(a) Malic acid (C4H6O5, CAS Reg. No. of L-form 97-67-6, CAS Reg. No. of DL-form 617-48-1) is the common name for 1-hydroxy-1, 2-ethanedicarboxylic acid. L (+) malic acid, referred to as L-malic acid, occurs naturally in various foods. Racemic DL-malic acid does not occur naturally. It is made commercially by hydration of fumaric acid or maleic acid.
(b) The ingredient meets the specifications of the “Food Chemicals Codex,” 3d Ed. (1981), pp. 183-184, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, 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.
(c) The ingredients are used as a flavor enhancer as defined in § 170.3(o)(11) of this chapter, flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter, and pH control agent as defined in § 170.3(o)(23) of this chapter.
(d) The ingredients are used in food, except baby food, at levels not to exceed good manufacturing practice in accordance with § 184.1(b)(1). Current good manufacturing practice results in a maximum level, as served, of 3.4 percent for nonalcoholic beverages as defined in § 170.3(n)(3) of this chapter; 3.0 percent for chewing gum as defined in § 170.3(n)(6) of this chapter; 0.8 percent for gelatins, puddings, and fillings as defined in § 170.3(n)(22) of this chapter; 6.9 percent for hard candy as defined in § 170.3(n)(25) of this chapter; 2.6 percent for jams and jellies as defined in § 170.3(n)(28) of this chapter; 3.5 percent for processed fruits and fruit juices as defined in § 170.3(n)(35) of this chapter; 3.0 percent for soft candy as defined in § 170.3(n)(38) of this chapter; and 0.7 percent for all other food categories.
(e) Prior sanctions for malic acid different from the uses established in this section do not exist or have been waived.
[44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984]
Notes of Decisions
Cited in
7
cases (
5 in the last 5 years), 2019–2025 · leading case:
Hilsley v. Gen. Mills, Inc., 376 F. Supp. 3d 1043 (S.D. Cal. 2019).
Hilsley v. Gen. Mills, Inc., 376 F. Supp. 3d 1043 (S.D. Cal. 2019).
· cites it 3× “) See 21 C.F.R. § 184.1069 (a) ("Racemic DL-malic acid does not occur naturally.”
Scheibe v. Fit Foods Distrib. Inc., No. 3:23-cv-00220 (S.D. Cal. Nov. 8, 2023).
· cites it 2× “14 15 21 C.F.R. § 184.1069 (a). “[T]he regulation plainly states that ‘malic acid’ is the common 16 name for the forms listed in parentheses, including [DL] malic acid .”
Hayes v. Gen. Mills, Inc., No. 1:19-cv-05626, 2021 WL 3207749 (N.D. Ill. July 29, 2021).
· cites it 2× “See also 21 C.F.R. § 184.1069 (c). To reiterate, however, whether malic acid functions as a flavor, a flavor enhancer, or a PH control agent in a food product is a question of fact inappropriate for resolution on a motion to dismiss.”
Gross v. Vilore Foods Co., No. 3:20-cv-00894 (S.D. Cal. Oct. 28, 2020).
“Vilore relies on this 17 reasoning, along with 21 C.F.R. § 184.1069 (a),3 to support its argument that listing malic 18 acid complies with the federal regulations.”
Boss v. Kraft Heinz Co., 690 F. Supp. 3d 912 (N.D. Ill. 2023).
“” 21 C.F.R. 184.1069. As a flavoring agent the compound confers a “tart, fruity” taste to fruit-flavored Products.”
Tatum v. Kraft Heinz Co., No. 1:23-cv-00073 (N.D. Ill. Sept. 7, 2023).
“” 21 C.F.R. 184.1069. As a flavoring agent the compound confers a “tart” taste to fruit-flavored Products.”
Serrano v. Campbell Soup Co., 773 F. Supp. 3d 127 (D.N.J. 2025).
“21 C.F.R. § 184.1069 (a). According to Plaintiffs, DL-malic acid □□□ made from petrochemicals, predominantly benzene or butane, with highly toxic intermediates and byproducts.”
21 C.F.R. § 184.1069(a): 1 case
Hayes v. Gen. Mills, Inc., No. 1:19-cv-05626, 2021 WL 3207749 (N.D. Ill. July 29, 2021).
“See also 21 C.F.R. § 184.1069 (c). To reiterate, however, whether malic acid functions as a flavor, a flavor enhancer, or a PH control agent in a food product is a question of fact inappropriate for resolution on a motion to dismiss.”
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