FDA to 'Exercise Enforcement Discretion' on Facilities Registration Renewals Submitted until Jan. 31, 2013

AHPA Updates

FDA to ’Exercise Enforcement Discretion’ on Facilities Registration Renewals Submitted until Jan. 31, 2013

Published: Friday, December 14, 2012

FDA to 'Exercise Enforcement Discretion' on Facilities

Registration Renewals Submitted until Jan. 31, 2013

The Food and Drug Administration (FDA) yesterday issued a guidance document stating that because there was a delay in FDA's implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until Oct. 22, 2012, FDA intends to exercise "enforcement discretion" with respect to registration renewals submitted after Dec. 31, 2012, for a period of 31 days, until Jan. 31, 2013.

As stated in the American Herbal Products Association (AHPA) Update issued yesterday reminding AHPA members to register their facilities as mandated under the Food Safety Modernization Act (FSMA), all food and dietary supplement facilities must renew their present registration. Those who are not registered must do so. Additional registration information to that previously required in the registration process is described in the fifth edition of Guidance for Industry: Questions and Answers Regarding Food Facility Registration.

AHPA members are encouraged to read the new guidance document and then check FDA's food facility registration website for more information and to register or perform registration renewal online.

The FSMA, signed into law in January 2011, amended registration requirements for food facilities so that the former one-time registration process has now been replaced by a requirement to renew registrations between Oct. 1 and Dec. 31 of each even-numbered year starting in 2012.

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