OCTOBER 4, 2013
AEMSA publicly announced its existence one year ago. However, that was not the true beginning. The idea of establishing some sort of collaboratively agreed upon self-regulating standards, and setting some sort of example for the e-liquid manufacturing industry, had been discussed by many different people and different groups for several years. In fact, the co-founders of AEMSA (both consumer volunteers) had been discussing the concept, in the more theoretical context of “someone should…”, for over six months prior to the first real discussion actually exploring the possibilities.
That first serious exploratory discussion occurred at VapeStock 2012. Linc Williams and Lou Ritter, over lunch, had the same repeating conversation “someone should…” Later that afternoon Linc took the initiative approaching a few e-liquid manufacturers, ones he knew well enough to broach the subject, and invited them to dinner. That night Linc, Lou and owners of some professional e-liquid manufacturing companies further examined the concept. The manufacturers not only liked the idea, they agreed to become the first founding members of an organized effort to further explore forming such an association. The actual name AEMSA came later but the 5 Core Belief Statements were solidified at that dinner table.
As those Belief Statements were discussed and refined, Linc and Lou were further impressed by a point raised by one of the manufacturers: “The Standards should be high, high enough that every member (including us) has to reach upwards to make operational improvements and changes to meet them”.
Everything AEMSA does, advocates and/or represents today is an extension of those 5 Core Belief Statements – in one way or another. They are the very foundation on which AEMSA was built and continues to grow and mature.
October 8th marks one year from the official launch of this ground breaking effort, we decided to review the path from that first dinner through today and highlight some of the milestones.
JUNE 9TH THROUGH OCTOBER 8, 2012
from inception to launch…
This period was the real testing ground for this group to grow the membership, organizational structure and basic advocacy message (the Standards). Videoconferences commenced, sometimes four or five each week, to discuss the details. How to expand the group, how should the organization be structured, what does such an organization need to operate (financially, specialists, etc.) and other related topics were exhaustively discussed.
Each and every line item of the Standards and By-Laws had to be discussed and refined in extreme detail. Finding/defining “Reasonable, Realistic and Sustainable” commonality was not always easy; there certainly were a few bumps in the road. Keeping the bigger picture goals (their industry, Harm Reduction and advocacy) in the forefront prevailed.
SEPTEMBER 21, 2012
AEMSA approached Ph.D. Organic Chemist Kurt Kistler inviting him to be the first Subject Matter Expert (SME). All knew of Dr. Kistler’s involvement in the “community” and as an individual advocate for science based safety, accuracy of content, and other various points related to product stewardship and consumer protectionism. All agreed that Kurt’s advocacy positions aligned well with AEMSA goals and his expertise would greatly facilitate. The invitation was extended and immediately accepted. Dr. Kistler was (and continues to be) enthusiastic about the group, the potential for such an organization to make a difference and creating an advocacy platform.
The structural and operational details continued to be refined. By Laws were ratified, the first version of the Standards was also ratified (knowing it would be a fluid set of Standards to be amended and refined over time and with newly available science and information). Dr. Kistler’s significant and substantial contributions to the development and refinement of the nicotine Standards were invaluable. State level Articles of Incorporation were filed, as was the application for federal exemption 501(c)(6) status.
OCTOBER 8, 2012
AEMSA launches with first public announcement.
This was an interesting time and the launch brought some unanticipated responses from the community. During the months prior to launch, the group decided to refrain from public announcement until the organization was a real entity with a solid structure and focus.
Some of the initial reactions, from within the “community”, were somewhat different than we had envisioned. In an unregulated industry, with so many unknowns and/or uncertainties about impending regulatory possibilities, and profound emotional connection to the first truly effective alternative to smoking, some of the initial reactions were understandable.
AEMSA was new, well structured and announced large. It would take some time for people to realize the Association members are just industry manufacturers choosing to collectively represent themselves. The Association provided a professional structure in which they could collaborate on a common set of good manufacturing practices/standards (cGMPs), establish a collective voice/platform from which to advocate (their interests = refillable liquids), and set an example/model for the industry. Their message was simple: we need to more closely focus on consumer protectionism and professional product stewardship in ways more consistent with other commercial consumable manufacturing industries. As time passed, and with AEMSA’s professional consistency in structure, function, actions and advocacy – reactions subsided and support from the community began to build.
