ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT’S MOTION TO DISMISS
Pending before the Court is Defendant Pepsico, Inc.’s (“Pepsi’s”) Motion to Dismiss Plaintiffs’ Consolidated Amended Complaint. Docket No. 82 (“Motion”). The operative complaint is the Consolidated Amended Complaint (“CAC”). Docket No. 68. For the reasons discussed herein, the Court GRANTS in part and DENIES in part Pepsi’s Motion to Dismiss.
I. FACTUAL & PROCEDURAL BACKGROUND
Nine putative class actions were filed against Defendant PepsiCo, Inc. (“Pepsi”). The Court appointed counsel for Plaintiffs Hall and Ree as interim lead counsel and consolidated the actions.
The CAC concerns Pepsi’s alleged “intentional concealment and/or failure to warn consumers in California that [the Pepsi Beverages] contain a harmful and carcinogenic chemical called 4-Methylimi-
In January of 2014, Consumer Reports published the results of tests it conducted in 2013 on a number of soft drinks, including the Pepsi Beverages. Id. ¶¶ 34-35. Consumer Reports found that the amounts of 4-MeI in the Pepsi Beverages were higher than in other soft drinks tested. Id. ¶ 37. The Consumer Reports testing revealed amounts of 4-MeI in a can or bottle of Pepsi Beverages that exceeded 29 micrograms — the safe harbor for daily exposure established by Proposition 65 below which the Proposition deems there is “no significant risk.” Id. ¶¶ 2; 26, 37-38. Consumer Reports’s findings as to the levels of 4-MeI in a single can or bottle were significant, because studies have concluded that soda consumers typically drink more than one twelve-ounce serving per day. Id.
According to the CAC, Pepsi made statements in its Annual Reports from 2010 to 2013 that suggested that it knew that it was subject to Proposition 65. Id. ¶ 30. Additionally, in a public statement, Pepsi said:
[Wjhen the regulatory requirements on 4-MEI changed in California, PepsiCo moved immediately to meet the new requirements and in order to maintain a harmonized supply chain globally committed to rolling out the changes across the rest of the U.S. and internationally. The work has been completed in California and several other U.S. states, and we are on track to complete the roll out by February 2014.
Id. ¶ 31 (emphasis in original). The CAC alleges that, contrary to its stated position, Pepsi did not comply with Proposition 65 and continued selling Pepsi Beverages with levels of 4-MeI in excess of Proposition 65’s safe harbor. Id. ¶¶ 32-33. The CAC charges that this public statement, among others, ' misled consumers into thinking the Pepsi Beverages were safe and complied with all relevant California regulations. Id.; see also ¶¶ 5-6, 41^12, 44-49.
Plaintiffs Hall and Ibusuki have alleged a violation of Proposition 65. The Plaintiffs and the Class have also alleged a violation of the Consumer Legal Remedies Act, Cal. Civ.Code § 1750, et seq., based on Pepsi’s alleged active concealment and failure to warn that Pepsi Beverages contain 4-MeI in excess of the levels permitted by Proposition 65. Finally, the Plaintiffs and the Class have also alleged that Pepsi engaged in unfair, unlawful, and fraudulent business practices in violation of Cal. Bus. & Prof.Code § 17200, et seq. (the “UCL”). The Plaintiffs and Class seek an order certifying the Class, civil penalties pursuant to California Health & Safety Code § 25249.7(b), damages, restitution, and in-junctive relief.
Pepsi moves to dismiss on the grounds that (1) Plaintiffs failed to comply with Proposition 65’s mandatory notice provisions before filing suit, (2) the federal Food, Drug, and Cosmetic Act (“FDCA”) and the Food and Drug Administration’s (“FDA”) regulations preempt Plaintiffs’ state law claims, and (3) the Court should not adjudicate this action because (a) the FDA has primary jurisdiction over the subject matter of this lawsuit and (b) there is a pending Proposition 65 action in state court.
A. Legal Standard
Federal Rule of Civil Procedure 8(a) requires a plaintiff to plead a claim with enough specificity to “give the defendant fair notice of what the ... claim is and the grounds upon which it rests.” Bell Atl. Corp. v. Twombly,
To survive a motion to dismiss under Rule 12(b)(6), a complaint must “contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’ ” Ashcroft v. Iqbal,
B. Proposition 65 Notice Requirements
California voters approved an initiative measure in November of 1986, enacting the Safe Drinking Water and Toxic Enforcement Act of 1986, which is now set forth in Health and Safety Code section 25249.5 et seq. and is commonly known as Proposition 65. Cal. Chamber of Commerce v. Brown,
Proposition 65’s warning requirement can be enforced by a public or private enforcement action and carries the possibility of both injunctive relief and civil penalties. Cal. Chamber of Commerce,
In a Proposition 65 warning case, pursuant to an amendment that took effect in 2002, statutory notice must include a certificate of merit that states that the “person executing the certificate has consulted with one or more persons with relevant and appropriate experience or expertise who has reviewed facts, studies, or other data regarding the exposure to the listed chemical that is the subject of the action, and that, based on that information, the person executing the certificate believes there is a reasonable and meritorious case for the private action.” DiPirro v. Am. Isuzu Motors, Inc.,
The requirement for a certificate of merit “operates as a brake on improvident citizen enforcement.” Ctr. for Self-Improvement,
Proposition 65’s pre-suit notice must be sent at least 60 days before a private person acting in the public interest “commences” an action “pursuant to this section.” Cal. Health & Safety Code § 25249.7(d)(1). In warning cases, pursuant to the “unambiguous” language of Proposition 65, “notice and certificate of merit must be provided before the action is commenced.” DiPirro,
1. Purpose of Notice
The provision for citizen enforcement was included to enhance enforcement of Proposition 65 and deter violations. Yeroushalmi v. Miramar Sheraton,
California cases make clear that the notice requirements in Proposition 65 encourage public enforcement and reduce private lawsuits by requiring a non-adversarial opportunity for public agencies to pursue investigation, settlement, and cure. The purpose of notice to the state and local government agencies was to enable the public prosecutors “to investigate and, if necessary, to institute a lawsuit against the [violator].” Yeroushalmi,
With these legislative purposes in mind, California cases strictly enforce the notice requirements and hold that pre-filing notice is mandatory. For example, two cases, DiPirro v. Am. Isuzu Motors, Inc.,
Similarly, in Physicians Comm. for Responsible Med. v. Applebee’s Int’l, Inc.,
2. Commencing An Action
Applying DiPirro, In re Vaccine, end Applebee’s, if a Plaintiff commenced an action under Proposition 65 without providing suitable statutory notice, the Plaintiff should not be able to maintain that action. Dismissal with prejudice would be proper, because improper notice cannot be retroactively cured.
