FDA Regulatory Compliance Efforts
USA Vape Lab is committed to being at the forefront of compliance and regulation, and we have been working diligently to ensure continuation of that commitment, even as the laws around vaping change. Recently, the vaping industry has seen an upheaval of new laws, bans, and regulations. Though these changes have been rapid, USA Vape Lab is confident in staying informed and observant of any and all laws and regulations, whether local or national, that may occur.
At present we have been PMTA accepted, and have received our filing letter from the FDA. We are moving into the substantive review phase, FDA evaluates the scientific studies and data presented in the application submitted, to confirm that our products are appropriate for the protection of the public health. As the FDA is still within the first stage of applications, it may yet be some time before we receive the results of that evaluation.
PMTA Review Process
PMTA Review Process
Human Subject Studies (Clinical Studies)
Clinical studies undertaken with our specific products examined the impact on human health to determine their potential impact on public health.
Examination of our specific product through various analytical, chemistry, and toxicology testing of aerosol. This includes use of a testing protocol to measure harmful and potentially harmful constituents HPHCs in tobacco products or tobacco smoke that involves appropriate sampling techniques to select samples for testing and provides reproducible results based on multiple measurements.
Perception and Behavior
To address the perception and usage patterns components of this PMTA, USAVL partnered with a CRO to perform consumer testing, including in-person qualitative focus groups, large scale quantitative online surveys, use diary recordings, and simulated use human factors trials.
Manufacturing and Quality
USA Vape Lab strictly markets only to adults of legal age looking to switch from combustible cigarettes to e-cigarettes. We follow all laws and regulations as well as our own self-imposed strict guidelines to prevent grow our brand with our intended market of adults looking to make the switch to e-liquid products.
As a leader in the vape industry, we are dedicated to providing our customers and partners with complete support. We are eager to share any new information we receive on our PMTA process with out distribution and retail partners for their support thoroughout this process, and look forward to providing our customers with the excellence we are snynonymous with for many years to come.
The Schwartz E-Liquid
5802 Engineer Drive
Huntington Beach, CA