Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 1 of 41
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`GUTRIDE SAFIER LLP
`Seth A. Safier (State Bar No. 197427)
` seth@gutridesafier.com
`Marie A. McCrary (State Bar No. 262670)
` marie@gutridesafier.com
`Hayley Reynolds (State Bar No. 306427)
` hayley@gutridesafier.com
`100 Pine Street, Suite 1250
`San Francisco, CA 94111
`Telephone: (415) 639-9090
`Facsimile: (415) 449-6469
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`Attorneys for Plaintiff
`
`
`UNITED STATES DISTRICT COURT FOR THE
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`NORTHERN DISTRICT OF CALIFORNIA
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`
`LYDIA HARVILLE, an individual, on
`behalf of herself, the general public, and
`those similarly situated,
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`THREE WISHES FOODS, INC.,
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`v.
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`Plaintiff,
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`Defendant.
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`CASE NO.
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`CLASS ACTION COMPLAINT FOR
`VIOLATION OF THE CALIFORNIA
`CONSUMERS LEGAL REMEDIES ACT;
`FALSE ADVERTISING; FRAUD,
`DECEIT, AND/OR
`MISREPRESENTATION; UNFAIR
`BUSINESS PRACTICES; AND UNJUST
`ENRICHMENT
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`JURY TRIAL DEMANDED
`
`INTRODUCTION
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`1.
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`Plaintiff Lydia Harville, by and through her counsel, brings this class action
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`against Defendant Three Wishes Foods, Inc. (“Defendant”) to seek redress for its unlawful and
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`deceptive practices in labeling and marketing the Three Wishes brand cereals which make
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`protein claims on the front of the product packages and are unlawfully fortified.
`2.
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`Consumers are increasingly health conscious and, as a result, many consumers
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`seek foods high in protein. To capitalize on this trend, Defendant prominently claims on the
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`front of its Three Wishes brand cereal product packages that they provide 8g protein per serving
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`and contain “More protein.” Consumers, in turn, reasonably expect that each product will
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`actually provide the amount of protein per serving claimed on the front of the product package
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`in a form the body can use.
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`CLASS ACTION COMPLAINT
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 2 of 41
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`3.
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`The Food and Drug Administration (“FDA”) prohibits such front label claims
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`about the amount of protein, unless manufacturers also provide additional information in the
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`nutrition fact panel about how much of the recommended daily value for protein that the
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`product will actually provide. 21 C.F.R. §§ 101.9(c)(7)(i), 101.13(b), (n). That is because the
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`FDA recognizes that (1) when manufacturers tout an amount of protein on the front label, that
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`amount is likely to be material to purchasing decisions, even though reasonable consumers may
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`not know the total amount of protein they need to ingest on a daily basis, and (2) not all proteins
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`are the same in their ability to meet human nutritional requirements, so a simple statement about
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`the number of grams does not actually inform consumers about how much usable protein they
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`are receiving. Some proteins are deficient in one or more of the nine amino acids essential to
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`human protein synthesis and/or are not fully digestible within the human gut. When a human
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`body uses up the least prevalent essential amino acid from a food product, protein synthesis
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`shuts down and all of the remaining amino acids from that protein source degrade mostly into
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`waste. Likewise, whatever portion of a protein source is not digestible is similarly unavailable
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`for protein synthesis. A protein’s ability to support human nutritional requirements is known as
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`its “quality.”
`4.
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`The FDA required method for measuring protein quality is called the “Protein
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`Digestibility Corrected Amino Acid Score”—known by its acronym PDCAAS (pronounced
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`Pee-Dee-Kass). It combines a protein source’s amino acid profile and its percent digestibility
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`into a discount factor ranging from 0.0 to 1.0 that, when multiplied by the total protein quantity,
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`shows how much protein in a product is actually available to support human nutritional
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`requirements. The regulations term this the “corrected amount of protein per serving.” 21 C.F.R.
