No. 21-______
`IN THE
`Supreme Court of the United States
`________________
`JOHNSON & JOHNSON AND JOHNSON & JOHNSON
`CONSUMER COMPANIES, INC.,
`Petitioners,
`
`v.
`LYNN FITCH, Attorney General of the State of
`Mississippi, ex rel. THE STATE OF MISSISSIPPI,
`Respondent.
`
`________________
`ON PETITION FOR A WRIT OF CERTIORARI TO
`THE MISSISSIPPI SUPREME COURT
`________________
`
`PETITION FOR A WRIT OF CERTIORARI
`________________
`E. Joshua Rosenkranz
`Robert M. Loeb
`Elizabeth R. Moulton
`Counsel of Record
`ORRICK, HERRINGTON &
`Sheila Baynes
`SUTCLIFFE LLP
`Zachary Hennessee
`51 West 52nd Street
`ORRICK, HERRINGTON &
`New York, NY 10019
`SUTCLIFFE LLP
`(212) 506-5000
`1152 15th Street, NW
`jrosenkranz@orrick.com
`Washington, DC 20005
`Counsel for Petitioners
`
`

`

`i
`
`QUESTIONS PRESENTED
`1. In Puerto Rico v. Franklin California Tax-Free
`Trust, this Court held that courts should “not invoke
`any presumption against pre-emption” when a “stat-
`ute ‘contains an express pre-emption clause.’” 136 S.
`Ct. 1938, 1946 (2016). Obeying that command, four
`circuits and a state supreme court no longer apply any
`such presumption to express pre-emption clauses.
`Four state supreme courts (now including the Missis-
`sippi Supreme Court) and two circuits, however, con-
`tinue to apply the presumption to pre-emption
`provisions that they find ambiguous, or that touch on
`a state’s historic police powers, or both.
`Did the Mississippi Supreme Court err in nar-
`rowly construing an express preemption clause on the
`ground that a presumption against pre-emption ap-
`plies here because it considered the pre-emption pro-
`vision ambiguous and because the provision touches
`on historic state police powers?
`2. The lower courts are divided over what types of
`agency actions can pre-empt state law. One circuit
`and the Mississippi Supreme Court hold that only no-
`tice-and-comment rulemaking qualifies as pre-emp-
`tive. In contrast, seven circuits and a state supreme
`court reject that line, giving pre-emptive force to final
`administrative actions that warrant Chevron defer-
`ence or to any final agency action with the force of law.
`Did the Mississippi Supreme Court err in holding
`that only notice-and-comment rulemaking can pre-
`empt state law?
`
`

`

`ii
`
`PARTIES TO THE PROCEEDINGS
`Petitioners Johnson & Johnson and Johnson &
`Johnson Consumer Companies, Inc. (now known as
`Johnson & Johnson Consumer Inc.) were
`defendants-appellants below.
`
`Respondent Lynn Fitch, Attorney General of the
`State of Mississippi, ex rel. the State of Mississippi,
`was plaintiff-appellee below.
`
`
`
`
`
`

`

`iii
`
`CORPORATE DISCLOSURE STATEMENT
`1. Johnson & Johnson is a publicly held company.
`It has no parent corporation, and no publicly held
`company owns 10% or more of Johnson & Johnson’s
`stock.
`2. Johnson & Johnson Consumer Companies, Inc.
`(now known as Johnson & Johnson Consumer Inc.) is
`wholly owned by Janssen Pharmaceuticals, Inc.
`Janssen Pharmaceuticals, Inc. is wholly owned by
`DePuy Synthes, Inc. DePuy Synthes, Inc. is wholly
`owned by Johnson & Johnson International. Johnson
`& Johnson International is wholly owned by Johnson
`& Johnson.
`
`
`
`
`
`

`

`iv
`
`
`
`RELATED PROCEEDINGS
`Supreme Court of Mississippi:
`
`Johnson & Johnson et al. v. Fitch ex rel. Missis-
`sippi, No. 2019-IA-00033-SCT (Miss. April 1, 2021)
`Chancery Court of Hinds County:
`
`State of Mississippi, ex rel. Jim Hood v. Johnson &
`Johnson et al., No. G-2014-1207 (Miss. Ch. Ct., Hinds
`Cty. Dec. 18, 2018)
`
`
`
`
`
`
`
`
`

