The Premarket Tobacco Product Application (PMTA) process is a critical step for manufacturers seeking to market new tobacco products in the United States. Established by the U.S. Food and Drug Administration (FDA) under the Deeming Regulations of the Family Smoking Prevention and Tobacco Control Act, the PMTA process requires manufacturers to submit comprehensive applications for new tobacco products. These applications must include scientific data and evidence demonstrating that the product is appropriate for public health and does not pose an undue risk to consumers.
The revised remedial order mandates that the FDA report the PMTA review status of all vaping products sold under prominent brand names such as Juul, Vuse, NJOY, Logic, Blu, Smok, Suorin, and Puff Bar. These brands hold significant market shares in the e-cigarette market, particularly in the sale of closed system vapes like VUSE pods and JUUL pods. In a significant legal development, Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ordered the FDA to submit quarterly status reports on the review of pending PMTAs for these popular vapor products, specifically those filed on or before September 9, 2020.
The PMTA process presents several challenges and implications. Manufacturers faced tight deadlines to submit PMTAs, with initial FDA guidance extending deadlines into 2021 and 2022. However, this guidance was later vacated by the court, requiring applications to be submitted by September 9, 2020. The COVID-19 pandemic further impacted these deadlines, leading to an extension. The market impact is significant, as brands … Read More