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`§ 101.9(c)(7)(ii). For example, a PDCAAS of .5 means that only half of the protein in that
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`product is actually available to support human protein needs. If the product contained 10 grams
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`total protein per serving, the corrected amount of protein would be only 5 grams per serving. As
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`a result, protein products can vary widely in their ability to support human protein needs—even
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`between two comparator products with the same total protein quantity.
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`CLASS ACTION COMPLAINT
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 3 of 41
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`5.
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`Because consumers are generally unaware about the usability of various proteins,
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`and may even be unaware of the total amount of usable protein they should ingest each day, the
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`FDA prohibits manufacturers from advertising or promoting their products with a protein claim
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`unless they have satisfied two requirements. First, the manufacturer must calculate the
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`“corrected amount of protein per serving” based on the quality of the product’s protein using the
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`PDCAAS method. Second, the manufacturer must use the PDCAAS computation to provide “a
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`statement of the corrected amount of protein per serving” in the nutrition facts panel (“NFP”)
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`“expressed as” a percent daily value (“%DV”) and placed immediately adjacent to the statement
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`of protein quantity. 21 C.F.R. § 101.9(c)(7)(i)-(iii). The %DV is the corrected amount of protein
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`per serving divided by the daily reference value for protein of 50 grams. Id. Using the same
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`example of a product containing 10 grams total protein per serving with a PDCAAS of .5, the
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`%DV is 10% (5g/50g). Had all of the protein in the product been useful in human nutrition, the
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`%DV would be 20% (10g/50g). The FDA regulations that govern nutrient content claims are
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`also clear that the manufacturer may not make any front label claims about the amount of
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`protein in the product unless it complies with these two requirements. See 21 C.F.R. § 101.13(b)
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`(“A nutrient content claim[] may not be made on the label…unless the claim is made in
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`accordance with this regulation [i.e., § 101.13]…” and (n) (“[n]utrition labeling in accordance
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`with § 101.8…shall be provided for any food for which a nutrient content claim is made”);
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`accord 58 Fed. Reg. 2302, 23310 (manufacturer can only make a ”nutrient content claim…on
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`the label or in labeling of a food, provided that the food bears nutrition labeling that complies
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`with the requirements in proposed § 101.9.”).
`6.
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`The primary protein sources in Defendant’s products are chickpea protein, pea
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`protein, and tapioca (which is extracted from cassava). The PDCAAS scores for these proteins
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`are as follows: (i) chickpea – 0.75; (ii) pea – .82; and (iii) tapioca – 0.57, which means
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`Defendant’s products will provide nutritionally as little as approximately half of the protein
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`quantity claimed. Nevertheless, Defendant failed to provide in the NFP a statement of the
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`corrected amount of protein per serving calculated according to the PDCAAS methodology and
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`expressed as a %DV. Accordingly, the protein claims on the front of the package, such as “8g
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`CLASS ACTION COMPLAINT
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 4 of 41
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`protein per serving” are unlawful in violation of parallel state and federal laws because
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`Defendant did not comply with the regulatory requirements for making a protein claim. 21
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`C.F.R. § 101.9(c)(7)(i), 101.13(b), (n). The failure to include a statement of the corrected
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`amount of protein inside the NFP also rendered the NFP itself unlawful. Id. § 101.9(c)(7)(i).
`7.
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`Where a product makes a protein claim, the NFP is required to contain a
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`statement of the corrected amount of protein per serving calculated according to the PDCAAS
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`methodology and expressed as a %DV. Accordingly, the protein claims on the front of the
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`cereal packages, such as “8g protein per serving,” are unlawful in violation of parallel state and
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`federal laws because Defendant did not comply with the regulatory requirements for making a
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`protein claim.
`8.
