Skip page top navigationFDA Logo--links to FDA home page Logo of and Link to start page of Office of Regulatory Affairs, U.S. Food and Drug Administration U.S. Food and Drug Administration Office of Regulatory Affairs HHS Logo and link to Department of Health and Human Services website

FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search

Updated: 2005-11-29

Sec. 527.100 Butter - Adulteration Involving Insufficient Fat Content (CPG 7106.05)

REGULATORY ACTION GUIDANCE:

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%;

    or
  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

SPECIMEN CHARGE:

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, 5/2005