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No. 07-1327

 

In the Supreme Court of the United States

ALBERTSON'S, INC., ET AL., PETITIONERS

v.

JENNIFER KANTER, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI
TO THE SUPREME COURT OF CALIFORNIA

BRIEF FOR THE UNITED STATES AS AMICUS CURIAE

DARYL JOSEFFER
Acting Solicitor General
Counsel of Record
GREGORY G. KATSAS
Assistant Attorney General
EDWIN S. KNEEDLER
Deputy Solicitor General
MATTHEW D. ROBERTS
Assistant to the Solicitor
General
DOUGLAS N. LETTER

ANISHA S. DASGUPTA

Attorneys

Department of Justice

Washington, D.C. 20530-0001

(202) 514-2217

 

THOMAS R. BARKER
Acting General Counsel
GERALD F. MASOUDI
Associate General Counsel
ERIC M. BLUMBERG
Deputy Chief Counsel,
Litigation
KAREN E. SCHIFTER
Associate Chief Counsel,
Litigation
Department of Health &
Human Services
Rockville, MD 20857

QUESTION PRESENTED

Whether the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., preempts respondents' suit to enforce state food-labeling requirements that are identical to requirements imposed under the FDCA.

 

 

In the Supreme Court of the United States

No. 07-1327

ALBERTSON'S, INC., ET AL., PETITIONERS

v.

JENNIFER KANTER, ET AL.

ON PETITION FOR A WRIT OF CERTIORARI
TO THE SUPREME COURT OF CALIFORNIA

BRIEF FOR THE UNITED STATES AS AMICUS CURIAE

This brief is filed in response to the Court's order in viting the Solicitor General to express the views of the United States. In the view of the United States, the pe tition for a writ of certiorari should be denied.

STATEMENT

1. The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301 et seq., prohibits the misbranding of food in interstate commerce. 21 U.S.C. 331(a)-(c) and (k). A food containing artificial coloring is misbranded "unless it bears labeling stating that fact." 21 U.S.C. 343(k). The Food and Drug Administration (FDA), which has authority to regulate the labeling of food products, has promulgated regulations providing that farmed salmon may be fed certain color additives "to enhance the * * * color of th[eir] flesh," 21 C.F.R. 73.35(c)(1), 73.75(c)(3)(ii), but "[t]he presence of the color additive * * * shall be declared" in the labeling, 21 C.F.R. 73.35(d)(3), 73.75(d)(4). The declaration may be accomplished by identifying the specific color addi tive or, alternatively, by using "an * * * informative term" such as "'Color Added' * * * that makes clear that a color additive has been used in the food." 21 C.F.R. 101.22(k)(2). See 21 U.S.C. 371(a), 393(b)(2)(A) and (d)(2) (Secretary of Health and Human Services, through FDA, may promulgate regulations to imple ment, and is otherwise responsible for executing, the FDCA, including its food-labeling requirements).

In 1990, Congress amended the FDCA to include additional requirements relating to food labeling. Nutri tion Labeling and Education Act of 1990 (NLEA), Pub. L. No. 101-535, 104 Stat. 2353. The NLEA contains an express preemption provision that generally prohibits States from establishing or continuing in effect "any requirement for the labeling of food" with artificial col oring "that is not identical to the requirement[s]" of 21 U.S.C. 343(k). 21 U.S.C. 343-1(a)(3). The NLEA pre emption provision contains specified exceptions, and it authorizes FDA to grant additional exemptions under certain circumstances. 21 U.S.C. 343-1. The NLEA states that its provisions "shall not be construed to pre empt any provision of State law, unless such provision is expressly preempted under [the NLEA]." § 6(c)(1), 104 Stat. 2364.

The FDCA provides that, in general, "proceedings for the enforcement, or to restrain violations, of the [FDCA] shall be by and in the name of the United States." 21 U.S.C. 337(a). Under an amendment added by the NLEA, a State may also bring proceedings, "in its own name and within its jurisdiction," to enforce cer tain food-labeling provisions of the FDCA if the State complies with specified procedural requirements. 21 U.S.C. 337(b). In particular, before commencing pro ceedings, a State must notify FDA and provide adequate time for FDA to bring its own enforcement action. 21 U.S.C. 337(b)(2)(A)-(B). A State may not bring its own action to enforce the FDCA if FDA "is diligently prose cuting a proceeding in court" pertaining to the food in question, "has settled such proceeding, or has settled [an] informal or formal enforcement action pertaining to such food." 21 U.S.C. 337(b)(2)(C).

