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1 Case:-cv-0-EMC Document Filed0// Page of MICHAEL EIDEL (State Bar No. 0) FOX ROTHSCHILD LLP 00 Kelly Road, Suite 00 Warrington, PA Telephone: () - Facsimile: () -0 meidel@foxrothschild.com Attorneys for Defendant Healthy Beverage, LLC d/b/a The Healthy Beverage Company UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF CALIFORNIA, SAN FRANCISCO DIVISION 0 MARY SWEARINGEN and ROBERT FIGY, individually and on behalf of all others similarly situated, v. Plaintiffs, HEALTHY BEVERAGE, LLC and THE HEALTHY BEVERAGE COMPANY Defendants. Case No. :-CV-0 - EMC DEFENDANT HEALTHY BEVERAGE, LLC D/B/A THE HEALTHY BEVERAGE COMPANY S NOTICE OF MOTION, MOTION TO DISMISS FIRST AMENDED COMPLAINT, AND, IN THE ALTERNATIVE, MOTION TO STAY; MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT Action Filed: September 0, 0 Hearing Date: June, 0 Time: :0 p.m. Courtroom: Judge: Honorable Edward M. Chen 0 NOTICE OF MOTION AND MOTION TO PLAINTIFFS AND THEIR ATTORNEYS OF RECORD: PLEASE TAKE NOTICE THAT on June, 0, at :0 p.m. or as soon thereafter as this may be heard in the above-referenced court, before the Honorable Edward M. Chen, Defendant Healthy Beverage LLC d/b/a The Healthy Beverage Company (erroneously sued as Healthy Beverage, LLC and The Healthy Beverage Company ) (hereafter, Healthy Beverage or Defendant ) will and hereby does move the court for an order dismissing the First Amended Complaint (the FAC ) filed by Plaintiffs Mary Swearingen and Robert Figy (collectively, Plaintiffs ), and, the alternative, for an order staying the action pending the Ninth Circuit s Case No: :-cv--emc

2 Case:-cv-0-EMC Document Filed0// Page of 0 0 decision in Kane, et al. v. Chobani, Inc., No. -0. This motion is made pursuant to Federal Rules of Civil Procedure, (b), (b)(), (b)(), and (b) is based on the following grounds:. Plaintiffs lack standing and fail to state a claim because they fail to plead plausible allegations of reliance, causation, and injury.. For the same reasons Plaintiffs fail to plausibly allege deception, Plaintiffs claims fail the reasonable consumer test and therefore, fail to state a claim.. Plaintiffs fail to plead their claims against Healthy Beverage with particularity, as required by Federal Rule of Civil Procedure (b).. Plaintiffs claims should be dismissed or stayed under the doctrine of primary jurisdiction based on the Food and Drug Administration s ( FDA ) ongoing consideration of the ingredient evaporated cane juice ( ECJ ) and the risk of inconsistent results if different courts determine labeling obligations.. Plaintiffs claims are expressly preempted by the Federal Food, Drug, and Cosmetic Act, U.S.C. 0 et seq. ( FDCA ) because they seek to impose additional requirements that are not identical to federal requirements.. Plaintiffs state law claims are impliedly preempted by uniform federal labeling law promulgated by Congress and the FDA.. Plaintiffs implied warranty of merchantability claim fails because the FAC lacks factual allegations that the products were not fit for their ordinary purpose.. This Court should stay the action pending resolution of the appeal in Kane because the Ninth Circuit s decision will benefit the Court, Plaintiffs will not be prejudiced by a brief delay in the resolution of their claims, and Defendant will suffer competitive injury if stay is not granted. This motion is based on this notice of motion, the accompanying statement of issues to be decided, the accompanying memorandum of points and authorities, all pleadings and documents on file in this case, and on such other written and oral argument as may be presented to the Court. Case No: :-cv--emc

3 Case:-cv-0-EMC Document Filed0// Page of 0 0 Dated: April, 0 FOX ROTHSCHILD LLP By: /s/ Michael Eidel Michael Eidel Attorneys for Defendant, Healthy Beverage LLC d/b/a The Healthy Beverage Company Case No: :-cv--emc

4 Case:-cv-0-EMC Document Filed0// Page of 0 0 STATEMENT OF ISSUES TO BE DECIDED. Plausibility. Do Plaintiffs fail to plausibly allege reliance and deception as required for standing and to state a claim because the product labels for Defendant s lightly sweetened iced tea and energy drinks negate any contention that Plaintiffs believed the products did not contain added sugar and Plaintiffs cannot plausibly allege that they believed ECJ to be something other than a form of sugar?. Reasonable Consumer Test. For the same reasons Plaintiffs fails to plausibly allege deception, should Plaintiffs claims be dismissed under the reasonable consumer test?. Rule (b) Particularity. Do Plaintiffs fail to plead their claims with particularity as required by Fed. R. Civ. P. (b) because they fail to allege, inter alia, what they understood ECJ to be if not a form of sugar, how they were misled by the listing of ECJ, why they believed the products did not contain added sugar, and where, when, and how many times they allegedly purchased the products?. Primary Jurisdiction. Should this Court defer to the FDA under the primary jurisdiction doctrine based on the FDA s recent notice of its ongoing consideration of the term evaporated cane juice and the risk of inconsistent results if different courts determine labeling obligations?. Express Preemption. Are Plaintiffs claims expressly preempted by U.S.C. - because they seek to impose requirements that are not identical to and conflict with uniform federal requirements?. Implied Preemption. Are Plaintiffs claims impliedly preempted by U.S.C. because they constitute an impermissible attempt to enforce the FDCA?. Implied Warranty of Merchantability. Have Plaintiffs failed to state a claim for implied warranty of merchantability where they fail to allege that the products were not fit for their ordinary purpose of human consumption.. Stay. Has Defendant demonstrated good cause for stay based upon the benefit to the Court, the lack of prejudice to Plaintiffs, and the prejudice to Defendant if stay is not granted. Case No: :-cv--emc

