Date: Dec 15, 2016
UPDATE: On December 9, 2016, FDA issued a revised guidance for industry, “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments,” extending the December 31, 2016 deadline for registration and product listing for U.S. manufacturers by six months by June 30, 2017. According to FDA, the guidance has been revised again to clarify that for U.S. manufacturers of newly regulated tobacco products who first manufactured those products prior to August 8, 2016, the FDA does not intend to enforce the submission deadline for establishment registration and product listing as long as submissions are received by the FDA on or before June 30, 2017. However, 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. The FDA is currently accepting submissions and encourages companies to register and list their products in advance of the new compliance date.
Please note that this does not change the fact that no new deemed tobacco products can be introduced into the U.S. market after August 8, 2016 without first obtaining FDA Premarket Tobacco Product marketing authorization (products marketed on August 8, 2016 can take advantage of the 2 year grace period before the PMTA deadline on August 8, 2018, pursuant to FDA’s compliance policy)
© 2018 Keller and Heckman LLP. All rights reserved