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`In addition to being unlawful under 21 CFR §§ 101.9 and 101.13, Defendant’s
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`prominent protein claim on the front of the package, in the absence of any statement of the
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`corrected amount of protein per serving expressed as a %DV in the NFP, also is likely to
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`mislead reasonable consumers. Consumers reasonably expect that Defendant’s products will
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`actually provide nutritionally the full amount of protein per serving claimed on the front of the
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`package and stated in the protein quantity section of the NFP. But Defendant’s products do not
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`do so on account of their low protein quality. Had Defendant included a statement of the
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`corrected amount of protein per serving in the NFP, as it was required to do under the law, it
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`would have revealed that the product provides nutritionally as little as half of their total protein
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`quantity. That information was material to reasonable consumers.
`9.
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`Additionally, Defendant’s protein claim is also misleading because it is stated in
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`the form of a quantitative amount appearing alone, without any information about protein
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`quality. FDA regulations prohibit a manufacturer from stating “the amount or percentage of a
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`nutrient” on the front label if it is “false or misleading in any respect.” 21 C.F.R. § 101.13(i)(3).
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`Defendant fails to disclose to consumers that the protein sources in the Three Wishes cereal are
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`low quality and only provide approximately half the protein claimed on the label. This is
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`misleading.
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 5 of 41
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`10.
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`Defendant’s Three Wishes cereals are additionally misbranded within the
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`meaning of section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §
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`343(r)(1)(A)] (the “Act” or the “FDCA”) because the addition of protein does not comply with
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`the FDA Fortification Policy, which is binding in these circumstances.
`11.
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`The FDA Fortification Policy establishes a “uniform set of principles to serve as
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`a model for the rational addition of nutrients to foods.” 21 C.F.R. § 104.20. Although
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`recognizing the benefits of adding nutrients to foods, the FDA cautioned that “[the random
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`fortification of foods] could also result in deceptive or misleading claims for certain foods.” Id.
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`The Fortification Policy provides that “[a]ny claims or statements in the labeling of food about
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`the addition of a vitamin, mineral, or protein to a food shall be made only if the claim or
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`statement is not false or misleading and otherwise complies with the act and any applicable
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`regulations.” 21 C.F.R. § 104.20(h).
`12.
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`The Fortification Policy is made binding where other binding regulations
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`incorporate it by reference. One such circumstance is 21 C.F.R. § 101.54(e). This regulation
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`governs the use of “more” claims, which includes “relative claim[s]” using terms such as “more”
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`to describe the level of a nutrient as compared to a reference food. 21 C.F.R. § 101.54(e)(1)(iii).
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`Among the requirements for the use of these terms is compliance with the Fortification Policy.
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`21 C.F.R. § 101.54(e)(1)(ii).
`13.
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`The Products have “more” claims, including “More protein” followed by, for
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`example, “2x more protein than the leading whole grain oat cereal” on the unsweetened flavor.
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`Therefore, the Products must comply with the Fortification Policy. 21 C.FR. § 101.54(e)(1)(ii).
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`However, the Products do not meet any of the four criteria where the FDA permits fortification
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`under the Fortification Policy. See 21 C.F.R. § 104.20(b)-(e). Specifically, the scientific
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`community has not recognized a dietary insufficiency of protein; the protein is not added to
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`restore nutrients to levels of the food prior to storage; the protein is not added to balance the
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`vitamin, mineral, and protein content in proportion to the total caloric content; and the protein is
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`not added “to avoid nutritional inferiority” when replacing a traditional food.” Id. Therefore, the
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`fortification of the Three Wishes cereal violates 21 C.F.R. § 101.54(e) and 21 C.F.R. § 104.20.
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 6 of 41
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`14.
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`Defendant’s unlawful and misleading protein claims caused Plaintiff and
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`members of the class to pay a price premium for the Three Wishes cereals.
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`PARTIES
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`15.
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`Plaintiff Lydia Harville is, and at all times alleged in this Class Action Complaint
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`was, an individual and a resident of Los Gatos, California. Plaintiff Harville makes her
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`permanent home in California and intends to remain in California.
`16.
