Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 1 of 34
`
`
`
`DAVID R. SINGH (Bar No. 300840)
`david.singh@weil.com
`AMY LE (Bar No. 341925)
`amy.le@weil.com
`WEIL, GOTSHAL & MANGES LLP
`201 Redwood Shores Parkway, 6th Floor
`Redwood Shores, CA 94065-1134
`Telephone: (650) 802-3000
`Facsimile: (650) 802-3100
`
`DIANE P. SULLIVAN (pro hac vice forthcoming)
`diane.sullivan@weil.com
`WEIL, GOTSHAL & MANGES LLP
`17 Hulfish Street, Suite 201
`Princeton, NJ 08542
`Telephone: (609) 986-1120
`Facsimile: (609) 986-1199
`
`Attorneys for Defendant BURGER KING CORPORATION
`
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`OAKLAND DIVISION
`AZMAN HUSSAIN, individually and on behalf
`Case No. 4:22-cv-02258-HSG
`of all others similarly situated,
`
`DEFENDANT BURGER KING
`
`CORPORATION’S NOTICE AND MOTION
`
`TO DISMISS AND MEMORANDUM IN
`v.
`SUPPORT
`
`BURGER KING CORPORATION,
`
`
`Date: January 26, 2023
`
`Time: 2:00 pm
`
`Dept.: Courtroom 2 – 4th Floor
`Judge: Honorable Haywood S. Gilliam, Jr.
`
`Plaintiff,
`
`Defendant.
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`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
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`CASE NO. 4:22-CV-02258-HSG
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 2 of 34
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`
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`NOTICE OF MOTION AND MOTION TO DISMISS
`TO PLAINTIFF AND HIS ATTORNEY OF RECORD:
`PLEASE TAKE NOTICE that on January 26, 2023, at 2:00 pm, or as soon thereafter as the
`matter may be heard, before the Honorable Haywood S. Gilliam, Jr., in Courtroom 2, 4th Floor,
`Defendant Burger King Corporation (“Burger King”) will and hereby does move to dismiss Plaintiff
`Azman Hussain’s (“Plaintiff”) Amended Complaint (Dkt. 13) filed in this action pursuant to Federal
`Rules of Civil Procedure 12(b)(1) for lack of standing and 12(b)(6) for failure to state a claim upon which
`relief can be granted.
`This Motion to Dismiss is submitted in the alternative if the Court denies Defendants’
`contemporaneously-submitted Motion to Compel Arbitration or Transfer.
`This Motion to Dismiss is based upon this Notice of Motion and Motion, the Memorandum of
`Points and Authorities in support thereof, all other pleadings and papers on file herewith, and such other
`argument and evidence as may be presented to the Court.
`Dated: July 25, 2022
`
`
`
`
`
`
`
`Respectfully submitted,
`WEIL, GOTSHAL & MANGES LLP
`
` /s/ David R. Singh___________
`By:
`DAVID R. SINGH
`
`DAVID R. SINGH
`david.singh@weil.com
`AMY LE
`amy.le@weil.com
`WEIL, GOTSHAL & MANGES LLP
`201 Redwood Shores Parkway, 6th Floor
`Redwood Shores, CA 94065
`Telephone: (650) 802-3000
`Facsimile: (650) 802-3100
`
`Diane Sullivan (pro hac vice forthcoming)
`diane.sullivan@weil.com
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`Telephone: (212) 310-8000
`Facsimile: (212) 310-8007
`CASE NO. 4:22-CV-02258-HSG
`
`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 3 of 34
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`Attorneys for Defendant BURGER KING
`CORPORATION
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`CASE NO. 4:22-CV-02258-HSG
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`
`
`I. 
`
`II. 
`
`III. 
`
`IV. 
`
`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 4 of 34
`
`TABLE OF CONTENTS
`PRELIMINARY STATEMENT .........................................................................................1 
`
`FACTUAL BACKGROUND ..............................................................................................3 
`
`A. 
`
`B. 
