AEMSA’s Second Year – President’s Review

The American E-liquid Manufacturing Standards Association (AEMSA) has now been in existence for over two years.  Each year, we try to add more services and benefits for our members and advance our advocacy, at the federal levels, for refillable products.  We had a productive first year and you can see that review here: AEMSA’s First Year – President’s Review

That last summary was dated October 4, 2013, as it reviewed the “First Year” of AEMSA’s efforts and activities.  This update will cover AEMSA’s highlights from that date to present.  As you will see, we continue our progress.

AEMSA representatives presented at the TMA Annual conference.  This presentation included a segment by one of our SMEs delineating the Science behind our nicotine standards.

AEMSA representatives, Lou Ritter and Linc Williams, are invited to participate in the SFATA Washington DC “Fly-In”. “Fly-in” events are one aspect or approach to “lobbying”. Organizations (SFATA in this case), and/or professional lobbyists, usually coordinate these events to introduce industry (and/or subject matter) involved participants to members of Congress.  Participants present facts, economic impact(s), informative/educational material, etc. and advocate.  Meetings are scheduled with Congressional offices (more-often Staffers assigned to the industry/issues of discussion).  This is often a first step in opening direct communication with these members of Congress, informing/raising awareness on the issues, and shining light on relevant factors, concerns and/or realities.

AEMSA’s Co-Founder and Chairman of Compliance – Linc Williams – attended a gathering of scientists, experts, policy-makers and industry figures at the E-Cigarette Summit held at The Royal Society in London. Linc met with fellow advocates from many groups (SFATA, ECF, ECCA, ECITA, Vapor Trails TV and more) to discuss the future of E-Cig advocacy and E-liquid good manufacturing practices. This event received global industry attention. Originally, AEMSA was invited to present at this event. Unfortunately we were unable to confirm our ability to attend until after the presentation schedule had been closed.

AEMSA meets with Office of Management and Budget (OMB)/Office of Information and Regulatory Affairs (OIRA) – a division of the White House.

More details on this meeting and the presentation can be found here: AEMSA Meets with OMB/OIRA  The document AEMSA filed with OMB/OIRA, now available on the whitehouse.gov website, can be seen here:  AEMSA’s OMB/OIRA Handout/Submission

AEMSA Sponsors Clinical Study and returns to the FDA with Dr. Farsalinos to present in our 3^rd “Listening Session”.

Immediately after returning from the second FDA Listening Session (July 12, 2013), we began to evaluate the next piece of urgently needed (and most relevant) information we could bring to the FDA and the world.  It quickly became clear that no one (worldwide) had clearly identified the amounts of nicotine actually being delivered into the bloodstream.  Liquids had been analyzed, vapor (first and second hand) had also been analyzed, but no clearly identifying and informative analysis had been conducted to provide what can be referred to as Plasma Nicotine Absorption Levels (PNLs).

Consistent with his usual professional competence, thoroughness and effectiveness, Dr. Farsalinos found effective ways to not only conduct and complete the Study – he also developed protocols that would identify a range of PNLs.  His Study protocols included over 400 blood samples and revealed PNLs from both ciga-likes and a “new-generation” (advanced/”enthusiast”) device at an average/more-common higher energy delivered (watts) level.  Dr. Farsalinos was able to compare these results to formerly peer-reviewed/published study material delineating PNLs from combusted tobacco cigarette use.

The study was conducted at the Onassis Cardiac Surgery Center in Athens-Greece.  The results showed that PNLs from ciga-likes were dramatically lower as compared to tobacco cigarettes.  The “new-generation” (advanced) devices delivered more nicotine (as evidenced by PNL) than the ciga-likes and they became increasingly more efficient at nicotine delivery over the time (more use – cumulatively) of the Study time-window.  The “new-generation” device came closer to tobacco cigarette PNLs, over time, yet indicated tobacco cigarettes still deliver substantively more nicotine puff-for-puff.

While AEMSA merely sponsored this study, and we are proud to share that 100% of our members (at that time) voluntarily contributed the needed funding (above and beyond annual dues), the full study, and all its protocols, were independently designed and conducted by Dr. Farsalinos and his team.  The peer-reviewed and published study, in full detail, can be found here:

Dr. Farsalinos’ published PNLs Study

As part of the FDA’s Notice of Proposed Rulemaking (NPRM) process, AEMSA files a 26-page submission to OMB/OIRA (a division of the White House).  The NPRM is written to “deem” e-cig/vapor products to be “tobacco products” and regulated under the Food, Drug and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009.  This submission to OMB/OIRA is in accordance with the Paperwork Reduction Act of 1995.