2. As permitted by Section 343-1, California regu lates the labeling of food under the Sherman Food, Drug, and Cosmetic Law (Sherman Law), Cal. Health & Safety Code §§ 109875 et seq. (West 2006). Like the FDCA, the Sherman Law provides that a food contain ing artificial coloring is misbranded "unless its labeling states that fact." Compare id. § 110740 with 21 U.S.C. 343(k). The Sherman Law's specific labeling require ments directly incorporate regulations promulgated un der the FDCA. See Cal. Health & Safety Code §§ 110085, 110090, 110100(a) (West 2006) (providing that current and future federal food-additive, color-additive, and food-labeling regulations shall be the "regulations of [California]"). California's food-labeling require ments are, therefore, substantively identical to the re quirements of the FDCA.

3. Respondents, who are consumers of farmed sal mon in California, filed a class action against petitioners in state court. Compl. paras. 1-4. Their complaint al leges causes of action for common-law negligent misrep resentation, as well as for violation of California con sumer protection laws prohibiting unfair competition, false advertising, and unfair and deceptive trade prac tices. Compl. paras. 46-64; see Cal. Bus. & Prof. Code §§ 17200 et seq. (West 2008) (unfair competition); id. § 17500 (false advertising); Cal. Civ. Code §§ 1750 et seq. (West 1998) (unfair and deceptive trade practices). All four causes of action are based on the claim that peti tioners "fail[ed] to label * * * farm-raised salmon as artificially colored * * * in violation of the [FDCA] and equivalent provisions of California law," including the Sherman Law. Compl. para. 28.

In response to a demurrer filed by petitioners, the California state trial court held that 21 U.S.C. 337 pre empts respondents' suit. Pet. App. 51-65. Respondents elected not to amend their complaint, and the trial court dismissed the action. Id. at 40-41.

The California Court of Appeal affirmed the dis missal. Pet. App. 36-50. The court held that "section 337(a) impliedly preempts all of [respondents'] causes of action." Id. at 38. The court stated that, "[i]n section 337(a), Congress clearly expressed its intention to pre clude private enforcement of the FDCA." Id. at 46. The preclusion of a private right of action under federal law, the court reasoned, reflected an effort to "afford[] the federal government a degree of oversight of the enforce ment of the act." Id. at 46-47. In the court's view, al lowing "a state law private right of action based on a violation of the FDCA would interfere with that govern mental prosecutorial discretion and * * * conflict with the clear congressional intent to provide for a compre hensive and exclusive governmental enforcement scheme." Id. at 47. Accordingly, the court concluded that Section 337(a) impliedly preempts "any private state law cause of action" based on "conduct [that] would [violate] the FDCA." Id. at 47-48. The court explained that, if the facts "plaintiffs will necessarily have to prove in order to recover under their state law claims * * * demonstrate violations of the FDCA, then preemption will apply irrespective of the particular state law theo ries of recovery relied upon by the plaintiffs." Id. at 49- 50.

4. The California Supreme Court reversed and re manded for further proceedings. Pet. App. 1-35. The court held that the FDCA does not preempt respon dents' suit to enforce state-law food-labeling require ments identical to FDCA requirements. Id. at 3.

The court first determined that 21 U.S.C. 343-1 indi cates that States may enact and provide for enforcement of food-labeling requirements that are identical to FDCA requirements. Pet. App. 8-9, 17-27. The court reasoned that, "[a]lthough section 343-1 speaks in terms of what states may not do, by negative implication, sec tion 343-1 also expresses what states may do." Id. at 9. In the court's view, "[t]he words of section 343-1 clearly and unmistakably evince Congress's intent to authorize states to establish laws that are 'identical to' federal law." Id. at 17 (quoting 21 U.S.C. 343-1(a)(3)).

