C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 131—MILK AND CREAM › Subpart B—Requirements for Specific Standardized Milk and Cream

21 C.F.R. § 131.110

Milk

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(a) Description. Milk is the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows. Milk that is in final package form for beverage use shall have been pasteurized or ultrapasteurized, and shall contain not less than 8 1/4 percent milk solids not fat and not less than 3 1/4 percent milkfat. Milk may have been adjusted by separating part of the milkfat therefrom, or by adding thereto cream, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may be homogenized.

(b) Vitamin addition (Optional). (1) If added, vitamin A shall be present in such quantity that each quart of the food contains not less than 2000 International Units thereof within limits of good manufacturing practice.

(2) If added, vitamin D shall be present in such quantity that each quart of the food contains 400 International Units thereof within limits of good manufacturing practice.

(c) Optional ingredients. The following safe and suitable ingredients may be used:

(1) Carriers for vitamins A and D.

(2) Characterizing flavoring ingredients (with or without coloring, nutritive sweetener, emulsifiers, and stabilizers) as follows:

(i) Fruit and fruit juice (including concentrated fruit and fruit juice).

(ii) Natural and artificial food flavorings.

(d) Methods of analysis. Referenced methods are from “Official Methods of Analysis of the Association of Official Analytical Chemists,” 13th Ed. (1980), which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

(1) Milkfat content—“Fat, Roese-Gottlieb Method—Official Final Action,” section 16.059.

(2) Milk solids not fat content—Calculated by subtracting the milk fat content from the total solids content as determined by the method “Total Solids, Method I—Official Final Action,” section 16.032.

(3) Vitamin D content—“Vitamin D—Official Final Action,” sections 43.195-43.208.

(e) Nomenclature. The name of the food is “milk”. The name of the food shall be accompanied on the label by a declaration indicating the presence of any characterizing flavoring, as specified in § 101.22 of this chapter.

(1) The following terms shall accompany the name of the food wherever it appears on the principal display panel or panels of the label in letters not less than one-half the height of the letters used in such name:

(i) If vitamins are added, the phrase “vitamin A” or “vitamin A added”, or “vitamin D” or “vitamin D added”, or “vitamin A and D” or “vitamins A and D added”, as is appropriate. The word “vitamin” may be abbreviated “vit.”.

(ii) The word “ultra-pasteurized” if the food has been ultra-pasteurized.

(2) The following terms may appear on the label:

(i) The word “pasteurized” if the food has been pasteurized.

(ii) The word “homogenized” if the food has been homogenized.

(f) Label declaration. Each of the ingredients used in the food shall be declared on the label as required by the applicable sections of parts 101 and 130 of this chapter.

[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993]
Notes of Decisions
Cited in 9 cases, 2000–2020 · leading case: Hillside Dairy Inc. v. Lyons, 539 U.S. 59 (2003).
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Hillside Dairy Inc. v. Lyons, 539 U.S. 59 (2003). · cites it 2× “See 21 CFR §§ 131.110 , 101.62 (2002). Some of California's standards were arguably pre-empted by Congress' enactment of the Nutrition Labeling and Education Act of 1990, 104 Stat.”
People Ex Rel. Lockyer v. Shamrock Foods Co., 11 P.3d 956 (Cal. 2000). “) Regulations implementing the Federal Food, Drug, and Cosmetic Act establish a standard of identity for whole milk ( 21 C.F.R. § 131.110 (2000)), and through 1997, which includes the period pertinent here, established standards of identity for lowfat milk {id.”
Koenig v. Boulder Brands, Inc., 995 F. Supp. 2d 274 (S.D.N.Y. 2014). “” 21 C.F.R. § 131.110 . The regulations set forth a “standard of identity,” or recipe, for the components of milk: to qualify as milk, a product must contain a minimum combination of "8 )4 percent milk solids not fat and .”
Mills v. Giant of Maryland, LLC, 508 F.3d 11 (D.C. Cir. 2007). “§ 343 -l(a)(l) and 21 C.F.R. § 131.110 . Similarly, we withhold judgment on whether the kinds of injuries al *16 leged by plaintiffs fall within the “safety” exception to the preemption provision.”
Mills v. Giant of Maryland, LLC, 441 F. Supp. 2d 104 (D.D.C. 2006). “21 C.F.R. § 131.110 (e)(1). 7 . Olestra is the common name for sucrose esterified with medium and long chain fatty acids as a replacement for fats and oils.”
CytoSport, Inc. v. Vital Pharm., Inc., 894 F. Supp. 2d 1285 (E.D. Cal. 2012). “21 CFR § 131.110 . When the FDA extensively regulates a certain area and does not act to enforce its regulations, the Lanham Act may not be used by a private party to “usurp, preempt, or undermine FDA authority.”
Farm-To-Consum. Legal Def. Fund v. Sebelius, 734 F. Supp. 2d 668 (N.D. Iowa 2010). · cites it 2× “61 and 21 C.F.R. § 131.110 against the plaintiffs or anyone else who wishes to distribute or take across state lines raw *681 milk and/or raw dairy products in final package form for personal consumption.”
South Mountain Creamery, LLC v. U.S. Food & Drug Admin. (M.D. Penn. 2020). · cites it 2× “21 C.F.R. § 131.110 defines “milk”4 and provides that vitamins may be added to milk optionally.”
In re: Application for an Order for Inspection of David Berglund & Lake View Nat. Dairy, 140 Cnty. Road 56, Grand Marais, MN 55604. (Minn. Ct. App. 2017). “” 21 C.F.R. § 131.110 (2016). The sale of unpasteurized milk is banned with the exception of “milk occasionally secured or purchased for personal use by any consumer at the place or farm where the milk is produced.”
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