FDA Issues Draft Guidance for Acidified Foods

WASHINGTONThe U.S. Food and Drug Administration (FDA) issued draft guidance intended to assist commercial food processors in determining whether their food products are subject to these regulations. The draft guidance also is intended to assist processors of acidified foods in ensuring safe manufacturing, processing and packing processes and in employing appropriate quality control procedures.

The draft guidance, Guidance for Industry: Acidified Foods", will complement FDA's regulations regarding acidified foods, including regulations for specific current good manufacturing practice (cGMP), establishment registration and process filing.

Under the draft guidance, processors of non-acidified foods (e.g., some acid foods or fermented foods) who are not subject to the acidified food regulations may choose to voluntarily register and file scheduled processes with us using existing forms (Forms FDA 2541 and 2541a). If such processors voluntarily submit this information, we plan to make the results of any FDA evaluation of the information available to our investigators, e.g., during inspections of food facilities and during evaluations of foods offered for import.

FDA is seeking public comments on the draft guidance available online and titled Guidance for Industry: Acidified Foods. Comments are due on or before Dec. 27, 2010. Electronic comments can be submitted at www.regulations.gov. Written comments can be sent to Division of Dockets Management (HFA305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.