The court next concluded that "nothing in the text of section 343-1 or its legislative history supports the as sertion that Congress intended to limit the scope of rem edies states might choose to provide" for violations of parallel state requirements. Pet. App. 27. The court observed that, "[w]hile Congress clearly stated its intent to allow states to establish their own identical laws, it said absolutely nothing about proscribing the range of available remedies states might choose to provide for the violation of those laws." Id. at 18. The court noted that Representative Waxman, who introduced the NLEA in the House of Representatives, explained that the state requirements "may be enforced in State court," without suggesting that enforcement would be restricted to actions brought by States themselves. Ibid. (quoting 136 Cong. Rec. 20,419 (1990)). The court reasoned that the absence of any suggestion that Congress intended to preclude private enforcement strongly suggests that it did not so intend, because Congress was presumably aware that "virtually every state in the nation permits one or more nongovernmental parties to enforce" state laws prohibiting unfair and deceptive practices. Id. at 20 (quoting Bob Cohen, Annotation, Right to Private Action Under State Consumer Protection Act-Precon ditions to Action, 117 A.L.R.5th 155 (2004)). That con clusion, the court observed, is also supported by Section 6(c)(1) of the NLEA, which indicates that the preemp tive effect of the NLEA "sweep[s] no further than the plain language of the statute itself." Ibid.

The California Supreme Court found additional sup port for its conclusion in this Court's decisions in Med tronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Bates v. Dow Agroscience LLC, 544 U.S. 431 (2005). Pet. App. 24-26. The court noted that, in those cases, this Court construed preemption provisions that closely resemble Section 343-1 and concluded that those provisions autho rized States not only "to adopt identical requirements" but also "to provide for private remedies for violations of those requirements." Id. at 25; see id. at 26. Accord ingly, the state supreme court concluded, "Congress's decision not to expressly supplant private claims based on * * * state laws authorized by section 343-1 should be interpreted as its considered decision to continue to allow states to provide such private remedies." Id. at 20.

The court then considered and rejected petitioners' contention that, notwithstanding Section 343-1, respon dents' suit is impliedly preempted by 21 U.S.C. 337. The court observed that Section 337, "by its very terms, only implicates efforts to enforce federal law." Pet. App. 29. Respondents, the court explained, "do not seek to en force the FDCA; rather their deceptive marketing claims are predicated on violations of obligations im posed by the Sherman Law." Id. at 28. "That the Sher man Law imposes obligations identical to those imposed by the FDCA, as it must under section 343-1," the court reasoned, "does not substantively transform [respon dents'] action into one seeking to enforce the FDCA." Ibid.

The court noted that FDA has stated that Section 337 "applies only to proceedings to enforce the [FDCA]" and that therefore "[n]othing in [Section 337] would pre clude a State from taking action against a particular food under its own state law." Pet. App. 29 (quoting 58 Fed. Reg. 2458 (1993)) (brackets and italics added by court). Likewise, the court reasoned, Section 337 does not "affect the ability of states to provide a private rem edy for violations of their laws if they so choose." Id. at 30.

The court also noted petitioners' admission that, not withstanding Section 337(b), "states may enforce their own laws in state court without notifying FDA at all, even [when] the laws impose requirements identical to those contained in the FDCA." Pet. App. 34. The court observed that petitioners had failed to explain why pri vate enforcement of state laws "would be of any greater concern to Congress than [state] enforcement of state laws," when "in both instances[] state laws identical to the FDCA are enforced without first notifying the FDA." Ibid. Accordingly, the court concluded that the FDCA "does not impliedly preempt private actions based on violations of state laws explicitly authorized by section 343-1." Id. at 35.

DISCUSSION

The California Supreme Court's ruling that the FDCA does not preempt respondents' state-law suit is correct. The state supreme court's decision does not conflict with any decision of this Court or a federal court of appeals. Moreover, the state supreme court's decision is interlocutory, and further proceedings may clarify the nature of any preemption issue that might be presented. Accordingly, the Court should deny the petition for a writ of certiorari.

