Wednesday, June 26, 2013

Who’s Minding the E-Cigarette Industry?

Should electronic tobacco devices be regulated as tobacco products or are they something completely different? Four new trade associations with varying opinions and agendas guide this booming category.
With 3.5 million e-cigarette users and an estimated $1 billion in smoke-free alternative sales, this up-and-coming industry continues to be as controversial as it is profitable. Central to the discussion is whether or not e-cigarettes are and should be regulated and taxed by the government as a tobacco product.
Needless to say, retailers have several trade groups looking out for their best interests—NACS, the National Association of Tobacco Outlets (NATO) and the Tobacco Merchants Association (TMA) to name a few—but the battle to represent the nascent e-cigarette industry is just brewing. And at just the right time, as the federal government cannot wait to grip its fangs into another of the industry’s promising profit centers.
To help guide manufacturers and retailers alike, multiple nonprofit associations have been formed, each with the purpose of taking a leadership role in representing and promoting the e-cigarette—or entire smoke-free—segment. The roots of the Tobacco Vapor Electronic Cigarette Association (TVECA) go back to 2008 when distributors and other interested parties got together “to be the voice of the beginnings of the ‘e-cig’ industry,” said founding member and CFO Thomas Kiklas.
Among initial activities of the TVECA (originally known as the Electronic Cigarette Association or ECA) were lobbying U.S. Senators and Congressmen for “responsible”  legislation of the products’ import and sales, and providing the media with information about what they are and how they work.
From the beginning, the association took the stand that e-cigarettes are tobacco products because the nicotine they deliver is derived from the plant. The association has never positioned the products as drug delivery or smoking cessation devices.
In 2009, the FDA seized association co-founder Ray Story’s shipment of e-cigarettes, claiming that the technology was an unapproved drug delivery device. When Story took his case to federal court, the court decided in his favor, ruling that e-cigarettes are not drugs/devices unless they are marketed for therapeutic purposes, and that they can be regulated as “tobacco products.” This decision still stands today.
To sway the court of public opinion, the FDA announced that it had found carcinogens and toxic chemicals, including an ingredient used in antifreeze, in e-cigarettes. TVECA refuted the claim by launching a “Truth About E-Cigarettes” campaign and Website (www.truthaboutecigarettes.com). The Website still provides legislators, media and consumers with basic facts and scientific studies about e-cigarettes.
Aside from disseminating information, the association works within the industry to establish codes of business practices and work with legislators to determine taxation and legislative parameters. Members include domestic suppliers (manufacturers and importers) and distributors. Now an international organization, TVECA also includes member organizations from Italy, Germany, the Netherlands and Spain
Building a Foundation
Last year, two new associations came to the industry forefront—the Smoke Free Alternatives Trade Association (SFATA) and the American E-Liquid Manufacturing Association (AEMSA).
Founded by VMR Products (V2 e-cigarettes), Green Smoke E-cigarettes and Johnson Creek Smoke Juice and Electronic Cigarettes, SFATA was formed “to speak for the industry as a whole, including the manufacturers, distributors, retailers, online sellers, wholesalers, importers, end users and ancillary service providers, such as insurance and trucking companies,” according to SFATA’s Executive Director Cynthia Cabrera.
Initially, dues were set high “to weed out people who wouldn’t take the association’s goals and activities seriously,” Cabrera said. Original funding was provided by VMR, Green Smoke and several Chinese companies that became members.
Since then, membership fees have been made more reasonable so they do not present a barrier to entry for smaller companies. Today, SFATA runs on membership dues and donations.
SFATA’s stance on e-cigarettes is that they are neither a tobacco product nor medical device. “Some don’t even contain nicotine,” Cabrera said, adding that VMR and Green Smoke position their products as “adult alternatives,” not smoking cessation devices. “It’s more of a technology product.”
Cabrera noted that the organization wants the FDA to take its time before categorizing e-cigarettes. “The FDA doesn’t have enough information at this time to make an informed decision with regard to regulating e-cigarettes purely as tobacco products. More testing and research has to be done, and we’re promoting that,” she said. “Our main focus right now is educating the FDA about what e-cigarettes are and what they aren’t.”
With the help of its legal team, including an FDA regulatory expert and the agency’s former lead counsel, SFATA is working to put good
manufacturing practices in place for the industry. The association is also battling the “knee jerk reaction” some special interest groups have to a product that looks so much like a regular cigarette with solid information, Cabrera said.
SFATA also offers “grassroots resources” and information to the public on its Website (www.sfata.org). Among those activities are “calls to action” and coming soon are form letters on its site that citizens can use to contact their legislators about particular regulations that pertain to e-cigarettes.
Liquid Verification
AEMSA was founded by two  vaping advocate volunteers, Lou Ritter and Linc Williams, who have no financial ties to the industry and continue to receive no remuneration. It is an all-volunteer organization that represents American manufacturers of e-liquids whether they sell wholesale or retail, online or in brick and mortar stores. Some non-manufacturing participants, such as consumer advocates and subject matter experts may also join by invitation.
“We were concerned about the lack of verifiable product content; there are many individual product Websites, but we didn’t see verifiable product content accuracy and ingredient quality disclosure/accuracy—what ingredients are in these products, the environments in which they are made and we wanted to inform the public about some of the scientific and medical research available,” said Ritter, who serves as president of AEMSA.
“Not only that, but prior to AEMSA posting our standards, many consumers didn’t even know what questions to ask. The posted AEMSA Standards provide detailed information to any and all interested parties, including consumers and regulators,” Ritter explained. “Every consumable product has some sort of regulatory guidelines for consumer confidence and stewardship; we thought this one should too.”
AEMSA considers the e-cigarette to be a “tobacco harm reduction smoking alternative.” Although the organization acknowledges that nicotine is, as Ritter described it, “an ingredient of concern that requires responsible handling,” it does not view the e-cigarette liquid as a tobacco product. “This is a new category of product,” he emphasized.
On AEMSA’s Website (www.aemsa.org) is an extensive set of self-regulatory standards that has been developed “to create responsible and sustainable practices and process for the safe manufacturing of ‘e-liquids’ used in electronic cigarettes” and “to provide consumers with higher degrees of confidence that our members’ products are manufactured with professionalism, accuracy and safety.”
On the site, the organization offers certification criteria and is in the process of actively certifying members, according to Ritter.
“We’re establishing a role model for the industry,” he said. The organization also supports continued research and testing to analyze any and all potential health implications of vaping.
Like the other organizations, AEMSA considers itself to be a “voice” for the industry with the FDA and other regulators. Its members believe that the primary focus of any potential regulation needs to be on the e-liquids themselves rather than on the technology because it is the liquids that are being vaporized, inhaled and exhaled.

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