The FDA announced today it has rejected 55,000 Premarket Tobacco Applications (PMTAs) from three small e-liquid manufacturers.
That eliminates about two percent of the more than two million remaining of the 6.5 million PMTAs originally submitted before last year’s Sept. 9 deadline.
More importantly, the federal regulator seemed to indicate that it will probably not authorize any bottled e-liquid in flavors other than tobacco. With two weeks before the Sept. 9, 2021 grace period is up, that will likely mean rejection for almost all of the remaining PMTAs.
The agency calls the letters sent to the three businesses “marketing denial orders” (MDOs), and they are the first outright rejections of any products that have been submitted. The products receiving MDOs must be immediately removed from the market or risk FDA enforcement.
Jim McDonald – Vaping360 – 2021-08-26.
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