California courts have held that plaintiffs cannot plead around the notice requirement by characterizing their claim as a UCL claim. Cases have dismissed UCL claims predicated on Proposition 65 claims that failed for defective notice. In re Vaccine Cases dismissed not only the direct Proposition 65 claim for failure to serve notice, but also a derivative UCL claim alleging unlawful business practices.
The purposefulness of the legislature in making notice an absolute pre-condition to suit is evident here as noted below. As applied to Proposition 65, California Health & Safety Code Section 25249.7(d)(1) therefore “prohibits plaintiffs from recasting their Proposition 65 action as an unfair competition action.” In re Vaccine Cases,
Pepsi contends that although the initial complaints did not contain a direct Proposition 65 cause of action, the initial complaints effectively “recast” the Proposition 65 claim as CLRA, false advertising, negligent misrepresentation, and UCL claims. Pepsi characterizes Plaintiffs’ initial complaint as an exercise in artful pleading designed to circumvent the strictures of Proposition 65.
Plaintiffs respond that the actions were not commenced as Proposition 65 actions, because none of the initial complaints brought a claim directly under Proposition 65. Instead, Plaintiffs contend that they have alleged (and continue to allege) material misrepresentations and omissions that provide grounds for claims under the CLRA and UCL independent of Proposition 65. Plaintiffs argue that they amended their complaints to add a direct Proposition 65 cause of action only after the 60-
The relevant plaintiffs are Plaintiffs Hall and Ibusuki, who are the named plaintiffs for the Proposition 65 claim in the CAC. See Hal Roach Studios v. Richard Feiner & Co.,
There are facts suggestive of an initial “pleading around” Proposition 65. Plaintiffs have generally characterized the case as “a Proposition 65 action” when counsel sought to be appointed interim lead counsel.
The question is whether the claims asserted in the initial complaint pri- or to the CAC, are entirely derivative of an unspoken Proposition 65 violation, or whether they assert claims independent of Proposition 65. If it is the former, the complaint may be treated as a “pleading around” Proposition 65. In this regard, Ibusuki’s' Complaint is problematic. As Plaintiffs’ counsel acknowledged at the hearing, Ibusuki’s initial complaint re-ferred to no other alleged misstatements other than the failure to warn under Proposition 65. Ibusuki Complaint ¶¶ 9-11, 25-27, 37, 41-42; see 2/19/15 Hrg. Tr. at 8. While the Plaintiffs argue that Ibusuki’s initial complaint did not arise “exclusively under Proposition 65,” the paragraphs that Plaintiffs cite from the Ibusuki complaint relate only to the omission of the “health-warning label per California’s Prop. 65” (Ibusuki Complaint ¶¶ 8-11) and allege but-for causation of loss, because Ibusuki “would have never purchased Pepsi One had he known it contained 4-MeI at a level that required a Proposition 65 warning.” Ibusuki Complaint ¶¶ 40-45.
The Court therefore finds that the gravamen of Ibusuki’s initial complaint was a Proposition 65 claim seeking to vindicate a right created by Proposition 65; all his claims were derivative of Proposition 65. Thus, where the California “Legislature did specifically conclude that ‘no action should lie’ unless plaintiffs provided a 60-day notice required by section 25249.7, subdivision (d)(1)” the Court concludes that Ibusuki “cannot evade the requirement of pre-suit 60-day notice in Proposition 65 by repleading [his] cause of action” as a violation of a consumer protection
To be sure, the Ninth Circuit has characterized the rule against using the UCL to plead around an absolute bar to relief as “rather narrow.” Chabner v. United of Omaha Life Ins. Co.,
By contrast, the Hail Complaint does not plead around Proposition 65. To be sure, the Hall Complaint referred multiple times to Proposition 65. Hall alleged that “[d]uring the Class Period, Pepsico knowingly and actively concealed the ma
However, Hall expressly disclaimed any Proposition 65 violation in her initial complaint. See Hall Complaint ¶ 3 (“This Complaint does not allege a violation of Proposition 65.”). Hall explained that “Proposition 65 is relevant to the extent it provides guidance as to a reasonable consumer’s purchasing decisions in California.” Id. ¶¶ 3, 29. More importantly, Hall’s initial complaint proceeded under two independent theories. First, Hall’s initial complaint is based not literally upon a violation of Proposition 65, but on Pepsi’s public statements which allegedly misrepresented its actions. Hall Complaint ¶¶ 21-25. In particular, Hall alleged that Pepsi “feigned action” in response to the changing regulatory environment in California, misleading consumers into believing that the amounts of' 4-MeI in the Pepsi Beverages were lower than they were. Id. The Hall Complaint alleged that Pepsi misrepresented it had “moved immediately to meet the new requirements” on 4-MeI and had “roll[ed] out ... changes” that had been completed in California as well as several other states. Hall Complaint ¶ 22. While the alleged misstatement is related to Proposition 65, the alleged wrong is not a failure to warn under Proposition 65, but rather a separate misrepresentation to consumers regarding what actions Pepsi had taken and what levels of 4-MeI were present in the Pepsi Beverages.
