Contains Nonbinding Recommendations 
 
 
 
 
 
 
Ultrafiltered Milk in the Production of 
Standardized Cheeses and Related Cheese 
Products: Guidance for Industry 
 
Additional copies are available from: 
Office of Nutrition and Food Labeling 
(HFS-800) 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740 
(Tel) 240-402-2373 
www.fda.gov/FoodGuidances 
 
 
 
You may submit written comments regarding this guidance at any time.  Submit written 
comments on the guidance to the Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should 
be identified with the title of the guidance document.   
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
August 2017 
    Contains Nonbinding Recommendations 
Table of Contents  
 
 
I.  Introduction  
 
II.  Background  
 
III.  Discussion  
 
IV.  References  
 
 
  2  Contains Nonbinding Recommendations 
 Ultrafiltered Milk in the Production of 
Standardized Cheeses and Related Cheese 
1
Products: Guidance for Industry   
  
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page. 
 
 
I.  Introduction  
 
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.   
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background 
 
Mechanical filtration technologies available for milk processing include ultrafiltration.  For 
purposes of this guidance, we consider 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. Ultrafiltration retains macromolecules 
and particles larger than about 0.0010.02 micrometers.  In dairy processing, ultrafiltration is 
typically used to retain all protein components of milk, including casein and whey proteins, 
while some of the lactose, minerals, and water soluble vitamins present in milk are lost along 
with water. 
                                                 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition at the U.S. Food and Drug Administration.    
  3  Contains Nonbinding Recommendations 
 
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.  (Additional specifications on UF milk are discussed in FDAs 2005 proposed rule, 
Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk, 70 FR 
60751 (October 19, 2005).)  UF nonfat milk is defined similarly, except that raw or pasteurized 
nonfat milk is used. 
 
Our regulations specify the standards of identity for cheeses and related cheese products in part 
133 (21 CFR part 133).  The general provisions within 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 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.  Fluid or dried filtered forms of milk 
obtained through mechanical filtration of milk or nonfat milk are not included within these 
definitions.  Therefore, 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. 
 
Consistent with our general labeling provisions in 21 CFR 101.4, ingredients used in 
standardized cheeses are required to be declared by their common or usual name in descending 
order of predominance by weight. 
 
III.   Discussion   
 
In the Federal Register of October 19, 2005 (70 FR 60751), we issued a proposed rule that 
would amend our regulations to provide for the use of fluid UF milk in the manufacture of 
standardized cheeses and related cheese products.  We 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.  We explained our tentative conclusion that fluid UF milk 
can be used in standardized cheeses while preserving the basic nature and maintaining the 
essential characteristics of the food, while providing for greater flexibility in cheesemaking. 
However, we also noted in the proposed rule that, [p]roviding 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 December 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, we have not completed the rulemaking.   
  4  Contains Nonbinding Recommendations 
 
Recently, we have become aware of issues regarding domestically produced UF milk in the 
international marketplace.  In brief, due to recent developments in some export markets, the 
United States dairy industry is experiencing an oversupply and pricing challenges with 
domestically produced UF milk (Refs. 1 and 2).  Additionally, we have received requests to 
exercise enforcement discretion while the rulemaking is pending, in part to mitigate the impact 
on U.S. companies producing UF milk (Ref. 3).   
 
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, we are 
announcing our 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. 
 
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.  
We are 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 we 
encourage industry to identify the ingredients as  ultrafiltered milk and ultrafiltered nonfat 
milk to the extent feasible and appropriate. 
 
We intend to exercise enforcement discretion until we have completed a rulemaking process 
amending our regulations with respect to the issues covered by this guidance, or announce in the 
Federal Register our determination not to proceed with such a rulemaking.   
 
IV.  References  
 
We have placed the following references on display with the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You may see 
them at that location between 9 a.m. and 4 p.m., Monday through Friday.  As of August 8, 2017, 
FDA had verified the Web site address for the references we make available as hyperlinks from 
the Internet copy of this guidance, but we are not responsible for any subsequent changes to 
Non-FDA Web site references after August 8, 2017.  
 
1.  Letter from Senator Amy Klobuchar, Senator Al Franken, Representative Collin Peterson, 
and Representative Tim Walz, to President Donald J. Trump, accessed on the Web at 
https://www.klobuchar.senate.gov/public/index.cfm/2017/4/klobuchar-franken-peterson-
walz-urge-administration-to-support-minnesota-dairy-farmers-through-strong-enforcement-
of-our-trade-laws-with-canada.  
 
  5  Contains Nonbinding Recommendations 
2.  Congressional Research Service, New Canadian Dairy Pricing Regime Proves Disruptive 
for U.S. Milk Producers, dated April 20, 2017, accessed on the Web at 
https://www.everycrsreport.com/reports/IN10692.html.  
 
3.  Letter from Michael D. Dykes, D.V.M., President and CEO, International Dairy Foods 
Association, to Stephen Ostroff, M.D., Deputy Commissioner for Foods and Veterinary 
Medicine, Food and Drug Administration, dated June 22, 2017. 
 
 
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