Many know AEMSA does not correspond in forums or on social media. As an all volunteer organization, there is just no time. Consumer emails are answered as time permits. I stepped aside from the position of President on 1/1/15 and now serve as president emeritus. Even so I do not have time for forum and social media correspondences. If any have questions, I will do my best to reply through PMs only and reply when I can spend the time to do so.
I just found this thread and took a few minutes to skim thru it. I decided to post to clarify a few issues on which I see ongoing inaccurate speculations.
1) AEMSA made no new changes - this thread started with misinterpretations of a vender/member email to their customers. AEMSA is not addressing anything not posted (we continue to research issues). AEMSA does not "impose" anything - the members vote on their standards, dues, board of directors and bylaws. AEMSA does NOT restrict mg level offerings to specific numbers - and there is nothing stopping any member from making 3 mg, 2 mg or 1 mg (other than their own business decisions). Moreover, there is nothing anywhere in this industry that says mg levels have to be 6, 12, 18, 24 - could just as easily be 1, 2, 3, 4, 5 ... 8, 10, 11, 14, 15, 17, etc. The industry started with 6, 12, 18, 24 (mostly coming from China) and those numbers just stuck. As some of you have pointed out, you can mix together different mg levels of the same e-liquid to achieve almost any mg level with no dilution of the original flavor: if you want 2 mg: buy 6mg and zero (same flavor obviously) and combine 2 parts zero mg to one part 6 mg. If you want 10 mg (or 8mg or 7mg, etc): buy some 12 mg and some 6 mg and combine accordingly. Even after FDA regs become final (in whatever form or structure), as long as refillables are allowed - and levels may get limited by the costs of applications - consumers can still buy higher and lower mg levels to combine to have any mg level they want in between the highest and zero - just some simple math and measure to your preference.
2) The vender/member email (where this thread started) could have been worded more clearly but there is nothing in the standards that prevents a member from fulfilling custom orders (as long as the standards are maintained). The DA/AP in flavorings has been an ongoing focus and a very difficult and expensive problem to solve uniformly. Testing is expensive, reformulating takes time, competitors continuing to sell untested flavors, etc., etc. AEMSA members have been wrestling with these issues at great expense and effort. There is no clear solution but we all know (plenty or material - seek and ye shall find) that DA and AP are known inhalent risks. If they can be eliminated from e-liquid - it just makes sense to eliminate a known risk and AEMSA members are working very hard to accomplish that. Many e-liquid manufacturers, not just AEMSA members, are changing product lines and eliminating high risk flavors and/or reformulating - many (including many non-members) are also testing their products - ask your vendor/manufacturer because many are happy to discuss (especially those working hard to make sure they are providing their customers with quality products and ingredients). AEMSA's position is clearly posted here:
AEMSA Recommends Flavor Testing | AEMSA
3) no one knows what will be in any FDA final rule. The NPRM does have extremely problematic issues with application filing requirements - estimated by FDA to demand 5000 hours each and extensive and expensive processes for each application. The NPRM indicates they anticipate ONLY 25 applications (we have probably 2000, 3000 or possibly more e-liquid manufacturers and all have multiple flavors, multiple MG levels and some still offer different diluent (VG/PG) ratios - EACH WOULD BE A SEPARATE application). They also have a problem on their hands with zero nic as that has nothing "derived from tobacco" and therefore does not fit the TCA "tobacco" definition. It is understandable that some venders may be preparing for the NPRM to become the final proposed rule but all will remain speculation until the FDA makes more announcements. The FDA held a workshop in December and another is scheduled for March 9 & 10:
March: A Public Workshop ? Electronic Cigarettes and the Public Health before people criticize e-liquid manufactures, they might actually READ the NPRM first and then ask questions - otherwise its just "draw, fire, aim".
