FDA completely overwhelmed.....This will undoubtedly impact TAAT getting new products to market in a "reasonable" timeframe.
https://www.ctvnews.ca/health/fda-weighs-oversight-changes-after-formula-juul-troubles-1.5994170
Parents and politicians also have expressed frustration over the agency's handling of a recent decision to ban all e-cigarettes from Juul, the leading U.S. vaping company. A federal court quickly blocked the agency's order. FDA then backtracked further in court, saying it needed more time to review Juul's application due to its “unique scientific issues.”
The FDA has also struggled to review millions of other applications from vaping companies, prompting multiple missed regulatory deadlines over the last two years.
Califf again cited funding challenges, pointing out that the FDA cannot collect user fees from vaping companies to review their products. The agency has asked Congress for that authority.
“I don't think anyone anticipated that there would be 6.7 million vaping product applications that came rolling in during a pandemic that was stressing the entire agency,” Califf said.