Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 1 of 10
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`UNITED STATES DISTRICT COURT
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`NORTHERN DISTRICT OF CALIFORNIA
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`DAVID SWARTZ,
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`Plaintiff,
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`v.
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`DAVE’S KILLED BREAD, INC. AND
`FLOWERS FOODS, INC.
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` Defendants.
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`Case No. 4:21-cv-10053-YGR
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`ORDER GRANTING IN PART AND DENYING
`IN PART DEFENDANTS’ MOTION TO
`DISMISS
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`Defendants Dave’s Killer Bread, Inc. and Flowers Foods, Inc. filed the pending motion to
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`dismiss. In this putative class action, plaintiff alleges state law claims premised on alleged
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`misrepresentations about the quantity and quality of protein in defendants’ products made on the
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`products’ packaging. (Dkt. No. 1, “Complaint,” “Comp.”) Plaintiff alleges that defendants’
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`actions caused plaintiff and others to pay a price premium for defendants’ products due to the
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`mistaken belief that the products contained a higher amount of digestible protein than they do.
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`(Comp. ¶ 24.) Plaintiff brings claims under the California Consumer Legal Remedies Act
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`(“CLRA,” Cal. Civil Code § 1750 et seq.); California False Advertising Law (“FAL,” Cal. Bus. &
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`Prof. Code § 17500 et seq.); and California Unfair Competition Law (“UCL,” Cal. Bus. & Prof.
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`Code § 17200 et seq.), as well as for fraud, deceit and/or misrepresentation; and unjust
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`enrichment.
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`Having considered the parties’ briefs and for the reasons set forth herein, the Court hereby
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`GRANTS WITH PREJUDICE dismissal of plaintiff’s claims regarding statements defendants make
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`about protein on the front label of their products and GRANTS WITH LEAVE TO AMEND dismissal
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`of plaintiff’s claims regarding defendants’ omission of percent daily value (“%DV”) protein from
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 2 of 10
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`nutrition labels.1
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`I. BACKGROUND
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`The complaint alleges as follows2:
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`Protein consumption is important for human health. (Comp. ¶ 26.) Health-conscious
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`consumers seek out products that will provide them with protein and make food purchases based
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`on nutritional representations made on product packaging. (Id. at ¶¶ 2, 25.) Some protein sources
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`are better than others. The human body can only use protein when nine specific amino acids are
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`present in the protein. (Id. at ¶ 3.) Proteins known as “complete proteins” contain all nine amino
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`acids. (Id. at ¶ 31.) Complete proteins are readily used by the human body. Other proteins do not
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`have all nine amino acids. Those proteins may go undigested and unused. (Id.)
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`Defendants manufacture, distribute, market, advertise, and sell a variety of bread products
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`under the label “Dave’s Killer Bread.” (Id. ¶ 22.) Their products include statements on the front
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`labels advertising the amount of protein in the product. (See, e.g., images of defendants’ products
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`at id. at ¶ 23.) These statements indicate the total amount of protein per serving, which includes
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`both digestible and non-digestible protein. (Id. at ¶ 24.) Defendants use low-quality proteins,
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`such as oats and wheat. (Id.) As a result, only about half of the protein in a serving of defendants’
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`products is digestible. (Id.) Defendants’ packaging therefore misleads reasonable consumers into
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`1 The Court has reviewed the papers submitted by the parties in connection with
`defendants’ motion to dismiss and has determined that the motion is appropriate for decision
`without oral argument, as permitted by Civil Local Rule 7-1(b) and Federal Rule of Civil
`Procedure 78. See Lake at Las Vegas Investors Group, Inc. v. Pacific Malibu Dev. Corp., 933
`F.2d 724, 729 (9th Cir. 1991).
