NEW FDA REGULATION
In March 2022, the US Congress extended the Food and Drug Administration's (FDA) authority over tobacco products to include synthetic nicotine in products such as vapes, heated products, and oral nicotine pouches.
The new regulation was passed on March 15th and came into effect immediately. This meant any synthetic nicotine NGP manufacturer that wanted to keep their products on the US market had to first prove that they were on sale as of April 14th and then file a PMTA application within 60 days of the law change, by May 14th. If a PMTA was submitted within that timeframe, products had the potential to remain on the market for an additional 60 days until July 13th. After July 13th any synthetic nicotine product that hasn’t received authorization or extension from the FDA will be removed from sale.
If a synthetic nicotine product was modified by a manufacturer based on a tobacco-derived nicotine product that had previously been denied a marketing order by the FDA, it was effectively banned from April 13th as manufacturers of these modified products were not allowed to submit a new PMTA application.
Manufacturers will now need to submit a PMTA to gain a Marketing Granted Order from the FDA. The first task is to understand how much data you already have about your synthetic nicotine ENDS product and then build additional analytical studies to fill gaps to file the best PMTA dossier possible.
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