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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 535.100 Oleomargarine - Misbranding Due to Insufficient Fat

REGULATORY ACTION GUIDANCE:

The following represents the criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by the District Offices:

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 NumberDate of Shipment
Article InvolvedDealer
Amount of LotShipper
CodesAnalytical Conclusions

SPECIMEN CHARGE:

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