REGULATORY ACTION GUIDANCE:
The following represent 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*:
A. Cheddar, washed curd, colby, granular, swiss, gruyere, brick, samsoe, muenster, edam, gouda, monterey, high-moisture jack, asiago, cook, sap sago, gammelost, hard, semi-soft part-skim, pasteurized process, pasteurized blended and cold pack cheese (with nothing added), and mozzarella, represented as standardized cheese. 1. For High Moisture a. If the average moisture of the vat, or lot if no vat numbers present, is at least 2 percentage points above the limit of the standard: or
b. If no vat numbers present, moisture of two subdivisions is at least 4 percentage points above the limit of the standard, or moisture of one subdivision is at least 5 percentage points above the limit of the standard.
2. For Insufficient Fat Content a. If the average fat of the vat, or lot if no vat numbers present, is at least 1.5 percentage points less than the limit of the standard: or
b. If no vat numbers present, the fat of two subdivisions is at least 2.5 percentage points less than the limit of the standard, or the fat of one subdivision is at least 3.5 percentage points less than the limit of the standard.
NOTE: Duplicate moisture determinations should check within 0.2% and check analysis within 0.3%. Duplicate fat determinations on dry basis should check within 0.5% and check analysis within 0.6%
B. Cottage Cheese, Dry Curd Cottage Cheese, and Low Fat Cottage Cheese represented as standardized. 1. For High Moisture
a. Cottage Cheese and Dry Curd Cottage Cheese. The average moisture is 81.0% or more.
b. Low Fat Cottage Cheese. The average moisture is 83.5% or more.
2. For Insufficient Fat Content The average fat is 3.6% or less.
NOTE: Duplicate moisture determinations should check within 0.2% and check analysis within 0.3%. Duplicate fat determinations and check analysis should check within 0.2%.
SPECIMEN CHARGE (example for cheddar cheese):
Article misbranded when introduced into and while in interstate commerce within meaning of *21 U.S.C. 343(g)(1),* in that it purports to be and is represented as cheddar cheese, a food for which a definition and standard of identity has been prescribed by Regulation (21 CFR 133.113) promulgated pursuant to 21 U.S.C. 341, and it fails to conform to such definition and standard, since *133.113(a)(1)* of such definition and standard requires that cheddar cheese contain not more than 39 percent of moisture, and that its solids contain not less than 50 percent of milk fat; whereas the article contains more than 39 percent of moisture and the solids of the article contain less than 50 percent of milk fat.
*Material between asterisks is new or revised.*
Issued: 10/1/80 Revised: 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.