Washington, D.C—The biennial registration renewal requirement for food facilities is now underway (which began at 12:01AM on October 22, 2012). Under the Food Safety Modernization Act registration requirements, renewals will take place between October 1 and December 1 of even years.

This requirement affects any domestic or international facility that previously registered under the Bioterrorism Act, which includes dietary supplement manufacturers. Overseas facilities can bypass the requirement if products are further processed, packaged or labeled in another country before coming to the United States.

Firms registering for the first time, according to information from the law firm Emord & Associates, P.C. of Chandler, AZ, now must give the U.S. Food and Drug Administration (FDA) permission to “inspect the facility at the times and in the manner permitted under the FDCA.” Also, the new rules allow FDA to suspend a facility’s registration if foods could harm to humans or animals. “A suspension effectively prohibits imports or exports of food into the U.S. from a facility or the introduction of food from the facility into U.S. commerce. Id. at § 350d(b)(4).”

Last, companies have 60 days to alert FDA if information on a registration changes.


Published in WholeFoods Magazine, December 2012 (online 10/23/12)