A. The Decision Below Is Correct

The California Supreme Court correctly held that the FDCA does not preempt respondents' action to enforce state food-labeling requirements that are identical to requirements imposed under the FDCA. Under 21 U.S.C. 343-1, States are generally permitted to enact and to provide for the enforcement of those state re quirements. Although 21 U.S.C. 337 precludes private actions to enforce the FDCA itself, Section 337 does not prohibit private actions to enforce parallel state require ments. A particular state-law suit might, in certain cir cumstances, impliedly conflict with provisions of the FDCA, implementing regulations, or a particular deter mination or enforcement action by FDA, but respon dents' suit poses no such conflict.

1. Because Section 343-1 expressly addresses pre emption of state food-labeling requirements, analysis of the preemption question "must in the first instance focus on the plain wording of [that provision], which necessar ily contains the best evidence of Congress' pre-emptive intent." CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993). As the California Supreme Court correctly concluded, Section 343-1 indicates that Congress gener ally intended to permit States to adopt food-labeling requirements identical to FDCA requirements and to provide for the enforcement of those state requirements in state court. See Pet. App. 17-27.

The plain text of Section 343-1 prohibits States from adopting "any requirement for the labeling of food" with artificial coloring "that is not identical to the require ment[s]" of 21 U.S.C. 343(k), the FDCA provision ad dressing artificial coloring. 21 U.S.C. 343-1(a)(3) (em phasis added). As the California Supreme Court recog nized, by preempting only requirements that are "not identical" to federal requirements, Section 343-1 strong ly suggests that States may adopt requirements that are identical to federal requirements. Pet. App. 9, 17. That conclusion is strengthened by Section 6(c)(1) of the NLEA, which indicates that Congress did not intend the preemptive effect of any provision of the NLEA, includ ing Section 343-1, to extend beyond its express lan guage. See 21 U.S.C. 343-1 note.

As the California Supreme Court also correctly con cluded, nothing in Section 343-1 suggests that Congress intended to limit the States' authority to prescribe the remedies for violations of the state requirements per mitted by Section 343-1. Pet. App. 18-27. "States are independent sovereigns with plenary authority to make and enforce their own laws as long as they do not in fringe on federal constitutional guarantees." Danforth v. Minnesota, 128 S. Ct. 1029, 1041 (2008). Although Congress, under the Supremacy Clause, may displace the remedies States have provided for violations of state law that does not conflict with federal law as a substan tive matter, this Court has been hesitant to conclude that Congress intends such "a serious intrusion into state sovereignty." Medtronic, Inc. v. Lohr, 518 U.S. 470, 488 (1996) (plurality opinion). Moreover, when Con gress enacted Section 343-1, it presumably was aware that the vast majority of States permitted private par ties to enforce state laws prohibiting deceptive business practices. See Pet. App. 20; Jeff Sovern, Private Ac tions Under the Deceptive Trade Practices Acts: Recon sidering the FTC Act As Rule Model, 52 Ohio St. L.J. 437, 448 (1991); see also U.S. Amicus Br. 3, Altria Group, Inc. v. Good, No. 07-562 (argued Oct. 6, 2008).1 Against that backdrop, the absence of any indication that Congress intended to preclude States from autho rizing private actions to enforce state substantive re quirements that are not themselves preempted strongly suggests that Congress did not foreclose such suits.

The conclusion that Section 343-1 does not prevent States from providing private actions to enforce state requirements that mirror FDCA requirements accords with this Court's interpretation of similar preemption provisions. In Lohr, the Court construed 21 U.S.C. 360k, a provision of the FDCA that prohibits States from establishing "any requirement * * * different from, or in addition to," FDCA labeling and design re quirements for medical devices. The Court concluded that Section 360k does not preempt "State or local re quirements that are equal to, or substantially identical to, requirements imposed by or under the [FDCA]." 518 U.S. at 496-497 (emphasis added) (quoting 21 C.F.R. 808.1(d)(2)). All nine Justices also agreed that Section 360k permits States "to provide a traditional damages remedy for violations of" those identical state require ments. Id. at 495; see id. at 513 (O'Connor, J., concur ring in part and dissenting in part). The Court recently reiterated that understanding of Section 360k in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), observing that Section 360k "does not prevent a State from providing a damages remedy" where "the state duties" being en forced "'parallel,' rather than add to, federal require ments." Id. at 1011 (quoting Lohr, 518 U.S. at 495).

