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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 527.100 Butter - Adulteration Involving Insufficient Fat Content


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

  1. The average of the fat determinations, by both original and check analysis, on the number of subdivisions shown in the following table is below 79.85%;

  2. The number of individual fat determinations by both original and check analysis meets or exceeds the figures in the right hand column of the following table:



  Lot Sizes No. Subs Examined No. Determinations Below 79.85%
Print Butter
Each Churn Mark Present
35cs or less
5 2
Over 35cs 8 3
No Churn Mark Present 35 cs or less 12 4
Over 35cs 20 7
Bulk Butter (Tub or Cube)
Each Churn Mark Present

1 - 2 units


All 1
3 units 2 1
Over 3 units 3 1
No Churn Mark Present 1 - 5 units All 1
6 - 14 5 2
15 - 24 units 7 3
25 - 150 units 8 3
Over 150 units 14 4

*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* to CFSAN, Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:

Sample Number Date of Shipment
Article Involved Dealer
Amount of Lot Shipper
Codes Analytical Conclusions


Article adulterated when introduced into and while in interstate commerce, within the meaning of 21 U.S.C. 342(b)(2) [Sec. 402(b)(2) of the Food, Drug, and Cosmetic Act], in that a product containing less than 80% by weight of milk fat has been substituted for butter, a product which should contain not less than 80% of milk fat as provided by the Act of March 4, 1923 (21 U.S.C. 321a).

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 8/96, 5/05

Updated: 11/29/05