The U.S. Food and Drug Administration (FDA) has issued the revised guidance, Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments.
In the previous guidance, issued in July, U.S. manufacturers of newly regulated products faced a deadline of Dec. 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 that 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.