A new advocacy group has form to small vapor industry manufacturers navigate the U.S. Food and Drug Administartion’s (FDA) premarket tobacco product appliucation (PMTA) process.
The American Vapor Manufacturers Association (AVM) was founded by two vapor business owners, Amanda Wheeler and Char Owen. Both have been longtime advocates for the vaping industry and have helped hundreds of other vapor business owners submit PMTAs. Wheeler will serve as president of the new organization, and Owen vice president.
“The founders of AVM have demonstrated a long standing commitment to our industry and have a proven track record of working hard for small business. Our President, Amanda Wheeler, has represented our industry at the federal regulatory level since June of 2019. At that time, Amanda began her journey by preparing a request to HHS and FDA to develop a small business PMTA pathway that was signed by 1,453 businesses,” the AVM website reads. “Amanda also collaborated with esteemed industry attorney Azim Chowdhury to develop a small business PMTA proposal. Since that time, Amanda has worked tirelessly to engage with HHS, FDA, the Trump Administration, and members of Congress to advocate for the small business proposal and the work that our co-founder, Char Owen has done to get over 200 businesses to the point they were able to submit pre-market tobacco applications for over 1.7 million products.”
Owen also began advocating for the vapor industry’s ability to participate in the PMTA process in June of 2019. “Char was motivated by the desire to honor her father’s memory, since he passed away from lung cancer due to a lifetime of smoking. Char had a conviction that there could be a viable path forward for small businesses to participate in the PMTA process,” the site states. “She set about her work to bring crowdsourced tools to small businesses that needed assistance preparing the documents necessary for successful PMTA submission. Over 200 businesses came together under Char’s leadership to successfully complete the requirements necessary to have PMTA’s successfully submitted and accepted.”
Other media outlets have reported that the AVM intends to create a vapor product testing lab specifically for small manufacturers. Labs have been overburdened since the PMTA guidelines were announced and a Maryland judge set Sept. 9 as the deadline to submit applications to the FDA.