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.
Fox Business: Build Back Better package's added vape tax leaves House Dems under scrutiny
Amanda Wheeler also pointed to National Institutes of Health (NIH)-funded research, which estimated the tax would result in "approximately a half million extra teenage smokers overall."
Fox Business: Pelosi's office defends vape tax, says practice not 'essential need for working families'
“Speaker Pelosi is wrong on the math, wrong on the science, and apparently has not even read the government’s own estimates of the public health disaster this vape tax will cause.”
Filter: Federal Vape Tax Reappears in “Build Back Better”—New Cigarette Tax Vanishes
“Members pushing this tax seem to have no conception of just how intensely irate voters are about it. Millions of vapers cut across every political and social demographic, and this is more than a single-issue passion for them; it’s life or death.”
Winston-Salem Journal: Potential removal of tobacco excise tax hike seen as win for manufacturers
“We are not surrendering our business or abandoning vapers to cigarettes. As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”
Filter: The FDA’s Vape Fiasco Will Perpetuate Smoking Deaths
“We are not surrendering our business or abandoning vapers to cigarettes. As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”
Vaping360: Biden Could Pick Vaping Foe Robert Califf as FDA Chief
“Senators should be skeptical and prepared to vote no until we have an FDA commissioner who is willing to use vaping as a tool to promote public health and not continue the FDA’s regulatory arson that leaves former and current smokers without a safe and effective way to quit.”
Politico: Confusion clouds FDA’s approach to e-cigarettes
“The most generous interpretation is that FDA has made a sweeping clerical error in denying these products.”
Reason: The FDA Ignores Latest Data Because It Weakens the Case for New Restrictions
“Federal regulators routinely downplay or purposefully spin their own research to prop up an alarmist narrative based on a mirage, and deep-pocketed anti-vaping activist groups continue to ignore or conceal the large-scale public health benefits of our products.”
Filter: Vape Advocates and Prohibitionists Temporarily Unite to Slam the FDA
“FDA could have approached this by allowing companies that have always been registered with them and inspected by them to continue serving their customers while approaching the broader issue on a basis of sound science and true public health.”
Filter: House Democrats Seek to Hike Taxes on Vapes as Smokers Keep Dying
“The new proposed nicotine tax will finish the job the FDA started when they denied over 90 percent of all vapor products submitted.”
CNBC: FDA Says It Won’t Complete Review of E-Cigarette Products by Thursday Deadline
“Lots of very good people who I respect deeply and who helped thousands of smokers quit, got told by our government that their products were illegal.”
Politico: FDA says more than 5 million electronic cigarettes must be taken off the market
“[I]t is absolutely absurd that the same agency that found time to ban over six million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares.”
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.”
Vaping Post: Colorado Smoke-Free Alliance Talks About the Burdensome PMTA
“As small vape businesses keep suffering due to the current COVID-19 situation, if left unamended, the FDA’s Premarket Tobacco Product Applications (PMTA) could be the final blow for more than 125 small businesses and threatens to obliterate about 2,821 jobs in Colorado.”
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.
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.”
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.”
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.”