In Bates v. Dow Agriscience LLC, 544 U.S. 431 (2005), this Court adopted a similar interpretation of 7 U.S.C. 136v(b), a statutory provision prohibiting States from adopting "any requirements * * * in addition to or different from those required" by the Federal Insec ticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. The Court held that, under the plain language of that provision, "a state-law labeling require ment is not pre-empted by § 136v(b) if it is equivalent to, and fully consistent with, FIFRA's misbranding provi sions." Bates, 544 U.S. at 447. The Court further held that, "although FIFRA does not provide a federal rem edy to farmers and others who are injured as a result of a manufacturer's violation of FIFRA's labeling require ments, nothing in § 136v(b) precludes States from pro viding such a remedy." Id. at 448. Consistent with Lohr and Bates, the California Supreme Court correctly con cluded that Section 343-1 indicates that Congress did not intend to preclude States from providing private remedies for violation of state requirements that paral lel requirements under the FDCA.

2. Notwithstanding Section 343-1, petitioners con tend that Section 337 impliedly preempts respondents' suit. Petitioners assert that Section 337 precludes all private actions requiring proof of facts "that would sup port an FDCA claim" (Pet. 16), including suits under state law to enforce the parallel state requirements au thorized by Section 343-1. Apparently relying on the principle that state law is impliedly preempted when it "stands as an obstacle to the accomplishment and execu tion of the full purposes and objectives of Congress," Hines v. Davidowitz, 312 U.S. 52, 67 (1941), petitioners contend that private actions to enforce parallel state requirements would interfere with the "exclusive gov ernment enforcement scheme" that they assert is em bodied in Section 337. Pet. 13. The California Supreme Court correctly rejected petitioners' contentions. See Pet. App. 27-35.

a. Nothing in the text of Section 337 suggests that it precludes actions under state law. Section 337(a) pro vides that, in general, "proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States." 21 U.S.C. 337(a). Section 337(b) authorizes a State to bring an action to enforce specified provisions of the FDCA provided that the State complies with procedural requirements de signed to ensure coordination with the FDA. 21 U.S.C. 337(b).

As FDA recognized when it promulgated regulations to implement Section 337(b), Section 337 "applies only to proceedings to enforce the [FDCA]." 58 Fed. Reg. at 2458. Accordingly, FDA concluded that Section 337 "does not prohibit a State from enforcing an identical State law." Ibid. Similarly, Section 337 does not prohib it a State from authorizing private suits to enforce such a law. Pet. App. 30.

Actions to enforce state laws that impose require ments identical to those under the FDCA are not actions to enforce the FDCA itself. Petitioners contend that such state actions always "necessitate establishing a violation of federal standards." Pet. Reply Br. 6; see id. at 4. As respondents' suit itself demonstrates, however, that contention is incorrect. Respondents' suit "can be resolved with reference to state law alone." Pet. App. 33. Their claims are predicated on violations of Califor nia's Sherman Law, which provides that food is mis branded "if it bears or contains any * * * artificial coloring * * * unless its labeling states that fact." Cal. Health & Safety Code § 110740 (West 2006). Although that requirement mirrors the FDCA's requirement in 21 U.S.C. 343(k), respondents can prove that petitioners violated the Sherman Law requirement without even referring to the FDCA.

