FDA Issues Draft Guidance on Changes to How Manufacturers of Acidified and Low-Acid Canned Foods Will Submit Information to FDA
CFSAN Constituent Update
January 13, 2014
FDA is issuing draft guidance to alert manufacturers of acidified and low-acid canned food products to changes FDA is planning for the procedures manufacturers use to submit information to FDA about the processes they use to ensure that the foods they produce are safe for consumers. FDA believes these changes will make it easier for manufacturers to submit information and will improve FDA’s ability to protect the public health.
The draft guidance describes:
- administrative procedures for submitting registration and process filing information required under 21 CFR 108.25(c) and 21 CFR 108.35(c)
- administrative procedures for voluntary registration and processing filing for certain products that are not subject to registration and filing requirements under 21 CFR 108.25(c) and 21 CFR 108.35(c)
- a voluntary process whereby, upon request, FDA reviews data and other information that support the establishment of a scheduled process for a new processing method or new equipment
FDA is in the process of developing improved paper and electronic forms for the submission of the process filing information described in this guidance. For information about the forms please see FDA’s September 17, 2013 CFSAN Constituent Update.
Until the information in the draft guidance is finalized and the new forms are made available for use, manufacturers of acidified and low-acid canned foods must continue to submit process filings using the forms that are currently in effect. FDA guidance issued in July 2012 provides information about procedures for submitting these forms to FDA.
All interested parties are invited to comment on the draft guidance.