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A joint agreement and a court order earlier this week led to a 3 month extension of the FDA’s “Deeming Rule” compliance deadlines impacting sellers of tobacco products.
Specifically, the agreement defers enforcement of all future compliance deadlines under the deeming rule for “e-cigarette products” for 3 months. It also requires that FDA issues a guidance to that effect.
Background
Interestingly, this extension actually appears to have arisen from the FDA needing time to decide how it wanted to handle this court case as it had already made a previous request for a 60 day extension within the case itself to figure this out. As FDA was seeking another extension, it was agreed as between the parties that along with the 3 month extension for FDA to figure out what to do with this case, a 3 month extension would extend to the compliance deadlines faced by the industry.
The judge signed the order on Tuesday making their agreement an official court decision and this essentially pushes back all of the compliance dates by 3 months.
Part of the order includes that the FDA will issue a Guidance related to this extension so we can anticipate a final document on this to be published by them in the near future.
This is great news for any company undergoing the PMTA process at this time. In a nutshell, those 3 extra months will be needed.
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