Tobacco Reporter: The Chosen Few
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Tobacco Reporter: The Chosen Few

Amanda Wheeler is angry.

Who is she angry with? I think it would be fair to say she is angry with a lot of people and organizations, but mainly she is angry with the U.S. Food and Drug Administration, some politicians, large swathes of the U.S. media, “scientists” who put their names to the findings of flawed research into vaping and people who use their wealth and influence to spread misleading stories about vaping, sometimes based on flawed research.

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Vaping360: Amanda Wheeler Will Lead New Small Vape Trade Group
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Vaping360: Amanda Wheeler Will Lead New Small Vape Trade Group

“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.”

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Roll Call: FDA to review huge applications from vaping companies
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Roll Call: FDA to review huge applications from vaping companies

Char Owen, a Texas vape shop owner with a background in programming and engineering, said she developed a software application that would allow other owners like her to automate some of the paperwork to make it more feasible to file applications for hundreds of flavors.

Owen is still pessimistic about her chances. She pointed to one of the previous PMTA authorizations, for a tobacco-heating device called iQOS, as proof that the FDA would want to see human studies that would cost millions of dollars to conduct.

“That’s what they want to see. We’re small businesses; we can’t provide that.” Using anecdotal evidence from customers “really is our only hope,” she said.

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Vaping360: How Will the PMTA Deadline Affect Vapers and the Industry?
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Vaping360: How Will the PMTA Deadline Affect Vapers and the Industry?

“After Sept. 9, 2020, the only vaping products that can be legally sold in the United States will be products approved for marketing by the FDA Center for Tobacco Products, or submitted to the agency and accepted for further review. The submission process is called a Premarket Tobacco Application, or PMTA. The actual deadline to submit is at 4:00 p.m. on Sept. 9.”

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United Vapers Alliance: Vaping Advocates and Leaders Hold Successful DC Rally Ahead of Industry-Killing PMTA Deadline & November Elections
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United Vapers Alliance: Vaping Advocates and Leaders Hold Successful DC Rally Ahead of Industry-Killing PMTA Deadline & November Elections

“Vaping advocates from across the country descended on Washington D.C. on Saturday to show support for small vapor businesses and to demonstrate to President Trump that their votes have the power to change the upcoming election. Vaping advocates demanded President Trump push for the Food & Drug Administration to reform the Pre-Market Tobacco Application (PMTA) process or extend the cutoff before the looming deadline of Sept. 9. With 14,000 small businesses in jeopardy of vanishing overnight, the FDA is still tracking towards the Sept. 9 deadline requiring small businesses to file pricey and burdensome PMTAs to keep their products for sale.”

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Inside Sources: As the PMTA Deadline Looms, the Vaping Industry Faces Potential Disaster
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Inside Sources: As the PMTA Deadline Looms, the Vaping Industry Faces Potential Disaster

“The costs associated with PMTA will force Jvapes’ five locations in Arizona, Colorado, and Oklahoma to close doors,” Amanda Wheeler told Inside Sources in an email, highlighting her extreme concern. Wheeler is the owner of JVapes in Prescott, Ariz., and is the vice president of the Rocky Mountain Smoke-Free Alliance. She explained that for each product that they produce in-house comes a stock-keeping unit (SKU) attached to UPCs to track sales and inventory.”

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