FDA Extends Compliance Period for Registration and Product Listing

On December 9 2016, the FDA issued revised guidance for the “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.” In the initial revised guidance issued in July 2016, U.S. manufacturers of newly regulated products faced a deadline of December 31, 2016 for compliance with the registration and product listing requirements of section 905 of the Tobacco Control Act.

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, 2016 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.

For further information visit the FDA website.