`
`The Extensive Federal Regulatory Scheme for Food Contact Substances
`Permits Burger King’s Use of PFAS in Packaging for the Whopper and
`French Fries .............................................................................................................3 
`
`Plaintiff’s Complaint Seeks to Challenge These Federal and State
`Regulations ..............................................................................................................5 
`
`LEGAL STANDARD ..........................................................................................................7 
`
`ARGUMENT .......................................................................................................................8 
`
`A. 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`
`Each of Plaintiff’s Claims Is Preempted ..................................................................8 
`
`Plaintiff’s Fraud-Based Claims Fail For Multiple Reasons (Counts 1, 2, 4-
`7, 10, and 11) .........................................................................................................10 
`
`1)  Plaintiff’s UCL, CLRA, and FAL Claims Are Barred by the Safe Harbor
`Doctrine ..........................................................................................................10 
`
`2)  Plaintiff Fails to Plead Reliance with Rule 9(b) Particularity ........................11 
`
`3)  Plaintiff Fails to Identify Any Statements or Representations That Are
`Actionable, False or Misleading .....................................................................13 
`
`4)  Plaintiff’s Negligence-Based Claims Are Further Barred by the Economic
`Loss Rule (Counts 11 and 14) ........................................................................15 
`
`Plaintiff’s Omission-Based Claims Likewise Fail (Counts 4, 6, 9 and 14) ...........15 
`
`Plaintiff Cannot Establish A Breach of Any Warranty (Counts 3 and 13) ............17 
`
`1)  Plaintiff Fails to Identify the Terms of Any Express “Warranty” ..................17 
`
`2)  Plaintiff’s Song-Beverly Claim Fails Because He Cannot Establish that
`Burger King’s Products are Unfit for Consumption or Fall Below a Minimum
`Level of Quality ..............................................................................................18 
`
`Plaintiff’s Equitable Claims Must Be Dismissed (Counts 8 and 12) .....................19 
`
`Plaintiff Has Failed to Plead A Claim for Medical Monitoring .............................21 
`
`V. 
`
`PLAINTIFF LACKS STANDING TO SEEK PROSPECTIVE INJUNCTIVE
`RELIEF ..............................................................................................................................22 
`
`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
`
`
`i
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`CASE NO. 4:22-CV-02258-HSG
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 5 of 34
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`
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`VI. 
`
`IN THE ALTERNATIVE, THIS COURT SHOULD DISMISS OR STAY THE
`CASE UNDER THE PRIMARY JURISDICTION DOCTRINE .....................................23 
`
`VII.  CONCLUSION ..................................................................................................................24 
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 6 of 34
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
`
`
`Page(s)
`
`Ahern v. Apple Inc.,
`411 F. Supp. 3d 541 (N.D. Cal. 2019) .............................................................................................. 16
`
`Almeida v. Apple Inc.,
`No. 21-CV-07109-VC, 2022 WL 1514665 (N.D. Cal. May 13, 2022) ...................................... 12, 13
`
`Arena Rest. & Lounge LLC v. S. Glazer’s Wine & Spirits, LLC,
`No. 17-CV-03805-LHK, 2018 WL 1710405 (N.D. Cal. Apr. 9, 2018) ........................................... 16
`
`Ashcroft v. Iqbal,
`556 U.S. 662 (2009) ........................................................................................................................ 7, 8
`
`Azoulai v. BMW of N. Am. LLC,
`No. 16-CV-00589-BLF, 2017 WL 1354781 (N.D. Cal. Apr. 13, 2017) .................................... 13, 14
`
`Backus v. Biscomerica Corp.,
`378 F. Supp. 3d 849 (N.D. Cal. 2019) .................................................................................... 9, 10, 15
`
`Backus v. Biscomerica Corp.,
`No. 16-CV-03916-HSG, 2017 WL 1133406 (N.D. Cal. Mar. 27, 2017) .................................. passim
`
`Backus v. Gen. Mills, Inc.,
`122 F. Supp. 3d 909 (N.D. Cal. 2015) ........................................................................................ 23, 24
`
`Barrett v. Apple Inc.,
`523 F. Supp. 3d 1132 (N.D. Cal. 2021) ............................................................................................ 20
`
`Bates v. United Parcel Serv., Inc.,
`511 F.3d 974 (9th Cir. 2007) ............................................................................................................ 22
`
`Beasley v. Lucky Stores, Inc.,
`400 F. Supp. 3d 942 (N.D. Cal. 2019) .............................................................................................. 10
