Since issuing the first Marketing Denial Orders (MDOs) on Aug. 26—rejecting Premarket Tobacco Applications (PMTAs) from three companies for 55,000 of their flavored products—the agency has been busy denying additional applications.
Today the FDA Center for Tobacco Products announced it has issued MDOs as of yesterday (Sept. 2) to 31 additional companies for approximately 300,000 products. However, the agency’s published list of MDOs—updated today, Sept. 3—only lists 23 new manufacturers, not 31, and the newest ones are from Sept. 1.
The updated list includes some notable names. Ohio-based NicQuid is one of the oldest American e-liquid manufacturers, and Big Time Vapes unsuccessfully sued the FDA in 2019, going as far as petitioning the Supreme Court to review its appeal.
Products receiving an MDO must be immediately removed from the market, or manufacturers can face additional enforcement steps from the FDA.
Jim McDonald – Vaping360 – 2021-09-03.