`

`v
`
`TABLE OF CONTENTS
`
`Page
`QUESTIONS PRESENTED ...................................... i
`PARTIES TO THE PROCEEDINGS ....................... ii
`CORPORATE DISCLOSURE STATEMENT ......... iii
`RELATED PROCEEDINGS .................................... iv
`TABLE OF AUTHORITIES .................................. viii
`INTRODUCTION ..................................................... 1
`OPINIONS AND ORDERS BELOW ........................ 4
`JURISDICTION ........................................................ 4
`CONSTITUTIONAL AND STATUTORY
`PROVISIONS INVOLVED ................................ 5
`STATEMENT OF THE CASE .................................. 7
`The FDA Regulates Cosmetics Labels ............... 7
`The FDA Denies Two Citizen Petitions
`Seeking To Place Warning Labels On
`Cosmetic Talc Products ................................. 9
`Mississippi Sues J&J For Failing To Give
`A Warning The FDA Rejected .................... 10
`The Mississippi Supreme Court Concludes
`That The State AG’s Labeling Claim Is
`Not Pre-Empted .......................................... 12
`REASONS FOR GRANTING THE WRIT.............. 13
`I. The Decision Below Deepens Two
`Important Splits ............................................... 13
`
`

`

`vi
`
`
`
`A. The decision below deepens a 6-5 split
`on whether, and when, a presumption
`against pre-emption applies to express
`pre-emption statutes ................................... 14
`1. Four state supreme courts and two
`circuits continue to apply the
`presumption ........................................... 15
`2. Four circuits and one state supreme
`court faithfully decline to apply the
`presumption against pre-emption to
`express pre-emption statutes ................ 17
`B. The Mississippi Supreme Court
`deepened an 8-2 split regarding what
`sorts of agency actions can pre-empt
`state law ...................................................... 19
`II. These Are Recurring Issues Of
`Exceptional Importance That Require
`This Court’s Review.......................................... 24
`A. The presumption against pre-emption
`affects the interpretation of dozens of
`federal statutes with express pre-
`emption provisions ...................................... 24
`B. The power of agency action to pre-empt
`is dispositive in both the express and
`implied pre-emption contexts ..................... 27
`III. This Case Provides An Excellent Vehicle
`For Resolving Both Issues ................................ 30
`IV. The Mississippi Supreme Court’s Decision
`Is Wrong ............................................................ 32
`CONCLUSION ........................................................ 39
`
`

`

`vii
`
`
`APPENDIX A Opinion of the Supreme Court
`of Mississippi (Apr. 1, 2021).......... 1a
`APPENDIX B Opinion of the Chancery Court
`of Hinds County Mississippi
`(Dec. 18, 2018) ............................. 18a
`
`
`
`

`

`
`
`viii
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Air Evac EMS, Inc. v. Cheatham,
`910 F.3d 751. (4th Cir. 2018) ...........14, 17, 18, 19
`Bates v. Dow Agrosciences LLC,
`544 U.S. 431 (2005) ..........................12, 15, 16, 38
`Bennett v. Spear,
`520 U.S. 154 (1997) ........................................... 37
`Brown v. Mortensen,
`253 P.3d 522 (Cal. 2011) ................................... 16
`Cal. Trucking Ass’n v. Bonta,
`996 F.3d 644 (9th Cir. 2021) ............................. 16
`Cerveny v. Aventis, Inc.,
`855 F.3d 1091 (10th Cir. 2017) ................... 23, 27
`Chamber of Com. of U.S. v. Whiting,
`563 U.S. 582 (2011) ............................2, 14, 32, 33
`
`Charter Advanced Servs. (MN), LLC v.
`Lange,
`903 F.3d 715 (8th Cir. 2018) ............................. 22
`
`Chicago & N.W. Transp. Co. v. Kalo Brick
`& Tile Co.,
`450 U.S. 311 (1981) ..................................... 36, 39
`
`

`

`ix
`
`
`
`
`Cipollone v. Liggett Grp., Inc.,
`505 U.S. 504 (1992) ..................................... 12, 33
`City of N.Y. v. FCC,
`486 U.S. 57 (1988) ............................................. 21
`
`City of N.Y. v. Permanent Mission of India
`to United Nations,
`618 F.3d 172 (2d Cir. 2010) .............................. 21
`Colacicco v. Apotex Inc.,
`521 F.3d 253 (3d Cir. 2008) .............................. 23
`Conklin v. Medtronic, Inc.,
`431 P.3d 571 (Ariz. 2018) ................................. 18
`Connell v. Lima Corp.,
`988 F.3d 1089 (9th Cir. 2021) ........................... 17
`Coventry Health Care of Mo., Inc. v. Nevils,
`137 S. Ct. 1190 (2017) ....................................... 14
`Cox Broad. Corp. v. Cohn,
`420 U.S. 469 (1975) ......................................... 4, 5
`Critcher v. L’Oreal USA, Inc.,
`959 F.3d 31 (2d Cir. 2020) ........................ 7, 8, 25
`
`Dialysis Newco, Inc. v. Cmty. Health Sys.
`Grp. Health Plan,
`938 F.3d 246 (5th Cir. 2019) ................. 17, 18, 19
`
`Dirty Boyz Sanitation Serv., Inc. v. City of
`Rawlins,
`889 F.3d 1189 (10th Cir. 2018) ................... 18, 19
`
`