Respondents can also prove that petitioners violated the Sherman Law by proving that they violated FDCA regulations, Cal. Health & Safety Code § 110100(a) (West 2006), and respondents' complaint contains such allegations, Compl. para. 28. But, as this Court has ex plained, even when state-law claims are predicated on violations of the FDCA, they remain state-law claims. In Lohr, this Court held that the FDCA did not preempt state-law claims that included allegations that the defen dant had "violated FDA regulations." 518 U.S. at 495. In Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), the Court rejected the plaintiffs' "at tempt to characterize * * * the claims at issue in [Lohr] * * * as 'claims arising from violations of FDCA requirements.'" Id. at 352 (citation omitted). As the Court explained, that characterization was inaccu rate because the claims in Lohr arose from a state-law duty, "not solely from the violation of FDCA require ments." Ibid.; see also Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804, 808, 809, 813 (1986). The same is true of respondents' claims here.2 "[T]he party who brings a suit is master to decide what law he will rely upon," Fair v. Kohler Die & Specialty Co., 228 U.S. 22, 25 (1913) (Holmes, J.), and may therefore sue only under state law whether or not the same allegations would sup port a federal-law cause of action. See, e.g., Merrell Dow, 478 U.S. at 809 & n.6.

b. This Court's decisions in Lohr and Riegel strongly support the conclusion that Section 337 does not prohibit private suits to enforce state laws that parallel the re quirements of the FDCA. In Lohr, after concluding that Section 360k does not preempt tort actions under state law if they "rest on claims that [the defendant] negli gently failed to comply with duties 'equal to, or substan tially identical to, requirements imposed' under [the FDCA]," the Court held that "there was no reason for the Court of Appeals to preclude" such claims. 518 U.S. at 497. The dissenting Justices agreed with that aspect of the Court's holding. See id. at 513 (opinion of O'Con nor, J.). No Member of the Court suggested that paral lel state-law claims might be precluded by Section 337. And if Section 337 imposed a blanket prohibition on such claims, the Court's holding that the claims in Lohr could proceed could not be sustained. Similarly, in Riegel, the Court concluded that state requirements for medical devices are preempted "only to the extent that they are 'different from, or in addition to' the requirements im posed by federal law," implicitly recognizing that the FDCA does not contain any generally applicable provi sion preempting such suits. 128 S. Ct. at 1011 (quoting 21 U.S.C. 360k(a)).

c. Petitioners nonetheless contend that Section 337 broadly preempts all private actions to enforce state laws that parallel FDCA requirements because, accord ing to petitioners, courts had uniformly construed Sec tion 337 to preempt such suits before Congress enacted the NLEA, and nothing in the NLEA changed the state of the law. Pet. 13-14, 17-21. Petitioners are wrong on both counts.

First, no uniform line of authority had interpreted Section 337 to preclude state-law causes of action before enactment of the NLEA. Petitioners cite only one court of appeals decision and two district court cases in sup port of their contention. The court of appeals decision did not address state-law claims. It held only that the FDCA does not itself provide a private right of action. Pacific Trading Co. v. Wilson & Co., 547 F.2d 367, 370 (7th Cir. 1976). The two district court decisions held that state-law actions were preempted, but the decisions did not cite Section 337 in support of their preemption holdings. See Animal Legal Def. Fund Boston, Inc. v. Provimi Veal Corp., 626 F. Supp. 278, 283-284 (D. Mass.), aff'd, 802 F.2d 440 (1st Cir. 1986) (Animal Legal Defense Fund); National Women's Health Net work, Inc. v. A.H. Robins Co., 545 F. Supp. 1177, 1180- 1181 (D. Mass. 1982) (National Women's Health). The courts relied primarily on what they described as the "comprehensive" or "pervasive" nature of the particular regulatory schemes-the regulations concerning medi cated animal feeds and new animal drugs in Animal Le gal Defense Fund, see 626 F. Supp. at 283-284, and the regulations concerning medical devices in National Women's Health, see 545 F. Supp. at 1181. In any event, as explained above, this Court has since concluded in both Lohr and Riegel that private suits can be brought based on violations of state law that parallel federal re quirements.