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`Defendant Three Wishes Foods, Inc. is a corporation existing under the laws of
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`Delaware, with its principal place of business in New York, New York.
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`JURISDICTION AND VENUE
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`17.
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`This Court has jurisdiction over the subject matter of this action pursuant to 28
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`U.S.C. § 1332(d)(2). The aggregate amount in controversy exceeds $5,000,000, exclusive of
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`interest and costs; and Plaintiff and Defendant are citizens of different states.
`18.
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`The injuries, damages and/or harm upon which this action is based, occurred or
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`arose out of activities engaged in by Defendant within, affecting, and emanating from, the State
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`of California. Defendant regularly conducts and/or solicits business in, engages in other
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`persistent courses of conduct in, and/or derives substantial revenue from products provided to
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`persons in the State of California. Defendant has engaged, and continues to engage, in
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`substantial and continuous business practices in the State of California.
`19.
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`Venue is proper in this District pursuant to 28 U.S.C. § 1391(b)(2) because a
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`substantial part of the events or omissions giving rise to the claims occurred in the state of
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`California, including within this District.
`20.
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`In accordance with California Civil Code Section 1780(d), Plaintiff concurrently
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`files herewith a declaration establishing that, at various times throughout the class period, she
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`purchased Three Wishes cereals in the Unsweetened and Cocoa flavors on Amazon.com and at
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`a Whole Foods retail store in California. ( Plaintiff’s declaration is attached hereto as Exhibit
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`A.)
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`21.
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`Plaintiff accordingly alleges that jurisdiction and venue are proper in this Court.
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 7 of 41
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`SUBSTANTIVE ALLEGATIONS
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`22.
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`Defendant manufactures, distributes, markets, advertises, and sells cereals in a
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`variety of flavors under the brand name “Three Wishes.” All the flavors of Three Wishes cereal
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`have packaging that predominately, uniformly, and consistently states on the principal display
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`panel of the product labels that they contain and provide 8 grams of protein per serving and
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`contain “More protein.” Plaintiff has attached, as Exhibit B, a non-exhaustive list of the Three
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`Wishes products that make protein claims on the front of the product packages. The products
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`listed in Exhibit B, and any other Three Wishes product that claims a specific amount of protein
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`on the front of its label or makes a “More protein” claim, will hereinafter be referred to as the
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`“Products.”
`23.
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`The representations that the Products contain and provide a specific amount of
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`protein per serving and that the Products contain “More protein” were uniformly communicated
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`to Plaintiff and every other person who purchased any of the Products in California. The same
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 8 of 41
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`or substantially similar product label has appeared on each Product during the entirety of the
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`Class Period in the general form of the following example:
`24.
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`The nutrition facts panel on the back of the Products uniformly and consistently
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`failed to provide any statement of the corrected amount of protein per serving, expressed as
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`a %DV, throughout the Class Period. The nutrition facts panel of the Products has appeared
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`consistently throughout the Class Period in the general form of the following example (from the
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`Three Wishes cereal in Unsweetened flavor):
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`25.
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`As described in detail below, Defendant’s advertising and labeling of the
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`Products as containing and providing specific amounts of protein per serving is unlawful,
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`misleading, and intended to induce consumers to purchase the Products at a premium price,
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`while ultimately failing to meet consumer expectations. The Products’ front label protein claims
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`are unlawful because Defendant did not: (1) calculate the “corrected amount of protein per
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`serving” based on the quality of the product’s protein using the PDCAAS method; (2) provide a
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`statement of that corrected amount of protein per serving in the NFP, expressed as %DV. 21
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`C.F.R. § 101.9(c)(7)(i) & (iii); and (3) comply with the FDA’s fortification policy. Defendant’s
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 9 of 41
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`failure to comply with § 101.9 also makes the front label claims unlawful under §§ 101.13(n)
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`and (b). The unlawful front label protein claims and fortification induced consumers to purchase
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`the Products at a premium price. Had Defendant complied with FDA regulations and not
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`included a protein claim on the front label of its Products and not fortified the Products,
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`reasonable consumers would not have purchased them or would have paid less for the Products.