Second, Hall’s initial complaint and the CAC both appear to allege that Pepsi should have disclosed the presence of 4-Mel in the Pepsi Beverages irrespective of Proposition 65, including, e.g., in its advertising and public statements.
The Court concludes that the Hall Complaint was not wholly derivative of a Proposition 65 warning 'violation. Hall did not “commence” an action “pursuant to” Proposition 65 in her initial complaint. Cal. Health & Safety Code § 25249.7(d)(1). Hall therefore only commenced a Proposition 65 action when the CAC was amended to add a direct claim under Proposition 65; that claim was properly preceded by the requisite notice. See Goya,
For the foregoing reasons, the Court DENIES Defendant’s motion to dismiss Hall’s claims on Proposition 65 notice grounds. The Court GRANTS Defendant’s motion to dismiss Ibusuki’s Proposition 65 claim, however, as discussed at the hearing, this dismissal has little practical effect. In this case “notice by [Hall] fulfills the true purpose of the notice requirement.” See Goya,
3. Merits Argument on Safe Harbor & Exposure Limits
Pepsi repeatedly raises a factual argument throughout its motion. Pepsi argues
Viewing the pleadings in the light most favorable to Plaintiffs, the CAC adequately pleads that the Pepsi Beverages at issue did not fall within the safe harbor established by Proposition 65. In particular, the CAC alleges that studies show that consumers who drink soda consume, on average, more than one twelve-ounce serving per day. Assuming the facts alleged in the CAC to be true, it is a plausible inference that, where each serving of the Pepsi Beverages contained more than 29 micrograms of 4-MeI, the average daily exposure to a consumer who drinks more than one serving per day exceeds 29 micro-grams. To the extent that Pepsi wishes to challenge Plaintiffs’ exposure calculation methodology, it can do so at summary judgment or at trial. For purposes of surviving a Rule 12(b)(6) motion to dismiss, Plaintiffs have adequately pled that the Pepsi Beverages did not fall within the safe harbor.
C. Preemption
Pepsi argues that federal labeling laws are the supreme law of the land, and that Congress (through the FDCA) and the FDA (through its regulations) have established a comprehensive federal system for food and beverage labeling. The FDCA and the FDA’s regulations, in Pepsi’s view, therefore preempt any claims arising under consumer state laws for warning labels or other disclosure of 4-MeI.
Under the Supremacy Clause, “Congress has the power to preempt state law.” Crosby v. Nat’l Foreign Trade Council,
Two presumptions regarding preemption guide the courts. Medtronic, Inc. v. Lohr,
Proposition 65 is a consumer protection law that is within the states’ historic police powers and subject to the presumption against preemption. In re Farm Raised Salmon Cases,
1. Express Preemption
The purpose of the FDCA is to “protect the health and safety of the public at large.” POM Wonderful LLC v. Coca-Cola Co., — U.S. —,
In 1990, Congress amended the FDCA by enacting the Nutrition Labeling and Education Act (“NLEA”) to “clarify and strengthen [the FDA’s] authority to require nutrition labeling on foods.... ” Nat’l Council for Improved Health v. Shalala,
To create the desired national uniformity, the NLEA amended the FDCA to include a provision preempting state laws on misbranding. The NLEA added the preemption provision as section 403A of the Federal Food, Drug, and Cosmetic Act, which was codified at 21 U.S.C. § 343-l(a). See POM Wonderful,
The uniform system for nutrition labeling inured to the benefit of both manufae-
The NLEA makes clear, however, that the NLEA does not occupy the field. Turek,
The FDCA misbranding provisions subject to express preemption deem food mis-branded if it is offered for sale under the name of another food (§ 343(b)), if it is an imitation of another food and does not properly state “imitation”, (§ 343(c)); if the container is made, formed, or filled in a misleading manner (§ 343(d)); if it is packaged and the package does not identify the source of the food or accurately identify its contents (§ 343(e)); if required information is not printed with sufficient prominence (§ 343(f)); if it does not comply with definitions and standards, including the common names of optional ingredients (other than spices, flavoring, and coloring) (§ 343(g)); if it does not make proper representations as to quality, fill, and pasteurization (§ 343(h)); if it does not bear the common or usual name of the food or component ingredients, ex
Where there is an express preemption clause applicable to a provision of the FDCA, the Court must determine whether the state law at issue falls within the scope of that preemption. Altria Grp., Inc. v. Good,
Here, the enumeration of the various sections of the FDCA that expressly preempt state law is “significant,” because “the complex pre-emption provision distinguishes among different FDCA requirements,” covering some, but not all, of the FDCA’s misbranding subsections. POM Wonderful,
In other words, the NLEA’s preemption provisions do not reflect an intent to preempt every state law requirement with some conceivable relationship to the labeling of food. Instead, express preemption applies only to requirements “of the type” enumerated.