`

`x
`
`
`
`
`Dolin v. GlaxoSmithKline LLC,
`951 F.3d 882 (7th Cir. 2020) ............................. 22
`
`Dowhal v. SmithKline Beecham Consumer
`Healthcare,
`88 P.3d 1 (Cal. 2004) ............................. 22, 23, 37
`Entergy La., Inc. v. La. Pub. Serv. Comm’n,
`539 U.S. 39 (2002) ....................................... 28, 36
`Feikema v. Texaco, Inc.,
`16 F.3d 1408 (4th Cir. 1994) ............................. 22
`Fellner v. Tri-Union Seafoods, L.L.C.,
`539 F.3d 237 (3d Cir. 2008) ....... 20, 21, 22, 23, 37
` Ferrell v. Air EVAC EMS, Inc.,
`900 F.3d 602 (8th Cir. 2018) ............................. 18
`Geier v. Am. Honda Motor Co.,
`529 U.S. 861 (2000) ...................... 3, 20, 35, 36, 38
`General Motors Corp. v. Abrams,
`897 F.2d 34 (2d Cir. 1990) .......................... 28, 29
`Gobeille v. Liberty Mut. Ins. Co.,
`577 U.S. 312 (2016) ........................................... 33
`Good v. Altria Grp., Inc.,
`501 F.3d 29 (1st Cir. 2007) ......................... 20, 21
`Hardeman v. Monsanto Co.,
`997 F.3d 941 (9th Cir. 2021) ................. 16, 22, 38
`
`

`

`xi
`
`
`
`
`In re Incretin-Based Therapies Prods.
`Liab. Litig.,
`--- F. Supp. 3d ---, 2021 WL 880316 (S.D.
`Cal. Mar. 9, 2021) ............................................. 23
`Int’l Bhd. of Teamsters, Loc. 2785 v.
`Fed. Motor Carrier Safety Admin.,
`986 F.3d 841 (9th Cir. 2021) ............................. 17
`La. Pub. Serv. Comm’n v. FCC,
`476 U.S. 355 (1986) ........................................... 35
`
`Lipschultz v. Charter Advanced Servs.
`(MN), LLC,
`140 S. Ct. 6 (2019) ..............................3, 20, 22, 23
`Lupian v. Joseph Cory Holdings LLC,
`905 F.3d 127 (3d Cir. 2018) .............................. 15
`Medtronic, Inc. v. Lohr,
`518 U.S. 470 (1996) ..........................14, 15, 33, 35
`Merck Sharp & Dohme Corp. v. Albrecht,
`139 S. Ct. 1668 (2019) ......................19, 35, 37, 38
`Minn. Pub. Utils. Comm’n v. FCC,
`483 F.3d 570 (8th Cir. 2007) ............................. 22
`New York v. FERC,
`535 U.S. 1 (2002) ............................................... 35
`PLIVA, Inc. v. Mensing,
`564 U.S. 604 (2011) ........................................... 38
`
`

`

`xii
`
`
`
`
`Puerto Rico v. Franklin Cal. Tax-Free Tr.,
`136 S. Ct. 1938 (2016) ...i, 2, 14, 16, 17, 24, 32, 33
`Reid v. Johnson & Johnson,
`780 F.3d 952 (9th Cir. 2015) ............................. 22
`Riegel v. Medtronic, Inc.,
`552 U.S. 312 (2008) .................... 14, 20, 28, 36, 37
`Robinson v. McNeil Consumer Healthcare,
`615 F.3d 861 (7th Cir. 2010) ............................. 23
`SEC v. Chenery Corp.,
`332 U.S. 194 (1947) ........................................... 28
`Shuker v. Smith & Nephew, PLC,
`885 F.3d 760 (3d Cir. 2018) .............................. 15
`Sprietsma v. Mercury Marine,
`537 U.S. 51 (2002) ............................................. 38
`State v. Norfolk S. Ry. Co.,
`107 N.E.3d 468 (Ind. 2018) ............................... 16
`Ter Beek v. City of Wyoming,
`846 N.W.2d 531 (Mich. 2014) ........................... 16
`Turek v. Gen. Mills, Inc.,
`662 F.3d 423 (7th Cir. 2011) ............................. 26
`United States v. Mead Corp.,
`533 U.S. 218 (2001) ........................................... 22
`
`