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`The front label protein claims are also false and misleading because they deceive reasonable
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`consumers into believing that a serving of the Products will provide the grams of protein as
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`represented on the label, when in fact, correcting for the Products’ poor protein quality through
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`PDCAAS, the amount provided will be approximately half or less because Defendant uses
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`proteins of low biological value to humans in its products, such as chickpea, pea, and tapioca
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`derived proteins.
`26.
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`Defendant’s failure to provide the required statement of the corrected amount of
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`protein per serving, as well as Defendant’s prominent front label protein claims made in the
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`absence of any statement of the corrected amount of protein in the NFP, also deceived and
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`misled reasonable consumers into believing that a serving of the Products will provide the
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`grams of protein represented on the label, when that is not true. Had Defendant complied with
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`the law, the statement of the corrected amount of protein would have revealed the Products
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`provide significantly less protein than claimed because Defendant uses low quality protein in
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`the Products such as chickpea, pea, and tapioca. The absence of this information also allowed
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`Defendant to charge a price premium. Had reasonable consumers been informed of the true
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`amount of protein that the products provided through a statement of the corrected amount of
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`protein per serving, as required by FDA regulations, they would not have purchased or would
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`have paid less for the Products.
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`Consumer Demand for Protein
`27. Many American consumers are health conscious and seek wholesome, natural
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`foods to keep a healthy diet, so they routinely rely upon nutrition information when selecting
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`and purchasing food items. As noted by FDA Commissioner Margaret Hamburg during an
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`October 2009 media briefing, “[s]tudies show that consumers trust and believe the nutrition
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 10 of 41
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`facts information and that many consumers use it to help them build a healthy diet.” Indeed, the
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`FDA recommends relying on Nutrition Facts Labels as the primary tool to monitor the
`consumption of protein.1
`28.
`Protein is found throughout the body—in muscle, bone, skin, hair, and virtually
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`every other body part or tissue. The health benefits of protein are well studied and wide ranging.
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`Scientific studies have confirmed that protein can assist in weight loss, reduce blood pressure,
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`reduce cholesterol, and control for risk factors for cardiovascular diseases. The National
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`Academy of Medicine recommends that adults get a minimum of .8 grams of protein for every
`kilogram of body weight per day, or just over 7 grams for every 20 pounds of body weight.2 For
`a 140-pound person, that means about 50 grams of protein each day. For a 200-pound person,
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`that means about 70 grams of protein each day.
`29.
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`The health benefits of protein are just as important, if not more important, for
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`children. Children are in a relative state of constant growth and rely on protein as the building
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`block of muscle, bone, skin, hair, and virtually every other body part or tissue. The National
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`Academies of Science recommends the following amounts of daily intake of protein based on
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`age group: 1-3 years old: 13 g of protein per day; 4-8 years old: 19 g of protein per day; 9-13
`years old: 34 g of protein per day.3
`30.
`Protein quantity by itself does not tell the full story of protein from a human
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`nutritional standpoint. A protein’s quality is also critical because humans cannot fully digest or
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`utilize some proteins. Proteins are not monolithic. They are simply chains of amino acids, and
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`different types of amino acids chained together in different ways will make different types of
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`proteins. Further, the makeup of the protein changes the function of that protein in the body, and
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`certain types of proteins are more easily digested and used by humans than others.
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`
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`1 FDA Protein Fact Sheet,
`https://www.accessdata.fda.gov/scripts/InteractiveNutritionFactsLabel/factsheets/Protein.pdf
`2 National Academies of Medicine. Dietary Reference Intakes for Energy, Carbohydrate, Fiber,
`Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients).
`3 Id.
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 11 of 41
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`31.
