The U.S Food and Drug Administration (FDA) announced last 9th September that it would need more time to process the remaining premarket tobacco applications (PMTAs) on vape companies that want to stay legally on the market. The delay comes after five years the regulatory body gained authority over vaping products and twelve months after vaping companies submitted millions of applications to meet the rules set by the FDA.
The stake is enormous because approval would mean that e-cigarettes could finally recognised as an effective smoking cessation tool. A groundbreak and historical development for Tobacco Harm Reduction in the United States. The delay left in limbo hundreds of companies and sparked outrage and different reactions among the experts.
Tobacco control expert and vaping international authority Clive Bates wrote:
“Step back and ask what FDA is actually doing today. Mainly trying to micro-manage which flavours can go into which vapes to somehow control who uses them and who doesn’t. Think about that for a minute: it’s surreal and ludicrous state meddling, and doomed to fail.”
Cliff Douglas, Director of the University of Michigan Tobacco Research Network, an adjunct professor at the School of Public Health:
“My new piece argues FDA’s scientific review process must be protected against the aggressive politicization of the process. We must support the health and well-being of everyone, both youth and adults.”
Gregory Conley, President of the vaping advocacy group American Vaping Association, has recently released this comment on the FDA decision:
“Zero product authorizations, millions of banned products, and hundreds of thousands of products left in limbo by the agency’s failure to do their job. That is the result of the FDA’s multi-year campaign to destroy the vaping industry and hand the remains over to large tobacco companies.”
Charles Gardner, expert in institutional communication and Chief Executive Officer of the International Network of Nicotine Consumer Organizations (INNCO):
“Rampant politicization of e-cigarettes will affect the health of millions of Americans. But leading tobacco control organizations and members of Congress have applied inordinate pressure on FDA, disregarding the agency’s scientific expertise.“
Matt Culley, vaping Advocate/Activist and Board member at Consumer Advocates for Smoke-free Alternatives Assoc. (CASAA)
“There was never a chance that FDA would approve millions of vaping applications. They aren’t built to handle a diverse marketplace with that many products. Tbh I think they’d prefer people just vape black market products than have to be the watchdog over all of it.”