DECEMBER 17, 2012
AEMSA presents to the FDA in a Public Hearing
During the formation stages, and right through and past launch, AEMSA held a goal to represent its members’ foci (both form and function of the association and its Standards) to the FDA. Such advocacy is even specifically listed in AEMSA’s corporate charter. No one imagined any such opportunity would present itself just two short months after launch. Presentations were recorded, posted on youtube and shared all around. While responses from the community were predominantly positive and supportive, not everyone agreed. Such is the way of things, put enough people in a room and there will be differences of opinion.
AEMSA availed itself of the Public Hearing opportunity to introduce the Association, its Standards, Self-Regulation and its primary points of advocacy to the FDA and any/all following.
MARCH 5, 2013
MARCH 18, 2013
AEMSA publicly announces working relationship with Enthalpy Analytical and AEMSA’s 2nd Subject Matter Expert (SME)
One of the AEMSA members had begun to work with Enthalpy Analytical (an accredited and well credentialed professional lab with over 20 years experience analyzing tobacco, nicotine, and already a couple years into developing e-liquid testing methodologies). This member introduced Dr. Gene Gillman, the Director of Enthalpy, to the AEMSA Board.
Both AEMSA and Enthalpy quickly realized working together could and would bring the first ongoing (and consistent) accredited laboratory testing to commercially manufactured and publicly sold e-liquids.
After collaborating only a few short weeks, Enthalpy Analytical Directors began to express increasing supportiveness towards AEMSA’s mission(s), Standards, directions and professionalism – all focused on product stewardship. Discussions led to the announcement that Enthalpy Group Leader, and highly credentialed/experienced Ph.D. Organic Chemist Matt Melvin would become AEMSA’s second volunteer Subject Matter Expert (SME).
MARCH 21, 2013
AEMSA/FDA “Listening Session”
AEMSA was granted a “Listening Session” with the FDA, the session occurred on this date. AEMSA presented with a team of six members (2 General – manufacturing – Members, the 2 Ph.D. Organic Chemist SMEs, and the 2 consumer volunteer Co-Founders).
The FDA contingent consisted of approximately 30 FDA representatives from various departments and divisions including CTP, Sciences, Policy Advisors and others. This session continued for close to two hours with many questions from the FDA representatives. We found the FDA representatives interested and engaged in the material. Their questions were relevant, thoughtful and substantive. All of the AEMSA attendees participated in responding to questions from the FDA panel. The AEMSA team unanimously agreed: the session was extremely positive, constructive and a substantial step in the process of advocating for refillable liquids and the profound contributions they make towards efficacy.
MAY 17, 2013
AEMSA presents on “Self-Regulation” to the Tobacco Merchants Association (TMA) annual conference (May 15-17) in Williamsburg Virginia.
During the Tobacco Products Expo (TPE) event, held in Las Vegas in January, AEMSA Co-Founders Linc Williams and Lou Ritter met with TMA President Farrell Delman. Mr. Delman had attended the FDA Public Hearing in December and had seen both Linc’s and Lou’s Public Hearing presentations. Mr. Delman researched AEMSA, its members, Standards, organizational structure and advocacy agenda. Mr. Delman’s findings motivated him to invite AEMSA to make the presentation at the TMA Annual Conference. For this three-day conference, the then new Director of the FDA’s Center for Tobacco Products (CTP) Mitch Zeller was the keynote speaker.
MAY 28, 2013
AEMSA posts ECigAdvanced’s video interview with AEMSA Members.
During VapeBash (Chicago April 12 & 13, 2013) ECigAdvanced’s Kevin Burke conducted video interviews with several AEMSA General Members asking how they feel about participating in AEMSA, the FDA Listening Session and more.
