Welcome To AEMSA
Welcome to AEMSA.ORG, the first and only Manufacturers’ trade association completely dedicated to creating responsible and sustainable standards for the safe manufacturing of “e-liquids” used in e-vapor products (aka electronic cigarettes). AEMSA is an all-volunteer organization, formed by American manufacturers of e-liquids, to promote safety and responsibility through self-regulation.
Our members believe we have a responsibility to self-regulate the e-liquid manufacturing process based on professional criteria. AEMSA aims to accomplish this by creating, implementing and upholding standards for the manufacture of e-liquids.
One of AEMSA’s primary goals is to provide consumers with confidence that our members’ products are manufactured with professionalism, accuracy and in a safe manner. As we approach three years in operation, we have clearly identified and established maintainable baselines for e-liquid manufacturers. Nicotine quality is easily verifiable (per batch) as are a variety of other components in the e-liquid manufacturing process: accuracy of content, quality of ingredients, clean manufacturing environments, appropriate (smear resistant) labels with warning content, child resistant caps, tamper evidence and batch traceability. Verifications are accomplished through a variety of approaches that include, but are not limited to: inspections (scheduled and surprise/un-scheduled – unfettered access), evidentiary documentation, random product analysis and more.
We note that although e-liquid and e-cigarette products manufactured by AEMSA’s member companies may have the corollary benefit of helping tobacco cigarette smokers quit smoking or nicotine use altogether, these products are not intended to be smoking cessation devices or nicotine replacement therapies (NRTs), and are not marketed as such; rather these are recreational use products. Although the available evidence demonstrates that most current e-cigarette users are using these products as an aid to help them quit or cut down on their use of traditional cigarettes, no claims to this effect are being made by AEMSA or any of its Member companies about their products.
Established on Core Beliefs
Nicotine Content Accuracy
We have a responsibility to verify the accuracy of any nicotine content in the products we distribute.
We have a responsibility to ensure the quality of all ingredients in our e-liquids.
We have a responsibility to prepare our products in a clean, sanitary and safe environment.
Responsible Product Packaging
We have a responsibility to ensure our products are packaged and delivered in a safe manner.
We have a responsibility to provide a level of transparency into the monitoring and verification process.
The use of electronic cigarettes (“vaping”/“vapers”) has been, and continues to be, embraced globally as a tool for Tobacco Harm Reduction, as these products provide an alternative to smoking tobacco. Electronic cigarettes do not use or contain tobacco and there is no combustion or smoke of any kind. The vapor produced by electronic cigarettes is created when a battery activates a heating coil that vaporizes the e-liquid. The e-liquid may, or may not, include nicotine as one of the ingredients. Consumers have the freedom to choose the level of nicotine content – including zero nicotine content. Many choose to reduce the nicotine content in their e-liquids over time while others choose to wean themselves off nicotine completely.
While nicotine is extracted from tobacco leaf, nicotine is not tobacco and is not a carcinogen. There are four primary ingredients used in manufacturing e-liquids: vegetable glycerin, propylene glycol, flavorings and nicotine.
We readily acknowledge and respect that nicotine is an ingredient of concern and, along with the other e-liquid ingredients, requires responsible and professional handling and distribution. In particular, the handling and combining of these ingredients, for consumption by consumers, deserves the highest level of quality control. AEMSA Standards achieve this by demanding high quality ingredients, accuracy in content and clean manufacturing environments like other products manufactured for human consumption.
AEMSA is not only for manufacturers. Another aspect of AEMSA’s mission is to welcome and embrace input from non-industry experts, consumers and more. AEMSA is designed to welcome a limited number of Consumer Advocates and Subject Matter Experts (SMEs) as non-manufacturing participants in the organization. Consumer Advocates and SME members can serve on various committees and even the Board of Directors itself. We readily acknowledge and appreciate there are non-manufacturing individuals with professional backgrounds and expertise who can greatly contribute to the overall mission and goals of this Association. We are continuously working to find ways to include many – if not most – of the various interests involved in this industry. Consumer Advocate and SME memberships will be on an invitation only basis.
Finally, AEMSA has been actively meeting with Government agencies and legislators for the purposes of contributing to the formation and establishment of reasonable, realistic and sustainable governmental regulations based on science. We have much to offer and contribute to the regulatory considerations.
We are committed to continue working towards preserving and promoting Tobacco Harm Reduction through the process of volunteer self-regulating e-liquid manufacturing until such time as the government establishes formal good manufacturing procedures. We are committed to providing consumers with a greater confidence in our members’ products, helping our members be ever more prepared for coming regulations and standards and continuing to set an example for the industry (both domestically and globally).
AEMSA’s Standards have been presented to the FDA, OMB/OIRA (division of the White House participating in the final rule-making process), presented at the Global Forum on Nicotine conference held in Warsaw Poland (2014 & 2015) and directly acknowledged by the International Organization for Standardization (ISO).
