The U.S. Food and Drug Administration (FDA) has issued a guidance document—“Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products”—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 the FDA’s 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.
In the Federal Register dated Oct. 19, 2005 (70 FR 60751), the FDA issued a proposed rule that would amend 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 of identity for cheeses and related cheese products.
The FDA explained its tentative conclusion that fluid UF milk can be used in standardized cheeses and preserve the basic nature and maintain the essential characteristics of the food, while providing for greater flexibility in cheese making. However, the agency also noted in the proposed rule that, “providing for the use of fluid UF milk does not preclude a standardized cheese from meeting the existing requirements within the applicable individual standard(s) of identity in part 133. Rather, the use of fluid UF milk would be optional and any cheese made using fluid UF milk would have to meet all the requirements, including the physical and chemical characteristics, specified in the applicable individual standards of identity” (70 FR 60751 at 60757).
The comment period for the 2005 proposed rule was reopened on Dec. 11, 2007 (72 FR 70251) and extended until April 11, 2008 (73 FR 7692 (Feb. 11, 2008)). However, due to competing priorities, as of August 2017, the FDA has not completed the rulemaking.
Recently, the FDA became aware of issues regarding domestically produced UF milk in the international marketplace. In brief, due to recent developments in some export markets, the U.S. dairy industry is experiencing an oversupply and pricing challenges with domestically produced UF milk. Additionally, the agency has received requests to exercise enforcement discretion while the rulemaking is pending, in part to mitigate the impact on U.S. companies producing UF milk.
The FDA believes that food standards should provide for flexibility in manufacturing procedures and ingredients, provided that the basic nature and essential characteristics of the food are preserved. Given the oversupply of UF milk and the pending rulemaking, through this guidance, the agency is announcing its intent to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products under 21 CFR part 133, in addition to the other required dairy ingredients, provided that the physical, chemical, and organoleptic properties of the cheese or cheese product are not affected.
The FDA is also announcing its intent to exercise enforcement discretion with respect to the labeling of standardized cheeses and related cheese products, when, in addition to milk or nonfat milk, fluid UF milk or fluid UF nonfat milk is used as an ingredient, but is not declared in the ingredient statement, provided that milk or nonfat milk is declared in the ingredient statement. The agency is exercising enforcement discretion with respect to the labeling of fluid UF milk and fluid UF nonfat milk in recognition of the costs and logistics involved in label changes, although it encourages industry to identify the ingredients as “ultrafiltered milk” and “ultrafiltered nonfat milk” to the extent feasible and appropriate.