21 U.S.C. § 343-1(a)(4). Any conceivable doubt on the meaning of the FDA regulations is eliminated by the FDA’s conclusion that, “[o]n foods that declare ‘0 g trans fat’ in nutrition labeling, in accordance with 21 CFR 101.9(c) as amended, FDA will not object to a firm voluntarily identifying ingredients that are generally understood by consumers to contain trans fat . . . with an asterisk that refers to a statement below the list of ingredients which states ‘adds a trivial (or negligible or dietarily insignificant) amount of trans fat.’” Letter from Felicia B. Satchell, Director, Food Label and Standards Staff, FDA, to Richard S. Silverman (Mar. 18, 2004) (Def.

For “Class I” nutrients, such the Products and the protein-spiking agents Defendant adds to them, the actual protein content must be “at least equal to the value for that nutrient declared on the label.” 21 CFR 101.9(g)(4)(i). Case3:14-cv-05006-MMC Document46 Filed07/13/15 Page18 of 24 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 14 OPPOSITION TO MOTION TO DISMISS — NO. 14-CV-5006 increases the misleading nature of its front labels, and cannot absolve Defendant of liability here.

5 gram [of trans fat], the content, when declared, shall be declared as zero.” 21 C.F.R. § 101.9(c)(2)(ii). The same regulation defines an “‘insignificant amount’” of a particular nutrient, in turn, as “that amount that allows a declaration of zero in nutrition labeling.”

“0g Trans Fat”: This is true because the FDA requires that trace amounts of trans fat be declared as zero on the Nutrition Facts box, and expressly authorizes this statement to be repeated elsewhere on the product packaging. 21 C.F.R. § 101.9(c)(2)(ii), 101.13(i)(3); supra Sect.

. amount in the familiar Nutrition Facts panel is not a ‘claim,’ while an identical statement voluntarily made elsewhere on a food product label is a ‘claim’ subject to § 343(r), the attendant FDA regulations . . . .”). 7 The sole FDA regulation concerning trans fat labeling is 21 C.F.R. § 101.9(c)(2)(ii) and deals only with the mandatory disclosure in the Nutrition Facts box. Case5:10-cv-00502-RS Document24 Filed06/17/10 Page15 of 33

Here, the FDA has specifically concluded that the use of the phrases “cholesterol free” and “0g Trans Fat” per serving are appropriate in connection with label disclosures. 21 C.F.R. § 101.9(c) and (d); § 101.13; and § 101.

09 specifically apply to food served in restaurants if that food bears “[c]laims or othe nutrition information.” 21 C.F.R. § 101.9(j)(2). Santa Clara also says that “claims” are limit d to statements that “inherently characterize” the nutrition information.

The applicable regulation concerning sugar disclosure not only requires labels to disclose total sugar (except where the amounts fall below thresholds), but also specifies the exact words to be used and the way in which such disclosure must be made. 21 C.F.R. § 101.9(c). With respect to ingredients lists specifically, federal law imposes sugar- related requirements not whenever ingredients add sugar, but only in limited circumstances.

25 times the nitrogen content of the food”). To the contrary, Plaintiff alleges the label overstates the protein content because it is calculated in conformity with 21 C.F.R. § 101.9(c)(7): “Nitrogen is the ‘marker’ used by the common test as a rough estimate of the amount of protein in a product, but it is not a direct measurement of the actual protein content. By adding nitrogen-rich ingredients, Body Fortress appears to contain more protein than it actually does.”

9(c)(2)(ii) (1993) (emphases added). The FDA provides a template for the required disclosure of TFAs: Guidance for Industry: A Food Labeling Guide, L 2 (Sep. 1994; Rev. Apr. 2008; Rev. Oct. 2009);5 see also 21 C.F.R. § 101.9(d)(11) & (12) (1993). The Instant Noodles labels conform to this template.