US FDA Approves Limited Tobacco Products: PMTA Regulations Discussed

Dec.28.2022
US FDA Approves Limited Tobacco Products: PMTA Regulations Discussed
The FDA approved few tobacco product applications and only from large companies with e-cigarette business, drawing controversy.

According to a report published in early December by Reagan-Udall, a limited number of tobacco product applications have been approved by the US Food and Drug Administration (FDA), and all products approved through PMTA are from large tobacco companies with electronic cigarette businesses.


Following the new regulations under PMTA, the Center for Tobacco Products (CTP) has received approximately 432 premarket applications for tobacco products. However, only a few applications have been approved, with the majority of PMTA approved products coming from large tobacco companies such as RJ Reynolds and independent e-cigarette manufacturers operating in the middle market like NJOY.


At present, the FDA is revising a controversial tobacco regulation plan due to numerous lawsuits faced by both the Center for Tobacco Products (CTP) and the entire FDA regarding public health and the tobacco industry.


In 2023, the Biden administration will be obligated to consider criticism and suggestions regarding the FDA's Center for Tobacco Products (CTP) and its policy on fairly allowing products to be released to the market.



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On-Site Report | CTP Details PMTA Backlog, 180-Day Review Goal and sPMTA Process
On-Site Report | CTP Details PMTA Backlog, 180-Day Review Goal and sPMTA Process
FDA’s Center for Tobacco Products detailed new PMTA review data and process changes at the 2026 FDLI conference. Pending PMTAs fell from about 450,000 at the start of 2025 to 135,000 by September 2026. CTP also discussed its 180-day review goal, current sPMTA pilot, alternate-supplier planning, more than 50,300 pending SE reports, and lessons from the nicotine pouch pilot already being applied to ENDS review.
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