`

`xiii
`
`
`
`
`Utah Native Plant Soc’y v. U.S. Forest
`Serv.,
`923 F.3d 860 (10th Cir. 2019) ........................... 22
`Wyeth v. Levine,
`555 U.S. 555 (2009) ........................................... 33
`In re: Zofran (Ondansetron) Prods.
`Liab. Litig.,
`--- F. Supp. 3d ---, 2021 WL 2209871
`(D. Mass. June 1, 2021) .................................... 23
`
`U.S. Constitutional Provisions
`U.S. Const. art. VI, cl. 2 ................................ 5, 36
`
`Statutes & Regulations
`Federal Insecticide, Fungicide, and
`Rodenticide Act, 7 U.S.C. § 136 et seq. ............ 16
`7 U.S.C. § 136d .................................................. 29
`7 U.S.C. § 4817(b) ................................................... 25
`Fair Packaging and Labeling Act,
`15 U.S.C. § 1451 et seq. ...................................... 6
`Poison Prevention Packaging Act of 1970,
`15 U.S.C. § 1471 et seq. ...................................... 5
`16 U.S.C. § 824d ................................................ 28
`16 U.S.C. § 824e ................................................ 28
`
`

`

`xiv
`
`
`
`
`Food, Drug, and Cosmetic Act,
`21 U.S.C. § 301 et seq. ........................................ 1
`21 U.S.C. § 331 .................................................. 36
`21 U.S.C. § 331(a) ............................................... 7
`21 U.S.C. § 331(b) ............................................... 7
`21 U.S.C. § 331(c) ................................................ 7
`21 U.S.C. § 331 (g) .............................................. 7
`21 U.S.C. § 360k(a) ........................................... 25
`21 U.S.C. § 362 .............................................. 7, 36
`21 U.S.C. § 371 .................................................... 7
`21 U.S.C. § 371(a) ............................................. 36
`21 U.S.C. § 374(a)(1) ........................................... 7
`21 U.S.C. § 379s ........... 5, 8, 13, 17, 25, 26, 34, 35
`21 U.S.C. § 379s(a) ......... 2, 5, 8, 13, 20, 34, 37, 38
`21 U.S.C. § 379s(b) .................................... 8, 9, 34
`21 U.S.C. § 379s(d)........................................ 9, 35
`21 U.S.C. § 379s(e) ................................ 5, 7, 9, 35
`21 U.S.C. § 393(b) ............................................. 36
`21 U.S.C. § 393(b)(2)(D) ................................ 7, 26
`
`

`

`XV
`
`xv
`
`
`
`
`21 U.S.C. § 467e ................................................ 25
`21 U.S.C. § 467. eeseessessseesseesseesseesseessteeseeessees 25
`21 U.S.C. § 678 .................................................. 25
`21 U.S.C. § 678..ccccescessseesseesseesseesseesseesstessneessees 25
`21 U.S.C. § 1052(b) ........................................... 25
`21 U.S.C. § 1052(b) veeseessseesssesseesseesstesstesseeessees 25
`28 U.S.C. § 1257(a) ............................................. 4
`2B U.S.C. § 125 7(8) seeesesesseessessseesssessseesseesseesseesses 4
`29 U.S.C. § 1144(a) ........................................... 25
`29 U.S.C. § 1144(a) veeeeeessessseeesseesseesstesseesseessees 25
`42 U.S.C. § 247d-6d(b)(8) .................................. 25
`42 U.S.C. § 247d-6d(b)(8).eeeseesseeeseesseesstesseeeseees 25
`49 U.S.C. § 14501(c)(1) ..................................... 25
`AQ U.S.C. § 14501(0)(1) ceeseseseeeseeessessstesstesseeseees 25
`49 U.S.C. § 41713(b)(1) ..................................... 25
`AQ U.S.C. § 41713 0D)(1) eeseeeseseseesseesstesstesseeeseees 25
`21 C.F.R. § 10.20(a) ...................................... 8, 39
`21 CFR. § 10.2008) weseeesesssesesseesseesseesseeeseees 8, 39
`21 C.F.R. § 10.20(j) ........................................... 39
`21 CFR. § 10.20()) voeeseessesessesseesseesseesstesseeessees 39
`21 C.F.R. § 10.20(j)(1)(i)...................................... 8
`21 CFR. § 10.20())1)@)..eeesseesseesseesseesseesseesseeseee 8
`21 C.F.R. § 10.45(d) ...........................8, 37, 38, 39
`21 CFR. § 10.45(d) weseeeseeeseeeseesseeeees 8, 37, 38, 39
`21 C.F.R. §§ 701.1-701.13 ................................... 7
`21 CFR. §§ 701.1-701.18 ...ccesseesseesseeesseesseesseeeees 7
`21 C.F.R. § 740.1 ................................................. 7
`21 CUFLR. § TAO. Liceessesessseesseesseessseesseesseesseesseeses 7
`21 C.F.R. § 740.1(a) ............................................ 7
`21 CUFUR. § 740.1(8) ceeseescesseesseessessseesseesseesseeeaes 7
`21 C.F.R. § 740.1(b) ............................................ 8
`21 CUFUR. § 740.10) ceeseeesseesseesseesssessseesseesseesseeees 8
`21 C.F.R. § 740.2 ................................................. 7
`21 CLFLR. § 740.2 .cccccccssecsecsssessessesessesseseesetseeseeeee 7
`
`

