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FDA Will Exercise Enforcement Discretion for the Use and Labeling of “Ultrafiltered Milk” in Certain Cheeses and Cheese Products

  • Mechanical filtration technologies available for milk processing include ultrafiltration.  Ultrafiltered milk (UF Milk) is milk that is mechanically filtered via semipermeable membranes to partially remove water, lactose, minerals, and water-soluble vitamins without altering the “casein to whey protein” ratio of the milk and resulting in a liquid product.
  • FDA’s regulations specify the standards of identity for cheeses and related cheese products in part 133 (21 CFR part 133). The relevant provisions within part 133 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” in § 133.3(a) and (b), 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. Of note, fluid or dried filtered forms of milk obtained through mechanical filtration of milk or nonfat milk are not included within these definitions.
  • In the Federal Register of October 19, 2005 (70 FR 60751), FDA issued a proposed rule that would have amended the Agency’s regulations to provide for the use of fluid UF milk in the manufacture of standardized cheeses and related cheese products.  But due to competing priorities, as of August 2017, FDA has not completed the rulemaking.
  • Today, the U.S. Food and Drug Administration (FDA) issued guidance to industry indicating that FDA will exercise enforcement discretion regarding the use and labeling of fluid ultrafiltered milk and fluid ultrafiltered nonfat milk to make certain cheeses and related cheese products.
  • The FDA states that it is taking this action in light of recent changes in some export markets that have caused the U.S. dairy industry to experience an oversupply and pricing challenges with domestically produced UF milk. The FDA further states that the exercise of enforcement discretion seeks to mitigate the impact on U.S. companies producing UF milk, while the Agency considers rulemaking concerning the issues about the use and labeling of UF milk and UF nonfat milk in certain cheeses and cheese products.
  • The FDA is encouraging manufacturers of standardized cheeses and related cheese products to identify fluid UF milk and fluid UF nonfat milk, when used as ingredients, as “ultrafiltered milk” and “ultrafiltered nonfat milk” when feasible and appropriate. That being said, the Agency notes that it does not intend to take action against companies that manufacture standardized cheeses and related cheese products that contain fluid ultrafiltered milk or fluid ultrafiltered nonfat milk without declaring them in the ingredient statement provided their labels declare milk or nonfat milk in the ingredient statement.
  • FDA states that it intends to exercise enforcement discretion until: (1) FDA has completed rulemaking to amend its regulations with respect to the issues covered by this guidance or (2) FDA announces in the Federal Register its determination not to proceed with such a rulemaking.
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...