5 Case:-cv-0-EMC Document Filed0// Page of 0 0 TABLE OF CONTENTS INTRODUCTION... BACKGROUND... A. The Products... B. Plaintiffs Allegations and Legal Theories... ARGUMENT... I. PLAINTIFFS FAIL TO STATE A CLAIM AND LACK STANDING... A. Plaintiffs Do Not and Cannot Plausibly Allege Reliance and Deception.... Defendant s Labels Negate Any Contention That Plaintiffs Believed the Products Contained No Added Sugar.... Plaintiffs Cannot Plausibly Claim That They Understood Evaporated Cane Juice To Mean Something Other Than a Form of Added Sugar... B. For the Same Reasons Plaintiffs Fail to Plausibly Allege Deception, Plaintiffs Claims Do Not Pass the Reasonable Consumer Test...0 II. PLAINTIFFS CLAIMS DO NOT SATISFY RULE (B)... III. PLAINTIFFS CLAIMS SHOULD BE DISMISSED BASED UPON THE FDA S PRIMARY JURISDICTION REGARDING FOOD LABELS... A. Plaintiffs Claims Are Expressly Preempted... B. Plaintiffs Claims Are Impliedly Preempted... IV. PLAINTIFFS BREACH OF IMPLIED WARRANTY CLAIM FAILS... V. THIS CASE SHOULD BE STAYED... CONCLUSION... i Case No: :-cv--emc

6 Case:-cv-0-EMC Document Filed0// Page of 0 0 CASES TABLE OF AUTHORITIES Page(s) American Suzuki Motor Corp. v. Superior Court of Los Angeles County, Cal. App. th ()... Ashcroft v. Iqbal, U.S. (00)... Astiana v. Ben & Jerry s Homemade, Inc., 0 WL 00 (N.D. Cal. Jan., 0)...,, 0 Astiana v. Hain Celestial Group, Inc., 0 F.Supp.d 0 (N.D. Cal. Nov., 0)..., 0 Avoy v. Turtle Mountain, LLC, 0 WL (N.D. Cal. Feb., 0)...,,, 0 Bell Atl. Corp. v. Twombly, 0 U.S. (00)... Brazil v. Dole Food Co., Inc., F.Supp.d (N.D. Cal. 0)..., Bruton v. Gerber Prods. Co., 0 WL (N.D. Cal. Jan., 0)... Buckman Co. v. Plaintiffs Legal Comm., U.S. (00)...,, Durell v. Sharp Healthcare, Cal. App. th 0 (00)... Dvora v. General Mills, Inc., No. -0, 0 WL (C.D. Cal. May, 0)..., Edmunson v. Procter & Gamble Co., 0 WL (S.D. Cal. May, 0)... Ermon v. Grand Auto Sales, Inc., F. Supp. d (N.D. Ill. 00)... Figy v. Amy s Kitchen, 0 WL 0 (N.D. Cal. Nov., 0)...,,,, Gitson v. Trader Joe s Co., 0 WL (N.D. Cal. Oct., 0)...,,, ii Case No: :-cv--emc

7 Case:-cv-0-EMC Document Filed0// Page of 0 0 Hill v. Roll Int l Corp., Cal. App. th (0)... Hood v. Wholesoy & Co., 0 WL (N.D. Cal. July, 0)...,, Kane v. Chobani, Inc., 0 WL 00 (N.D. Cal. Feb. 0, 0)... passim Kane v. Chobani, Inc., 0 WL (N.D. Cal. Sept., 0)...,, 0, Kearns v. Ford Motor Co., F.d 0 ( th Cir. 00)... Khasin v. Hershey Co., No. -0, 0 WL (N.D. Cal. Nov., 0)... Kwikset Corp. v. Superior Court, Cal. th 0 (0)... Lavie v. Procter & Gamble Co., 0 Cal. App. th (00)... Leonhart v. Nature s Path Foods, Inc., 0 WL (N.D. Cal. Mar., 0)...,, 0 Lockwood v. Conagra Foods, Inc., F. Supp. d 0 (N.D. Cal. 00)... Loreto v. Procter & Gamble Co., F. App x ( th Cir. 0)... Luna v. American Airlines, F. Supp. d (S.D.N.Y. 00)... McKinnis v. Kellogg USA, No. 0-, 00 WL 00 (C.D. Cal. Sept., 00)... McKinniss v. Sunny Delight Beverage Co., No. 0-0, 00 WL (C.D. Cal. Sept., 00)... Mediterranean Enterprises, Inc. v. Ssangyong Corp., 0 F.d ( th Cir. )... Merrell Dow Pharms., Inc. v. Thompson, U.S. 0 ()... Morgan v. Wallaby Yogurt Co., 0 WL 0 (N.D. Cal. Mar., 0)... iii Case No: :-cv--emc

8 Case:-cv-0-EMC Document Filed0// Page of 0 0 PhotoMedex, Inc. v. Irwin, 0 F.d ( th Cir. 00)... Pom Wonderful LLC v. Coca-Cola Co., F.d 0 ( th Cir. 0)...,, 0 Pratt v. Whole Foods Mkt. Cal., Inc., 0 WL (N.D. Cal. Mar., 0)...,, 0 Reese v. Odwalla, Inc., 0 WL 0 (N.D. Cal. Mar., 0)...,, Rooney v. Cumberland Packing Corp., No. -00, 0 WL 0 (S.D. Cal. April, 0)... Rossi v. Whirlpool Corp., 0 WL (E.D. Cal. Oct., 0)... Samet v. Procter & Gamble Co., No. -0, 0 WL (N.D. Cal. June, 0)... Stearns v. Select Comfort Retail Corp., 00 WL (N.D. Cal. June, 00)... Stengel v. Medtronic, Inc., 0 F.d ( th Cir. 0)... 0, Sugawara v. Pepsico, Inc., No. 0-0, 00 WL (E.D. Cal. May, 00)... Swartz v. KPMG LLP, F.d ( th Cir. 00)... Swearingen v. Amazon Preservation Partners, Inc., 0 WL 00 (N.D. Cal. Mar., 0)... Swearingen v. Santa Cruz Natural Inc., 0 WL (N.D. Cal. Apr., 0)...,, Syntek Semiconductor Co. v. Microchip Tech. Inc., 0 F.d ( th Cir. 00)..., Thomas v. Costco Wholesale Corp., 0 WL (N.D. Cal. Mar., 0)...,,, 0 Turek v. Gen. Mills, Inc., F.d ( th Cir. 0)..., Werbel ex rel. v. Pepsico, Inc., 00 WL 0 (N.D. Cal. July, 00)... 0 iv Case No: :-cv--emc