`

`xvi
`
`
`
`
`Mississippi Regulation of Business for
`Consumer Protection Act,
`Miss. Code § 75-24-5 .................................... 11
`
`Other Authorities
`Amy Coney Barrett, Substantive
`Canons and Faithful Agency,
`90 B.U. L. Rev. 109 (2010) .......................... 33
`FDA-1994-P-0067,
`https://tinyurl.com/44vx7dpe ...................... 10
`FDA-2008-P-0309,
`https://tinyurl.com/djs996bx ....................... 10
`Jay B. Sykes, et al. Cong. Rsch. Serv.,
`R45825, Federal Preemption: A Legal
`Primer (July 23, 2019),
`https://tinyurl.com/wp3mfu92 ..................... 24
`H.R. Rep. No. 105-399 (1997) (Conf.
`Rep.) ............................................................. 26
`Petition, Monsanto Co. v. Hardeman,
`No. 21-241 (Aug. 16, 2021) .......................... 17
`Press Release, Johnson & Johnson
`Consumer Health Announces
`Discontinuation of Talc-based
`Johnson’s Baby Powder in U.S. and
`Canada, Johnson & Johnson (May
`19, 2020),
`https://tinyurl.com/dvymsfka ...................... 11
`
`

`

`
`
`INTRODUCTION
`The lower courts are making a hash out of pre-
`emption law in ways that dangerously flout both con-
`gressional commands and important federal policies.
`This case is the latest—and most extreme—illustra-
`tion of the trend in judicial defiance and confusion re-
`garding express pre-emption statutes.
`The Food, Drug, and Cosmetic Act (FDCA) grants
`the Food and Drug Administration (FDA) broad au-
`thority to regulate cosmetic products and to decide
`when warning labels are necessary. In 2014, the FDA
`made a reasoned regulatory decision not to require
`talc products—like Johnson’s Baby Powder—to bear
`warning labels stating that using talcum powder in-
`creases the risk of ovarian cancer. The decision came
`in the form of a final agency action that denied two
`citizen petitions. The FDA issued those rulings after
`considering a large body of scientific literature and
`public comments. The agency concluded that the evi-
`dence did not justify a warning. The FDA’s decision
`was public, final, and appealable.
`The Attorney General of Mississippi disagrees
`with the FDA’s expert determination. Just months af-
`ter the FDA announced its regulatory decision, the
`State AG filed this action contradicting the FDA.
`Wielding a state consumer protection statute, the
`State AG sued J&J1 insisting that J&J was legally re-
`quired to use an ovarian cancer warning label even
`though the FDA already rejected one. The State AG
`sought an injunction forcing J&J to affix that warning
`
`1 Petitioners are collectively referred to as “J&J.”
`
`

