Compare: [Plaintiff’s version, from FAC ¶ 14 (emphasis added)]: “The label also must ‘include a statement of the presence or absence of any characterizing ingredient . . .” with [The actual text of § 102.5(c) (emphasis added)]: “The common or usual name of a food shall include a statement of the presence or absence of any characterizing ingredient . . .” Case3:12-cv-04936-LB Document27 Filed02/14/13 Page21 of 21

Manufactured noncompliance is different than actual noncompliance. Plaintiffs attempt a similar renaming of Cheez-It Baked Snack Crackers in their argument concerning 21 C.F.R. § 102.5(b). Plaintiffs’ assertions are, therefore, wrong again.

Case 5:17-cv-00462-DOC-SP Document 14 Filed 05/03/17 Page 14 of 27 Page ID #:73 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 8 MOTION TO DISMISS 5:17-CV-00462 300676882 V4 Finally, plaintiff appears to assert that Full Circle Almondmilk must disclose the percentage of “characterizing ingredients” in its statement of identity; however, plaintiff fails to allege any “characterizing ingredient” that Topco must disclose on the Full Circle Almondmilk label. Indeed, the common or usual name—almondmilk— does not identify any “characterizing ingredients,” and therefore, any reliance on 21 C.F.R. § 102.5(b) is misplaced. In sum, federal law, not only permits, but requires that product labels identify almond milk as almond milk because that is the common or usual name for the product.

The court reasoned, [T]he names “soymilk,” “almond milk,” and “coconut milk” accurately describe Defendants’ products. As set forth in [21 C.F.R. § 102.5], these names clearly convey the basic nature and content of the beverages, while clearly distinguishing them from milk that is derived from dairy cows. Moreover, it is simply implausible that a reasonable consumer would mistake a product like soymilk or almond milk with dairy milk from a cow.

CV 12-02724 LHK 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 The FDA regulations and guidance prohibiting the use of “evaporated cane juice” are clear. 21 C.F.R. § 102.5 requires companies to use “[t]he common or usual name of a food” and to “identify or describe, in as simple terms as possible, the basis nature of the food or its characterizing properties or ingredients.” The ingredient in Defendant’s products is “sugar,” not “evaporated cane juice,” and should have been labeled as sugar.31 Even if Defendant disagrees with that legal application, it will have the opportunity to address that on a class-wide basis.

5, which provides: The common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or component(s) when the proportion of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may Case 1:15-cv-05405-MKB-VMS Document 19 Filed 02/19/16 Page 17 of 33 PageID #: 275 -11- otherwise create an erroneous impression that such ingredient(s) or component(s) is present in an amount greater than is actually the case. In essence, therefore, Plaintiffs’ claim regarding the Made With Real Fruit Label is merely a contention that the provisions of 21 C.F.R. § 102.5 should apply to Fruit Snacks packaging. This Court should leave this determination to the sound discretion of the FDA, the entity that has been charged by Congress with developing, promulgating and determining the application of this rule.

5(a)). Further, 21 C.F.R. § 102.5(d) states that “[a] common or usual name of a food may be established by common usage or by establishment of a regulation in subpart B of this part, in part 104 of this chapter, in a standard of identity, or in other regulations in this chapter.” Such regulations require that the ingredient Defendant calls “evaporated cane juice” be referred to as “sugar” on food labels.

Plaintiff contends that his claim is actionable under FDA regulations (21 C.F.R. § 101.4(a)(1), 21 C.F.R. § 102.5(a), (d)) and a non-binding, draft FDA Guidance for Industry. (FAC, ¶¶43-46.)

36 21 C.F.R. 102.5(b). 37 21 C.F.R. 104.20(a). 38 See FDA Guidance for Industry: Questions and Answers on FDA’s Fortification Policy, available at http://www.fda.gov/Food/GuidanceRegulation/Guidance DocumentsRegulatoryInformation/ucm470756.htm (“random fortification of foods could . . . result in deceptive or misleading claims on certain foods”)

4(a)(1)……………………………………………………………………………....8 21 C.F.R. § 102.5(a)…………………………………………………………………………………8 21 C.F.R. § 102.5(d)…………………………………………………………………………...……8 21 C.F.R. § 101.22………………………………………………………………………………….