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` 2
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` In connection with their motion to dismiss defendants request that the Court take judicial
`notice of several documents. Dkt. No. 21. The Court denies the request as to Exhibits 1-2, copies
`of email exchanges allegedly between counsel in other cases and the FDA, and 6-7, declarations
`submitted in those same cases to substantiate the emails, as inappropriate under Rule 201
`(prohibiting judicial notice of facts “subject to reasonable dispute”). The Court grants notice of
`Exhibits 3-5, the complaints from two cases and a page from the FDA website, and will afford
`them their proper evidentiary weight. See Rejoice! Coffee Co., LLC v. Hartford Fin. Servs. Grp.,
`No. 20-cv-06789-EMC, 2021 U.S. Dist. LEXIS 235263, at *32-33 (N.D. Cal. Dec. 8, 2021)
`(stating a court may take judicial notice of a public record, but not the facts therein when the facts
`are in dispute).
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 3 of 10
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`believing that “a serving of the Products will provide the grams of protein as represented on the
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`label, when in fact, correcting for the Products [sic] poor protein quality [ ] the amount provided
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`will be approximately half of less because Defendants uses [sic] proteins of low biological value
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`to humans.” (Id. at ¶ 24.)
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`On these grounds, plaintiff asserts the six claims listed above.
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`II. LEGAL STANDARD
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`A defendant may move to dismiss a complaint for failing to state a claim upon which relief
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`can be granted under Federal Rule of Civil Procedure 12(b)(6). “Dismissal under Rule 12(b)(6) is
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`appropriate only where the complaint lacks a cognizable legal theory or sufficient facts to support
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`a cognizable legal theory.” Mendiondo v. Centinela Hosp. Med. Ctr., 521 F.3d 1097, 1104 (9th
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`Cir. 2008). To survive a Rule 12(b)(6) motion, a plaintiff must plead “enough facts to state a
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`claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007).
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`A claim is facially plausible when a plaintiff pleads “factual content that allows the court to draw
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`the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal,
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`556 U.S. 662, 678 (2009). In reviewing the plausibility of a complaint, courts “accept factual
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`allegations in the complaint as true and construe the pleadings in the light most favorable to the
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`nonmoving party.” Manzarek v. St. Paul Fire & Marine Ins. Co., 519 F.3d 1025, 1031 (9th Cir.
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`2008). Nonetheless, courts do not “accept as true allegations that are merely conclusory,
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`unwarranted deductions of fact, or unreasonable inferences.” In re Gilead Scis. Sec. Litig., 536
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`F.3d 1049, 1055 (9th Cir. 2008).
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`Federal Rule of Civil Procedure 9(b) heightens these pleading requirements for all claims
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`that “sound in fraud” or are “grounded in fraud.” Kearns v. Ford Motor Co., 567 F.3d 1120, 1125
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`(9th Cir. 2009) (citation omitted); Fed. R. Civ. P. 9(b) (“In alleging fraud or mistake, a party must
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`state with particularity the circumstances constituting fraud or mistake.”). The Ninth Circuit has
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`interpreted Rule 9(b) to require that allegations of fraud are “specific enough to give defendants
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`notice of the particular misconduct which is alleged to constitute the fraud charged so that they can
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`defend against the charge and not just deny that they have done anything wrong.” Neubronner v.
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`Milken, 6 F.3d 666, 671 (9th Cir. 1993) (internal quotation omitted).
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`Northern District of California
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`United States District Court
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 4 of 10
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`III. DISCUSSION
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`Plaintiff’s claims are based on two theories of why defendants’ packaging is misleading.
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`First defendants violate the federal Food Drug and Cosmetics Act (“FDCA”), 21 U.S.C. §§ 301 et
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`seq. and mislead consumers into believing that defendants’ products contain more digestible
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`protein than they do by representing total protein (calculated using the nitrogen-content method) in
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`nutrient content claims. Second, defendants fail to include %DV corrected protein per serving in
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`the nutrient label of their products, as required by 21 C.F.R. § 101.9(c)(ii) on any packaging
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`containing a nutrient content claim about protein.