JUNE 10, 2013
AEMSA announces newest Subject Matter Expert (SME) Dr. Konstantinos Farsalinos
Dr. Farsalinos is a Cardiologist, currently performing research at Onassis Cardiac Surgery Center in Athens-Greece and at Medical Imaging Research Center, University Hospital Gathuisberg in Leuven-Belgium. In addition to his several other medically based scientific studies (several now published and Peer-reviewed), effects of electronic cigarettes to myocardial function – as compared to tobacco cigarette smoke – and others, Dr. Farsalinos conducted the first ever study on e-cigarette vapor cytotoxicity potential on cultured cells.
From launch, and prior, AEMSA members had long held Dr. Farsalinos in high esteem for his research, competence, professionalism and advocacy positions. As part of the initial AEMSA launch, links to Dr. Farsalinos’ most recent studies (as of October 8, 2012) were posted on the the AEMSA website links page.
Over time, Dr. Farsalinos followed AEMSA’s progress. Likewise, AEMSA followed Dr. Farsalinos’ continued devotion to researching, advocating and realizing effective Tobacco Harm Reduction through medical/scientific studies of electronic cigarettes and inhaled vapor.
Dr. Farsalinos attended the May TMA Annual Conference as a presenter (with multiple presentations). During the three days of the event, Dr. Farsalinos had opportunity to spend time with AEMSA representatives and Gene Gillman, Director of Enthalpy Analytical (also presenting at TMA on e-liquid testing, methodologies, results and the need for more focus/ongoing testing industry wide). Through these discussions, Dr. Farsalinos was able to become more directly familiar with the representatives and learn more detail about the various foci and directions of AEMSA (and our working relationship with Enthalpy). Near the end of this conference, Dr. Farsalinos approached the AEMSA representatives and volunteered to become AEMSA’s 3rd, and only Medical, Subject Matter Expert (SME).
JUNE 8, 2013
VapeStock 2013 marked One Year from the AEMSA inception dinner.
While AEMSA had only been functioning for almost 9 months, it had been a full year of notable progress since that fateful first dinner. AEMSA members attending VapeStock 2013 got together for a first “anniversary” celebratory dinner (and at the very same Restaurant too).
JULY 12, 2013
AEMSA returns to the FDA for a Second “Listening Session”
The AEMSA Board knew we had introduced the FDA to refillable liquids, nicotine quality issues and Science, content accuracy and all of our Standards – as the primary focus of the Association – during the March Listening Session. It became obvious refillable liquids were somewhat less than familiar to the FDA (with the Industry prevalence being cigarette look-a-likes and/or prefilled cartomizers). We knew the next step was to offer to return and show them the gear (atomizers, cartomizers, clearomizers, tanks, etc.) specifically designed for refillable e-liquids. We also realized showing the FDA just the gear for the liquids would be incomplete without showing them a representative spectrum of the devices on which refillable gear is commonly paired (including safety features like over/under charge protection, short circuit protections, “smart charging”, etc.).
We presented on the evolution, application(s) and contributions these products make towards efficacy. Product samples were made available for FDA representatives to see in both sealed packaging (as sold) and open for hands-on direct viewing. We believe that for the FDA to understand these products, they needed to see and learn about them with direct and actual physical interaction.
It has been an eventful first year…
Countless hours have been spent in videoconferences. Countless miles have been traveled attending various industry events (both within and outside of the “community”), physically inspecting our members’ e-liquid manufacturing labs and operations, making presentations on Self-Regulation, advocating for Refillable e-liquids and their contributions to efficacy.
AEMSA currently has 20 General Members (representing 25 labs – with more labs under construction), 2 Consumer Advocate Volunteers (the Co-Founders), 3 Subject Matter Experts (all volunteers) and more General Memberships Applications currently being processed. We also have more speaking engagements/presentations on the calendar (all invitations).
We are all proud and honored to announce many of the members’ labs are now inspected, completely AEMSA “Certified” and operating in compliance with all AEMSA Standards. Some of our members are building and opening additional labs and we have some recently announced new members. These labs will all be inspected within the next few months.