a. Violation of Proposition 65 Warning Requirements
Plaintiffs allege that Pepsi failed to include a health warning even though exposure to 4-MeI from the coloring of Pepsi Beverages was at a level above Proposition 65’s safe-harbor level. CAC ¶¶ 1, 4-6, 8, 40, 49, 63-65, 69, 76, 85. Pepsi argues that mandating a Proposition 65 warning would impose a labeling requirement that is not identical to requirements of the FDCA and is thus subject to the NLEA’s express preemption provision. Motion at 16-18.
i. No Conflict with NLEA Labeling Requirements
In asserting preemption, Pepsi refers generally to 21 U.S.C. §§ 343-l(a)(2),
In this case, a Proposition 65 warning is not a statement explicitly covered by the
Thus, the misbranding provisions subject to express preemption under the NLEA do not in an obvious facial manner cover the warning required by Proposition 65, because the duties imposed by Proposition 65 are not “of the type” of those imposed under the misbranding provisions subject to preemption; i.e., §§ 343(i) (common or usual name for food or ingredients) and 343(k) (labeling of any artificial coloring). Proposition 65 does not take issue with the use of the term “caramel color” for the color additive at issue here. Instead, it addresses the safety of the compound that is a byproduct of the additive. Cf. Altria,
The lack of a specific FDA labeling requirement which conflicts with the Proposition 65 warning sought by the plaintiffs distinguishes this case from others, wherein the alleged statement or omission was specifically sanctioned by particular federal labeling regulations. Cf. In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liab. Litig., No. 08-1967-MD-W-ODS,
ii. The Savings Clause Under Section 6(c)(2)
Even if a Proposition 65 warning somehow improperly added a non-identical burden on labeling or conflicted with the FDA’s listing of caramel color in a way that implicated Section 3431, Section 6(c)(2) saves from express preemption state laws such as Proposition 65 requiring food safety warnings for e.g., cancer. The NLEA specifically provides that the express preemption provision “shall not be construed to apply to any requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food.” Pub.L. No. 101-535, § 6(c)(2) (21 U-S.C. § 343-1 note). Thus, the NLEA carves out 'an exemption from its express preemption clause where warnings concerning the safety of food or component of food are at issue.
In this regard, Pepsi’s reliance on two cases it cites is inapposite. These cases grappled with the initial question of whether the safety of food was sufficiently implicated to invoke the Section 6(c)(2) exemption. Mills v. Giant of Maryland, LLC,
Pepsi also points to In re Bisphenol-A (BPA) Polycarbonate Plastic Products Liab. Litig., No. 08-1967-MD-W-ODS,
The Court disagrees with In re BPA’s conclusion that a safety determination by the FDA precludes application of Section 6(c)(2), the NLEA’s savings clause. Instead, this Court concludes that state law warning requirements as to food safety are saved from express preemption under Section 6(c)(2) of the NLEA. This conclusion is faithful to the plain language, legislative history, and purpose of the NLEA as set forth by Section 6(c)(2). See Lockwood,
First, the language of the Section 6(c)(2) exemption is plain. Congress specifically determined that the express preemption provision shall not be construed to apply to
Second, the legislative history supports a broad construction of the savings clause. The NLEA was sponsored by Representative Henry Waxman. When the House considered and passed the NLEA, Congressman Waxman addressed certain changes made to the bill’s language since it had been initially reported — changes that arose in the course of negotiations within the Committee on Energy and Commerce and in connection with input from private parties. See 136 Congressional Record, 101st Congress, 2nd Session at 20414-21 (July 30, 1990) (statement of Mr. Wax-man). These changes added the provision regarding construction, which narrowed the scope of the preemption provision contained in the bill from when it was first reported by the Committee. Id. In particular, Congressman Waxman explained why the original, more expansive preemption provision was explicitly narrowed. Id. He deemed “most important ]” the principle that “the most compelling argument for State regulation is where the States have adopted laws to protect the safety of their citizens.” Id. at 20419. He explained that “[therefore, the [amended] preemption provisions in H.R. 3562 explicitly permit the States to adopt requirements for warning about the ingredients or components of food.” Id. Hence, the sponsor of the NLEA made clear the importance of exempting state safety laws from federal preemption.
The legislative intent behind the changes to the preemption provision was also memorialized in a separate statement of intent. Id. at 20418. That statement provides:
Section 403A(b)(l) [later enacted as Section 6(c)(2)] states that section 403(a) does not apply to any requirement for a statement in food labeling (including statements on the label) that provides a warning concerning the safety of the food or a component of the food. This section may be unnecessary because section 403 does not require health warnings and therefore, by the terms of section 403A, state laws requiring health warnings would not be preempted. Nevertheless, section 403A(b)(l) has been included to underscore that State laws requiring warnings pertaining to the safety of foods are not preempted.
Id. at 20419 (emphasis added). Following Congressman Waxman’s comments, Representative Tom McMillen rose in support of passage of the bill, which he viewed as a “positive step toward national uniformity in food labeling,” but also voiced his “disappointment that this legislation is silent on the issue of health warnings.” Id. at 20423. He explained that “[w]ithout national uniformity requirements for health warnings on food labels, manufacturers are forced to continue operating in a system of patchwork regulations.” Id. Notwithstanding Congressman McMillen’s statements regarding the pitfalls of a patchwork of health warning regulations, the House passed the amended bill. Id. Health warnings were never incorporated into the NLEA or the related FDCA mis-branding provisions.
