PMTA Confusion: Vape Companies Misled by FDA

Date:

Following attorney Azim Chowdhury’s discussion with the Center for Tobacco Products ombudsman (described in the article below) and a letter to CTP Director Mitch Zeller from pro-vaping British consultant Clive Bates, the FDA sent an email today to all PMTA applicants intended to clarify the agency’s position on PMTA enforcement deadlines and the one-year grace period for applicants who submitted applications on time.

Essentially, the agency repeated the wording from previous communications, confirming that it intended to grant a one-year extension on the market—which ends Sept. 9, 2021—for products that were submitted for premarket review by the Sept. 9, 2020 deadline. Business owners should read this as confirmation that FDA employees and temporary contractors are not granting additional extensions to applicants.

Unfortunately, the agency didn’t address the question of what it intends to do with applications that are still being processed after Sept. 9, 2021.

This is the letter sent by the agency:

Read full article here.

Jim McDonald – Vaping360 – 2021-04-26.

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