36
TOBACCO BUSINESS
SEPTEMBER/OCTOBER 2013
electric
ALLEY
As published on its website,
AEMSA’s current standards
include six sections under
Verifying
the
Nicotine
Content;
six
under
Ensuring the Quality and
Safety of Ingredients in
the E-Liquid; nine under
Clean, Sanitary and Safe
Preparation of Products;
five under Safe Packaging
and Delivery of Products, and
three under Transparency into
the Monitoring and Verification
Process.
• This summer, the association
wrapped up final inspections with its
current membership (12 members and
18 labs), now able to claim AEMSA
certification;members all met every standard
through scheduled and unscheduled
inspections. Additionally, each bears the
AEMSA standards seal, which was granted
trademark protection this summer as well.
• Non-members are also benefitting
from AEMSA’s “mentor protégé program,”
which is “absolutely free” for other e-liquid
manufacturers for the purpose of raising their
standards,according toRitter.“We’ve created
an opportunity for them to work with a
mentor at AEMSA to give them guidance
on lab, equipment, ingredients and materials
standards free of charge.They don’t pay dues
until they’ve become a full member. It’s
something we offer to raise more standards
throughout the industry—those that haven’t
done it yet can learn from those who have
already accomplished it.”
• AEMSA moved forward to set a
regulatory example and be heard. The
association upholds that it was created right
from the start to bring “real science” to the
industry and to “promote and advocate
real manufacturing practices” in light of
impending regulatory issues. “We wanted
regulators to see there are responsible
manufacturers out there operating with
stewardship on their own; we wanted to be
able to advocate an industry role model to
the regulatory arena as well as the regular
market,”says Ritter.
“We had heard from regulators and
political bodies that one of their industry
concerns [was] related to the manufacturing
process and the quality of products, so we
took that as an opportunity to directly
address their concerns, showing that there
are standards out there and cost-feasible
ways to make a verifiable product,” adds
Williams.
And when he says “directly address their
concerns,” he is referring to the fact that the
association moved forward in getting the
FDA’s ear to listen.
In fact, AEMSA met with the FDA not
once, but twice so far in 2013. On March
21, 2013, AEMSA held its first “Listening
Session” with the FDA, introducing the
governmental agency to its structure,
membership, mission, standards, science
behind the standards, and how the standards
are applied by members in their facilities
through scheduled and unscheduled
inspections.
“Even though we know there are a lot of
unknowns in the future of this process, we
feel very satisfied that the FDA embraced
our Listening Session with relevant and
pertinent questions,” begins Ritter.
“They were engaged by the
material we presented,andwe feel
confident the FDA is making
an effort to learn more about
[e-liquids and e-cigs].”
Another
plus
from
AEMSA’sperspectiveisthefact
that 30 FDA representatives
were present for the March
meeting. “We weren’t expecting
that many,” says Williams. “We
got a good feeling, too, because
their questions were engaging, not
adversarial—they wanted to learn
more information, and that is always a
great sign from any governmental agency.
The questions showed they were absorbing it
and considering the possibilities of it—it was
a very positive sign and reflective of its new
leadership under Mitch [Zeller].”
AEMSA then returned to the FDA
for a second Listening Session on July 12,
2013. It brought a representative collection
of sample hardware products (examples
of the most common spectrum, according
to the association) and 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.
AEMSA reports that the FDA panel
for the second meeting was comprised of
approximately 20 representatives from various
departments. The session was scheduled for
one hour and lasted just shy of two hours.
Once again, Williams reports, “we found
FDA representatives interested and engaged
in the material.Their questions were relevant,
thoughtful and substantive.”
TB
Future Electric Alley columns will cover
other emerging electronic cigarette industry
associations, including the Smoke-Free
Alternatives Trade Association (SFATA)
and the Tobacco Vapor Electronic Cigarette
Association (TVECA).