`

`2
`
`label, plus a retroactive penalty of up to $10,000 for
`every bottle of baby powder sold in Mississippi for the
`last 50 years.
`The State AG’s effort to impose a cancer warning
`the FDA rejected runs headlong into an express pre-
`emption provision that prohibits a state from impos-
`ing “any requirement for labeling … that is different
`from or in addition to … a requirement specifically ap-
`plicable to a particular cosmetic.” 21 U.S.C. § 379s(a).
`In holding that the State AG’s claim is not pre-
`empted, the Mississippi Supreme Court deepened two
`entrenched splits among the circuits and state su-
`preme courts over two of this Court’s commands—
`commands that seemed clear but have engendered
`profound confusion.
`The first command is that when a “statute ‘con-
`tains an express pre-emption clause,’ [courts] do not
`invoke any presumption against pre-emption but in-
`stead ‘focus on the plain wording of the clause, which
`necessarily contains the best evidence of Congress’
`pre-emptive intent.’” Puerto Rico v. Franklin Cal.
`Tax-Free Tr., 136 S. Ct. 1938, 1946 (2016) (quoting
`Chamber of Com. of U.S. v. Whiting, 563 U.S. 582, 594
`(2011)). Yet, the Mississippi Supreme Court applied
`the presumption against pre-emption as justification
`for torturing the plain language of the FDCA’s pre-
`emption provision. This holding took sides on a broad
`and acknowledged 6-5 split. Some courts apply this
`Court’s command faithfully, but others carve out ex-
`ceptions, as the court below did, for pre-emption pro-
`visions that the court considers unclear or that touch
`on subjects of traditional state police power.
`
`

`

`3
`
`The second command also seems clear, but like-
`wise is not being followed. This Court has held that
`courts may not “insist on a specific expression of
`agency intent to pre-empt, made after notice-and-
`comment rulemaking,” because to do so “would be …
`to tolerate conflicts that an agency, and therefore
`Congress, is most unlikely to have intended.” Geier v.
`Am. Honda Motor Co., 529 U.S. 861, 885 (2000).
`Again, without acknowledging this rule, the Missis-
`sippi Supreme Court held that “[i]n order to” pre-empt
`state law, “the Food and Drug Administration must
`follow the notice and comment rule making process.”
`Pet. App. 15a.
`That holding deepened another entrenched 7-2
`split on what types of agency actions are capable of
`pre-empting state law. As Justice Thomas recently
`observed, the time has come for this Court to address
`that very question “in an appropriate case.” Lip-
`schultz v. Charter Advanced Servs. (MN), LLC, 140 S.
`Ct. 6, 7 (2019) (concurring in the denial of cert.). This
`is that case.
`If the Mississippi Supreme Court’s ruling stands,
`other state officials will join the fray, seeking their
`own paydays. Consumers will soon find drugstore
`shelves filled with products covered in conflicting
`warnings. Manufacturers will face the threat of huge
`retroactive penalties for failing to include labels the
`FDA rejected as scientifically unsound, and will be
`forced to defend their labels before juries who will sec-
`ond-guess the FDA’s expert judgment. More broadly,
`rulings like this will undermine dozens of express pre-
`emption provisions and nullify the pre-emptive effect
`of innumerable federal agency actions, subjecting a
`
`

`

`4
`
`wide range of federally regulated industries to confus-
`ing and contradictory state and local requirements.
`This Court should grant certiorari to resolve both
`enduring and important splits.
`
`OPINIONS AND ORDERS BELOW
`The opinion of the Mississippi Supreme Court is
`reported at 315 So. 3d 1017, and reprinted at Pet.
`App. 1a-17a. The decision of the Chancery Court of
`Hinds County is not reported, and is reprinted at Pet.
`App. 18a-22a.
`
`JURISDICTION
`The Mississippi Supreme Court issued its deci-
`sion on April 1, 2021. Pet. App. 2a. This petition is
`timely under this Court’s March 19, 2020 order ex-
`tending the deadline to petition for a writ of certiorari
`to 150 days.
`This Court has jurisdiction under 28 U.S.C.
`§ 1257(a). The Mississippi Supreme Court finally de-
`cided the federal pre-emption issues raised in this pe-
`tition when it affirmed the denial of J&J’s motion for
`summary judgment. See Cox Broad. Corp. v. Cohn,
`420 U.S. 469, 482-83 (1975). If this case proceeds to
`trial, J&J may “prevail on the merits on nonfederal
`grounds, thus rendering unnecessary review of the
`federal issue by this Court.” Id. at 482. The matter is
`final under § 1257(a) because “reversal of the state
`court on the federal issue would be preclusive of any
`further litigation on the relevant cause of action.” Id.
`at 482-83. Moreover, “a refusal immediately to review
`
`

