REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure *requests to the Office of Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the Human and Animal Food Program*:
The average fat content by both original and check analysis is below 79.85%.
REMARKS: (For Seizures Only)
If there is reason to believe that a lot was packed under the supervision of or certified by the U. S. Department of Agriculture, submit the following information *by e-mail* or FAX to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:
Sample Number Article Involved Amount of Lot Codes
Date of Shipment Dealer Shipper Analytical Conclusions
The article was misbranded when introduced into, while in, and is misbranded while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 343(g)(1) in that it purports to be and is represented as oleomargarine, a food for which a definition and standard of identity has been prescribed by regulation (21 CFR 166.110) promulgated pursuant to 21 U.S.C. 341 and it fails to conform to such definition and standard, in that Section 166.110(a) of such definition and standard provides, among other things, that oleomargarine contain not less than 80 percent fat as determined by the method prescribed in such definition and standard, whereas, the article contains less than 80 percent fat.
*Material between asterisks is new or revised.*
Issued: 11/7/79 Revised: 10/1/80, 11/22/88, 3/95, 8/96, 5/05 Updated: 11/29/05
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.