New US vape association found to help small businesses pass PMTA

A new trade association for vape has recently been found in the United States, called the “American Vapor Manufacturers Association (AVM)”.

“The goal of the American Vapor Manufacturers (AVM) is to represent small businesses attempting to navigate through the FDA’s complex regulatory pathway for vape products, engage in federal lobbying, and provide members with less costly scientific testing and expert regulatory compliance advice.”

The founders of the association are Amanda Wheeler and Char Owen; Wheeler serves as president and Owen as vice president. Over the past year, the association has gathered ideas from small business owners who have developed programs for small manufacturers who have submitted premarket tobacco applications (PMTAs) to the FDA.

According to Wheeler, 230 e-liquid manufacturers have submitted PMTAs for more than 1.7 million e-liquid products using a program she developed with Washington, DC., regulatory attorney Azim Chowdhury and fleshed out in a private Facebook group run by Owen. The group made it possible for many small companies that would otherwise have been excluded from the program to submit PMTA’s.

Now, as Wheeler, Owen, and other small manufacturers work to provide the FDA with elements missing from their basic applications, they are looking for solutions that reduce costs and save time, while also allowing companies to provide the FDA with high-quality data about their products.

The announcement of the new organization: the AVM will build a lab from scratch to provide testing services to its members. The cost of testing and testing has been the biggest challenge in the small-scale testing that manufacturers try to perform.

According to Wheeler, the AVM lab will be able to handle a large volume of testing by adding additional equipment that general-purpose labs don’t have enough of to test steam products and by using advanced hybrid testing methods. The result will be fast but high-quality tests that don’t rely on the shortcuts used by some labs.

Wheeler said the organization has many options for financing the labs and it has not yet been determined if they will be able to pool their funds to raise capital or if they will bring in outside investors.

AVM offers tiered memberships, similar to those offered by established steam trade organizations. The new group will need to draw from over 230 members to pay for the services it plans to provide. They hope to attract larger companies that have been forced by cost to limit their PMTA submissions to a few products.

While the AVM seeks only small manufacturer members and has no plans to offer national-level lobbying, it could be attractive to larger companies or even non-manufacturing steam shops.

Wheeler has lobbied not only the FDA herself, but also its head at the Department of Health and Human Services, and even the White House itself, to make the PMTA process more accessible to small companies, according to the report. She also leads two-state trade organizations in Arizona and Colorado and keeps in touch with top regulatory attorneys and compliance experts who are willing to work with new AVM members.

The group’s membership reached double digits on its first day, and Wheeler believes many other companies are joining. Much of the immediate success can be attributed to the trust of Wheeler and Char Owen’s (Wheeler) and Char Owen’s small e-cigarette business, who got them through the difficult first phase of the PMTA submission.

“I take my credibility very seriously,” said Wheeler. “I want to represent the industry in such a way that the industry follows me in this fight.”


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