Our Standards Committee has now been populated and is fully functioning. Amendments and refinements are being reviewed and analyzed for the Committee’s recommendations to the Board and General Membership for discussion and subsequent ratification. We will post the revised 2014 version of the Standards by the end of this calendar year.
Looking forward into year TWO and beyond…
As we look forward, we are all committed to continuing AEMSA’s mission(s), advocacy and focus on refillable e-liquids and Tobacco Harm Reduction. This has been accomplished, and will continue, through the rigorous processes of establishing/refining/maintaining high Standards for consumer protection(s), product stewardship, verifications (inspections – both scheduled and unannounced), maintaining an example/model for the industry, supporting and encouraging ongoing medical and scientific research and more.
AEMSA encourages any/all regulators to educate themselves BEFORE proposing and/or enacting any regulatory legislation. Time and again we have seen municipalities approach legislative efforts (for these products) acknowledging, right on the record, “we do not know”. There are already substantive bodies of scientific and medical research (many are Published and Peer-reviewed) focusing specifically on many different aspects of these products and the various Harm Reduction factors. Such include (but are not limited to): the ingredients, the vapor itself (both first and second hand), effects of electronic cigarettes on myocardial function, cytotoxicity on cultured cells and more. While we acknowledge more research is needed, the results and conclusions in the substantive (and verifiable) research findings already available are notably consistent – electronic cigarettes are exponentially less harmful than combusting and smoking tobacco.
AEMSA encourages (more-so we implore) any and all regulators to learn about these products and read the verifiable studies BEFORE PROPOSING and/or ENACTING ANY REGULATION. Some notable research sources available: Dr. Konstantinos Farsalinos, Dr. Michael Seigel, Dr. Riccardo Polosa, Dr. Joel Nitzkin, Dr. Brad Radu, Professor Etter, Dr. Chris Bullen, Dr. Murray Laugesen, Professor Igor Burstyn, ClearStream LIFE, ClearStream Air and others. The former US Surgeon General, Dr. Richard Carmona, joined the board of the electronic cigarette manufacturing company NJOY in March of this year.
Many research citations can be found on the AEMSA website Links page:
As we approach AEMSA’s second year, we will be conducting Board elections, evaluating and proposing goals, budgets, ways to possibly expand the Association and more. As co-founders, Linc Williams and I are honored by, and proud of, the General Members and all our SMEs.
The SMEs give tirelessly of their time and expertise. They have individually, and collectively, made profound contributions to the Association and our progress overall.
Our Members are making the requisite commitments to raise their operating procedures and facilities to meet and maintain AEMSA’s stringent Standards. These manufacturers (each also are venders) are leading the way by setting the example for responsible, professional, and consumer oriented cGMPs. They are showing the world this Industry can be (and is) responsible, professional, and ready to function under Reasonable, Realistic and Sustainable regulations. AEMSA is the delineation of Self-Regulation, something that has never before been accomplished anywhere near, or in any aspect of, the nicotine industry.
We look forward to seeing the membership grow and continuing our advocacy efforts. AEMSA’s structure is designed to facilitate collaboration, growth, professionalism, creativity and to influence Reasonable, Realistic and Sustainable regulation for the manufacture and sale of electronic cigarette e-liquids. AEMSA has been created, in both form and function, to accommodate any and all professional American e-liquid manufacturers who choose to participate while meeting and maintaining all of AEMSA’s product stewardship Standards.
The AEMSA 5 Core Belief Statements remain the fundamental foundation (or backbone – if you will) of the Association. All AEMSA members are completely dedicated to them.
AEMSA’s Core Beliefs
WE HAVE A RESPONSIBILITY TO:
– Verify the accuracy of any nicotine content in the products we distribute.
– Ensure the quality of all ingredients in our e-liquids.
– Prepare our products in a clean, sanitary and safe environment.
– Ensure our products are packaged and delivered in a safe manner.
– Provide a level of transparency into the monitoring and verification process.
We can watch disinformation, and fear from ignorance, continue to disseminate or we can co-create a structure to educate, inform and facilitate.