A new vaping industry trade association launched Monday, with the goal of representing small businesses trying to navigate the FDA’s complex regulatory pathway for vaping products. The new organization, the American Vapor Manufacturers Association (AVM), plans to engage in federal lobbying and provide reduced-cost scientific testing and expert regulatory compliance advice for members.
The founders are Amanda Wheeler and Char Owen, vaping business owners who have worked over the past year to create a plan for small manufacturers submitting Premarket Tobacco Applications (PMTAs) to the FDA. Wheeler will be the president of the new organization, and Owen vice president.
According to Wheeler, 230 e-liquid manufacturers submitted PMTAs for more than 1.7 million products using the plan she developed with Washington, D.C. regulatory lawyer Azim Chowdhury, and fleshed out in a private Facebook group run by Owen. That group made PMTA submissions possible for many small companies that would have otherwise been shut out of the process.
The announcement of the new group included one big surprise: AVM will build a laboratory from scratch to provide testing services to members. Among the greatest challenges for small manufacturers attempting to submit viable PMTAs have been the cost of testing and the lack of available labs to do the work.
A non-profit lab dedicated to small e-liquid manufacturers could dramatically reduce the cost of testing, and make small manufacturers’ applications more likely to pass FDA muster. The question is whether a single lab can handle the testing volume needed to analyze hundreds of thousands of product SKUs in the next year or so.
The AVM lab will be able to handle a high volume of testing, according to Amanda Wheeler, by adding additional equipment necessary for vape product testing that general-purpose labs don’t have enough of, and by using cutting edge pooled testing methods. The result will be rapid but high-quality testing that doesn’t rely on the shortcuts used at some labs. The group has multiple options for financing the lab, says Wheeler, and hasn’t yet determined whether they’ll be able to crowd-source the cost or if they’ll bring in outside investors.
AVM offers tiered memberships, similar to those available at the established vape trade organizations. The new group will need to draw from a pool of more than 230 potential members to pay for the ambitious services it plans on providing. They expect to attract some larger companies that were forced by cost to limit their PMTA submissions to just a few products.
The group already has its membership in double digits—on the first day. According to Wheeler, many others are in the process of joining.
Vapesourcing Opinion:
It is a great thing to help more small e-cigarette companies pass PMTA, so that more smokers have more alternative products to choose from.
