While the FDA has indicated they will allocate $270 million to related research over the next five years, results may not be available for years. Regulation considerations are being actively considered now and the FDA anticipates a final version of the proposed rules in the next year or two. The private sector can move independent medical/science research along at a much faster pace.
One example of private sectors’ expediency: AEMSA sponsored the first and only independent clinical Plasma Nicotine Absorption Levels study; the study has already been peer-reviewed and published. This study, incorporating over 400 clinical blood samples, shows electronic cigarettes (both first and new generation devices) deliver nicotine at a much slower rate compared to tobacco cigarettes. From study idea conception through in-person presentation (completed results) to the FDA, the time frame for this study was only five months in duration. While this time frame is not necessarily representative of all study time frames, it does demonstrate how the private sector can be substantially more expedient. The study was published only two months after presentation to the FDA Nature: Scientific Reports.
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E-Research Foundation has assembled recognized leaders, from all categories of the vapor products marketplace, to participate on our Grant Committee. These categories include leading representatives from: device manufacturing, e-liquid manufacturing (AEMSA Certified Members), non-manufacturing vendors, leading advocacy association senior executives (domestic and international), knowledgeable consumers, leading international forum CEO and public policy.
Any and all proposed studies, to receive finding, must commit to immediate Peer-review and publication to qualify for funding. The Grant Committee will evaluate proposed studies, prioritize based on relevance (e.g. consumer protections and public health concerns, requests for input to the FDA’s proposed deeming rules, and other considerations of significance) and make final decisions on all grants issued. E-Research Foundation also has a team of recognized Advisors to guide the Grant Committee’s understanding of logistics, time frames, cost factors and more. These advisors are all leading Subject Matter Experts (SMEs); each is highly credentialed, knowledgable and experienced.
Independent professional and/or clinical medical/science, independently verifiable through the professionally scrutinized process of Peer-review and publication, will expand fact-based information to further accuracy in global education. Once published, the comprehensive details of each study (including the researchers and their affiliations, abstracts, protocols and processes, and results) will be openly available to consumers, the general public, regulators, manufacturers, vendors, global media and critics alike.