9 Case:-cv-0-EMC Document Filed0// Page of 0 0 Wilson v. Frito-Lay N. Am., Inc., 0 WL 0 (N.D. Cal. Oct., 0)... Yumul v. Smart Balance, Inc., F. Supp. d (C.D. Cal. 00)... STATUTES U.S.C U.S.C...., U.S.C Cal. Health & Safety Code 000(a)... 0 Pub.L. No. 0-, 0 Stat. (0)... OTHER AUTHORITIES C.F.R C.F.R C.F.R C.F.R , 0 Fed. R. Civ. P....,, Fed. R. Civ. P....,,, Fed. R. Civ. P...., Fed. R. Civ. P.... v Case No: :-cv--emc

10 Case:-cv-0-EMC Document Filed0// Page0 of MEMORANDUM OF POINTS AND AUTHORITIES 0 INTRODUCTION In the original complaint, Plaintiffs did not allege that they ever read or relied upon the ingredient evaporated cane juice ( ECJ ) on Defendant s product labels, and in fact, expressly disclaimed the need to do so. See Compl. [Docket Index Number ( D.I. ) #],. Rather, Plaintiffs brought this case founded solely on alleged technical violations of FDA labeling laws and contended this was a matter of strict liability. Id. This Court held that reliance was required and flatly rejected Plaintiffs strict liability theory. See Transcript of Proceedings on March, 0 [D.I. #] at :-:. Plaintiffs now miraculously contend that they did actually rely and base their respective purchasing decisions on the Defendant s claims on its products that the products contained evaporated cane juice. FAC [D.I. #],. Plaintiffs purport to allege reliance and deception in the FAC, but do so with implausible allegations that although they read the ingredient evaporated cane juice, they did not know the products contained added sugar. There can be no dispute, however, that product labels for Defendant s iced tea and energy drinks clearly disclose the amount of sugars to the gram. See Healthy Beverage s Request for Judicial Notice ( RJN ), filed concurrently herewith, Exs. B-F. Indeed, the Nutrition Facts section disclosing the amount of sugars in Defendant s products is located right next to the ingredient list that Plaintiffs 0 now contend they read before purchasing. See id. In addition, all of Defendant s iced tea products allegedly purchased by Plaintiffs state on the front of the label that they are lightly sweetened. See RJN, Exs. B-C, G-K. Nevertheless, Plaintiffs appear to proceed on the theory that they purchased Healthy Beverage s lightly sweetened ice tea and energy drinks, containing grams of sugars per serving, believing that the products did not contain any added sugar. FAC, ; RJN, Exs. B-F. Judge Koh recently rejected as implausible similar ECJ theories of reliance and deception when they were asserted by the same plaintiff s counsel in Avoy v. Turtle Mountain, LLC, 0 WL, *- (N.D. Cal. Feb., 0) and Kane v. Chobani, Inc., --- F. Supp. d ---, 0 Case No: :-cv--emc

11 Case:-cv-0-EMC Document Filed0// Page of 0 0 WL 00, *-0 (N.D. Cal. Feb. 0, 0) (discussing the evolution and implausibility of plaintiffs various ECJ theories of reliance and deception). In Kane, Judge Koh found that it was simply implausible that plaintiffs believed that the term cane in evaporated cane juice referred to something other than sugar cane when reading the term evaporated cane juice in the ingredient list on defendant s products. Id. at *. Judge Koh noted that, as in this case, plaintiffs failed to explain what plaintiffs believed evaporated cane juice to be if not a form of sugar and that plaintiffs new allegation that they were looking for added sugar was insufficient. Id. at *. Judge Koh s incredulity has more force in the instant matter where all of Defendant s iced tea products at issue are labeled lightly sweetened unlike the products in Kane, and all of Defendant s energy drinks allegedly purchased by Plaintiffs disclose they contain grams of sugars. Likewise, in Avoy, Judge Koh found that the product labels disclosing the amount of sugars negated plaintiff s contention that, even though she was purchasing frozen desserts and yogurts with sugar, the listing of organic evaporated cane juice misled her into believing or would mislead a reasonable person into believing the products did not contain added sugar. Avoy, 0 WL, at *. Judge Davila recently affirmed the reasoning in Kane and Avoy and dismissed ECJ claims in three other class actions brought by the same plaintiff s counsel for failure to allege a plausible theory of deception and reliance. See Pratt v. Whole Foods Mkt. Cal., Inc., 0 WL, * (N.D. Cal. Mar., 0); Leonhart v. Nature s Path Foods, Inc., 0 WL, * (N.D. Cal. Mar., 0); Thomas v. Costco Wholesale Corp., 0 WL, * (N.D. Cal. Mar., 0). In each of these cases, Judge Davila found plaintiffs allegations to be defective because plaintiffs did not allege what they believed ECJ to be if not a form of sugar, and did not explain what a reasonable person would believe ECJ to be. Id. The analysis in these five () recent cases - Kane, Avoy, Pratt, Leonhart, and Thomas - demonstrate the implausibility of the allegations in this case that Plaintiffs were deceived by the listing of ECJ on Defendant s product labels. Notably, and just like the plaintiffs in those cases, Plaintiffs FAC never alleges what they believed the cane ingredient to be if not a form of sugar. Moreover, Plaintiffs do not explain how a reasonable consumer especially one supposedly Case No: :-cv--emc

12 Case:-cv-0-EMC Document Filed0// Page of 0 0 concerned about added sugar could be unaware that cane refers to sugar cane. Also notably absent from the FAC is any factual allegation of how exactly Plaintiffs finally learned what ECJ was, if in fact they did not know what it was before. Plaintiffs failure to plead reliance and deception in the original complaint was no accident. As the FAC reveals, Plaintiffs do not and cannot plausibly allege that they reasonably relied upon the ingredient ECJ on Defendants labels and were thereby deceived. On this basis alone, the FAC should be dismissed for failure to state a claim and lack of standing. In addition, the doctrine of primary jurisdiction presents a compelling basis to dismiss the FAC. Plaintiffs contend that the FDA has determined that use of the term ECJ is unlawful, and that this ingredient must be called sugar or cane syrup to comply with federal law, and through the Sherman Law, state law. See FAC,,,,. Plaintiffs rely heavily on the draft, non-binding guidance regarding ECJ (the Draft Guidance ) that the FDA issued back in 00. See RJN. Ex. M. On March, 0, the FDA published a notice in the Federal Register (the New FDA Notice ) stating that it has not reached a final decision on the proper name for evaporated cane juice, that it is reopening the comment period to request further comments, data, and information about the ingredient, and that it intend[s] to revise the [00 ECJ] draft guidance, if appropriate, and issue it in final form. See RJN, Ex. N (Docket No. FDA-00-D- 00, Notice of Reopening of Comment Period) (emphasis added). In light of the New FDA Notice reopening the regulatory process, dismissal of this case under the doctrine of primary jurisdiction is not only appropriate, it is necessary. Even prior to the New FDA Notice, this Court dismissed a similar ECJ class action in Hood v. Wholesoy & Co., 0 WL (N.D. Cal. July, 0). Since publication of the New FDA Notice, three more Orders by this Court have dismissed ECJ class actions under the Defendant asks this Court to take judicial notice of the fact that Mr. Figy is a plaintiff in at least eight other ECJ lawsuits filed by the same plaintiff s counsel. See RJN, Ex. A. Adding up just the purchases alleged in these lawsuits, Mr. Figy repeatedly purchased at least twenty-two ECJ products over the last two years. Id. Despite purporting to care deeply about avoiding added sugar (FAC, ), Mr. Figy alleges that he purchased all of these ECJ products without knowing what the ECJ ingredient was in any of them and never bothering to check. That is simply not plausible. Case No: :-cv--emc

