavors based on the "marketing to children" argument?
Again, my personal views here. The tobacco control extremists in this country exploit emotions. “Don’t you want to protect children from harm?” Of course. Everyone does. If you have your hand out, which is a better slogan to raise money: “Help us protect kids and save lives.” or “Help us reduce premature morbidity and mortality by educating the public on the continuum of risk and less harmful alternatives.”? One catch phrase allows your organization to have a $7 million payroll, the other catch phrase clearly defines your missions and actually works to save lives at the cost a vast reduction in public interest and donations.
The problem is that if you ban flavors, you essentially hang all adult tobacco consumers out to dry. While I strongly oppose youth smoking, and vaping, you cannot relegate adult consumers to die from combustible tobacco.
This industry, by and large, are not tobacco companies. We were not the companies advertising during morning cartoons. We didn’t use the Flintstones to market our products. We are not attracting youth in order for them to gateway to tobacco products. Considering most of us in this industry started smoking cigarettes in our rebellious teen years and were only able to quit tobacco by vaping, I cannot be convinced that we are trying to attract youth. That is not to say that we, as an industry, don’t have responsibilities. We should not be infringing on other products. We should not use packaging that is questionable. Likewise, the distributors and consumers should let it be known that these types of products are inappropriate for our industry, especially considering the heightened attention we have seen recently.
Youth are going to experiment and the desire to experiment only grows when it’s forbidden or clearly something they shouldn’t do. Two words; Tide Pods. Let me be clear. I am not being dismissive of attempts to prevent youth access. Quite the opposite. But, focusing on flavors in not the solution to preventing youth access.
Scott, I read about your plea to the FDA to suspend the deeming regulations. Can you talk about why this is so important and what you would like to see in an ideal world with the FDA (I realize this is a huge undertaking, so perhaps the top 3 wish list.)
First off, I think we can all agree that the Tobacco Control Act is an inappropriate regulatory instrument for vapor products. It is antiquated, written and implemented with little foresight to future product or technological advances, and was intended to keep future products off the market. It’s a perfect example of unintended consequences. Furthermore, I believe that since I entered this industry in 2009, the industry has matured greatly, albeit with growing pains, and is not mainstream. It’s time to admit that regulation is a fact of life, and this industry, like every other, will be regulated. But it CAN be done in a way the protect future innovation, small-business and educates the public.
Vapor products are not tobacco products and should not be regulated as such. They do not fit under the current tobacco regulatory framework. A new framework needs to be developed. Regulation of tobacco and nicotine products should be based on an evidence-based “continuum of risk” of the relative harm or benefit the products. More harmful products, combustible cigarettes far and away the most harmful, require more stringent regulation. Less harmful products require regulations that encourage adult consumers to move from more harmful to lower risk products.
Regulation of electronic vapor products should be based on industry-generated standards that promote consumer safety through mandatory quality-controlled manufacturing and battery/device safety requirements. These requirements you have to include that Industry should be accountable and transparent.
Regulation must promote continued innovation in the technology, regulation should not impede small business entrepreneurs, and regulation must ensure adult consumers access to the flavors they choose to encourage them in continued harm reduction.
Within the last year AEMSA has expanded its membership beyond e-liquid manufacturers. Can you talk about that decision and for those who don't know, who is eligible? And, why AEMSA?
AEMSA expanded its membership categories and eligibility to encompass all segments of the vapor industry. In 2017, we expanded our categories to include e-liquid components, such as PV, VG, nicotine and flavoring suppliers, hardware manufacturing and device category, and retail/distributor category. Additionally, previous to 2017, our bylaws only allowed to U.S.-based businesses to be members. Now, any business having an impact to the U.S. vapor industry may join.
The goal with the expanded membership categories and eligibility is to unify, within one organization, manufacturing and product standards for all industry touchpoints. It wouldn’t make sense to have an organization just for e-liquid, and organization just for e-liquid flavoring, etc.
Also, given the unique way in which AEMSA operates according to its bylaws, all members, including consumer advocates, subject matter experts and other industry organizations, have opportunity to provide input, as well as crafting, standards revisions through multiple committees. For example, an e-liquid manufacturer may have direct input on e-liquid flavoring manufacturing standards or distributor standards, and vice versa. Standards may only be ratified by member vote. Therefore, we encourage, and welcome, as much industry participation as possible.
For our readers who don't know, why is advocating for this incredibly evolving and interesting industry become near and dear to your heart?
As I mentioned earlier, I was a long-time heavy smoker who tried to quit a number of times using the woefully inadequate “traditional” methods. The products this industry produces, and the enthusiasm seen daily by both consumers, and small-business entrepreneurs, is the best “self-help group” this world has ever seen. And, largely ad hoc and independently driven.
For me, it’s about making sure these products stay fully accessible to adult consumers and making sure small business can thrive in the face of the harmful and traditional big tobacco monopoly.
Can you name the top three current objectives that AESMA is working on (or you) are working on?
The largest initiative that AEMSA has in the pipeline is creation of the next iteration of standards and encompasses e-liquid, component, hardware, and retail/distributor accreditation and certification. Again, AEMSA welcomes broad industry, consumer, and subject matter input on these standards. We have already seen organizations such as UL and their 8139 standard for Electrical Systems of Electronic Cigarettes. We know FDA is looking at crafting manufacturing standards for this industry. There is work and the ISO and ANSI level. Why shouldn’t the industry do everything possible to craft the framework for the products that we understand better than these other groups? FDA, ISO, ANSI, UL, these organization will favor input from the largest companies with the deepest pockets. AEMSA wants the input from ALL industry stakeholders.
Additionally, after meeting with FDA in June, AEMSA accelerated work on an initiative that I can discuss in more detail at a later date. But, I can say that it is a subject matter that FDA took note of positively and they were very interested in hearing more.
There are a number of exciting announcements that AEMSA will release in a short amount of time. Stay tuned!
Finally, what are some things that you wish e-liquid manufacturers would or could do to help their industry and cause?
Actually become active in your state groups. It takes more than just attending a conference call or being a member. Every little way you can help, helps your state fight off flavors bans, or taxes, or any other misguided control attempt.
Educate yourself on laws and regulations. Read for yourself. Don’t trust what social media says. I’ve seen so much bad information spread through social media over the past 9 years. Not properly abiding by laws and regulations has serious consequences that could spell the end to your business due to fines and civil money penalties. Don’t be afraid to spend money on attorneys who understand the laws and regulations. You should see it as an investment!
Listen to, and interact with, the advocacy and education panels at trade shows. Time and time again I see a totally empty audience for a panel. These are the experts. These are the people who are in the ring doing the fighting. This is your opportunity to let them know what they are doing right, or doing wrong. They never take very long, and you’ll have plenty of opportunity to get back to the trade show. Also, can we stop with the swag giveaway right next to a panel discussion while it’s happening?
Finally, there are a number of fights underway from a number of groups. They may be legal challenges, fighting flavor bans, fighting taxes, fighting regulation, fighting to not include vapor products in tobacco 21 proposals, or fighting for standards adoption. We’ve recently seen the industry and community come together to fund the Right 2 Be Smoke-Free coalition after the it had been fighting first the law in Indiana that was ruled unconstitutional on appeal, and now fighting FDA on appeal on similar constitutional grounds. These fights had been going on for a long time with little support outside of those businesses that initially formed the coalition. We all need more broader industry support for all groups.
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