Azim Chowdhury Quoted in STAT Article on FDA Pausing Crackdown on Synthetic Nicotine
Keller and Heckman Partner Azim Chowdhury was quoted in the STAT article, “FDA appears to hold off on crackdown on synthetic nicotine products, despite calls from Congress.” The article discusses the U.S. Food and Drug Administration’s (FDA) new authority over synthetic nicotine-containing e-cigarettes pursuant to the recently expanded definition of “tobacco product” in the Food, Drug and Cosmetic Act (FDCA). In addition to re-defining tobacco products to include products containing nicotine from any source, Congress further required manufacturers of these products to submit Premarket Tobacco Product Applications (PMTA) by May 14, 2022. Products subject to timely submitted applications can remain on the market for another 60 days, until July 13, 2022. After that date, only synthetic nicotine products that have received marketing authorization orders can be legally marketed. However, an official with the Agency indicated that FDA has not yet taken action against companies selling synthetic nicotine products that failed to submit PMTAs. FDA further stated that unauthorized products with pending PMTAs that remain available for sale after July 13 will be subject to FDA enforcement, at the Agency’s discretion. Azim indicated that he expects FDA to focus enforcement against manufacturers of products that have a known youth issue, but hopes FDA will not move to shut down small e-liquid companies and vape shops that are now using synthetic nicotine to manufacture open-system e-liquids marketed to adult smokers.
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