The Senate hearings addressed the scope of preemption as well. Senator Metzenbaum discussed the “uniformity question” with the then-Commissioner of the FDA. Hearing on S. 1425, Before the Senate Comm, on Labor and Human Resources, 101st Cong., 1st Sess. 13 at 24 (November 13, 1989). Senator Metzen-baum observed that while the NLEA included specific preemption of nutrition provisions, it did “not preempt State label
Later, during Senate consideration and passage of the NLEA, Senator Hatch stated:
[T]he carefully crafted uniformity section of this legislation is limited in scope. That section does not preempt or affect a requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of a food or a component of a food.... [Although the provisions of this bill may not preempt a State warning requirement ... that very same State warning may be preempted by virtue of the Constitution, another statutory provision, or agency action.... [T]he limited preemption in this bill [is] only one step toward expanding uniformity of labeling laws and food safety requirements through existing law as well as future legislation.
136 Congressional Record, 101st Congress, 2nd Session at 33429 (October 24, 1990) (statement of Mr. Hatch).
This legislative history weighs strongly against preemption. “ ‘The case for federal pre-emption is particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest, and has nonetheless decided to stand by both concepts and to tolerate whatever tension there [is] between them.’ ” Wyeth,
Third, preemption is particularly disfavored where state laws in exercise of traditional and historic police powers to protect health and safety are rendered ineffective, Allenby,
Finally, it is noteworthy that food manufacturers have petitioned Congress to enact legislation expressly preempting state warning requirements as to ingredients that the FDA has deemed safe. See Peter Barton Hutt, Richard A. Merrill & Lewis A. Grossman, Food and Drug Law 315 (4th ed.2014). Such legislation was reported in 2000, 2004, and 2006, but no such legislation has been passed. Id.
In sum, the plain language of the NLEA, which is uncontradicted by its legislative history, excludes state law safety warning requirements from the scope of the NLEA’s express preemption provision. The legislative history illustrates that Congress specifically considered preempting state causes of action that require health warnings, such as Proposition 65 particularly as applied to carcinogens. Congress
b. The FDA’s Regulatory Finding That Caramel Color is Safe Does Not Expressly Preempt Proposition 65
Defendant argues that the “identical to” standard encompassed in the FDA misbranding provisions applies with particular vigor here, because as explained below, the FDA authorization of the descriptive term “caramel color” arguably encompasses the FDA’s predicate determination that caramel color is safe which allowed caramel color to be listed as a color additive exempt from certification. Importantly, that FDA determination was made under the Color Additive Amendments, which predated the NLEA.
In 1960, thirty years before the enactment of the NLEA, the FDCA was amended to add the Color Additive Amendments, which “establish[ed] an elaborate system for regulation of color additives in the interests of safety.” Pub. Citizen v. Young,
A color additive [...] shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal[.]
21 U.S.C. § 379e(b)(5)(B).
Thus, under the Color Additive Amendments, a “color additive may be used only after the [FDA] has published a regulation listing the additive for such uses as are safe.” Pub. Citizen,
Here the FDA made a safety determination under the Color Additive Amendments in permitting caramel color to be listed and exempt from certification. 21 C.F.R. §§ 73.85; 182.1235; 21 U.S.C. § 379e(b)(4); 21 U.S.C. § 379e(b)(5)(B). Plaintiffs allege that Class IV caramel coloring is found in the Pepsi Beverages and is created through an ammonia-sulfate process. CAC ¶¶ 18-19. The CAC identifies 4-MeI as a byproduct of the manufacturing of caramel color IV. CAC ¶¶ 19, 22. The FDA has determined that the additive described as caramel color includes caramel manufactured with ammonium- and sulfate-containing compounds, such as that used in the Pepsi Beverages. See 21 C.F.R. § 73.85(a)(2)(iii). Nonetheless, the FDA specifically approved “caramel” for use as a color additive after the agency concluded that caramel color is “generally recognized as safe when used in accordance with good manufacturing practice” and does not induce cancer in man or animals at any level. 21 C.F.R. §§ 73.85 (identifying the “color additive caramel” as the dark-brown material “resulting from the carefully controlled heat treatment” of certain food-grade carbohydrates and sub
In contrast with the NLEA, however, the Delaney Clause does not have a preemption provision. Riegel,
Even if the lack of a preemption provision in the Color Additive Amendments did not complete the inquiry and the Court was to give effect to the more general preemption provisions of the subsequently enacted NLEA, the Court finds that the FDA’s regulatory finding regarding the safety of caramel coloring does not expressly preempt Proposition 65 under the NLEA. The FDA’s safety determination is itself not a regulation of “the labeling of food,” 21 U.S.C. 343-l(a). Instead it was a subsidiary finding predicate to a labeling determination. The ultimate preemption question turns on whether Proposition 65 conflicts with that ultimate labeling determination. As noted above, Proposition 65 is not a requirement for the “labeling of food of the type required by” Section 343(i) or 343(k). Furthermore, as discussed above, Congress intended the NLEA (and the misbranding provisions) to cover “only nutrients or substances in food that 'nourish!;]’ ” the NLEA “does not in any way regulate carcinogens or other, non-nutritive substances in foods.” H.R.Rep. No. 101-538, at 7 (1990), reprinted at 1990 U.S.C.C.A.N. 3336, 3337. Proposition 65 is therefore not subject to express preemption under the NLEA. 21 U.S.C. 343-l(a); see POM Wonderful,
In sum, considering (1) the plain language of the government statutes, (2) the presumption against preemption of the states’ historic police powers, Medtronic,
c. Material Misrepresentations
The CAC alleges a material misstatement in the form of a public statement regarding steps that Pepsi had taken to conform its beverages to state regulations. CAC ¶¶ 31; 40; 47-48. In the light most favorable to Plaintiffs, the misstatement or omissions that Pepsi made in its public statements and/or on its website is a deceptive claim regarding a consumer product. Pepsi has pointed to no provision of the FDCA or FDA regulations that preempts claims based on such alleged misrepresentations, which are not alleged to be included on product labels or packaging. As noted above, the alleged misstatements are independent of Proposition 65 compliance. The Court concludes that these claims are not preempted, expressly or otherwise. Astiana,
2.' Implied Preemption
Having found that the NLEA does not expressly preempt Proposition 65, the Court addresses implied preemption. In particular, the Court addresses field and conflict preemption; as to conflict preemption, the Court examines both impossibility and obstacle preemption.
