Guidance for Industry: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products

Description

The purpose of this guidance is to advise manufacturers who wish to use ultrafiltered milk (UF milk) or ultrafiltered nonfat milk (UF nonfat milk) in the production of standardized cheeses and related cheese products. More specifically, this guidance is intended to advise food manufacturers of our intent to exercise enforcement discretion regarding the use and labeling of UF milk and UF nonfat milk in these cheeses, when used in addition to the dairy ingredients specified in the standards of identity in 21 CFR part 133.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

1

Standardized Cheeses

Production of standardized cheeses and related cheese products

Stakeholders

4

Stephen Ostroff, M.D.

Deputy Commissioner for Foods and Veterinary Medicine at FDA

Michael D. Dykes, D.V.M.

President and CEO of International Dairy Foods Association

U.S. Milk Producers

Entities affected by the New Canadian Dairy Pricing Regime

Manufacturers

Responsible for declaring acceptable market names on labels.

Regulatory Context

Regulatory Activities

1

Rulemaking

Potential notice-and-comment proceedings to permit NAC

Document Types

2

Letter dated June 22, 2017

Correspondence from IDFA to FDA regarding dairy policy

New Canadian Dairy Pricing Regime Proves Disruptive for U.S. Milk Producers

Report by Congressional Research Service

Attributes

1

Casein:Whey Protein Ratio

UF milk process does not alter this ratio

Technical Details

Substances

2

Ultrafiltered Nonfat Milk

Use of UF nonfat milk in the production of standardized cheeses

Ultrafiltered Milk

Use of UF milk in the production of standardized cheeses

Processes

1

Ultrafiltration

Mechanical filtration technology used to retain protein components

Related CFR Sections (2)

21CFR101.4§ 101.4 Food; designation of ingredients.
(a)Read full regulation →
21CFR133.3§ 133.3 Definitions.
(a) Milk means the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows, which may be clarified and may be adjusted by separating part of the fat therefrom; concentrated milk, reconstituted milk, and dry whole milk. Water, in a sufficient qRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Misbranded within the meaning of section 403(i)(2)

2

misbranded within the meaning of section 403(q) of the Act

1

Misbranded

1

Failure to declare net quantity of contents

1

Misbranded drugs

1

Adulterated food

1

Misbranded within the meaning of section 403(a)(1)

1

Failure to declare the major food allergen milk

1

misbranded within the meaning of section 403(i)(2) of the Act

1

misbranded within the meaning of section 403(w) of the Act

1