13 Case:-cv-0-EMC Document Filed0// Page of 0 0 doctrine of primary jurisdiction. Figy v. Amy s Kitchen, Inc., --- F. Supp. d ---, 0 WL (N.D. Cal. April, 0); Swearingen v. Santa Cruz Natural Inc., 0 WL (N.D. Cal. Apr., 0); Reese v. Odwalla, Inc., --- F. Supp. d ---, 0 WL 0 (N.D. Cal. Mar., 0). As the Court in Amy s Kitchen reasoned, deferring to the FDA will allow for uniformity in administration on this issue. If the Court were to proceed with this action and issue a decision that is contrary to the FDA s formal position on ECJ, it would disrupt the uniform application of the FDA s regulatory rules. Amy s Kitchen, 0 WL, at *-. As argued further below, resolving the ECJ labeling issue through piecemeal litigation will lead to uncertainty and unfair competition in the interstate marketplace. Such a result can and should be avoided by deference to the FDA as the agency charged with making uniform labeling determinations. For these and other reasons detailed below, Healthy Beverage respectfully requests that the FAC be dismissed with prejudice. A. The Products BACKGROUND Plaintiffs are California residents who seek to represent a nationwide class of consumers who purchased Healthy Beverage products sweetened with ECJ. FAC,,. Plaintiffs allege that at some time during the Class Period, Plaintiffs purchased the following five () Healthy Beverage products: ) Steaz Iced Green Tea with Blueberry Pomegranate; ) Steaz Iced Green Tea with Peach; ) Steaz Organic Energy Drink Orange; ) Steaz Organic Energy Drink Berry; and ) Steaz Organic Energy Drink Super Fruit. Id. at. Plaintiffs also purport to bring claims on behalf of a putative class of people in California and elsewhere who bought the following six () Healthy Beverage products Plaintiffs did not buy: ) Steaz Iced Green Tea with Mint; ) Steaz Iced Green Tea with Super Fruit; ) Steaz Iced Green Tea with Lime Pomegranate; ) Steaz Iced Green Tea with Lemonade; ) Steaz Iced Green Tea with Coconut Water; and ) Steaz Energy Shot Berry. Id. at -. True and correct copies of the labels for these products are attached as Exhibits B-L to Healthy Beverage s accompanying RJN. This Court may take judicial notice of the product labels because they are referenced in the FAC. See, e.g., Dvora v. General Mills, Inc., No. -0, 0 WL, at * Case No: :-cv--emc

14 Case:-cv-0-EMC Document Filed0// Page of 0 All of Healthy Beverage products are labeled with a Nutrition Facts panel that provides consumers with detailed information about nutrients and calorie content. See RJN, Exs. B-L. The Nutrition Facts panel is located immediately next to the ingredient list and prominently discloses the total grams of sugars in each product. See id. Nowhere on Defendant s product packaging does it state that the products are sugar free or that they contain no added sugar. To the contrary, all of the iced tea products purchased by Plaintiffs specifically state that they are lightly sweetened. See RJN, Exs. B-C, G-K. Additionally, all of the energy drink products allegedly purchased by Plaintiffs specifically list that they contain grams of sugar. See RJN, Exs. D-F. B. Plaintiffs Allegations and Legal Theories In response to this Court s rejection of Plaintiffs strict liability theory [D.I. #], Plaintiffs filed a cumbersome, repetitive -page FAC with seven causes of action. Plaintiffs 0 now allege that this case has two facets, () the UCL unlawful part, and () the deceptive part. FAC, -. Despite the Court s clear pronouncement that Plaintiffs needed to plead reliance, Plaintiffs persist in contending that the unlawful part stand[s] alone without any allegations of deception or reliance. Id. at. This strict liability theory was already considered and properly rejected by this Court, and Healthy Beverage will not devote undue time addressing (C.D. Cal. May, 0) (granting Defendant s Request for Judicial Notice of complete color copy of Total Pomegranate Blueberry cereal package referenced throughout Plaintiff s complaint). In requesting leave to amend, Plaintiffs proffer was limited to amending the complaint to plead reliance. See Transcript of Proceedings on March, 0 [D.I. #] at :-. Nevertheless, the amendments in the FAC go far beyond the scope of that proffer. The FAC makes substantial changes to the allegations and purports to add five additional causes of action. The original complaint asserted only two claims: () a claim under the unlawful prong of California s Unlawful Business Act ( UCL ); and () a claim for injunctive relief only under the Consumer Legal Remedies Act ( CLRA ). [D.I. #]. The FAC now asserts seven claims. Specifically, the FAC now asserts three claims under the UCL for violations of the unlawful, unfair, and fraudulent prongs, two claims under the False Advertising Law ( FAL ) for misleading advertising and deceptive advertising, a claim under the CLRA for both injunctive relief and damages, and a claim for breach of the implied warranty of merchantability. In amending the CLRA claim to add a claim for damages, Plaintiffs also violated the parties prior stipulation made an Order of Court. The parties entered a stipulation on October, 0, to permit Plaintiffs to amend their CLRA cause of action, on or before November, 0, to add a claim for damages. [D.I. #]. The stipulation was entered as an Order of Court on October, 0. [D.I. #]. Plaintiffs did not amend their CLRA cause of action to add a claim for damages on or before November, 0, and their attempt to do so now in the FAC is time-barred by the stipulated and Court-ordered deadline to do so. [D.I. #]. Defendant respectfully requests the Court strike Plaintiffs improperly added claims and allegations under Rule (f). Case No: :-cv--emc