`

`5
`
`the state court decision might seriously erode” the
`federal policy of uniform nationwide labeling require-
`ments for cosmetics. Id. at 483.
`
`CONSTITUTIONAL AND STATUTORY
`PROVISIONS INVOLVED
`The Supremacy Clause, U.S. Const. art. VI, cl. 2,
`provides:
`This Constitution, and the Laws of the United
`States which shall be made in Pursuance
`thereof; and all Treaties made, or which shall
`be made, under the Authority of the United
`States, shall be the supreme Law of the Land;
`and the Judges in every State shall be bound
`thereby, any Thing in the Constitution or
`Laws of any State to the Contrary notwith-
`standing.
`21 U.S.C. § 379s provides:
`(a) In general
`Except as provided in subsection (b), (d), or
`(e), no State or political subdivision of a State
`may establish or continue in effect any re-
`quirement for labeling or packaging of a cos-
`metic that is different from or in addition to,
`or that is otherwise not identical with, a re-
`quirement specifically applicable to a particu-
`lar cosmetic or class of cosmetics under this
`chapter, the Poison Prevention Packaging Act
`of 1970 (15 U.S.C. 1471 et seq.), or the Fair
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`Packaging and Labeling Act (15 U.S.C. 1451
`et seq.).
`(b) Exemption
`Upon application of a State or political subdi-
`vision thereof, the Secretary may by regula-
`tion, after notice and opportunity for written
`and oral presentation of views, exempt from
`subsection (a), under such conditions as may
`be prescribed in such regulation, a State or
`political subdivision requirement for labeling
`or packaging that—
`(1) protects an important public interest
`that would otherwise be unprotected;
`(2) would not cause a cosmetic to be in vi-
`olation of any applicable requirement or
`prohibition under Federal law; and
`(3) would not unduly burden interstate
`commerce.
`(c) Scope
`For purposes of subsection (a), a reference to
`a State requirement that relates to the pack-
`aging or labeling of a cosmetic means any spe-
`cific requirement relating to the same aspect
`of such cosmetic as a requirement specifically
`applicable to that particular cosmetic or class
`of cosmetics under this chapter for packaging
`or labeling, including any State requirement
`relating to public information or any other
`form of public communication.
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`(d) No effect on product liability law
`Nothing in this section shall be construed to
`modify or otherwise affect any action or the
`liability of any person under the product lia-
`bility law of any State.
`(e) State initiative
`This section shall not apply to a State require-
`ment adopted by a State public initiative or
`referendum enacted prior to September 1,
`1997.
`
`STATEMENT OF THE CASE
`
`The FDA Regulates Cosmetics Labels
`Congress charged the FDA with ensuring that
`“cosmetics are safe and properly labeled.” 21 U.S.C.
`§ 393(b)(2)(D). The FDCA “establishe[s] a comprehen-
`sive regulatory scheme” governing cosmetics, includ-
`ing cosmetic talcum powder. Critcher v. L’Oreal USA,
`Inc., 959 F.3d 31, 35 (2d Cir. 2020). The FDCA pro-
`hibits “misbranded” cosmetics, and it empowers the
`FDA to inspect, sample, seize, and otherwise broadly
`regulate any cosmetic product. See 21 U.S.C.
`§§ 331(a)-(c), (g), 362, 371, 374(a)(1).
`The FDA has developed detailed requirements
`governing the placement, size, and content of cosmet-
`ics labels. 21 C.F.R. §§ 701.1-701.13, 740.1-2. It re-
`quires all cosmetics “bear a warning statement
`whenever necessary or appropriate to prevent a
`health hazard that may be associated with the prod-
`uct.” Id. § 740.1(a). The FDA can require cosmetic
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`warning labels either on its own initiative or in re-
`sponse to a citizen petition from “any interested per-
`son.” Id. § 740.1(b). When filed, citizen petitions are
`publicly docketed, id. § 10.20(j)(1)(i), and subject to
`public comment after the petition is published on reg-
`ulations.gov, id. § 10.20(a). The FDA’s decision on a
`citizen petition is a “final agency action” judicially re-
`viewable under the Administrative Procedure Act. Id.
`§ 10.45(d).
`The FDCA includes an “expansive preemption
`provision” specific to cosmetics, which is designed to
`“ensure that these various federal requirements are
`not obstructed by state law.” Critcher, 959 F.3d at 35
`(citing 21 U.S.C. § 379s). Section 379s prohibits any
`state from “establish[ing] or continu[ing] in effect any
`requirement for labeling or packaging of a cosmetic
`that is different from or in addition to, or that is oth-
`erwise not identical with, a requirement specifically