Second, Section 343-1, which was enacted as part of the NLEA, signaled Congress's intent to permit States to adopt food-labeling requirements identical to FDCA requirements and to provide for the enforcement of those state requirements in state court. See pp. 8-11, supra. Indeed, petitioners concede that Section 343-1 authorizes States to sue to enforce such state require ments and that Section 337 does not preempt or other wise limit those suits. Pet. 20. As the California Su preme Court recognized, that concession is fatal to peti tioners' contention that Section 337 nonetheless pre empts States from authorizing private suits to enforce the same state requirements. See Pet. App. 33-34. If Section 337(b)'s restrictions on a State's direct enforce ment of the FDCA itself do not preempt or otherwise restrict a State's enforcement of its own parallel state requirements, then it follows that Section 337(a)'s re strictions on private enforcement of the FDCA likewise do not preempt a State from allowing private suits based on those parallel state requirements.

d. Petitioners contend that private actions to en force parallel state requirements would frustrate the FDCA's goal of uniformity in regulation and enforce ment. Pet. 21-27; Pet. Reply Br. 5. The interest in uni formity of regulation and enforcement under the FDCA is, however, not so "unyielding" as to bar all private state-law suits concerning food labeling. Sprietsma v. Mercury Marine, 537 U.S. 51, 70 (2002). As described above, Section 343-1 expressly allows States to impose food-labeling requirements that are identical to federal law. Section 343-1 also allows States to impose food- labeling requirements that are not identical to FDCA requirements in specified circumstances or when FDA grants an exemption from preemption. 21 U.S.C. 343-1(a)(1)-(5) and (b). And Section 337(b) even ex pressly allows States to bring actions to enforce the fed eral FDCA food-labeling requirements themselves. 21 U.S.C. 337(b). Thus, the interest in uniformity does not deprive the States of any role in enforcing food-labeling requirements.

In the view of FDA, private suits under state law to enforce state food-labeling requirements that parallel FDCA requirements do not necessarily pose a conflict with the FDCA or its enforcement scheme. On the con trary, the requirements of 21 U.S.C. 343-1 will ensure that any state-law action is consistent with federal re quirements. Unless the state requirement is "identical" to the federal requirement, or the statute or FDA grants an exemption, the state-law suit will be preempted.

Even a suit to enforce an identical state requirement would be preempted if the particular suit "actually conflict[ed]" with provisions of the FDCA, implementing regulations, or an administrative determination or en forcement action by FDA. Geier v. American Honda Motor Co., 529 U.S. 861, 874 (2000). For example, FDA might resolve an enforcement action against a food com pany that had violated the FDCA's labeling require ments by entering into a consent decree under which the company agreed to change its labeling in a particular manner prospectively. FDA might decide, however, that the decree should affirmatively allow products already distributed to remain on the market because they did not present a health or safety risk, they provided recog nized nutritional benefit, and the risk from their mis branding was negligible. Once the consent decree was approved by the court, a state-law action against the company to remedy the violation of an identical state labeling requirement might well be preempted, if it would actually conflict with the federal enforcement bal ance reflected in the consent decree.

Respondents' suit, however, does not pose any such conflict, and the California Supreme Court correctly held that it is not preempted. See Lohr, 518 U.S. at 496 ("Because the FDA is the federal agency to which Con gress has delegated its authority to implement the pro visions of the Act, the agency is uniquely qualified to determine whether a particular form of state law 'stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress,' Hines[, 312 U.S. at 67,] and, therefore, whether it should be pre- empted.") (footnote omitted).

B. The Decision Below Does Not Conflict With Any Deci sion Of This Court Or A Federal Court Of Appeals

1. Contrary to petitioners' contention (Pet. 12-13, 14-15; Pet. Reply Br. 11-12), the California Supreme Court's decision does not conflict with this Court's deci sion in Buckman. In Buckman, the Court held that the FDCA preempted state-law claims alleging that the de fendant had made fraudulent representations to FDA in order to secure clearance to market certain medical de vices. 531 U.S. at 343-344. The Court concluded that those claims conflicted with federal law because they would "skew[]" the "delicate balance of statutory objec tives" that FDA was charged with achieving in policing fraud and administering the device clearance process. Id. at 348. The Court explained that, among other things, the claims might deter would-be applicants from seeking approval for beneficial devices or lead appli cants to deluge FDA with information that the agency neither wanted nor needed to determine whether to ap prove the devices. Id. at 350-351. Unlike the suit in Buckman, respondents' suit does not involve alleged fraud on the FDA, the FDA's approval of a product, or any other FDA determination. Respondents' suit there fore does not pose the concerns about skewing the FDA's approval process on which this Court relied in Buckman.

