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FDA Invites Comments And Questions Regarding Its New Recordkeeping Requirements

December 8, 2005

The Food and Drug Administration (FDA) has just issued a final rule that require persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States to establish and maintain records to allow for the identification of the immediate previous supply sources and immediate subsequent recipients of food products.

Persons covered by the regulations must comply by December 9, 2005, June 9, 2006, or December 11, 2006, depending on the size of the business. While the general compliance date is December 9, 2005, "small businesses" employing 500 or fewer have until June 9, 2006, to comply, and "very small businesses" (10 or fewer full-time equivalent employees) have until December 11, 2006, to comply. Failure to maintain the required records is a "prohibited act" under 21 U.S.C. §331, and the violator may be subject to monetary penalties and possibly criminal sanctions under 21 U.S.C. §333, depending on the severity of the violation.  

In the Federal Register of November 11, 2005, FDA informed the public of the issuance entitled "Questions and Answers Regarding Establishment and Maintenance of Records (Edition 2)." This guidance responds to various questions regarding the recently enacted recordkeeping regulations. The FDA issuance is intended to allow the public to ask questions and make comments to assist the industry to better understand and comply with the new requirements. FDA notes that, although the new recordkeeping regulations are now in effect, comments will help clarify the final rule, facilitate prompt compliance, and complete the rule's implementation.

FDA invites comments either electronically or in writing. FDA requests that submitters follow the instructions and, when asked on the website, identify the matter as Docket No. 2005D-0356. Written submissions, which should also list the Docket Number, may be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

If you have any questions regarding this newsletter or the new FDA recordkeeping requirements, please do not hesitate to contact George R. Tuttle at (415) 288-0425 or or Gary L. Graff at (415) 986-8780 or

George R. Tuttle and Gary L. Graff are attorneys with the Law Offices of George R. Tuttle in San Francisco. The information in this article is general in nature, and is not intended to constitute legal advice or to create an attorney-client relationship with respect to any event or occurrence, and may not be considered as such.

Copyright 2006 by Tuttle Law Offices.

All rights reserved. Information has been obtained from sources believed to be reliable. However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.

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