This submission addresses the following:

“Specifically, as required by the PRA, you have requested comments with regard to the following: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.”

The full submission can be viewed here:  AEMSA’s submission to OMB/OIRA in accordance with PRA of 1995

AEMSA announces new GMP Specialist SME.  We know our standards are a powerful first step; we anticipate the government may demand industry specific GMPs, so we invited the President of ‘InstantGMP’, Richard Soltero, Ph.D., to help our members learn about real GMPs.  See the full post here:  AEMSA’s New GMP Specialist SME

AEMSA’s president, Lou Ritter, was invited to attend and present at the First Global Forum On Nicotine (Science conference) held at the Marriott Hotel, Warsaw Poland.

“The first Global Forum on Nicotine took place in Warsaw, Poland, in June 2014. The event attracted around 200 people from 26 countries. The discussions were shaped by presentations from the world’s leading nicotine researchers and policy analysts.”

“The context for the conference is that the science and understanding of nicotine is rapidly changing. The arrival of new nicotine delivery systems, along with other lower risk alternatives to smoking, has forced rapid changes in nicotine science, public understanding, and the regulatory landscape. This has implications for many sectors including consumers, researchers, regulators, public health, tobacco control, policy analysts, and industry. The conference was designed to facilitate discussion across sectors.”

“Among the many highlights of the conference were:

• The Michael Russell Oration, delivered by Prof Peter Hajek, on Nicotine Science and Public Health
• An overview of the scientific evidence on nicotine safety
• The first international meeting of consumer advocates – vapers and snus users
• Overviews of the uptake of e-cigarettes and snus
• The first international meeting on e-cigarette standards
• Update on the place of nicotine products in tobacco harm reduction
• New insights into nicotine addiction and health effects
• Discussions on regulatory landscapes in the context of the European Union, the US FDA proposals, and the World Health Organization Framework Convention on tobacco control
• How to engage stakeholders
• Insights into the new science agenda for nicotine”

Many of the Expert presentations, from this 2014 GFN Conference, can be seen (with

the expert presenter’s bios) here: Expert Presentations from GFN 2014

GFN 2015 will be an even more impactful conference event.

Mark your calendars:  GFN 2015

AEMSA responds to the FDA’s request for comments on the Notice of Proposed Rulemaking (NPRM) for the “Deeming Regulation” (Docket No. FDA -2014-N -0189; RIN 0910-A G38), which proposes to deem currently unregulated tobacco and nicotine products as regulated tobacco products pursuant to the Food, Drug and Cosmetic ACT (FDCA).

The AEMSA submission may be one of the most comprehensive and professional documents the FDA will receive from the industry.  The submission is over 100 pages with every position, legal and/or medical/science, supported with correlative and appropriate verifiable citations.   The AEMSA Board of Directors worked intensively with counsel, and our SMEs, to produce this substantial submission.  A full version of AEMSA’s Standards is attached to the submission, as an Appendix, making the submission 118 pages.

The full submission can be viewed here: AEMSA’s comprehensive submission to the FDA’s NPRM

AEMSA continues to receive invitations to attend, and present at, various industry conferences and expos around the country.  Some other events, not already listed herein above, at which AEMSA has presented this year:

• Vapor World Expo – Rosemont IL
• SFATA conference – Chicago IL
• Tobacco Products Conference (TPC Expo) – Las Vegas NV
• Tobacco Merchants Association (TMA)  – Annual Conference, Williamsburg VA
• World Vapor Expo – Miami FL
• ECC – Ontario California
• eCig USA – Las Vegas NV
• Vapor Dynasty Expo – Tempe AZ
• Vapor Summit Expo – Houston TX
• FDA Workshop – Silver Spring MD

AEMSA recommends flavor testing to the Industry.
Our tireless SMEs continue their independent work and research.  An independent study, conducted by Dr. Farsalinos, revealed some known inhalation risk adulterants in some e-lquids; this came as quite a surprise.

