• Letter or Testimony
  • April 30, 2020

CHA Joins Allied Groups in Letter to FDA Encouraging Transparency in Review of Premarket Tobacco and E-cigarette Product Applications

On April 22, a federal court issued a decision delaying the deadline that e-cigarette manufacturers would be required to submit premarket tobacco product applications (PMTAs) for deemed tobacco and e-cigarette products that were on the market as of Aug. 8, 2016, for review to the FDA. The court decision extended the deadline from May 12 to Sept. 9, 2020, because of impacts from the COVID-19 public health emergency. Manufacturers will now have additional time to submit PMTAs to the FDA and demonstrate a public health benefit in order to keep their products on the market.

On April 23, we joined allied groups in sending a letter to the FDA urging them to adopt a policy of disclosing to the public the products for which PMTAs have been filed by the new deadline and are undergoing the premarket review process, as well as products for which applications were not filed by the deadline. The letter emphasizes the importance of promoting transparency and that the FDA disclose this information so individuals can determine the extent of industry compliance with the September deadline, as well as to monitor the FDA's enforcement of that deadline moving forward. 

CHA contact:
Rachel Bonesteel