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`All of a human’s proteins are formed through the process of protein synthesis
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`within their own bodies. That is, although humans consume dietary proteins, they digest those
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`proteins, break them down into their constituent amino acids, and then use those amino acids as
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`building blocks to synthesize the human proteins necessary for life, tissue repair, and other
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`functions. Of the twenty total amino acids, humans can produce only eleven of them on their
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`own. Humans cannot produce, under any circumstances, nine of the amino acids required for
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`protein synthesis. These nine amino acids are called the “essential amino acids” and they must
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`be supplied through the diet.
`32.
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`All nine essential amino acids are necessary for protein synthesis to take place.
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`Lacking even one essential amino acid will prevent protein synthesis from occurring, and the
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`rest of the proteins will degrade into waste. Accordingly, once the body uses up the limiting
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`essential amino acid from a protein source, the remainder of that protein becomes useless to
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`human protein synthesis and has little nutritional value. As the FDA has explicitly recognized,
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`“[b]ecause excess amino acids are not stored in the body, humans need a constant supply of
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`good quality dietary proteins to support growth and development.” 58 Fed. Reg. 2079 at 2101.
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`High-quality proteins, therefore, are those that contain all nine essential amino acids because
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`they have a greater effect on protein synthesis and are fully digestible. A dietary protein
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`containing all of the essential amino acids in the correct proportions is typically called a
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`“complete protein.”
`33.
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`A protein source’s digestibility also affects the amount of useable protein a
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`person receives from consuming it. Plant-based proteins like chickpea, pea, and tapioca are less
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`than 85% digestible, meaning 15% of the protein from that source will simply pass through the
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`body without ever being absorbed at all.
`34.
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`As the FDA has stated in official guidance, “Accurate methods for determining
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`protein quality are necessary because different food protein sources are not equivalent in their
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`ability to support growth and body protein maintenance.” 56 Fed. Reg. 60366, § B. The Protein
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`Digestibility Corrected Amino Acid Score (“PDCAAS”), is the FDA mandated measure of
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 12 of 41
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`protein quality, and it accounts for both the amino acid profile and the digestibility of the
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`protein. 21 C.F.R. § 101.9(c)(7)(ii).
`35.
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`The PDCAAS method requires the manufacturer to determine the amount of
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`essential amino acids that the food contains and then combine that with the proteins’
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`digestibility into an overall discount factor (i.e., a “score” from 0.0-1.0) that represents the
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`actual amount of protein the food provides nutritionally when multiplied by raw protein
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`quantity. The regulations term this the “corrected amount of protein per serving.” 21 C.F.R.
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`§ 101.9(c)(7)(i).
`36.
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`Defendant uses plant-based proteins in its products. Because of the differences in
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`benefits depending on the amino acid composition of a protein, the source of protein is
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`important. protein does not contain all nine essential amino acids and is low quality to humans.
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`Chickpea protein, pea protein, and tapioca typically have a PDCAAS of between .57 and .82,
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`meaning only approximately 60-80% of the protein from those sources will be useable by
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`humans as protein.
`37.
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`Accordingly, Defendant’s use of low quality proteins means that they actually
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`provide far less protein to humans than the Product labels claim.
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`Federal and State Regulations Governing Food Labeling
`38.
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`Identical federal and California laws regulate the content of labels on packaged
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`food. The requirements of the Act, and its labeling regulations, including those set forth in 21
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`C.F.R. §§ 101, 102, were adopted by the California legislature in the Sherman Food Drug &
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`Cosmetic Law (the “Sherman Law”). California Health & Safety Code § 110100 (“All food
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`labeling regulations and any amendments to those regulations adopted pursuant to the federal
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`act, in effect on January 1, 1993, or adopted on or after that date shall be the food labeling
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`regulations of this state.”). The federal laws and regulations discussed below are applicable
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`nationwide to all sales of packaged food products. Additionally, none of the California laws
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`sought to be enforced here imposes different requirements on the labeling of packaged food for
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`sale in the United States.