`
`Bell Atl. Corp. v. Twombly,
`550 U.S. 544 (2007) ............................................................................................................................ 8
`
`Birdsong v. Apple Inc.,
`590 F.3d 955 (9th Cir. 2009) ............................................................................................................ 19
`
`Brown v. Grimes,
`120 Cal. Rptr. 3d 893 (2011) ............................................................................................................ 19
`
`Buckley v. Align Tech., Inc.,
`No. 13-CV-02812-EJD, 2015 WL 5698751 (N.D. Cal. 2015) ................................................... 19, 20
`
`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
`
`
`iii
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 7 of 34
`
`
`
`Chandler v. State Farm Mut. Auto. Ins. Co.,
`598 F.3d 1115 (9th Cir. 2010) ............................................................................................................ 7
`
`Cohen v. Apple Inc.¸
`
`497 F. Supp. 3d 769 (N.D. Cal. 2020) ................................................................................................ 8
`
`Davidson v. Apple Inc.,
`No. 16-CV-04942-LHK, 2017 WL 976048 (N.D. Cal. Mar. 14, 2017) ............................................. 8
`
`Dinan v. SanDisk LLC,
`844 F. App’x 978 (9th Cir. 2021) ..................................................................................................... 10
`
`Dinan v. SanDisk LLC,
`No. 18-CV-05420-BLF, 2020 WL 364277 (N.D. Cal. Jan. 22, 2020) ............................................. 10
`
`Eidmann v. Walgreen Co.,
`522 F. Supp. 3d 634 (N.D. Cal. 2021) .............................................................................................. 14
`
`Fireman’s Fund Ins. Co. v. Com. & Indus. Ins. Co.,
`No. C-98-1060-VRW, 2000 WL 1721080 (N.D. Cal. Nov. 7, 2000) ............................................... 20
`
`Hawkins v. Advancepierre Foods, Inc.,
`No. 15-CV-2309-JAH (BLM), 2016 WL 6611099 (S.D. Cal. Nov. 8, 2016) .................................... 3
`
`Hawkins v. Kellogg Co.,
`224 F. Supp. 3d 1002 (S.D. Cal. 2016) ............................................................................................. 10
`
`Kearns v. Ford Motor Co.,
`567 F.3d 1120 (9th Cir. 2009) ............................................................................................................ 8
`
`Kumandan v. Google LLC,
`No. 19-CV-04286-BLF, 2022 WL 103551 (N.D. Cal. Jan. 11, 2022) ....................................... 16, 17
`
`Ladore v. Sony Computer Ent. Am., LLC,
`75 F. Supp. 3d 1065 (N.D. Cal. 2014) .............................................................................................. 15
`
`Love v. Ashford San Francisco II LP,
`No. 20-CV-08458-EMC, 2021 WL 1428372 (N.D. Cal. Apr. 15, 2021) ..................................... 6, 12
`
`Lusson v. Apple Inc.,
`No. 16-CV-00705-VC, 2016 WL 10932723 (N.D. Cal. June 20, 2016) .................................... 11, 15
`
`Magic Leap, Inc. v. Chi Xu,
`No. 19-CV-03445-LHK, 2020 WL 3268659 (N.D. Cal. June 17, 2020) ......................................... 15
`
`Mandani v. Volkswagen Grp. of Am., Inc.,
`No. 17-CV-07287-HSG, 2019 WL 652867 (N.D. Cal. Feb. 15, 2019) ...................................... 14, 18
`
`Norkunas v. Wynn Las Vegas, LLC,
`343 F. App’x 269 (9th Cir. 2009) ....................................................................................................... 7
`
`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
`
`
`iv
`
`CASE NO. 4:22-CV-02258-HSG
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 8 of 34
`
`
`
`Pirozzi v. Apple Inc.,
`913 F. Supp. 2d 840 (N.D. Cal. 2012) .............................................................................................. 13
`
`Price v. Apple Inc.,
`No. 21-CV-02846-HSG, 2022 WL 1032472 (N.D. Cal. Apr. 6, 2022) ............................................ 20
`
`Riva v. Pepsico, Inc.,
`82 F. Supp. 3d 1045 (N.D. Cal. 2015) .............................................................................................. 21
`
`Smith v. LG Elecs. U.S.A., Inc.,
`No. C 13-4361 PJH, 2014 WL 989742 (N.D. Cal. Mar. 11, 2014) ...................................... 13, 17, 18
`
`Sonner v. Premier Nutrition Corp.,
`971 F.3d 834 (9th Cir. 2020) ............................................................................................................ 20
`
`Spokeo, Inc. v. Robins,
`136 S. Ct. 1540 (2016) ........................................................................................................................ 7
`
`Swearingen v. Yucatan Foods, L.P.,
`59 F. Supp. 3d 961 (N.D. Cal. 2014) ................................................................................................ 23
`
`Syntek Semiconductor Co v. Microchip Tech., Inc.,
`307 F.3d 775 (9th Cir. 2002) ............................................................................................................ 23
`
`T & M Solar & Air Conditioning, Inc. v. Lennox Int’l Inc.,
