FDA Mandatory biennial registration renewal to take place October-December 2014

The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach.

Biennial Registration Renewal for Food Facilities will soon be required, on October 1, 2014 until December 31, 2014. If your facility is not re-registered with the FDA by December 31, 2014, FDA will cancel your Bioterrorism Act registration and your importations will be delayed. A FDA Registration number is mandatory to import food products into the U.S.

Here’s what you need to know about FDA’s new FSMA requirement on Bioterrorism Act registrations. Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October– December 2014 registration renewal period. 

The Food Safety Modernization Act of 2011 (FSMA) has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the biennial registration requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse.

New Biennial Registration Requirements

FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. The first Biennial registration occurred October-December 2012, and the next is soon approaching from October-December, 2014.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October – December registration renewal period.

Source: Jennifer Diaz U.S. Agent

http://www.customsandinternationaltradelaw.com/2014/09/articles/uncategorized/mandatory-biennial-registration-renewal-to-take-place-october-december-2014/