15 Case:-cv-0-EMC Document Filed0// Page of 0 0 it. Suffice it to say, this Court correctly held that under Kwikset Corp. v. Superior Court, Cal. th 0, n. (0), the actual reliance requirement applies to UCL unlawful prong claims when the alleged unlawful conduct is, as alleged in the instant case, that the defendant engaged in misrepresentation and consumer deception. This Court s ruling finds itself in good company with other decisions in this district. See, e.g., Wilson v. Frito-Lay N. Am., Inc., 0 WL 0, at *- (N.D. Cal. Oct., 0) (citing Kwikset and similarly rejecting Plaintiffs argument that a mislabeling claim can be brought under the UCL s unlawful prong absent allegations of reliance); Kane v. Chobani, Inc., 0 WL, at * (N.D. Cal. Sept., 0) ( Plaintiffs illegal product theory would eviscerate the enhanced standing requirements imposed by Proposition and the California Supreme Court s decision in Kwikset. ); Bruton v. Gerber Prods. Co., 0 WL, * (N.D. Cal. Jan., 0) (holding that there is a reliance requirement for claims brought under the UCL s unlawful prong to the extent the predicate unlawful conduct is based on misrepresentations. ) (citation omitted); Figy v. Amy s Kitchen, 0 WL 0, at * (N.D. Cal. Nov., 0) (same). While a few cases have gone the other way, as Judge Koh observed in Kane, those cases are not persuasive because they do not discuss the impact of Proposition and Kwikset on the standing requirements under the UCL, and thus do not address clear California Supreme Court authority on point. Kane, 0 WL 00 at * (collecting and distinguishing cases). The deceptive part of Plaintiffs case relies upon several vague allegations about added sugar that fail to set forth a plausible and coherent theory of reliance and deception. Plaintiffs allege that they read the ingredient ECJ and somehow did not know that the ingredient was a form of sugar, and purchased the products believing that they did not contain added sugar. See FAC,. Despite the fact that all of the iced tea products allegedly purchased by Plaintiffs expressly state that they are lightly sweetened, Plaintiffs claim they did not know, and had no reason to know that the products actually contained added sugar which Plaintiffs wanted to avoid. FAC,. As set forth below, Plaintiffs theory of reliance and deception is implausible as a matter of law. /// Case No: :-cv--emc

16 Case:-cv-0-EMC Document Filed0// Page of 0 0 ARGUMENT I. PLAINTIFFS FAIL TO STATE A CLAIM AND LACK STANDING Under the federal plausibility standard for pleading, a complaint must be dismissed when it fails to allege enough facts to state a claim to relief that is plausible on its face. Bell Atl. Corp. v. Twombly, 0 U.S., 0 (00). A claim is facially plausible when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. Ashcroft v. Iqbal, U.S., (00). Furthermore, the tenet that a court must accept as true all of the allegations contained in a complaint is inapplicable to legal conclusions. Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice. Id. Dismissal is appropriate under Rule (b)() where the complaint lacks a cognizable legal theory or sufficient facts to support a cognizable legal theory. To state a claim and establish standing under the UCL, FAL, and CLRA, Plaintiffs must allege facts sufficient to show that they relied on the defendant s alleged misrepresentation. See Kane v. Chobani, 0 WL, at *- (N.D. Cal. Sept., 0) (collecting authority). Because they sound in fraud, Plaintiffs allegations of reliance must meet the strictures of Rule (b). See Brazil v. Dole Food Co., Inc., F.Supp.d, - (N.D. Cal. 0) (applying Rule (b) to similar claims of food misbranding under the UCL, FAL, and CLRA). Here, the few conclusory allegations that Plaintiffs relied and were deceived by Defendant s product labeling do not set forth a coherent, plausible theory of reliance, fail to state a claim under Rule and (b), and demonstrate that Plaintiffs lack standing. A. Plaintiffs Do Not and Cannot Plausibly Allege Reliance and Deception Plaintiffs do not and cannot set forth a plausible theory of reliance and deception. Even viewed in a light most favorable to Plaintiffs, the totality of their reliance allegations consist of the following generalities and conclusions: Plaintiffs did actually rely and base their respective purchasing decisions on the Defendant s claim on its products that the products contained evaporated cane juice, FAC,, Plaintiffs reasonably relied in substantial part on the labels to indicate that the products contained no added sugar, and were thereby deceived, in deciding to Case No: :-cv--emc

17 Case:-cv-0-EMC Document Filed0// Page of 0 0 purchase these products, id.,, Plaintiffs did not know, and had no reason to know that Defendant s Purchased Products actually contained added sugar which Plaintiffs wanted to avoid, id.,, a reasonable person would attach importance to whether the Defendant s products contained added sugar in determining whether to purchase the products. Plaintiffs would not have purchased the products had they know [sic] that the products contained added sugar. Id.,. Plaintiffs newly pled added sugar theory of reliance and deception raises more questions than it answers. The FAC fails to allege any facts explaining how Plaintiffs relied on Defendants labels, how they were misled into believing that the products contained no added sugar, where they thought the sugars listed on the products came from, what they thought evaporated cane juice to mean if not a form of sugar, or how they supposedly might have discovered what ECJ really was such that they ceased buying the products. These questions underscore the inadequacy and implausibility of Plaintiffs allegations. Based on similar inadequacies, ECJ claims in at least six other cases brought by the same plaintiff s counsel have been dismissed for failing to plausibly allege reliance and deception. See Pratt, 0 WL, *; Leonhart, 0 WL, *; Thomas, 0 WL, *; Kane, --- F. Supp. d ---, 0 WL 00, at *-; Avoy, 0 WL, at *; Gitson v. Trader Joe s Co., 0 WL, at * (N.D. Cal. Oct., 0).. Defendant s Labels Negate Any Contention That Plaintiffs Believed the Products Contained No Added Sugar Plaintiffs claims that they relied upon Healthy Beverage s product labels and were deceived into believing that the products they purportedly purchased contained no added sugar Even if this case were to survive a motion to dismiss, Plaintiffs added sugar theory of reliance shows that Plaintiffs will never be able to certify a class in that common issues do not predominate because reliance and causation are inherently individual. There are any number of ways putative class members may have relied on Defendant s labels. Plaintiffs will never be able to establish that their added sugar theory of reliance was common among class members, let alone predominate. Moreover, there are any number of different factors that impact a consumer s purchase of a particular product and Plaintiffs will not be able to show a likelihood that the listing of ECJ was a factor in consumers choosing to purchase Defendant s products. See, e.g., Astiana v. Ben & Jerry s Homemade, Inc., 0 WL 00 (N.D. Cal. Jan., 0) (denying certification in putative class action related to all natural labels on Ben & Jerry s ice cream products for lack of predominance and ascertainability). Case No: :-cv--emc

