According to reports, a new e-cigarette Industry Association, the American Steam Manufacturers Association (AVM), was established on Monday, local time, with the goal of trying to pass the FDA's complex e-cigarette product regulatory approach on behalf of small businesses. The association plans to participate in federal lobbying and provide members with lower cost scientific testing and expert regulatory compliance advice.
The founders of the association are Amanda Wheeler and char Owen, with Wheeler as president and Owen as vice president. Over the past year, the association has collected ideas from small business owners who have plans for small manufacturers who have submitted pre market tobacco applications (pmtas) to the FDA.
According to Wheeler, 230 E-liquid manufacturers used a plan she developed with azim Chowdhury, a Washington, D.C., regulatory lawyer, to submit pmtas for more than 1.7 million E-liquid products and augment the plan with a private Facebook group run by Owen. The organization makes it possible for many small companies that were otherwise excluded from the program to submit to the PMTA.
Now, as Wheeler, Owen, and other small manufacturers are working to provide the FDA with elements missing from their basic applications, they are looking for cost-effective and time-saving solutions, while also allowing companies to provide FDA with high-quality data about their products.
The announcement of the new organization: AVM will set up a laboratory from scratch to provide testing services for its members. Of the small tests that manufacturers are trying to do, testing and the cost of testing have always been the biggest challenge.
According to Wheeler, AVM laboratories are able to handle a large number of tests by adding additional equipment that the general laboratory does not have enough steam product testing needs and using advanced hybrid testing methods. The results will be fast but high-quality tests, independent of the shortcuts used by some laboratories.
Wheeler said the group has a variety of options for funding laboratories, and it has not yet been determined whether they will be able to pool funds or whether they will bring in outside investors.
AVM offers tiered membership, similar to that offered by the established steam trade organization. The new group will need to draw money from more than 230 members to pay for the services it plans to provide. They hope to attract larger companies, which are constrained by costs to limit their PMTA submissions to a few products.
Although AVM seeks only small manufacturer members and has no plans to provide national lobbying, it may be attractive to large companies and even non manufacturing steam shops.
Wheeler not only lobbied the FDA, but also the head of the FDA's Department of health and human services, and even the white house itself, to make the PMTA process more accessible to small companies, the report said. She also heads two state trade organizations in Arizona and Colorado and keeps in touch with top regulatory lawyers and compliance experts willing to work with new members of AVM.
On its first day, the group had double-digit membership. Wheeler believes that many other companies are joining. Much of the current success is due to the trust of Wheeler's and char Owen's small e-cigarette companies, which got them through the difficult first phase of the PMTA submission.
"I value my credibility very much," Wheeler said. "I want to represent the industry in this way and make it follow me."