How AEMSA Aims to Protect the E-cigarette Industry

Source from:  Tobacco Reporter  12/18/2013

As U.S. e-cigarette retail sales nearly doubled from $1 billion to $1.8 billion in 2013 and are expected to cross $10 billion in the next five years, there's no question about it: Consumption is exploding. While the number of people "vaping" grows exponentially, however, the regula-tions and industry standards surrounding the practice and products remain nonexistent or unclear.

Without proper standards, manufacturers and consumerscould be vulnerable to less-than-Good Manufacturing Practices (also known as current Good Manufacturing Practices, or cGMPs), uncertain product quality and manufacturing quality controls. To provide professional consumer protections, Linc Williams and Lou Ritter co-founded the American E-Liquid Manufacturing Standards Association (AEMSA), an all-volunteer trade organization quickly gaining traction within the industry.

To protect and preserve

It all started over dinner at a 2012 industry event when Williams and Ritter met with a few e-liquid manufactur-ers to explore thepossibility of a self-regulation organiza-tion. "We asked ourselves, 'If we had to stand before the FDA to advocate how refillable e-liquids could or should be regulated, what would we advocate?'" Williams recalls.

Now the organization's president, Ritter says the question spurred AEMSA's start and solidified its commitment to content accuracy, quality ingredients, professional manufacturing envi-ronments, responsible/professional packaging and transparency.

Defining their organization's mission was only the beginning for Williams and Ritter. "Building the details for how to define and accomplish these beliefs took months to complete, and our standards continue to receive ongoing review, evaluation and refinement as new science and information becomes available," Ritter says.

Through in-depth research, evaluations, discussions and input from subject matter experts, AEMSA now has a well-developed mission to self-regulate and advocate for governmen-tal regulation of e-liquid products. As a result, manufacturers are taking note.

Reasonable, realistic and sustainable

Ritter and Williams believe e-liquids and e-cigarettes require regulation because all commercially manufactured and publicly sold consumables should be and are manufactured according to cGMPs. "There are potential issues related to ingredients' quality control, content accuracy, manufacturing environments, packaging and traceability," says Ritter. "Consumers need and deserve the confidences of clearly and transparently defined man-ufacturing practices, verifications, traceability and accountability."

He adds that AEMSA's Good Manufacturing Practices Standards address all these issues. "AEMSA constitutes self-regulation, and participation is voluntary, but many of our stan-dards follow the FDA's standards for commercial food manufac-turing," Ritter says.

For AEMSA, providing standards that are "reasonable, realis-tic and sustainable" is paramount, as many e-liquid manufactur-ers are smaller businesses. "We see this industry as somewhat of an analogous cross between commercial food manufacturing and liquor distillation—like microbreweries or micro wineries," Ritter says.  

AEMSA believes standards first need to address consumer protections and good product stewardship. They also have to be achievable and sustainable for smaller manufacturers. Additionally, there must be a realistic path to compliance, as manufacturers can't change their operations overnight. Ritter adds that "cGMPs are already established and are already reason-able, realistic and sustainable for manufacturers of these sizes in analogous industries, including small industries with ingredients of concern like alcohol (or nicotine in this case)."

AEMSA co-founder Williams agrees. "Regulations out of reach for the very manufacturers who created, risked, intro-duced, nurtured and grew this industry would be both a crime and a shame."

Clearing misconceptions

Coupled with this rapid industry growth is an increased miscon-ception about e-cigarettes. "Unfortunately, there is much misin-formation circulating that has been taken out of context and/or is being presented fractionally," says Ritter. He notes a significant lack of public and regulators' awareness relative to the quantity, quality and content of verifiable research available.

"The public, regulators and consumers need to learn about the real and existing scientific and medical research findings— and the proven harm-reduction realities of e-cigarettes," says Ritter. "These readily available published and peer-reviewed medi-cal and scientific studies already answer many of the questions both regulators and the public have about these products." Ritter says these studies include analysis of the ingredients and the vapor itself (from both firsthand and secondhand exposure), effects on myocardial function, cytotoxicity on cultured cells and more.

"The links page on our website lists extensive citations verify-ing that research has been conducted on e-cigs so manufacturers, regulators and consumers can have current and accurate infor-mation," says Ritter. "We acknowledge the need for ongoing medical and scientific research to identify any and all realistic potential health impacts related to these products and their use."