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`In response, defendants move to dismiss on the grounds that claims under plaintiff’s first
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`theory are preempted by the FDCA and that plaintiff lacks standing to bring claims brought under
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`his second theory because he has not properly alleged reliance on defendants’ allegedly
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`misleading representation. The Court addresses each.
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`A. Preemption of Plaintiff’s Claims Regarding Defendant’s Use of Total Rather
`Than Corrected Protein in Nutrient Content Claims
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`Plaintiff claims that defendants’ use of total protein in nutrient content claims violates 21
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`C.F.R. §§ 101.9(c)(7), 101.13(i)(3), and 343(a). Defendants respond that plaintiff’s claims are
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`preempted on the grounds that 21 C.F.R. § 101.9(c)(7) allows them to use total protein and the
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`nitrogen-content method for nutrient content claims on their labels.
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`There is a “strong presumption” against federal preemption, especially regarding laws,
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`such as those at issue in this case, that address health and safety, which are traditionally governed
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`by the states. Law v. Gen. Motors Corp., 114 F.3d 908, 910 (9th Cir. 1997). This presumption
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`may be overcome where a statute includes express language preempting conflicting state law. The
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`FDCA includes this kind of preemption statute. Hawkins v. Kroger Co., 906 F.3d 763, 769 (9th
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`Cir. 2018). Under 21 U.S.C. § 343–1(a)(5) states are prohibited from imposing any requirement
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`for the labeling of food that is “not identical to” the federal requirements. “The phrase ‘not
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`identical to’ means ‘that the State requirement directly or indirectly imposes obligations or
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`contains provisions concerning the composition or labeling of food [that] . . . [a]re not imposed by
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`or contained in the applicable [federal regulation] . . . or [d]iffer from those specifically imposed
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 5 of 10
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`by or contained in the applicable [federal regulation].’” Hawkins v. Kroger Co., 906 F.3d 763,
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`769 (9th Cir. 2018) (citing Reid v. Johnson & Johnson, 780 F.3d 952, 959 (9th Cir. 2015)). In
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`effect, to avoid preemption under section 343–1(a), “the plaintiff must be suing for conduct that
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`violates” the FDCA or its enabling regulations. Trazo v. Nestle USA, Inc., 2013 WL 4083218, at
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`*5 (N.D.Cal. August 9, 2013); see also Nacarino v. Kashi Company, 2022 WL 390815 *5 (finding
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`plaintiff’s claims preempted where based on conduct permitted by FDCA regulations); Chong v.
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`Kind LLC, 2022 WL 464149 *3 (same); Brown v. Natures Path Foods, Inc., No. 21-CV-05132-
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`HSG, 2022 WL 717816, at *7 (N.D. Cal. Mar. 10, 2022) (same).
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`In assessing the preemptive effect of the FDCA and its regulations, courts consider FDA
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`guidance. Courts defer to such guidance unless “demonstrably irrational,” Ford Motor Credit Co.
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`v. Milhollin, 444 U.S. 555, 565–66 (1980), such as where an “alternative reading is compelled by
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`the regulation’s plain language.” Bassiri v. Xerox Corp., 463 F.3d 927, 931 (9th Cir. 2006)
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`(internal quotation omitted).
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`To analyze whether the FDCA preempts plaintiff’s claim that defendants may not make
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`nutrient content claims on products based on total protein, an overview of relevant federal
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`authority governing nutritional information on packaged foods is warranted. The FDCA, “governs
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`the labeling of food.” Lilly v. ConAgra Foods, Inc., 743 F.3d 662, 664 (9th Cir. 2014). The FDA
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`has promulgated regulations on how information about nutrient content is provided on packaged
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`foods. Several of these regulations are relevant here.