`83 F. Supp. 3d 855 (N.D. Cal. 2015) ................................................................................................ 17
`
`Tabler v. Panera LLC,
`No. 19-CV-01646-LHK, 2020 WL 3544988 (N.D. Cal. June 30, 2020) ................................... 11, 12
`
`Transunion LLC v. Ramirez,
`141 S. Ct. 2190 (2021) ...................................................................................................................... 22
`
`Vitt v. Apple Computer, Inc.¸
`
`469 F. App’x 605 (9th Cir. 2012) ............................................................................................... 13, 14
`
`Walker v. B&G Foods, Inc.,
`No. 15-CV-03772-JST, 2019 WL 3934941 (N.D. Cal. Aug. 20, 2019) ........................................... 19
`
`Walker v. ConAgra Foods, Inc.,
`No. 15-CV-02424-JSW, 2017 WL 11674907 (N.D. Cal. Mar. 31, 2017) .......................................... 8
`
`Wilson v. Hewlett-Packard Co.,
`668 F.3d 1136 (9th Cir. 2012) .................................................................................................... 15, 16
`
`Statutes
`
`21 U.S.C. § 342(a)(1) ...................................................................................................................... 3, 4, 22
`
`21 U.S.C. § 348 ................................................................................................................................... 3, 24
`
`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
`
`
`v
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`CASE NO. 4:22-CV-02258-HSG
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 9 of 34
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`
`
`21 U.S.C. § 348(a) ........................................................................................................................... passim
`
`21 U.S.C. § 348(h) .................................................................................................................................... 4
`
`21 U.S.C. § 348(h)(1) ............................................................................................................................... 4
`
`21 U.S.C. § 348(h)(2)(A) .................................................................................................................... 4, 24
`
`Cal. Civ. Code § 1791.2(a)(2)(b) ............................................................................................................ 18
`
`Cal. Com. Code § 2313 ........................................................................................................................... 18
`
`Cal. Health & Safety Code § 109000.......................................................................................... 11, 19, 22
`
`Cal. Health & Safety Code § 109000(a)(3) .......................................................................................... 5, 6
`
`Cal. Health & Safety Code § 109000(b) ................................................................................................... 5
`
`Other Authorities
`
`21 C.F.R. §§ 170.100-170.106 ........................................................................................................ 4, 9, 11
`
`21 C.F.R. § 170.105 .............................................................................................................................. 4, 5
`
`87 F.R. 3949-01 ........................................................................................................................ 5, 9, 10, 19
`
`Fed. R. Civ. P. 8(a) ................................................................................................................................... 7
`
`Fed R. Civ. P. 9(b) ........................................................................................................................... passim
`
`
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`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 10 of 34
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`
`
`MEMORANDUM OF POINTS AND AUTHORITIES
`
`
`I.
`
`PRELIMINARY STATEMENT
`Plaintiff attempts in this lawsuit to evade the Food and Drug Administration’s (“FDA”)
`comprehensive regulation of food contact substances, including the packaging on Burger King’s
`Whopper and French Fries. Rife with conclusory assertions that Burger King’s products are “unsafe”
`because the product packaging for the Whopper and French Fries contains certain per- and polyfluoralkyl
`substances (“PFAS”), the Amended Complaint ignores that “[s]ince the 1960s, the FDA has authorized
`specific PFAS for use in specific food contact applications,” including in “food packaging.”1 Burger
`King’s food packaging uses authorized PFAS and, per federal law, the food products are accordingly not
`adulterated, not unsafe, and not illegal for sale. California law likewise still permits the use of PFAS
`and has enacted a phasing-out program that does not limit the use of PFAS in food packaging until
`January 1, 2023 and, even then, will permit the use of PFAS below a specified level. As set forth below,
`this fundamental flaw, and a litany of other deficiencies, requires dismissal of the Amended Complaint
`in its entirety.