a. Field Preemption
As discussed supra, the NLEA provides that it “shall not be construed to preempt any provision of State law, unless such provision is expressly preempted.” 21 U.S.C. § 343-1. The NLEA’s savings clause reflects that Congress “disavowed] any implied preemption.” Lockwood,
Moreover, Congress enacted the FDCA to protect consumers and was cognizant of the existence of state law causes of action. Wyeth,
b. Conflict Preemption
The NLEA left open the possibility that warning requirements regarding food safety may be preempted by federal law not amended by the NLEA. See Pub.L. No. 101-535, § 6(c)(3) (21 U.S.C. § 343-1 note); see also Reid,
The amendment made by subsection (a), the provisions of subsection (b) and paragraphs (1) and (2) of this subsection shall not be construed to affect preemption, express or implied, of any such requirement of a State or political subdivision, which may arise under the Constitution, any provision of the Federal Food, Drug, and Cosmetic Act not amended by subsection (a), any other Federal law, or any Federal regulation, order, or other final agency action reviewable under chapter 7 of title.5, United States Code.
Pub.L. No. 101-535, § 6(c)(3). Arguably then, Plaintiffs’ safety warning assertedly required under California law may be subject to implied preemption by a federal law that pre-dates (and was left unamended by) the NLEA.
As discussed above, there are two types of conflict preemption: (1) impossibility preemption and (2) obstacle preemption. Federal law preempts state law “where compliance with both federal and state regulations is a physical impossibility.” Florida Lime,
Pepsi alleges that the Proposition 65 warning claim is preempted by the FDA’s listing of caramel color pursuant to the Delaney Clause.
A color additive [¶]... ] shall be deemed unsafe, and shall not be listed, for any use which will or may result in ingestion of all or part of such additive, if the additive is found by the Secretary to induce cancer when ingested by man or animal, or if it is found by the Secretary, after tests which are appropriate for the evaluation of the safety of additives for use in food, to induce cancer in man or animal[.]
21 U.S.C. § 379e(b)(5)(B).
Specifically, Pepsi argues that Proposition 65’s warning requirement for 4-MeI is inconsistent with the FDA’s finding that caramel color is safe even though it contains 4-MeI. As discussed above, the Delaney Clause is not subject to an express preemption provision. There is a reason for this. The D.C. Circuit in Public Citizen v. Young,
Nor is there obstruction preemption; Proposition 65 is not an “obstacle to the accomplishment and execution” of Congress’s “full purposes and objectives” in enacting the Delaney Clause. Crosby,
The more protective warning requirement of Proposition 65 does not prevent the Delaney Clause from achieving its vigorous anti-cancer purpose, reflecting Congress’s “willingness to take extreme steps to lessen even small risks [of cancer].” See Pub. Citizen,
In undertaking “extreme steps” to prevent cancer through the passage of the Delaney Clause, Congress eschewed any attempt to strike a particular balance between the safety interests of the public and the financial interests of industry. See Pub. Citizen,
Hence, this is not a case where Proposition 65 interferes with a more nuanced balance struck by Congress or by delegation to the FDA acting under the Delaney Clause. See Wyeth,
Finally, as noted above, where the “regulated conduct touche[s] interests so deeply rooted in local feeling and responsibility,” preemption will not be inferred absent clear congressional intent. Sears, Roebuck & Co. v. San Diego Cnty. Dist. Council of Carpenters,
For the foregoing reasons, the Court DENIES Pepsi’s motion to dismiss the state law claims alleged in the CAC under a theory of preemption.
D. Primary Jurisdiction Doctrine
Primary jurisdiction “comes into play whenever enforcement of the claim requires the resolution of issues which,
Primary jurisdiction is a “prudential” doctrine “under which a court determines that an otherwise cognizable claim implicates technical and policy questions that should be addressed in the first instance by the agency with regulatory authority over the relevant industry rather than by the judicial branch.” Clark v. Time Warner Cable,
There is not a “fixed formula” for when to apply the doctrine of primary jurisdiction. W. Pac. R. Co.,
If primary jurisdiction applies, a district court should enable a “referral” of the issue to the relevant agency. Clark,
The circumstances requiring application of the primary jurisdiction doctrine have been described as “limited.” Clark,
[The FDA] is currently reviewing all available data on the safety of 4-MEI and is reassessing potential consumer exposure to 4-MEI from the use of Class III and Class IV caramel coloring in food products. This safety analysis will help FDA determine what, if any, regulatory action needs to be taken. Such actions could include setting a limit on the amount of 4-MEI that can be present in caramel coloring. However, in the interim, FDA is not recommending that consumers change their diets because of concerns about 4-MEI.