18 Case:-cv-0-EMC Document Filed0// Page of are undermined by even a cursory review of Defendants product labels. See RJN, Exs. B-L. The Nutrition Facts panel located immediately above the ingredient list Plaintiffs now claim to have read specifically discloses that each iced tea product has 0 grams of sugars per serving and that each energy drink allegedly has grams of sugars per serving. See id. Plaintiffs therefore were aware, before making the alleged purchases, of precisely how much sugars were in Defendant s products. Just as the Court concluded in Gitson, this fact defeats the FAC s allegations (at ) that Plaintiffs would not have purchased the products had they know [sic] that the products contained added sugar. Gitson, 0 WL, at *. The facts in this case are even more compelling in that the label on each of Defendant s 0 iced tea products specifically states that they are lightly sweetened. It is simply not plausible 0 as a matter of law that Plaintiffs purchased lightly sweetened iced tea containing 0 grams of sugars and energy drinks containing grams of sugars but the listing of organic evaporated cane juice misled Plaintiffs into believing or would mislead a reasonable person into believing the products did not contain added sugar. Certainly Plaintiffs and the reasonable consumer can be charged with knowing that tea is not inherently sweet and that lightly sweetened tea must contain added sugar. Indeed, Plaintiffs vaguely pled theory of reliance and deception fails to explain what Plaintiffs thought the iced tea and energy drinks were sweetened with if not with a form of added sugar.. Plaintiffs Cannot Plausibly Claim That They Understood Evaporated Cane Juice To Mean Something Other Than a Form of Added Sugar Plaintiffs added sugar theory of deception is presumably based on the premise that Plaintiffs did not understand ECJ to be a form of added sugar and that Plaintiffs believed the sugars listed in the Nutrition Facts panel were from other ingredients. As Judge Koh concluded in Kane, in sound reasoning negating that theory, it is not plausible that Plaintiffs understood ECJ to mean something other than a sugar cane ingredient. Addressing such allegations, Judge Koh asked the same Plaintiffs counsel: [W]hat kind of cane is there other than sugar cane? Kane, 0 WL 00, at * (citing, ECF No. at ). Plaintiffs counsel answered: None. Id. Plaintiffs do not attempt to provide a different answer in this case they never identify what they Case No: :-cv--emc

19 Case:-cv-0-EMC Document Filed0// Page of purportedly thought ECJ meant, if not a form of added sugar. That omission is fatal to any claim premised on an added sugar theory of deception. See Kane, 0 WL 00, at * (dismissing ECJ claims where plaintiffs could not explain what they believed evaporated cane juice to be, if not a form of sugar ) (emphasis in original). As 0 0 Judge Koh concluded in Kane, [a]bsent some factual allegation concerning what [plaintiff] believed ECJ to be if not a form of sugar or a juice containing some form of sugar, any assertion that plaintiff was somehow deceived into believing the products were free of added sugar is simply not plausible. Kane, 0 WL 00, at * (emphasis in original). Despite being fully aware of the decisions above, and despite now having had the opportunity to amend, Plaintiffs still have not alleged any facts about what they believed ECJ to be if not some form of sugar or juice containing some form of sugar, nor what a reasonable person would believe ECJ to be. Plaintiffs added sugar theory of deception is rendered further implausible by their allegations regarding dried cane syrup. Throughout the FAC, Plaintiffs allege that an alternative name for ECJ is dried cane syrup. See, e.g.,,. Just as in Kane, however, the FAC fails to explain how Plaintiff[] could have realized that dried cane syrup was a form of sugar, but nevertheless believed that evaporated cane juice was not. Kane, 0 WL, at * (emphasis in original). Not surprisingly, and although on notice of the Kane decision, Plaintiffs fail to provide such an explanation in this case as well. There is none. B. For the Same Reasons Plaintiffs Fail to Plausibly Allege Deception, Plaintiffs Claims Do Not Pass the Reasonable Consumer Test Claims under the UCL, FAL, and CLRA are governed by the reasonable consumer test. Werbel ex rel. v. Pepsico, Inc., 00 WL 0, at * (N.D. Cal. July, 00). Under this test, Plaintiffs must show that members of the public are likely to be deceived. Id. Likely to deceive implies more than a mere possibility that the advertisement might conceivably be See, also, Avoy, 0 WL, at * (dismissing ECJ claims where plaintiff did not provide any plausible explanation for what she (or a reasonable person) believes evaporated cane juice to be, if not sugar ); Thomas, 0 WL, at * (dismissing ECJ claims where complaint did not allege what plaintiff believed ECJ to be if not sugar and does not explain what a reasonable person would believe ECJ to be); Pratt, 0 WL, at * (same); Leonhart, 0, at * (same). 0 Case No: :-cv--emc