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`By way of background, 21 C.F.R. § 101.9(c)(7) allows two different approaches to
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`representing and measuring protein content on food packaging. Protein representations may either
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`indicate “total protein” or “corrected protein.” Total protein must be calculated using a method
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`commonly referred to as the “nitrogen-content method.”3 See, e.g., Nacarino v. Kashi Co., No.
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`3 Specifically, the regulation states that “[p]rotein content may be calculated on the basis
`of the factor 6.25 times the nitrogen content of the food as determined by the appropriate method
`of analysis as given in the ‘Official Methods of Analysis of the AOAC International,’ except when
`official AOAC procedures described in this paragraph (c)(7) require a specific factor other than
`6.25, that specific factor shall be used.” 21 C.F.R. § 101.9(c)(7).
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 6 of 10
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`21-CV-07036-VC, 2022 WL 390815, at *2 (N.D. Cal. Feb. 9, 2022) (using this term). Corrected
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`protein is calculated using a method commonly referred to as the Protein Digestibility Corrected
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`Amino Acid Score or “PDCAAS.”4 21 C.F.R. § 101.9(c)(7)(ii); (Comp. ¶ 33).
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`All nutrition labels for packaged foods must include the total amount of protein per
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`serving, calculated using the nitrogen-content method. 21 C.F.R. § 101.9(c)(7). In addition to
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`stating protein per serving in the nutrition label, manufacturers may include explicit statements
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`about protein on areas of the packaging other than the nutrition label. These are called “nutrient
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`content claims.” 21 C.F.R. § 101.13(c). For example, the statement “5 Grams of Protein”
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`included on the front label of defendants’ products constitutes an explicit nutrient content claim.
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`(See Comp. ¶ 23 for images of this packaging.) The regulations do not specify whether nutrient
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`content claims must indicate total or corrected protein.
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`In 2022, the FDA released guidance explaining that use of total or corrected protein,
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`calculated using the nitrogen-content method or PDCAAS respectively, are appropriate for
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`nutrient content claims. Industry Resources on the Changes to the Nutrition Facts Label, U.S.
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`Food & Drug Administration (content current as of May 11, 2022),
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`https://www.fda.gov/food/food-labeling-nutrition/industry-resources-changes-nutrition-facts-label
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`(“2022 Nutrient Content Claim Guidance”). If a manufacturer includes a nutrient content claim
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`for protein, it must add the percent daily value 5 protein per serving to the nutrition label. 21
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`C.F.R. § 101.9(c)(7)(i). The %DV protein must be calculated using corrected protein as calculated
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`by PDCAAS. (Id.)
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`4 The exact language of 21 C.F.R. §101.9(c)(7)(ii) states that this test measures: “the
`actual amount of protein (gram) per serving multiplied by the amino acid score corrected for
`protein digestibility.”
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`5 “Daily values” are the recommended amounts of nutrients to consume or not to exceed
`each day. The %DV is how much a nutrient in a single serving of an individual packaged food or
`dietary supplement contributes to your daily diet. Daily Value on the New Nutrition and
`Supplement Facts Labels, U.S. Food & Drug Administration (content current as of May 10, 2022),
`https://www.fda.gov/food/new-nutrition-facts-label/daily-value-new-nutrition-and-supplement-
`factslabels#:~:text=DVs%20are%20the%20recommended%20amounts,contributes%20to%20your
`%20daily%20diet.
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 7 of 10
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`Further, and in general, the FDCA prohibits false or misleading nutritional statements on
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`packaged foods. 21 U.S.C. § 343(a) provides that a food label is unlawfully misbranded if it is
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`“false or misleading in any particular.” In addition, any explicit nutrient content claim must not
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`be “false or misleading in any respect.” 21 C.F.R. § 101.13(i)(3).
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`The Court analyzes the parties’ arguments in the context of the legal framework described.