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 13 of 41
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`39.
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`The Act, 21 U.S.C. § 343(a), and the Sherman Law, CITE, provides that a food
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`is misbranded
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`if
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`“its
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`labeling
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`is
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`false or misleading
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`in
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`any particular.”
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`PDCAAS for Protein
`40.
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`According to FDA regulations, “[a] statement of the corrected amount of protein
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`per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of
`the RDI or DRV for protein, as appropriate, and expressed as a Percent of Daily Value . . . shall
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`be given if a protein claim is made for the product . . .” 21 C.F.R. 101.9(c)(7)(i) (emphasis
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`added). If a manufacturer does not want to perform PDCAAS and provide a statement of the
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`corrected amount of protein per serving in the NFP, then it shall not make any protein claims.
`41.
`
`The regulation governing nutrient content claims, section 101.13, also makes this
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`plain. Section 101.13(n) provides that “[n]utrition labeling in accordance with § 101.9 . . . shall
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`be provided for any food for which a nutrient content claim is made” and § 101.13(b) states “a
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`nutrient content claim[] may not be made on the label . . . unless the claim is made in
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`accordance with this regulation [i.e., § 101.13] . . . .” In other words, a manufacturer may not
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`make any protein nutrient content claims on the front labels of their products unless they have
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`complied with the requirements for protein labeling in the nutrition facts panel pursuant to
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`section 101.9(c)(7). Indeed, the FDA made clear when promulgating § 101.13(n) that it means
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`that a manufacturer can only make “a nutrient content claim . . . on the label or in labeling of a
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`food, provided that the food bears nutrition labeling that complies with the requirements in
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`proposed § 01.9.” 58 Fed. Reg. 2302, 23310.
`42.
`
`Further, FDA regulations require the %DV for protein to be calculated using
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`PDCAAS, a method that accounts for both protein quantity and protein quality. 21 C.F.R. §
`101.9(c)(7)(i)-(iii); FDA Food Labeling Guide, p. 29, Question N.22.4 The first step is to
`calculate the “corrected amount of protein per serving” by multiplying protein quantity by the
`
`
`
`
`
`4 Guidance for Industry: A Food Labeling Guide (“FDA Food Labeling Guide”) p. 29, Question
`N22, U.S. Food & Drug Administration, https://www.fda.gov/media/81606/download (last
`accessed February 18, 2020).
`
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`Case 5:22-cv-04774-NC Document 1 Filed 08/19/22 Page 14 of 41
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`PDCAAS quality value, and then dividing that “corrected amount” by 50 grams (the
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`“recommended daily value” for protein) to come up with the %DV. Id.
`43.
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`The Products all make protein claims on the front label, but fail, uniformly to
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`provide a statement of the corrected amount of protein per serving in the NFP calculated
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`according to the PDCAAS method. The protein claims on the front are, therefore, unlawful, and
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`were never permitted to be on the labels in the first instance under §§ 101.9(c)(7)(i), 101.13(n),
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`and 101.13(b).
`44.
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`Defendant’s failure to include a statement of the corrected amount of protein per
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`serving expressed as a %DV in the NFP also renders the NFP itself unlawful under §§
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`101.9(c)(7)(i)-(iii).
`45.
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`Defendant’s use of a front-label protein claim, while failing to include the
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`required statement of the corrected amount of protein per serving in the NFP calculated using
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`the PDCAAS method and expressed as a %DV, is also misleading. By failing to provide it,
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`Defendant misled consumers into believing that the Products provide a higher amount of protein
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`than they really do. It also enabled Defendant to conceal the fact that its Products consist of low
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`quality proteins derived from chickpea, pea, and tapioca that simply do not provide all of the
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`protein that quantity alone represents. Indeed, when promulgating 21 C.F.R. § 101.9(c)(7), the
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`FDA explained in published guidance that “Information on protein quantity alone can be
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`misleadin