20 Case:-cv-0-EMC Document Filed0// Page0 of misunderstood by some few consumers viewing it in an unreasonable manner. Lavie v. Procter & Gamble Co., 0 Cal. App. th, 0 (00). This objective standard requires a probability that a significant portion of the general consuming public or of targeted consumers, acting reasonably in the circumstances, could be misled. Id. The reasonable consumer is not the least sophisticated consumer or an unwary consumer, but rather the ordinary consumer within the larger population. Hill v. Roll Int l Corp., Cal. App. th, 0 (0) (citations omitted). Courts in the Ninth Circuit including this Court do not hesitate to dismiss false advertising cases where plaintiffs claims do not satisfy the reasonable consumer test. For 0 0 example, in Gitson, Judge Orrick dismissed plaintiffs ECJ claims under the reasonable consumer test because plaintiffs allegations that they would not have purchased defendant s products if they knew the products contained sugar or dried cane syrup were defeated by the Nutrition Facts panel disclosing that the products contained between and grams of sugars per serving. 0 WL, at *. For this same reason, Plaintiffs cannot meet the reasonable consumer test in this case. A reasonable consumer would not be deceived by the ingredient evaporated cane juice on Defendants iced tea and energy drinks. Consumers know that the Nutrition Facts panel provides relevant nutritional information about the foods they purchase. See, e.g., McKinnis v. Kellogg USA, 00 WL 00, * (C.D. Cal. Sept., 00) (Nutrition Facts panels have long been required on food products and are familiar to a reasonable consumer ). Thus, as Judge Orrick concluded in Gitson, no reasonable consumer would believe that the accused products See, e.g., Rooney v. Cumberland Packing Corp., No. -00, 0 WL 0, * (S.D. Cal. April, 0) (holding brand name Sugar in the Raw would not make a reasonable consumer believe that the product is actually raw where package expressly stated sugar was not raw); Dvora v. General Mills, Inc., No. -0, 0 WL, at * (C.D. Cal. May, 0) (no reasonable consumer would think that fruit flavored clusters on product package would contain blueberries and/or pomegranates); Sugawara v. Pepsico, Inc., No. 0-0, 00 WL, at * (E.D. Cal. May, 00) ( This Court is not aware of, nor has Plaintiff alleged the existence of, any actual fruit referred to as a crunchberry. ); McKinniss v. Sunny Delight Beverage Co., No. 0-0, 00 WL, at *- (C.D. Cal. Sept., 00) ( [D]epictions of various fruit on Defendant s product labels are simply not deceptive as a matter of law because a reasonable consumer understands that SunnyD is merely a fruit-flavored drink and a reasonable consumer can readily and accurately determine the composition and nutritional value of a product. ); McKinnis v. Kellogg USA, No. 0-, 00 WL 00, at * (C.D. Cal. Sept., 00) ( If an alleged misrepresentation would not deceive a reasonable consumer then any cause of action having deception as an element may be addressed, as a matter of law, on a motion to dismiss. ). Case No: :-cv--emc

21 Case:-cv-0-EMC Document Filed0// Page of 0 containing evaporated cane juice do not contain sugar, given that each product expressly disclosed its sugar content in the Nutrition Facts section of each product label. 0 WL, at *. The reasonable consumer especially one concerned about the source of sugars appreciates that cane juice refers to a sweetener. Indeed, Plaintiffs have not alleged what they, let alone the reasonable consumer, believed evaporated cane juice to be if not a form of sugar. The reasonable consumer would not be deceived into thinking a cane ingredient in Defendants lightly sweetened iced tea and energy drinks is not a form of added sugar. Moreover, there is nothing on Defendants product labels that states that the products contain no added sugar or otherwise suggests that the sugars come only from the non-ecj ingredients. The reasonable consumer test provides yet another basis supporting dismissal. II. PLAINTIFFS CLAIMS DO NOT SATISFY RULE (B) Plaintiffs fail to plead their claims with particularity as required by Fed. R. Civ. P. (b). Where a plaintiff alleges fraudulent conduct as the basis for his claims, the claims sound in fraud, and the pleading as a whole must satisfy the particularity requirement of Rule (b). Kearns v. Ford Motor Co., F.d 0, ( th Cir. 00). Claims sounding in fraud must allege an account of the time, place, and specific content of the false representations as well as the identities of the parties to the misrepresentations. Swartz v. KPMG LLP, F.d, ( th Cir. 00). The plaintiff must also specify what is false or misleading about a statement, and 0 why it is false. Kane, 0 WL, at *. Here, there can be no question that Plaintiffs claims sound in fraud. See, e.g., FAC,,, 0-, 0, 0,,. Plaintiffs fail to comply with Rule (b) in at least three respects. First, Plaintiffs do not allege what they understood evaporated cane juice to be and how they were misled by the listing of that ingredient. This omission is fatal to Plaintiffs claim. See Kane, 0 WL 00, at * (dismissing ECJ claims where plaintiffs could not explain what they believed evaporated cane juice to be, if not a form of sugar ) (emphasis in original). Alleged regulatory violations are no substitute for plausible allegations that Plaintiffs (and reasonable consumers) were actually deceived. Case No: :-cv--emc

22 Case:-cv-0-EMC Document Filed0// Page of 0 Second, Plaintiffs make a number of references to Defendant s website (FAC,,, ), but they never allege that they viewed any statements on Defendants website, when they viewed them, how they influenced Plaintiffs purchasing decision, or why they are allegedly deceptive. Without an allegation that Plaintiffs were somehow aware of the statements on Defendants website, Plaintiffs cannot allege they were an immediate cause of any injury-causing conduct. See, e.g., Durell v. Sharp Healthcare, Cal. App. th 0, (00) ( the [complaint] does not allege Durell ever visited Sharp s Web site or even that he ever read the Agreement for Services. ). Third, Plaintiffs do not identify with the requisite specificity when they purchased the products, where they purchased them, or how many times. Such allegations are needed to satisfy Rule (b). See Ermon v. Grand Auto Sales, Inc., F. Supp. d, (N.D. Ill. 00) (Rule (b) requires more than an allegation that the fraud occurred sometime during a period of months or years ); Yumul v. Smart Balance, Inc., F. Supp. d, - (C.D. Cal. 00) (allegations that plaintiff purchased product repeatedly during class period are insufficient); Edmunson v. Procter & Gamble Co., 0 WL, at * (S.D. Cal. May, 0) (dismissing claims under Rule (b) where plaintiff failed to allege when during the class period, where, how many, or how many times plaintiff purchased the products at issue). III. PLAINTIFFS CLAIMS SHOULD BE DISMISSED BASED UPON THE FDA S PRIMARY JURISDICTION REGARDING FOOD LABELS 0 As this Court is well aware, a flurry of class-action lawsuits have been filed in this district asserting ECJ claims against food and beverage manufacturers premised on FDA regulations. See RJN, Ex. A. In each instance, the Court is being asked to decide whether evaporated cane juice is the common and usual name of an ingredient under C.F.R. 0.? If the answer is yes, the manufacturer must identify the ingredient as evaporated cane juice on the product label. The doctrine of primary jurisdiction applies in cases like this one where there is: () [a] need to resolve an issue that () has been placed by Congress within the jurisdiction of an administrative body having regulatory authority () pursuant to a statute that subjects and industry or activity to a comprehensive regulatory authority that () requires expertise or uniformity in administration. Syntek Semiconductor Co. v. Microchip Tech. Inc., 0 F.d, ( th Cir. 00). Case No: :-cv--emc