`Federal Law Preempts All of Plaintiff’s Claims. As an initial matter, Plaintiff’s claims are
`inconsistent with and preempted by the Federal Food, Drug, and Cosmetic Act’s comprehensive
`regulatory process governing food contact substances like PFAS. Through this regulatory process, the
`FDA specifically considered reports by consumer advocacy groups regarding PFAS and has determined
`that the type of PFAS used in the packaging at issue are safe. Plaintiff cannot use litigation to overturn
`this FDA regulatory determination. As such, the Court should dismiss all of Plaintiff’s claims.
`Plaintiff Has Not Plead any Actionable Fraud-Based Claims. Plaintiff’s fraud-based claims
`suffer from numerous other pleading deficiencies. Because Burger King’s use of PFAS is specifically
`authorized by the FDA and California law, Plaintiff’s Unfair Competition Law, Consumer Legal
`Remedies Act, and False Advertising Law claims fail as a matter of law. Further, each of Plaintiff’s
`fraud and misrepresentation claims fail because Plaintiff fails to plead reliance with requisite Rule 9(b)
`
`
`1 U.S. Food & Drug Admin., Authorized Uses of PFAS in Food Contact Applications (Feb. 24, 2022),
`https://www.fda.gov/food/chemical-contaminants-food/authorized-uses-pfas-food-contact-applications
`(RJN Ex. A). Defendant has filed a Request for Judicial Notice simultaneously with this Motion to
`Dismiss. Exhibits to that Request for Judicial Notice are cited as (RJN Ex. __).
`BURGER KING CORPORATION’S NOTICE AND
`1
`CASE NO. 4:22-CV-02258-HSG
`MOTION TO DISMISS
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 11 of 34
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`particularity and, in any event, fails to identify any actionable or false statement by Burger King that a
`reasonable consumer would interpret as representing that Burger King’s food packaging for the Whopper
`and French Fries does not contain permitted PFAS. Similarly, Plaintiff’s omission-based claims likewise
`fail as Plaintiff has failed to allege a duty to disclose or that Burger King had knowledge of any purported
`“defect” (i.e., that its packaging was not “safe”) and ignores that the very website he cites in support of
`his claims discloses the use of PFAS in Burger King’s packaging.
`Plaintiff Has Not Plead any Actionable Warranty Claims. Plaintiff’s claims for breach of
`express and implied warranties and for violation of the Song-Beverly Act should fare no better. The
`Amended Complaint does not identify the terms of the purported “express” warranty on Whoppers,
`French Fries, or other food products, nor plausibly allege that any statement formed part of the basis of
`the bargain. The implied warranty claim fails because Plaintiff cannot plausibly allege that Burger
`King’s products are not fit for human consumption. Indeed, the FDA’s authorizations establish as a
`matter of law that the use of PFAS in packaging does not render Burger King’s food products unsafe.
`Without an actionable state law warranty claim, the Song-Beverly claim must fail too.
`Plaintiff Has Not Plead any Actionable Equitable Claims. Plaintiff’s equitable claims suffer
`from additional flaws. Plaintiff’s own allegations claim that he has an adequate legal remedy, which
`forecloses the availability of equitable relief. Moreover, Plaintiff cannot even establish the most basic
`elements of his Money Had and Received claim.
`Plaintiff Lacks Standing to Seek Prospective Injunctive Relief. Plaintiff also lacks standing to
`secure prospective injunctive relief requiring Burger King to provide what he terms “accurate
`disclosures.” Plaintiff’s theory of injury is that he suffered an informational injury by Burger King not
`disclosing to him that its food packaging is allegedly not “safe”; this theory, however, does not suffice
`to establish a concrete injury as required for Article III standing and fails as a matter of law because it
`stands in direct conflict with the FDA regulatory approval process providing that Burger King’s use of
`PFAS in packaging for the Whopper and French Fries does not render the products unsafe.