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`First, the Court finds that the FDA’s explicit statement that nutrient content claims may be
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`based on total protein, calculated using the nitrogen-content method, is dispositive. The 2022
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`guidance is reasoned and aligns with the plain language of the regulations. The regulations do not
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`state whether nutrient content claims must indicate total or corrected protein or specify a required
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`method of calculation. The guidance merely confirms that there is no preferred or required
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`method. If, as plaintiff alleges, the FDA required that nutrient content claims show corrected
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`protein, it would have said so, as it does at various other points in the regulation. See, e.g., §
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`101.9(c)(7) (requiring total protein be used to show protein per serving in nutrition labels and that
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`corrected-protein be used to determine what statements must be included on packaging when a
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`product is intended for certain populations); § 101.9(c)(7)(i) (requiring that when %DV protein is
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`included in a nutrition label that corrected-protein be used). Any claim alleging that defendants’
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`use of total protein in nutrient content statements violates section 101.9(c)(7) is preempted.
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`Alternatively, plaintiff argues that even if the nitrogen-content method is allowed under
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`section 101.9(c)(7), use of this method violates both section 101.13(i)(3), which prohibits false or
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`misleading statements about the amount of a nutrient in a product, and section 343(a), which
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`prohibits as misbranding any label that is “false or misleading in any material respect.” The Court
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`disagrees.6
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`6 Plaintiff cites several decisions denying dismissal of the claim that use of total protein in
`nutrient content claims is misleading. (Dkt. 24 at 2.) (Porter v. NBTY, Inc. (Porter I), 2016 U.S.
`Dist. LEXIS 163352, at *17–18 (N.D. Ill. Nov. 28, 2016); Ulrich v. Probalance, Inc., 2017 U.S.
`Dist. LEXIS 132202, at *11–12 (N.D. Ill. Aug. 18, 2017); Gubala v. CVS Pharmacy, Inc., 2016
`U.S. Dist. LEXIS 32759, at *40 (N.D. Ill. Mar. 15, 2016).) These decisions preceded release of
`the 2022 Nutrient Content Claim Guidance clarifying that it is permissible to use total protein for
`nutrient content claims. As such, they fail to address the significant issue created by interpreting
`FDA regulations to conflict and are unpersuasive.
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 8 of 10
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`The Court declines to interpret sections 101.13(i)(3) and 343(a) to conflict with section
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`101.9(c)(7). Regulations may not be interpreted “in isolation” or in ways that would lead to
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`“absurd results,” such as rendering a statement that is approved by one regulation misleading
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`under another. Yumul v. Smart Balance, Inc., No. CV 10-00927 MMM, 2011 WL 1045555, at *9
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`(C.D. Cal. Mar. 14, 2011) (“If Smart Balance complied with the regulatory requirements for
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`labeling a product “Cholesterol Free”, then its label is not “false and misleading” under 21 C.F.R.
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`§ 101.13(i)(3)); see also United Savings Association of Texas v. Timbers of Inwood Forest
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`Associates, Ltd., 484 U.S. 365, 371 (1988) (“A provision that may seem ambiguous in isolation is
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`often clarified by the remainder of the statutory scheme . . . because only one of the permissible
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`meanings produces a substantive effect that is compatible with the rest of the law.”).
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`The Court acknowledges that total protein may be misleading in the colloquial sense, but
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`the FDA has explicitly addressed how to communicate with consumers about the nutrient content
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`of packaged foods. The difference between total and corrected protein is not an issue that the
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`agency has overlooked. As the FDA states in the 2022 guidance, use of both total and corrected
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`protein in the regulations is “by design.” 2022 Nutrient Content Claim Guidance. The Court sees
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`no reason to second-guess the FDA’s chosen approach.
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`In sum, sections 101.13(i)(3) and 343(a) do not save plaintiff’s claims from preemption.