4) WTAs!!! This has been addressed so many times that I am amazed to still see people discussing it like AEMSA "did something". Hopefully the facts will eventually circulate. AEMSA is a professional trade association of, by and for its members. More importantly, AEMSA is a STANDARDS organization and members agree to those standards with VERIFICATIONS (everything in the standards gets verified through on-site inspections - both scheduled and surprise - evidentiary documentation, random product analysis and much more). When AEMSA launched in October 2012, we approached both manufacturers of WTAs (there were only two when AEMSA launched - do not know if others now), sat down with both and had the same discussion with both: we have no issues with WTAs and see how they can help people get off tobacco. But we ARE a
verifications organization and we do not spend members' dues money to test non-member products (which would be unprofessional anyway). We told the WTA manufacturers that if they wanted their products to be considered by AEMSA for our standards, THEY - THE WTA MANUFACTURERS - would have to submit quantitative GCMS results to our SMEs for evaluation and that is were the conversation could begin.
They refused. AEMSA verifies all member are operating in compliance with the standards and requires batch level traceability with batch level evidentiary documentation for verifications. So ALL nicotine used is batch quality verified and traceable, all VG and PG are USP Certified (seal cracked by member and nic suppliers), etc. WTA manufacturers did not want to show even one round of analysis of their product (no less every batch). As an organization that verifies everything - it cannot ignore a nicotine product verification (especially one involving a chemical extraction process). And no AEMSA members add WTAs to their products - and THAT is the AEMSA standard (
that it cannot be added as we have no verifications on the product). There is nothing stopping any consumer from buying WTAs and adding them to whatever e-liquid they wish. AEMSA is not advocating anything in regards to WTAs and WTAs have never even mentioned in our advocacy. The plain and simple fact is: AEMSA position on WTAs (a tobacco/nicotine product) is one of verification - just like nicotine. Standards verifications would be worthless to verify nicotine and not WTAs.
The simple fact IS the manufacturers of WTAs are the ones who are refusing verifications. AEMSA remains open to the discussion but, as we indicated back in 2012, that discussion can only
start with verifications (quantitive GCMS)
from WTA manufacturers (just as all AEMSA members do likewise for their nicotine).
AEMSA has now proven, with over two years of operation, that it is exactly what it presents itself to be - a standards and verifications organization promoting good product stewardship through verifications of the standards. AEMSA makes many presentations and is 100% consistent in clarifying it represents their members and only their members. We have presented before the FDA 5 times (4 in Listening Sessions), met with OMB/OIRA, attend the FDA workshops, top level industry conferences (often invited as speakers), have highly credentialed-qualified and well respected SMEs and advocate for refillable e-liquids. AEMSA is self-regulation, promotes self-regulation and works very hard to demonstrate there ARE ways to regulate these products with reasonable, realistic and sustainable consumer protections through good product stewardship. When we go to the FDA, we take SMEs with us - as VERIFICATION of the science facts. AEMSA is not trying to control anything - we have worked tirelessly, and voluntarily for no pay (yes, I am an unpaid consumer volunteer with no financial interest in the industry), to advocate FOR refillable e-liquids and to help the government see that there ARE ways to keep these products on the market with "reasonable, realistic and sustainable regulation" (in other words - we are directly fighting for refillables).
FDA regulations WILL have standards and likely much more strict than AEMSA's. AEMSA members ARE being responsible in that they are meeting the standards and willing to have their operations, processes and ingredients verified. Their customers have the comfort of knowing the quality of the ingredients, the cleanliness of the labs, that bottles are sealed and nothing can be added, proper labeling, tamper evidence, childproof caps etc. (just like ALL other consumable products on store shelves).
I am not defending AEMSA; our members are happy and we are an organization of, by and for our members so it is their happiness with the organization that counts most. I, personally, am just getting tired of seeing accusations that have absolutely zero facts to support them (more draw, fire, aim). I am a co-founder of AEMSA and served as president for the first two years. I have put in countless hours, traveled to perform many of these inspections, traveled to conferences and meetings, presented before FDA and other governmental bodies - all because these products changed my life and I want to see them stay available to everyone. If you have specific
questions about AEMSA, PM me and I will try to find time to answer questions (not accusations). If you genuinely want to learn about AEMSA - ask, baseless accusations are no better than the junk accusations we see posted in the media about vape products.
If you want to see the quality and content of AEMSA advocacy, we have one of the most comprehensive and professional public comment submissions to the FDA's NPRM; it is a public document (available on the FDA postings of submitted comments) and we have it clearly posted for any and all to see:
http://www.aemsa.org/wp-content/upl...ents-to-Proposed-Deeming-Regulation-Final.pdf