Docket No. 83-2, RJN, Ex. A. The FDA has also stated that it plans to “further investigate[ ]” 4-MeI exposures by, among other things, conducting analysis of general exposures, including from other food products, and analyzing 4-MeI in caramel color samples. Docket No. 83-4, RJN, Ex. B2. The FDA has also stated that it is considering citizen petitions, such as those from Consumer Reports and the Center for Science in The Public Interest, which have advocated for more restrictive regulations, particularly as to how caramel color is permitted to be processed and labeled. Id.; see also Docket Nos. 83-10, 83-11.
Nevertheless, the Court concludes that Plaintiffs’ allegations regarding Pepsi’s materially misleading public statements as well as its failure to warn under Proposition 65 do not clearly fall within the labeling jurisdiction of the FDA. This is particularly so where Congress has stated that the NLEA labeling requirements, which Plaintiffs primarily rely upon,
More importantly, to the extent the FDA has stated any intent to take action, the FDA appears to have stated that it is solely considering tightening its restrictions on 4-MeI. Consequently, dismissing or staying as a matter of primary jurisdiction is not indicated here because even “if the FDA were to [take action to regulate the labeling and permitted amounts of 4-Mel more stringently,] federal law would not dispose of plaintiffs’ state law claims.” Lockwood,
Moreover, with respect to the FDA’s authority as to the FDCA’s Color Additive Amendments, at least one of the citizen petitions at issue was submitted to the FDA more than four years ago. See Docket No. 83-11 (CSPA citizen petition, dated February 16, 2011). Consequently, there does not appear to be any imminent FDA rule-making that would create a risk of inconsistent rulings. See Reid,
Furthermore, the issues raised by Plaintiffs’ claims, particularly its state law misrepresentation claims, do not clearly require the FDA’s expertise or benefit from uniformity in administration. See Reid,
Finally, although both the Proposition 65 claim and FDA regulations do involve some scientific analysis of the actual health and safety risk of 4-MeI in Pepsi beverages, invoking the primary jurisdiction doctrine would frustrate positive state law on this precise subject. The state of California has evaluated and made a public safety determination. Dismissing or staying the enforcement action at bar, preventing an adjudication on the merits, would be inconsistent with Congress’s desire to leave to the states room to enact food safety warning laws as discussed above. The Court therefore DENIES Pepsi’s request to dismiss or stay the action under a theory of primary jurisdiction.
E. Abstention in Favor of Pending State Action
Pepsi also seeks to dismiss based on abstention. Abstention in favor of a parallel state action may be proper due to considerations of “[w]ise judicial administration giving regard to conservation of judicial resources and comprehensive disposition of litigation.” Nakash v. Marciano,
In determining whether to stay a case pursuant to Colorado River,
(1) which court first assumed jurisdic: tion over [the case]; (2) the inconvenience of the federal forum; (3) the desire to avoid piecemeal litigation; (4) the order in which the forums obtained jurisdiction; (5) whether federal law or state law provides the rule of decision on the merits; (6) whether the state court proceedings can adequately protect the rights of the federal litigants; (7) the desire to avoid forum shopping; and (8)whether the state court proceedings will resolve all issues before the federal court.
R.R. St.,
Nevertheless, certain of the eight factors are “dispositive.” Intel Corp. v. Advanced Micro Devices, Inc.,
In this ease, Pepsi argues that the Court should abstain from adjudicating this action in light of a pending state action, Center for Environmental Health v. Pepsi Beverages Co., et al., No. RG14711020,
It is true that a partial stay is permissible and does not run afoul of Intel or Holder. See Daugherty v. Oppenheimer & Co., No. 06-7725-PJH,
III. CONCLUSION
For the reasons discussed herein, the Court GRANTS Defendant’s motion to dismiss Plaintiff Ibusuki’s Proposition 65 claims on notice grounds. Otherwise, the Court DENIES Pepsi’s motion to dismiss. Plaintiff Hall’s Proposition 65 notice was timely, because she did not commence a Proposition 65 action until she added a direct claim under Proposition 65 in the CAC after giving notice. Plaintiffs’ claims arising out of material misrepresentation in Pepsi’s public statements and out of the alleged violation of Proposition 65 are not preempted. The Court DENIES Defendant’s motion to stay or dismiss under primary jurisdiction and abstention doctrines.
This order disposes of Docket No. 82.
IT IS SO ORDERED.
Notes
. The Court severed the Riva case from the consolidated actions to allow Plaintiffs Riva and Ardagna an opportunity to plead a personal injury claim seeking medical monitoring.
