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FDA To Exercise Enforcement Discretion On UF Milk In Cheese

Agency Won’t Take Action Against Cheese Makers That Use Fluid UF Milk And Don’t Declare It On Label

The US Food and Drug Administration (FDA) today issued guidance to industry stating that the agency will exercise enforcement discretion regarding the use and labeling of fluid ultrafiltered milk (UF milk) and fluid ultrafiltered nonfat milk (UF nonfat milk) to make standardized cheeses and related cheese products.

FDA said it also intends to exercise enforcement discretion regarding the declaration of ingredients in the labeling of standardized cheeses and related cheese products when fluid UF milk and fluid UF nonfat milk are used as ingredients.

For purposes of this guidance, FDA considers filtration to be a process whereby milk is passed over a series of semipermeable membranes with varying pore sizes.
The portion of milk that passes through the membranes is referred to as the “permeate,” and the portion that does not pass through the membranes is referred to as the “retentate.”

Also for purposes of this guidance, UF milk means raw or pasteurized milk that is passed over one or more semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the casein:whey protein ratio of the milk and resulting in a liquid product. UF nonfat milk is defined similarly, except that raw or pasteurized nonfat milk is used.

FDA’s standards of identity for cheeses and related cheese products in 21 CFR part 133, in part, define “milk” and “nonfat milk” that may be used in the manufacture of cheeses and related cheese products.

The definitions for “milk” and “nonfat milk,” respectively, list different forms of milk and nonfat milk, including concentrated, reconstituted, and dried forms, that may be used in the making of cheeses and related cheese products.

Fluid or dried filtered forms of milk obtained through mechanical filtration of milk or nonfat milk are not included within these definitions. Therefore, the guidance explained, while current regulations permit the use of concentrated, reconstituted, and dried forms of milk and nonfat milk as basic dairy ingredients (i.e., the only difference in these ingredients is the amount of water), they do not provide for the use of fluid or dried filtered milk or fluid or dried filtered nonfat milk as basic dairy ingredients in standardized cheeses and related cheese products.

In October 2005, FDA had issued a proposed rule that would have amended its regulations to provide for the use of fluid UF milk in the manufacture of standardized cheeses and related cheese products.

The agency tentatively concluded that the proposed rule, if finalized, would promote honesty and fair dealing in the interest of consumers and, to the extent practicable, achieve consistency with existing international standards

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