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.
Wednesday, June 26, 2013
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