Azim Chowdhury Quoted in Article on Confusion in the Vapor Industry on FDA’s PMTA Compliance Policy
Keller and Heckman Partner Azim Chowdhury was quoted in the Vaping 360 article, “PMTA Confusion: Vape Companies Misled by FDA.” The article discusses how some vaping product manufacturers are confused by the Food and Drug Administration’s (FDA) compliance policy, and how long they can continue to sell products legally after having submitted Premarket Tobacco Product Applications (PMTAs) for their vapor products last year.
September 9, 2020 was the deadline for manufacturers to submit Premarket Tobacco Applications (PMTAs) to the FDA. Manufacturers who submitted applications for products on time were granted a one-year extension – until September 9, 2021 – to continue marketing their products while the FDA Center for Tobacco Products (CTP) reviews their applications.
“CTP Director Mitch Zeller said that FDA anticipated getting about 6,000 applications, and they wound up getting literally millions,” said Azim.
Because the agency is prioritizing PMTA reviews based on market share, many small manufacturers fear their products will be removed from the market on September 9, 2021 simply because the FDA cannot get to their applications in time. FDA has subsequently clarified that a vapor product risks enforcement if the agency has not yet begun review of its PMTA by the end of the one-year review period, and that FDA “is planning and striving to review as many applications as possible during this one-year period.” FDA has further stated that it has discretion to defer enforcement action against a particular product, on a case-by-case basis, as the one-year period for review comes to an end in September 2021.
To read the full article, please click here.