`At bottom, Plaintiff’s Amended Complaint is a plea for regulatory reform that is better addressed
`to the political branches, not the courts. Indeed, both the FDA and California legislature have rejected
`Plaintiff’s preference that all PFAS be banned immediately, much less retroactively. These fundamental
`
`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
`
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`2
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 12 of 34
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`failures render any leave to amend futile. The Amended Complaint should be dismissed with prejudice.
`If not dismissed due to pleading deficiencies or lack of subject matter jurisdiction, it should be dismissed
`without prejudice or stayed so Plaintiff’s concerns can be addressed to the regulators with primary
`jurisdiction.
`II.
`FACTUAL BACKGROUND
`A.
`The Extensive Federal Regulatory Scheme for Food Contact Substances Permits
`Burger King’s Use of PFAS in Packaging for the Whopper and French Fries
`The United States Congress has vested the FDA with the authority to regulate the safety of
`ingredients used in foods and beverages through the Federal Food, Drug, and Cosmetic Act (“FFDCA”).
`“Specifically, the [FFDCA] requires the FDA to (i) ensure that ‘foods are safe, wholesome, sanitary, and
`properly labeled,’ (ii) promulgate regulations to enforce the provisions of the FDCA, and (iii) enforce
`its regulations through administrative proceedings.” Hawkins v. Advancepierre Foods, Inc., No. 15-CV-
`2309-JAH (BLM), 2016 WL 6611099, at *3 (S.D. Cal. Nov. 8, 2016), aff'd, 733 F. App’x 906 (9th Cir.
`2018) (citing 21 U.S.C. §§ 371, 393(b)(2)(A); 21 C.F.R. § 7.1 et seq).
`In 1958, Congress enacted the Food Additives Amendment to the FFDCA in order to “protect
`the public health by amending the [FFDCA] to prohibit the use in food of additives which have not been
`adequately tested to establish their safety.” Pub. L. No. 85-929, 72 Stat. 1784, 1784 (1958). Through
`the Food and Drug Administration Modernization Act of 1997, Congress further amended the FFDCA
`to include regulation concerning food contact substances, such as food packaging. See Pub. L. 105–115,
`111 Stat. 2296 (1997). Now codified at 21 U.S.C. § 348(a), these amendments provide that a “food
`additive shall . . . be deemed unsafe . . . unless” in the case of a “food contact substance,” there is either
`“in effect, and such substance and the use of such substance are in conformity with, a regulation issued
`under this section prescribing the conditions under which such additive may be safely used” or there is
`“a notification submitted under subsection (h) that is effective.” Id. (emphasis added). Further, the Act
`provides that while a regulation or “notification under subsection (h)(1)” relating to a food contact
`substance is in effect and has not been revoked, “a food shall not, by reason of bearing or containing
`such a food additive in accordance with the regulation or notification, be considered adulterated” under
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`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
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`CASE NO. 4:22-CV-02258-HSG
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 13 of 34
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`Section 342(a). Id. (emphasis added).2
`Subsection (h), in turn, provides an exhaustive process for the submission and FDA review of
`notifications relating to food contact substances. See 21 U.S.C. § 348(h). Pursuant to this Congressional
`mandate, the FDA has issued regulations governing the submission of and FDA action on premarket
`notifications for food contact substances (“FCN”). See 21 C.F.R. §§ 170.100-170.106. In sum, a
`manufacturer or supplier of a food contact substance may “at least 120 days prior to the introduction or
`delivery” of a food contact substance, “notify the Secretary of the identity and intended use of the food
`contact substance, and of the determination of the manufacturer or supplier that the intended use of such
`food contact substance is safe under the standard described in subsection (c)(3)(A).” 21 U.S.C.
`§ 348(h)(1). Such a notification becomes effective after this 120-day period, unless the Secretary makes
`a determination within that period that “based on the data and information before the Secretary, such use
`of the food contact substance has not been shown to be safe under the standard described in subsection
`(c)(3)(A), and informs the manufacturer or supplier of such determination.” Id. § 348(h)(2)(A).3 The
`regulations also provide that if the “FDA determines that an FCN is no longer effective,” it will inform
`the manufacturer or supplier “in writing” and provide the manufacturer or supplier “an opportunity to
`show why the FCN should continue to be effective.” 21 C.F.R. § 170.105. Further, the “FDA’s
`determination that an FCN is no longer effective is [] subject to judicial review.” Id.
