December 12, 2016

FDA PTMA update Dec 2016

Alex Clark This only changes the product registration deadline. August 8th, 2016 is still the cutoff for new products to be introduced w/out filing a PMTA right away. In fact, if you re-read the second to last sentence in this announcement, it says “…companies which begin manufacturing newly regulated tobacco products in a domestic establishment on or after the August 8 effective date of the deeming rule >>must register and list immediately<< with the FDA.”

and Listing Guidance Revised with New Compliance Period

Source: News & Events > Compliance and Enforcement Update– December 9, 2016

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