AEMSA/FDA “Listening Session”

AEMSA AEMSA Updates, Federal Advocacy

AEMSARoundBorder-01-01 FDA

Continuing with our stated mission and charter, AEMSA met with representatives of the FDA on March 21, 2013 in the context of what the FDA refers to as a “Listening Session”.

 The purpose of this session was to present our Standards, scientific information and advocate for Reasonable, Realistic, and Sustainable regulation of refillable e-liquids.  Appropriately, AEMSA represented its membership.  A select panel of AEMSA representatives presented our Standards (both in design and in the context of actual application by its members).  AEMSA presented and advocated how refillable liquids enhance Consumer Protectionism, improve efficacy, and incentivize ongoing scientific and medical evaluation and study.

 The structure of the AEMSA presentation:

 –          Introduction of AEMSA and its Consumer founded/facilitated origin: Lou Ritter (Co-Founder and President)

–          Overview of the AEMSA Standards: Linc Williams (Co-Founder and Board Member)

–          Scientific (detailed) presentation of the nicotine Standards, testing methodology and evidentiary documentation: Matt Melvin (Enthalpy Analytical Ph.D. Organic Chemist and AEMSA SME), Kurt Kistler (Ph.D. Organic Chemist and AEMSA SME), and Rich Henning (AEMSA General Member and commercial nicotine supplier)

–          Presentation of AEMSA Standards in actual practice and application by a general member/e-liquid manufacturer: Scott Eley (Vice-President and General Member)

–          Overview of submitted Research Citations (30+ citations): Linc Williams

–          Conclusion: Lou Ritter

The FDA panel was comprised of approximately 30 representatives.  The AEMSA presentation lasted approximately 45 minutes and the Q&A (from FDA representatives to AEMSA) lasted approximately 45 minutes.  All of the AEMSA attendees participated in responding to questions from the FDA panel. We found the FDA representatives interested and engaged in the material.  Their questions were relevant, thoughtful and substantive. Contrary to common belief, we saw absolutely no indications of confrontational or adversarial intent.

 The AEMSA team unanimously agreed: the session was extremely positive, constructive and a substantial step in the process of advocating for refillable liquids and the profound contributions they make towards efficacy.