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.”
Members of Congress speak out on behalf of small businesses in the PMTA process and demand answers from FDA.
“Unlike the large tobacco companies, nearly 14,000 small vape shops are in danger of going out of business if the FDA does not delay or make adjustments to their PMTA guidelines. These small businesses support 160,000 jobs and produce an economic impact of over $24 billion. In the interest of the economic health for small businesses across the nation, we ask that you work with these small vapor businesses to find a reasonable solution to the problems arising from the PMTA requirements.”
Premarket Tobacco Authorization Coalition Letter
“In the interests of public health and the economic health of small businesses across the country, we strongly urge you to issue guidance to allow small ENDS manufacturers to request deferral of PTMA enforcement once basic requirements are met.”
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.
Reason: Today's Deadline for Seeking FDA Approval of Vaping Products Means Small Businesses Have To Pray for Bureaucratic Flexibility
“When the Food and Drug Administration (FDA) first outlined its plan to regulate vaping equipment and nicotine e-liquids as "tobacco products" in 2014, it estimated that it would receive 25 applications a year. Since the vaping industry includes thousands of manufacturers, ranging from big companies like Juul to mom-and-pop shops that mix the e-liquids they sell, the implication was that FDA regulation would wipe out almost all of them. Today the deadline for submitting applications, which has been moved repeatedly by the FDA and the courts, finally arrived, and the outlook for small businesses, though still daunting and highly uncertain, is not quite as dire as the agency initially suggested.”
BuzzFeed News: An FDA Deadline For Vape Shops Is Today. No One Knows What Comes Next.
“Most vape shops might end up being, well, vaporized following the passing of an FDA deadline on Wednesday for legalizing some 400 million varieties of nicotine-laced liquids nationwide.
Vaping liquids have long been sold in a legal gray zone, placed under FDA regulation only four years ago. But under an April federal court order in an American Academy of Pediatrics lawsuit, vape shops and manufacturers were required to file FDA “premarket review” applications for vaping flavors, proving they benefit public health, by Sept. 9.”
Bloomberg: Millions of Applications Could Hit FDA as E-Cig Deadline Arrives
“The U.S. Food and Drug Administration is girding for a possible deluge of tens of millions of e-cigarette review applications by a Wednesday deadline, setting up a process to prioritize prominent brands like Juul and preparing a labor-intensive effort to root out companies making illegal sales.”
FDA: National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
“Today, the U.S. Food and Drug Administration, in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey (NYTS), which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019. After two years of disturbing increases in youth e-cigarette use, we are encouraged by the overall significant decline reported in 2020.“
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.”
Colorado Politics: Federal regs confuse little vape with Big Tobacco
“The Trump Administration recognized an opportunity to save thousands of small businesses across Colorado. The president issued an executive order requiring federal agencies to identify burdensome regulations hindering economic recovery and propose modifications or waivers “for the purpose of promoting job creation and economic growth.” One Food and Drug Administration (FDA) regulation that must be on the list to alter per this executive order is the pre-market tobacco application (PMTA) that would destroy approximately 125 small vapor businesses, like mine, across Colorado.”