`The FDA has regulated the use of PFAS in food packaging in accordance with this scheme.
`“Since the 1960s, the FDA has authorized specific PFAS for use in specific food contact applications,”
`including in “food packaging.” See n.1, supra. Plaintiff does not—and cannot—allege that the PFAS
`in the packaging for Burger King’s Whopper and French Fries is not authorized. In fact, Burger King
`only permits the use of food contact substances that have been approved for use in food packaging by
`the FDA. See Declaration of Diego Beamonte in Support of Burger King’s Motion to Dismiss
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`2 Section 342(a) concerns “adulterated food” and provides that food “shall be deemed to be adulterated”
`where “it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section
`348 of this title.” 21 U.S.C. § 342(a)(1).
`3See also U.S. Food & Drug Admin., About the FCS Review Program (Jan. 25, 2022),
`https://www.fda.gov/food/inventory-effective-food-contact-substance-fcs-notifications/about-fcs-
`review-program (“If the agency does not express any objections about the safety of the substance in that
`time-period, then the company can legally market the product.”) (RJN Ex. B).
`BURGER KING CORPORATION’S NOTICE AND
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`CASE NO. 4:22-CV-02258-HSG
`MOTION TO DISMISS
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`Case 4:22-cv-02258-HSG Document 21 Filed 07/25/22 Page 14 of 34
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`(“Beamonte Decl.”) at ¶ 4. Accordingly, the wrappers used on Burger King’s products are not
`adulterated, 21 U.S.C. § 342(a)(1), or unsafe, 21 U.S.C. § 348(a), and their use is authorized, 21 U.S.C.
`§ 348(h).
`The FDA has recently reviewed certain PFAS used on food contact paper. See n.1, supra. It has
`not determined that the FCN for these PFAS is no longer effective, nor followed the procedure set forth
`in 21 C.F.R. § 170.105; rather, certain manufacturers have reached agreements with the FDA to
`voluntarily phase out these certain PFAS within three years from January 1, 2021 (i.e., by 2024). See
`Food Additives: Food Contact Substance Notification That Is No Longer Effective, 87 F.R. 3949-01
`(proposed regulation explaining “voluntary” process, noting that, in the meanwhile, “these FCNs remain
`effective”); n.1, supra; RJN Ex. C (FDA Food Contact Substance FCN Number database).
`California has also adopted a phasing-out program for “regulated” PFAS, which provides a
`phasing-out period such that by January 1, 2023 the sale of “food packaging that contains regulated
`perfluoroalkyl and polyfluoroalkyl substances or PFAS” will be prohibited. Cal. Health & Safety Code
`§ 109000(b). Recognizing that the presence of some level of PFAS is acceptable, California defines
`“regulated” PFAS as either that which is “intentionally added” or has a presence of more than 100 parts
`per million. Id. § 109000(a)(3). Importantly, neither the FDA nor California currently prohibits the use
`of PFAS, nor have they previously prohibited the use of PFAS. Accordingly, the use of PFAS in
`compliance with a FCN is permitted and recognized as safe.
`B.
`Plaintiff’s Complaint Seeks to Challenge These Federal and State Regulations
`Plaintiff Azman Hussain is a California resident who allegedly purchased Burger King’s
`Whopper or French Fries “for several years,” most recently in March 2022. Am. Compl. ¶ 11.
`Apparently unsatisfied with the FDA’s decision-making, or the scope or speed of the FDA and California
`phasing-out program, Plaintiff filed this lawsuit alleging that the packaging Burger King’s Whopper and
`French Fries “are unfit for human consumption because the packaging in which they are contained”
`“contain heightened levels of organic fluorine and unsafe [PFAS].” Id. ¶ 1. Plaintiff claims that Burger
`King deceived customers because it markets its products “as safe and sustainable.” Id. ¶ 21. Without
`identifying precisely which statements he allegedly viewed (or when he viewed them), Plaintiff lists a
`series of advertisements by Burger King, including advertisements stating “Have it Your Way, the Real
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`BURGER KING CORPORATION’S NOTICE AND
`MOTION TO DISMISS
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