. Pepsi requests judicial notice over five categories of documents: (1) FDA guidance and explanatory materials (Docket Nos. 83-2, 83-3, 83-4); (2) Pepsi product labels (Docket Nos. 83-5, 83-6, 83-7); (3) Proposition 65 notices (Docket Nos. 83-8 (Ibusuki Letter); 83-9 (Hall Letter)) (4) citizen petitions submitted to the FDA (Docket Nos. 83-10 (Consumer Reports); 83-11 (Center for Science in The Public Interest)); and (5) records of judicial proceedings (Docket No. 83-12). Plaintiffs have filed a limited opposition to Pepsi's requests for judicial notice as to the FDA guidance and explanatory materials. Plaintiffs “do not oppose PepsiCo's request for judicial notice of [the FDA guidance documents] generally.” Docket No. 87 at 2. Instead, Plaintiffs oppose noticing the truth of the contents of the FDA documents. Id. The Court GRANTS Pepsi’s unopposed requests for judicial notice of the documents in categories 2 — 5. The Pepsi product labels are referred to in the CAC and placed in issue by Plaintiffs’ claims. See CAC ¶¶ 1, 4, 42, 47, 48, 64. The Proposition 65 notices are also proper to consider, because they are incorporated by reference in the CAC and no party questions their authenticity. See United States v. Corinthian Colleges,
. When counsel for Hall sought to be appointed interim lead counsel, counsel argued that it should be appointed, because “PSW and several other firms followed the necessary procedures for enforcement of Proposition 65, and their cases are now ripe for adjudication under Proposition 65.” Docket No. 46 at 2.
. Plaintiffs have filed a statement of recent decision from the Southern District. Under Local Rule 7 — 3(d)(2): "Before the noticed hearing date, counsel may bring to the Court's attention a relevant judicial opinion published after the date the opposition or reply was filed by filing and serving a Statement of Recent Decision, containing a citation to and providing a copy of the new opinion — without argument.” Id. (emphasis added). Pepsi objects to consideration of the recent decision, which was proffered after the hearing date. Docket No. 103. Pepsi seeks to strike the supplemental submission as unauthorized, or, alternatively, requests to submit a six-page supplemental memorandum addressing differences between this case and Goya. Id. The purpose of Local Rule 7-3(d)(2) is to "deter an endless cycle of filings and counter-filings while preserving the Court’s ability to render a decision that is fully-informed by any particularly germane legal authority that may emerge.” Michael Taylor Designs, Inc. v. Travelers Prop. Cas. Co. of Am.,
. At argument, Pepsi contended that an unco-dified portion of the NLEA should not merit weight. While the appearance of a provision in the United States Code "is ‘prima facie’ evidence that the provision has the force of law, 1 U.S.C. § 204(a), it is the Statutes at Large that provides the ‘legal evidence of laws,' § 112.” U.S. Nat. Bank of Oregon v. Indep. Ins. Agents of Am., Inc.,
. In contrast to the NLEA, the express preemption provision included in the Medical Device Amendments to the FDCA contains more expansive language. The Medical Device Amendments provided that no state "may establish or continue in effect with respect to a device ... any requirement relating to safety or effectiveness that is different from, or in addition to, federal requirements. Riegel v. Medtronic, Inc.,
. FIFRA’s preemption provision provides: “Such State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.” Id. at 443,
. Section 343-l(a)(2) preempts state requirements that are not identical to sections 343(c), 343(e), 343(i)(2), 343(w), or 343(x).
. Section 343-l(a)(3) preempts state requirements that are not identical to sections 343(b), 343(d), 343(f), 343(h), 343(0(1), or 343(k).
. A more detailed list of color additive ingredients is required when caramel color is a "mixture.” Id. § 70.25 (color additives must include "[t]he name of the straight color or the name of each ingredient comprising the color additive, if it is a mixture.”). Under the FDA’s implementing regulations, a "mixture” is defined as "a color additive made by mixing two or more straight colors, or one or more straight colors and one or more dilu-ents.” Id. § 70.3(k). 4-MeI, which, as alleged in the CAC and recognized by the FDA is "a byproduct” of the manufacturing process for Caramel Color III and IV, does not appear to be a mixed, separate ingredient requiring specific listing under the FDA’s regulations. CAC ¶¶ 19, 22; Docket No. 83-2, Ex. A.
. 'Plaintiffs' opposition to the Motion raises the argument that their claims are based, at least in part, on the premise that Pepsi Beverages were “misbranded” within the meaning of the FDCA. See Docket No. 86, Opp. at 13. Section 343-1, by its terms, allows states to establish requirements identical to FDCA requirements that are otherwise subject to express preemption. See In re Farm Raised Salmon Cases,
. For example, cases involving nutrient and disease prevention claims under Section 343(r) are distinguishable. See Chacanaca,
. "WARNING: This product contains a chemical known to the State of California to cause cancer.” 27 Cal.Code Regs. § 25603.2.
. Indeed, Pepsi cites no preemption provision other than that provided under the NLBA.
. Public Citizen analyzed a challenge to the FDA’s decision to list two color additives for which the FDA's scientific review panel concluded the “lifetime cancer risks of the substances [were] extremely small,” ranging from one in nine million to one in 19 billion. Id., at 1111. Public Citizen concluded that the Delaney Clause was not subject to de minimis exceptions even for "exceedingly small (but measurable) risks." Id. at 1113; cf. Les v. Reilly,
Public Citizen distinguished Scott v. Food & Drug Administration, in which the Sixth Circuit determined that the Delaney Clause "did not bar the permanent listing of D & C Green No. 5” even where p-toluidine, a known carcinogen, was present in minute quantities as a chemical impurity in the color additive. Scott v. Food & Drug Admin.,
. If Congress thought Proposition 65 suits as to safety warnings “posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA's 70-year history.” Wyeth,
. Defendant has cited two regulations purportedly governing warnings, (21 C.F.R. §§ 101.2, 101.4), yet these regulations appear to pertain to standards of identity under the NLEA.
. “We generally require a stay rather than a dismissal.” R.R. St.,