23 Case:-cv-0-EMC Document Filed0// Page of 0 See C.F.R. 0.(a)(). If the answer is no, the manufacturer must not identify the ingredient as evaporated cane juice or risk marketing a misbranded product. If the cases render inconsistent results, it will create uncertainty and unfair competition in an interstate marketplace that the federal government has elected to regulate uniformly through the FDA. Inconsistent results can also result in a multiplicity of actions. Imagine the result if one court (or courtroom) decides that a beverage manufacturer can use ECJ, and the courtroom next door decides that a competing beverage manufacturer cannot use ECJ and issues an injunction against its use. Would the beverage manufacture enjoined from using ECJ then have an unfair competition claim against every competitor who continues to use ECJ? Logic would say so. The lack of uniform rulings on ECJ in different states could also lead to manufacturers being forced to print different labels to satisfy the determinations of different states. These hypotheticals 0 illustrate why judicial resolution of ECJ claims is incompatible with a national uniform labeling standard. Plaintiffs whole case is based on the faulty premise that the FDA has decided that use of evaporated cane juice on product labels is illegal and violates the common or usual name requirement in C.F.R. 0.(a)(). As set forth in the FAC, that incorrect position is reached by erroneously relying on non-binding Draft Guidance that FDA issued back in 00. FAC, -0. However, that Draft Guidance expressly states until finalized, it does not represent the FDA s current thinking on this topic. Id. Just last month, the FDA issued a Notice that resolves which makes clear that FDA s position is not settled [and] FDA has not yet set a uniform enforcement standard. RJN, Ex. N. The Notice provides: We have not reached a final decision on the common or usual name for [the ECJ] ingredient and are reopening the comment period to request further comments, data, and information about the basic nature and characterizing properties of the ingredient On the need for certainty in the marketplace, the Seventh Circuit observed, [i]t is easy to see why Congress would not want to allow states to impose disclosure requirements of their own on packaged food products, most of which are sold nationwide. Manufacturers might have to print 0 different labels. Turek v. Gen. Mills, Inc., F.d, ( th Cir. 0) Case No: :-cv--emc

24 Case:-cv-0-EMC Document Filed0// Page of 0 0 sometimes declared as evaporated cane juice, how this ingredient is produced, and how it compares with other sweeteners... After reviewing the comments received, we intend to revise the draft guidance, if appropriate, and issue it in final form[.] Id. (emphasis added). Thus, the Notice confirms: the FDA has not reached a decision regarding use of the ingredient name ECJ, the FDA is in the midst of its regulatory process regarding that precise issue, and Plaintiffs reliance on the Draft Guidance is an invitation for legal error. Even prior to the Notice, Judge Rogers correctly found that the FDA s position regarding ECJ was not settled and that the four Syntek factors were met. Hood, 0 WL, at * (dismissing a similar ECJ suit based on primary jurisdiction grounds). In so holding, the Court recognized that: () Congress placed the ECJ food labeling issue within the jurisdiction of the FDA based on the FDA s regulatory expertise and the need for uniformity in administration, and () the FDA is in the midst of considering the ECJ food labeling issue but has not yet rendered a uniform enforcement standard. Id. at *. Under these circumstances, the Hood Court concluded: [I]t is appropriate to defer to the authority and expertise of the FDA to say what the appropriate rules should be with respect to evaporated cane juice. Rendering a decision based on what this Court believes the FDA might eventually decide would usurp the FDA s interpretative authority. [ ] Deference in this case is the appropriate course. Id. at *. The analysis in Hood is sound and should be followed here. In three separate decisions issued after FDA published its Notice, courts in the district have recognized that [i]n light of the fact that FDA has revived its review of the ECJ issue, FDA s position on the lawfulness of the use of that term is not only, as stated in Hood, not settled, it is also under active consideration by the FDA. Reese, 0 WL 0, at *; accord, Swearingen, 0 WL, at *; Figy, 0 WL, at *. In each of these Defendant anticipates that Plaintiffs will cite two decisions issued by Judge Orrick in Swearingen v. Amazon Preservation Partners, Inc., 0 WL 00 (N.D. Cal. Mar., 0) and Morgan v. Wallaby Yogurt Co., 0 WL 0 (N.D. Cal. Mar., 0), both of which post-date the Notice and both of which declined to apply the primary jurisdiction doctrine because, in Judge Orrick s view, [i]t remains unclear when or if the FDA will conclusively resolve this issue. Morgan, 0 WL 0, at * n.. Case No: :-cv--emc

25 Case:-cv-0-EMC Document Filed0// Page of 0 0 decisions, Judge Illston and Rogers found that the FDA should interpret and apply its technical and integrated regulations to provide a uniform standard regarding ECJ. As the Notice confirms, that ECJ labeling raises a whole host of technical and regulatory issues that the FDA the agency responsible for establishing uniform food labeling standards should determine in the first instance. For example: How is evaporated cane juice similar to or different from other sugars and syrups derived from sugar cane?... How is evaporated cane juice manufactured? Specifically, how is its method of manufacture different from that of other sweeteners made from sugar cane (such as cane sugar, cane syrup, etc.)? Is there a uniform industry standard for this ingredient as traded in the marketplace?... Does the name evaporated cane juice adequately convey the basic nature of the food and its characterizing properties or ingredients? Id. at. It is precisely these types of technical regulatory issues that should be left to the FDA to resolve in the first instance under its carefully constructed regulatory scheme. Adjudicating Plaintiffs ECJ claims would require the Court to predict the outcome of the FDA s regulatory process. Moreover, the relief demanded by Plaintiffs would require Defendant to re-label its products under state law when the FDA has not imposed and, indeed, may never impose, such a federal requirement. This action should be dismissed under the doctrine of primary jurisdiction. Alternatively, this Court should stay the acting pending the FDA s issuance of final guidance regarding ECJ. A. Plaintiffs Claims Are Expressly Preempted The FDA comprehensively and extensively regulates food labeling through the Food, Drug, & Cosmetic Act ( FDCA ) ( U.S.C. 0, et seq.) and implementing regulations. In 0, Congress enacted the Nutrition Labeling and Education Act ( NLEA ) to amend the FDCA Significantly, the decisions do not analyze the Notice in any detail, and, as Judge Illston noted, they fail to recognize that the March, 0 notice explicitly states that after reviewing comments, the FDA intends to issue guidance in final form. Swearingen, 0 WL, at * n. ; Figy, 0 WL, at * n. (emphasis added). What is more, the timing in which FDA completes its important work is not a valid basis to refuse to apply the primary jurisdiction doctrine if it otherwise is applicable. Thus, like Judge Illston, this Court should decline[] to follow those decisions (id.) and instead adopt the more wellreasoned approach set forth in Hood, Reese, Swearingen, and Figy. Case No: :-cv--emc

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