Originally, almost all flavorings used in e-liquids came from the food flavorings supply chains.  Diacetyl, a known inhalation risk molecule, had been represented as non-present by many food flavoring suppliers.   A subsequent study, independently conducted by 3 of our SMEs, confirmed the earlier findings and we learned that acetyl propionyl (2,3 pentanedione) – a common substitute for diacetyl – was also identified as present in some e-liquids.

The extensive efforts of our SMEs, combined with expansive analysis (costs borne by AEMSA members individually), performed by accredited labs, helped us learn a great deal about these molecules, the complexities of the food flavorings supply chains and the requisite protocol Limits Of Detection (LOD) needed to effectively identify presence.  While these molecules are not found in all flavorings used, as many have tested to be absent of them, some (including some tobacco flavors – as all artificial flavorings are molecularly composed) do show some varying levels of these molecules present.

Many e-liquid manufacturers, including some who are not AEMSA members, are now testing regularly, removing certain flavors from production lines and/or reformulating.  Hopefully, we will soon see all flavoring suppliers consistently providing batch level test results (using appropriately low LODs).  Some newer industry specific flavoring manufacturers (who provide batch level test results) are entering the market. See our recommendations post here:  AEMSA Recommends Flavor Testing

First announcement and soft-launch of the “E-Research Foundation” (ERF):
As part of the 2014 budget, AEMSA members decided to allocate a portion of their dues to fund preliminary establishment of this new foundation.  ERF’s primary mission is to facilitate advancing research urgently needed to educate consumers, the industry, regulators, media and the world in general.

While there are many different industry organizations, each working on different facets of e-cig/vapor and tobacco harm reduction advocacy, clean and independent verifiable professionally scrutinized research is an essential tool needed by all these organizations.  ERF functions independently, but the idea originated with the AEMSA Board of Directors and the first funding dollars came from the AEMSA members’ 2014 dues.

E-Research Foundation is designed to be a collective funding portal to advance independent medical/science research targeted for peer-review and publication.  As a non-profit foundation seeking 501(c)(3) status, ERF operates in accordance with all rules and regulations applicable to 501(c)(3) organizations and will not participate in inappropriate advocacy (e.g. lobbying) efforts.  The sole mission and focus of E-Research Foundation is the advancement of independent medical/science research subject to the scrutiny of peer-review and publication by the professional medical/science community.

E-Research Foundation has assembled recognized leaders, from all categories of the vapor products marketplace, to participate on the Grant Committee. These categories include leading representatives from: device manufacturing, e-liquid manufacturing (AEMSA Certified Members), non-manufacturing vendors, leading advocacy association senior executives (domestic and international), knowledgeable consumers, leading international forum CEO and public policy.

E-Research Foundation also has a team of recognized Advisors to guide the Grant Committee’s understanding of logistics, time frames, cost factors and more. These advisors are all leading Subject Matter Experts (SMEs); each is highly credentialed, knowledgeable and experienced.  Meet The ERF Team (all serving as unpaid volunteers).

The ERF website has a wealth of information valuable as global education for consumers, the general public, regulators, media and even those who may be opposed to these products.  The “Direct From The Experts” pages provide a substantive list of published studies and even some responses to other “science”.  Also, on the “Direct From The Experts” pages, are video presentations from some of the worlds leading experts in the field of tobacco harm reduction.  We get invited to attend, and present at, top industry leading conferences but the rest of the world does not get to see and hear these global experts and the profoundly important messages they have to share.  We encourage everyone to visit these pages and hear the facts from the true experts themselves.  With permission from the current (2014) leading conferences, ERF has reposted expert presentation videos (and the bios of these experts) on these pages of the ERF website.

ERF will not design studies or protocols. However, it may, from time to time, initiate Requests For Proposals (RFPs). ERF will receive ideas and constructed protocols from researchers that will be considered for funding. Research will be investigator-initiated and investigator-driven.