`applicable to a particular cosmetic or class of cosmet-
`ics under” the FDCA. 21 U.S.C. § 379s(a).
`Three savings clauses (none of which applies
`here) cabin the scope of § 379s(a). First, § 379s(b) al-
`lows “a State or political subdivision thereof” to apply
`for an exemption. The Secretary of HHS “may by reg-
`ulation, after notice and opportunity for written and
`oral presentation of views,” grant the exemption to a
`“State or political subdivision requirement for label-
`ing or packaging that—
`(1) protects an important public interest that
`would otherwise be unprotected;
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`(2) would not cause a cosmetic to be in viola-
`tion of any applicable requirement or prohi-
`bition under Federal law; and
`(3) would not unduly burden interstate com-
`merce.”
`Id. § 379s(b). Second, § 379s(d) clarifies that product
`liability causes of action are not expressly pre-
`empted. Third, § 379s(e) exempts state requirements
`adopted by public initiative or referendum prior to
`September 1, 1997.
`
`The FDA Denies Two Citizen Petitions Seeking
`To Place Warning Labels On Cosmetic Talc
`Products
`Before the State AG commenced this action, the
`FDA actively studied whether a warning label was ap-
`propriate. The Cancer Prevention Coalition filed two
`citizen petitions requesting that all cosmetic talc
`products include an ovarian cancer warning on the la-
`bel. The first petition, filed in 1994, asked the agency
`to mandate that all cosmetic talc products bear a
`warning stating that “[t]alcum powder causes cancer
`in laboratory animals. Frequent talc application in
`the female genital area increases the risk of ovarian
`cancer.” App’x 96.2 The second petition, filed in 2008,
`similarly urged the FDA to “[i]mmediately require
`cosmetic talcum powder products to bear labels with
`a prominent warning such as: ‘Frequent talc applica-
`tion in the female genital area is responsible for major
`
`2 The appendix before the Mississippi Supreme Court is
`cited as “App’x.”
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`risks of ovarian cancer.’” App’x 102. Both petitions
`were publicly docketed and open to public comment.3
`The State did not submit any comment on either pe-
`tition.
`The FDA denied both petitions. App’x 88-93. The
`FDA explained that one of the principal studies on
`which the citizen petitions relied “lack[ed] convincing
`scientific support because of serious flaws in its de-
`sign and conduct” and had “no relevance to human
`risk.” App’x 90-91. Other studies had “biases in the
`study design,” failed to “consider[] all the factors that
`potentially contribute to ovarian cancer,” and “re-
`vealed no overall association” between talc use and
`ovarian cancer. App’x 91-92. The FDA’s review in-
`cluded an “expanded literature search dating from the
`filing of the petition in 2008 through January 2014,”
`and an “exploratory survey of … cosmetic products
`containing talc.” App’x 90, 93. That investigation
`“failed to identify any new compelling literature data
`or new scientific evidence” supporting the petitions.
`App’x 93. Accordingly, the FDA concluded that the
`“evidence is insufficient” to warrant the warning re-
`quested. App’x 92. No one sought judicial review of
`that final FDA decision.
`
`Mississippi Sues J&J For Failing To Give A
`Warning The FDA Rejected
`Shortly after the FDA’s decision denying a talc
`warning, the Mississippi Attorney General sued J&J
`in state court, asserting a single cause of action under
`
`3 See FDA-2008-P-0309, https://tinyurl.com/djs996bx; FDA-
`1994-P-0067, https://tinyurl.com/44vx7dpe.
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`Mississippi’s consumer protection act, Miss. Code
`§ 75-24-5. The complaint alleges that J&J “should
`have warned the public … not to use its Talc Products
`perineally [sic] or in the alternative, at a minimum,
`should have informed the public that perineal use of
`talc-containing products causes an increased risk of
`ovarian cancer.” App’x 61.
`The State AG’s consumer protection act complaint
`cites many of the same studies the FDA found insuf-
`ficient to justify a warning label.4 The complaint
`sought a wide array of relief: actual and punitive dam-
`ages; disgorgement of “ill-gotten revenue”; an injunc-
`tion
`requiring a warning and
`removal
`of
`nonconforming products; and a civil penalty of up to
`$10,000 for each sale of J&J’s talc products since
`1974. App’x 35-36.5
`
`
`4 For instance, it relies heavily on a 1993 study published
`by the National Toxicology Program, App’x 24-25, which the
`FDA deemed to “lack[] convincing scientific support because of
`serious flaws in its design and conduct,” App’x 90. Simil