Nutrition information (1) Except as provided in subparagraphs (3), (4), and (5), if it is a food intended for human consumption and is offered for sale, unless its label or labeling bears nutrition information that provides-- * * * (C) the total number of calories-- (i) derived from any source, and (ii) derived from the total fat, in each serving size or other unit of measure of the food, * * * (5)(A) Subparagraphs (1), (2), (3), and (4) shall not apply to food— (i) which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments[.] 21 U.S.C. § 343(r). Nutrition levels and health-related claims (1) Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended for human consumption which is offered for sale and for which a claim is made in the label or labeling of the food which expressly or by implication-- (A) characterizes the level of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food unless the claim is made in accordance with subparagraph (2), or (B) characterizes the relationship of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food to a disease or a health-related condition unless the claim is made in accordance with subparagraph (3) or (5)(D).

C, at 4. Plaintiffs’ challenge 6 Plaintiffs assert in passing that Quaker’s claim is “not stated in a manner so that it is an accurate representation of the authoritative statement on which it relies,” purportedly in violation of 21 U.S.C. § 343(r)(3)(C)(iv). Plaintiffs do not elaborate, but in any event Quaker’s claim precisely tracks the FDA-approved statement that “[d]iets rich in whole grain foods and other plant foods, and low in saturated fat and cholesterol, may help reduce the risk of heart disease.”

But Plaintiffs do not explain how Quaker’s inclusion of an FDA-approved health claim could simultaneously function as a therapeutic claim transforming oatmeal into an unapproved drug. To the contrary, the statutory provision invoked by Plaintiffs, which defines the term “drug” under the FDCA, provides that a food “is not a drug solely because the label or the labeling” of the food contains a health-related claim under 21 U.S.C. § 343(r)(1)(B). See id.

Indeed, she recognizes that the FDA’s regulations were wholly incorporated into California law, and Plaintiff includes near carbon copies of allegations from the FDA’s warning letter (which has not yet been resolved) in the 2AC. Compare 2AC at ¶¶ 43, 46, 48- 56, 62-71 (citing 21 U.S.C. § 343 and 21 C.F.R. § 101.13) with Nierlich Decl., Ex. A. The propriety of the statements challenged in the 2AC is an issue explicitly placed by Congress within the FDA’s exclusive jurisdiction.

See Plaintiff’s Request for Judicial Notice and Exhibits A-D attached thereto. This especially makes sense since, as noted supra, 21 U.S.C. § 343(a)(1), provides that a food is misbranded if “its labeling is false or misleading in any particular,” which parallels California state law.

Because it requires disclosure of purely factual information, Ordinance 40-08 is no different than numerous other commercial disclosure requirements mandated by federal and state law, including the NLEA's nutrition facts panel. See, e.g., 21 U.S.C. § 343(q)(1) (nutritional labeling); 15 U.S.C. § 78 l (securities disclosures); 15 U.S.C. § 1333 (tobacco labeling); 21 C.F.R. § 202.1 (disclosures in prescription drug advertisements).

150)). Plaintiff additionally argues 21 U.S.C. § 343(q)(1)(D) does not govern here because it governs only the “‘Supplemental Facts’ section located on the back of the [Product] label,” whereas he challenges only claims made on the front. (Opp., p. 8.)

See Advisory Committee Notes to 1993 Amendments (“Nor should Rule 11 motions be prepared to . . . intimidate an adversary into no way, violated federal or state law. 22 This product also violates 21 U.S.C. § 343(r) and Cal. Health & Safety Code § 110670, which prohibits the characterization of levels of nutrients except as provided in the FDCA.

; Zeisel v. Diamond Foods, Inc., 2010 U.S. Dist. LEXIS 141941, at *2-9 (N.D. Cal. Sept. 3, 2010) (representations actionable under § 343(a)). Plaintiffs purchased Quaker Chewy Granola Bars, Instant Oatmeal and Oatmeal to Go Bars relying on statements and images that expressly or impliedly tell consumers, especially when taken as a whole, that the pro

Secondly, to claim that the name or statements on the Cheez-It box are Case 2:16-cv-02552-SJF-AYS Document 17-5 Filed 10/07/16 Page 13 of 23 PageID #: 144 8 misleading is off-base when the exact amount of whole grain is stated on the front of the box, e.g., “Made with 8g of Whole Grain.” Plaintiffs still claim that, even if the whole grain statement were a nutrient content claim, it would still be subject to the “catch-all anti-consumer deception provision of 21 U.S.C. § 343(a)(1).” Opp., at 15.