- Our first year review of activities and progress: Read More
- Our Second year review of activities and progress: Read More
- AEMSA recommends flavor testing and disclosure: Read More
- Regulatory Agency submissions and filings: Read More
AEMSA encourages all USA e-liquid manufacturers to participate directly in this organization and/or raise (and publicize) their own manufacturing standards.
Why is there a need for AEMSA?
Current estimates indicate numbers exceeding Twenty Million people worldwide are using e-vapor products as an alternative to combusting and smoking tobacco. The popularity and use of electronic cigarettes is growing daily all around the world. Vaping is a relatively newer smoking alternative that made its primary debut into the USA approximately eight years ago and has grown in popularity at unprecedented rates.
Electronic cigarettes, e-liquids (with and without nicotine) and vaping are not yet subject to Federal FDA regulation. The U.S. Court of Appeals, District of Columbia, upheld a lower court decision holding that FDA can regulate electronic cigarettes that contain nicotine derived from tobacco leaf as tobacco products once the agency finalizes its “Deeming Regulation”. Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010). Such products that contain tobacco-derived nicotine and intended for recreational (not therapeutic use) could be regulated as tobacco products and not drug-delivery devices. To date, the FDA has not regulated electronic cigarettes or the manufacturing of e-liquids vaporized while using electronic cigarettes. It is also important to recognize that e-liquids that contain nicotine derived from non-tobacco sources or zero-nicotine liquids would not fall under FDA’s tobacco authority.
The FDA has acknowledged its intent to “deem” nicotine containing e-liquids as “tobacco products” in a formally executed Notice of Proposed Rule-Making (or NPRM) on April 25, 2014: Federal Register. While AEMSA acknowledges nicotine is derived from tobacco, we do not agree that electronic cigarettes are “tobacco products”.
The Charter Members of AEMSA decided to create this organization to facilitate, develop, self-regulate and verify standards designed to provide consumers with much higher degrees of confidence in the manufacturing ingredients and processes of these products. AEMSA advocates the responsible and professional approach to the manufacturing process and hopes to contribute to, and assist with, the actual regulatory formation of reasonable, realistic and sustainable regulations (and oversight) for the manufacture and distribution of American made e-liquids in the marketplace.
AEMSA believes e-liquid, as an entirely new consumable product category, requires a new approach to regulation. AEMSA acknowledges the reality that government regulation is on the immediate horizon and advocates for reasonable, realistic and sustainable regulatory structure(s), procedures and oversight(s) that are based on science.
As a newer technology and smoking alternative, various scientific research/testing on the ingredients, health implications, possible impacts of second-hand vapor and more are being conducted by research scientists and institutions around the world. Existing Research. We are all enthusiastic about the consistency of the results of testing completed and in progress – indicating electronic cigarettes are significantly less harmful than combusting/smoking tobacco. More testing is needed, including long-term studies, and AEMSA supports informative testing to effectively and accurately analyze any/all potential health implications of this newer alternative. While certainly not the only consideration, AEMSA believes the primary focal point of potential regulation needs to be on the e-liquids themselves. After all, it is the e-liquids that are being vaporized, inhaled and exhaled.
Vaping has grown at such an unprecedented rate, as evidenced by the industry’s exponential growth rate. Millions of people have transitioned away from smoking altogether and made a complete switch to using electronic cigarettes. Consequently, the demand for these products is also climbing at an unanticipated scale. Such profound demand seeks supply and there is no shortage of those willing to pursue the economic opportunities.
While so many are enthralled by the growth and popularity of this Tobacco Harm Reduction smoking alternative, it has clearly been seen that some form of regulation is both inevitable and necessary. However, the simple identification of this necessity does not help create the needed regulation. We strongly believe AEMSA’s standards, now applied and maintained with verifications for almost three years, and circulated and respected globally, provide realistically obtainable and consistently professional consumer oriented protections for the manufacture and distribution of e-liquid products.
We appreciate the reality that the legislative process can, and probably will, be arduous and lengthy. We have seen fear based efforts to ban electronic cigarettes and vaping in various municipalities around the world. Regulators attempting such bans often self-admit they lack sufficient information and are therefore acting from fear and ignorance. While we do not agree with such actions, we acknowledge these are sometimes promulgated with protective intent. However, even though possibly well intended, such actions could effectively eliminate an obviously popular and effective Tobacco Harm Reduction smoking alternative that seems to be having profoundly positive impacts on millions of lives around the world.
The American E-liquid Manufacturing Standards Association has been created, in both form and function, to accommodate any and all American e-liquid manufacturers who choose to participate while meeting and maintaining all AEMSA standards. This structure is designed to facilitate collaboration, growth, product innovation/refinement and to influence reasonable, practical and effective regulation for the manufacture and sale of electronic cigarette e-liquids. We have established an application and review process along with a full structure for various committees, evaluations, reviews, amendments, and more. Members agree to both scheduled and unscheduled inspections (unfettered access), evidentiary documentation verifications and traceability, random product analysis and more.
AEMSA is a nonprofit 501(c)(6) entity.
AEMSA welcomes and encourages all American e-liquid manufacturers to apply, join and have a VOICE in the growth and development of this unique trade association.