USA Vape Lab Sues FDA Over PMTA Delay - Tobacco Reporter
USA Vape Lab sued the FDA for unlawfully delaying decisions on its PMTAs for over five years.Summary
USA Vape Lab, the maker of Naked100 e-liquids, filed a lawsuit against the Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia on November 21. The company alleges the FDA has unlawfully delayed issuing decisions on its premarket tobacco applications (PMTAs) for more than five years, despite a Tobacco Control Act provision requiring action within 180 days of submission before the September 9, 2020 deadline. USA Vape Lab seeks a court order compelling the FDA to issue final determinations. The company contends its submissions include robust evidence, such as a randomized controlled trial showing Naked100 e-liquids achieved six-month cigarette abstinence rates nearly two to three times higher than FDA-approved nicotine replacement therapies. Founder Huy Nguyen stated the lawsuit was necessary due to the agency's lengthy delays while simultaneously threatening enforcement against products without marketing orders.
(Source：Tobacco Reporter)