As petitioners note (Pet. 14), in a footnote in Buck man, the Court stated in passing that the FDCA does not authorize private litigants to sue for noncompliance with the FDCA's medical device provisions. See 531 U.S. at 349 n.4 (citing 21 U.S.C. 337(a)). But, as ex plained above, respondents' suit is based on a violation of state law, not the FDCA itself.

2. The decision below also does not conflict with the decision of any federal court of appeals. Petitioners cite three court of appeals decisions and imply that those decisions conflict with the California Supreme Court's decision here. See Pet. 14-15 n.2. All three of those de cisions stated that the FDCA does not create a federal private right of action. See In re Orthopedic Bone Screw Prods. Liab. Litig., 193 F.3d 781 (3d Cir. 1999); PDK Labs, Inc. v. Friedlander, 103 F.3d 1105 (2d Cir. 1997); and Bailey v. Johnson, 48 F.3d 965 (6th Cir. 1995). None of the decisions, however, addressed the distinct question at issue here-whether the FDCA pre empts private actions under state law to enforce state requirements that are identical to federal requirements. The court of appeals decisions therefore do not conflict with the holding in this case.

C. The Decision Below Is Interlocutory

Even if the question presented otherwise warranted review, this Court should deny the petition for a writ of certiorari because the decision below is interlocutory. The California Supreme Court merely reversed the dis missal of respondents' complaint and remanded for fur ther proceedings. The state courts therefore have not yet made any determinations concerning whether the elements of respondents' various state-law causes of action are satisfied, the nature of petitioners' conduct, or what form of relief, if any, might be available as a matter of state law. The proceedings on remand will yield more information about the precise contours of respondents' claims and may clarify the nature of any preemption issue that might be presented. Accordingly, it would be premature for the Court to grant review at this time.

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully submitted.

DARYL JOSEFFER
Acting Solicitor General
GREGORY G. KATSAS
Assistant Attorney General
EDWIN S. KNEEDLER
Deputy Solicitor General
MATTHEW D. ROBERTS
Assistant to the Solicitor
General
DOUGLAS N. LETTER

ANISHA S. DASGUPTA

Attorneys

 

THOMAS R. BARKER
Acting General Counsel
GERALD F. MASOUDI
Associate General Counsel
ERIC M. BLUMBERG
Deputy Chief Counsel,
Litigation
KAREN E. SCHIFTER
Associate Chief Counsel,
Litigation
Department of Health &
Human Services

 

 

DECEMBER 2008

 

* The Solicitor General is recused in this case.

1 As explained in the United States' amicus brief in Wyeth v. Levine, No. 06-1249 (argued Nov. 3, 2008), such suits would be preempted where the substantive state law to be applied conflicted with the FDCA, implementing regulations, or an approval or other determination made by FDA.

2 As explained above, California law imposes an independent state- law duty that requires the labeling of food that contains artificial color ing to state that fact. See Cal. Health & Safety Code § 110740 (West 2006). Moreover, respondents' claims, like the state-law tort claims in Lohr, require proof not only of violation of that state requirement but also of additional elements, such as damage or injury as a result of the violation. See Cal. Civ. Code § 1780 (West Supp. 2008) (requiring proof that damage resulted from the unfair or deceptive practice); Cal. Bus. & Prof. Code §§ 17204, 17535 (West 2008) (requiring proof of injury in fact and loss of money or property as a result of unfair competition or false advertising); Apollo Capital Fund, LLC v. Roth Capital Partners, LLC, 70 Cal. Rptr. 3d 199, 213 (Cal. App. 2007) (stating that proof of justifiable reliance and resulting damage is necessary to establish negli gent misrepresentation). The existence of those additional elements reinforces the conclusion that respondents are not seeking to enforce the FDCA itself but rather to enforce a parallel state-law duty that the FDCA does not preempt. See also Lohr, 518 U.S. at 495 (explaining that the fact that plaintiffs must prove additional elements to prevail on their state-law claims does not make the state-law requirements "differ ent from" federal requirements for preemption purposes).