Ritter points to the often-cited public misperception that e-cigarette flavors are a marketing ploy to attract minors. "This is blatantly untrue," he says. "Adults like flavors. There are many adult alcohol products, coffee creamers and even nico-tine replacement therapies with the exact same types of flavors, but they are not accused of marketing to kids." He says these accusations are often targeted toward Big Tobacco's entrance into the e-cigarette market and that, conversely, Big Tobacco actually offers few flavors. "Most of the flavors are sold in the refillable end of the industry, where the manufacturers do not have advertising budgets."

Ritter also says people should take a closer look at the implica-tions that e-cigarettes could be gateway products for minors and adults alike. "Millions of people worldwide are switching from tobacco to  electronic cigarettes," he says. "Once consumers have tried electronic, especially if they stick with it and switch, they often find vaping more satisfying than tobacco."

Ritter says AEMSA's research has found no evidence of con-sumers switching from e-cigs to conventional cigarettes. And, Ritter adds, "The recent CDC survey is often misrepresented. The survey does not reflect teen 'use' rates; it reflects survey participants who have  tried  the products. In context, similar to tobacco products, the numbers of youths who 'try' versus con-tinue to 'use' are very different."

Making tracks

With only one year under its belt, AEMSA has a big footprint in the e-cigarette manufacturing world. It has stood before the FDA three times, was invited to present at the Tobacco Merchants Association Annual Conference and continues to receive invita-tions for speaking engagements.

"We are always looking to further raise awareness of our stan-dards, structure and advocacy messages," says Ritter. "We also encourage ongoing scientific and medical research. While we do not have the publicity budgets of larger industry, we feel we have valid and strong advocacy positions, and we will continue to encourage more and more e-liquid manufacturers to join and further expand the AEMSA voice."

Because AEMSA is a professional trade association, member-ship is voluntary and members can be as active as they wish. AEMSA's structure includes committees for compliance, stan-dards, ongoing evaluations and more. They conduct regular videoconference meetings, and manufacturing members make all major decisions.

According to Ritter, members reap many benefits from participating in AEMSA. "Both they and their customers know how the products are manufactured, that the products con-tain the highest-available-quality ingredients and meet all our standards—with verifications," he adds. "We can and do verify electronically with evidentiary documentation, live video inspec-tions, random product testing and on-site inspections of all labs and operations, both scheduled and unannounced."

AEMSA members have other benefits, too, Ritter notes. "They have direct access to our subject matter experts, accred-ited lab testing, input and feedback from other manufacturing members. Members also benefit from collective representation and advocacy before the FDA, the public, within the industry and more."

The association's collective voice can be much more power-ful than a single voice, Ritter believes. "As members of a professional trade association, members have a level of product credibility backed by verifications."

AEMSA membership is multitiered. Members first identify themselves as gen-eral members. After they pass inspections and verify that they are operating com-pliant with AEMSA's standards, they can identify themselves as "certified members." They can promote their AEMSA member-ship in their stores, on their websites and through their promotional materials. Ritter says this can prove beneficial for members as AEMSA grows. "Word of what AEMSA is, does and means for the consumer is growing," he says. "Obviously, we hope it continues to grow and be shared."

Right now, AEMSA membership applies only to U.S. manufacturers, but the board is exploring alternatives for how they might be able to expand to other countries. Until then, "we encourage every country to  consider similar standards and/or self-regulating organizations," Ritter says.

Manufacturer response

AEMSA received mixed feelings from manufacturers when it first launched. "There is a lot of emotional attachment to this industry, protecting this harm-reduction alternative, and fear of losing product accessibility with governmental regulations," he says. "All of this is completely understandable; these products are having profoundly positive impacts on consumers' lives, and for those around them, too."

Over time, Ritter says AEMSA has proven to be a good steward, and membership and industry support for AEMSA has steadily grown. What started as an association with just eight members has now ballooned into 20, with more membership applications in process.

He believes part of AEMSA's strength comes from its num-bers. "The larger the membership grows, the stronger the advo-cacy message," he says. "Our structure is designed both in form and function to accommodate any and all American e-liquid manufacturers who choose to participate while meeting and maintaining all our standards."

To date, participation has proven beneficial for AEMSA members. "So far, we can only identify positive impacts," says Ritter. "We are proud of our members. They are sort of pioneers blazing a trail of responsible product stewardship, consumer protectionism and advocacy."

Ritter believes the membership's spirit reflects the organiza-tion itself. "Our members are good people with heart and convic-tion," he says. "They are setting a responsible example and model for the industry, advocating tobacco harm reduction, and for the legal right for their businesses to exist and continue to promote harm reduction. Their willingness to help others, even if those others may become their competition, is quite admirable." Enditem