 There is a great deal of information available within this website.  ERF encourages any and all to spend some time browsing, learning and hopefully sharing this profoundly important material and the urgent need to fund ongoing verifiable science:

E-Research Foundation website

AEMSA returns to the FDA for our 4th “Listening Session”
While AEMSA may not have had new material of its own to share with the FDA, Dr. Farsalinos had completed more independent research studies during the year. Dr. Konstantinos Farsalinos, Cardiologist at Onassis Cardiac Surgery Center in Athens-Greece, is one of the world’s most prolific and well-respected independent e-cig/vapor medical/science Tobacco Harm Reduction researchers. He is also an AEMSA volunteer SME. Dr. Farsalinos tirelessly continues his independent research and presents, around the world, to accurately and factually educate consumers, regulators, industry participants and the general public.

AEMSA brought Dr. Farsalinos to the USA to participate in the TMA research collective funding conference and to be a panelist at the FDA’s Workshop in Silver Spring MD. As he was going to be here, AEMSA reached out to the FDA requesting another Listening Session in which Dr. Farsalinos could directly present 4 more completed studies. Some are already published and others are in various stages of Peer-review and pending publication.

In this Listening Session, four clinical studies were presented. Three of them refer to cardiovascular factors and one refers to respiratory effects of electronic cigarette use.

◦ The first study (published in the journal BMC Cardiovascular Disorders) evaluated the acute effects of electronic cigarette use on myocardial function, in comparison to smoking. The study confirmed previous observations that smoking has immediate adverse effects on cardiac function. Electronic cigarette use did not cause any alteration in cardiac function.

◦ The second study (presented in the annual congress of the European Society of Cardiology) evaluated the acute effects of electronic cigarette use on coronary blood flow and blood carboxyhemoglobin levels. The study confirmed previous observations that smoking has immediate adverse effects on coronary flow (reducing blood and oxygen delivery to the heart muscle), while a significant elevation in blood carboxyhemoglobin (carbon monoxide levels) was observed immediately after smoking. Electronic cigarette use did not affect coronary blood flow or carboxyhemoglobin levels.

◦ The third study (submitted for publication in a medical journal) evaluated the effects of continuous smoking reduction and abstinence on blood pressure in smokers switching to electronic cigarette use. The study found that, in smokers with elevated blood pressure at baseline, switching from tobacco to electronic cigarette use led to significant improvement (reduction) in blood pressure levels after 12 months. The effect was significant for both quitters (who were exclusively using e-cigarettes) and dual users (reduced smoking consumption with the use of e-cigarettes).

◦ The fourth study (published in International Journal of Environmental Research and Public Health) evaluated effects of smoking reduction or abstinence on respiratory function in a cohort of asthmatic patients. Smokers with asthma who switch to electronic cigarette use exhibited significant improvements in lung function at 6 and 2 months. A smaller, but still significant, improvement was observed in dual users.

FDA attendance (15+) included representatives from the Office of the Center Director, Office of Regulations, Office of Science (including Dr. David Ashley – Director of the Office of Science for CTP), and Office of Compliance and Enforcement. As usual, they seemed interested and engaged. They asked Dr. Farsalinos many technical medical/science questions about the studies and results.

2014 closed with AEMSA’s annual elections for the 2015 Board of Directors. This year marks a significant change for AEMSA as co-founder and President (since the formation of AEMSA), Lou Ritter, retires from the lead office.

We are proud to introduce AEMSA’s new President:

Jeff obtained his undergraduate and M.B.A. degrees from Indiana University in Bloomington, Indiana and his C.P.A. certification in the State of Ohio.  After beginning his career with KPMG Peat Marwick in Cincinnati and Indianapolis, Jeff has spent the past 20 years working in healthcare, including pharmaceuticals as Controller with Eli Lilly in Indianapolis and medical devices as Global Spine C.F.O. with Orthofix in Dallas.  He is currently the Chief Financial Officer with Cell Medica, a biotechnology company with a focus on T cell immunotherapy for the treatment of cancer and immune reconstitution.  Jeff grew up in Huntington, WV.  He and his family currently live in Katy, TX outside of Houston.

While Jeff is not directly in the industry, he served on the AEMSA Board, as Treasurer, for the 2014 year.  He well knows this association and its members, missions, foci, finances and operations.  Jeff’s wife, Schell Hammel, owns and operates The Vapor Bar – an e-liquid manufacturer and AEMSA member since November 2013.  The Vapor Bar owns and operates 8 brick and mortar locations across three metro areas in two states.

The AEMSA Board of Directors for 2015 now also has a new Chair of the Standards Committee: Mr. Brett Coppolo.