The misunderstanding doesn’t seem to involve outright deception
Some small vaping manufacturers are being misled by FDA employees regarding the final date on which they can sell products legally. The misunderstanding doesn’t seem to involve outright deception, but may nevertheless lead to unwelcome surprises for many when the current one-year grace period ends in September.
Many small business owners believe they’ve been told by the FDA that they have an additional year to sell their products, according to a lawyer who represents many vaping industry clients. But that isn’t true.
What’s happening exactly? Let’s start by going back to last year’s PMTA deadline.
The 2020 PMTA deadline and the application tsunami
Sept. 9, 2020 was the deadline for manufacturers to submit Premarket Tobacco Applications (PMTAs) to the FDA. Manufacturers of products submitted on time were granted a one-year extension to continue selling them while the FDA Center for Tobacco Products (CTP) assessed their applications. To be eligible to remain on the market during that grace period, the product must have also been on the market before Aug. 8, 2016—the date the FDA’s Deeming Rule went fully into effect, and the market was frozen.
The 2020 PMTA deadline was imposed by a federal judge (who later postponed it from May to September) as part of a ruling against the FDA in a lawsuit filed by the American Academy of Pediatrics (AAP) and several other tobacco control groups. In his ruling, Judge Paul Grimm agreed that manufacturers of products submitted on time could have a one-year extension to sell their products while they were reviewed, and that the FDA could grant further extensions to the one-year grace period on a “case-by-case basis” for “good cause.”
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