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`Nacarino, 2022 WL 390815 at *5 (“Given the FDA’s express approval of the nitrogen-content
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`method and failure to require manufacturers to adjust for protein quality when stating the amount
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`of protein in the nutrition label, it does not make sense to read the regulations as barring
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`manufacturers from making identical statements elsewhere on their packaging.”); Chong, 2022
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`WL 464149 at *3 (“[A] correct reading of the regulations establishes that producers may state
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`grams of protein even outside the Nutrition Facts panel calculated by the nitrogen-content method,
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`and without adjustment for digestibility.”); Brown, 2022 WL 717816 at *7 (“the FDA has now
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`made clear that its regulations do not require protein content claims to adjust for digestibility or to
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`be calculated using amino acid contest testing”).
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`Given the inability to avoid the FDA’s guidance, the court DISMISSES plaintiff’s claims
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`regarding defendants’ use of total protein in nutrient content claims WITH PREJUDICE.
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`Northern District of California
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`United States District Court
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 9 of 10
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`B. Plaintiff’s Standing to Bring Claims Regarding Defendants’ Omission of %DV
`Protein
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`The remainder of plaintiff’s claims are based on the contention that defendants’ nutrient
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`content claims indicating total protein are misleading because defendants fail to include %DV
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`corrected protein per serving in the nutrient label, as required by section 101.9(c)(7)(ii).
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`Defendants respond that plaintiff lacks standing to bring these claims because he has not alleged
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`that he read or relied upon the nutrition label when he decided to purchase defendants’ products.
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`The Court agrees. Brown, 2022 WL 717816 at *4 (finding same).
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`To have standing, a plaintiff must show that his injury-in-fact is concrete, particularized,
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`and actual or imminent; fairly traceable to the challenged action; and redressable by a favorable
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`ruling. Monsanto Co. v. Geertson Seed Farms, 561 U.S. 139, 149 (2010). To plead standing
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`under the FAL, CLRA, or UCL, a plaintiff must also allege that he relied on the defendants’
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`purported misrepresentations and suffered economic injury as a result. Brown, 2022 WL 717816
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`at *4 (citing Kwikset Corp. v. Superior Court, 51 Cal. 4th 310, 326 (2011)).
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`Plaintiff does not allege that he read or relied upon the nutrition labels prior to purchasing
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`defendants’ products. As such, he has failed to show that his injury is fairly traceable to the
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`alleged misrepresentation (defendants’ omission of %DV from the nutrition label) or that
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`requiring defendants to include %DV on the nutrition label would redress his alleged confusion
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`over the protein content of the products he purchased. See, e.g., Pardini v. Unilever United States,
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`Inc., 961 F. Supp. 2d 1048, 1060 (N.D. Cal. 2013) (“Plaintiff has not pled that she ever looked at
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`the nutrition panel. As such, it is implausible that she was deceived by its lack of disclosures.”);
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`Delacruz v. Cytosport, Inc., No. C 11-3532 CW, 2012 WL 1215243, at *9 (N.D. Cal. Apr. 11,
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`2012) (dismissing claims based on misrepresentations made on the defendant's website because
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`the plaintiff did “not plead that she read or relied on any statements on the website”). Thus,
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`plaintiff has not met his burden to show standing. Brown, 2022 WL 717816 at *4 (dismissing
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`claims based on defendants’ omission of %DV protein on a nutrition label where plaintiff only
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`alleged reliance on front label).
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`Case 4:21-cv-10053-YGR Document 34 Filed 05/20/22 Page 10 of 10
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`That said, it is possible that plaintiff may be able to amend the complaint. Thus, the Court
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`DISMISSES WITH LEAVE TO AMEND plaintiff's claims based on defendants’ omission of %DV
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`protein on nutrition labels.7
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`IT IS SO ORDERED.
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`Dated:
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`May 20, 2022
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`______________________________________
`YVONNE GONZALEZ ROGERS
`UNITED STATES DISTRICT JUDGE
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`7 In light of these findings, the parties’ remaining arguments regarding these claims are
`premature and the court declines to address them at this time.
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