# United States **Court of Appeals**  **for the Federal Circuit**

______________________ ALLERGAN, INC. , AND DUKE UNIVERSITY, Plaintiffs

- Appellees,

AND

MURRAY A. JOHNSTONE, M.D., Plaintiff,

v.

ATHENA COSMETICS, IN C., Defendant

- Appellant,

AND

PHARMA TECH INTERNAT IONAL, INC., PRODUCT INNOVATIONS, LLC, NORTHWEST COSMETIC L ABORATORIES, LLC , AND R & G BUSINESS LLC, Defendants.

______________________

2013

- 1286

______________________ Appeal from the United States District Court for the Central District of California in consolidated No s

. 07

- CV

1316 and 09

- CV

- 0328, Judge James V. Selna.

______________________
Decided: December 30, 2013

______________________ALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 2

M ARK A. P ERRY , Gibson, Dunn & Crutc her LLP, of Washington, DC, argued for plaintiffs

- appellees. With him on the brief were J EFFREY T. T HOMAS and B LAINE H. E VANSON , of Irvine, California.

S TEVEN A. Z ALESIN , Patterson Belknap Webb & Tyler LLP, of New York, New York, argued for defendant

appellant. With him on the brief were T RAVIS J. T U , J ONAH M. K NOBLER and J ANE M. M ETCALF . Of counsel

was S TEPHEN P. B ENSON , Katten Muchin Rosenman, LLP, of Chicago, Illinois.

______________________
Before R ADER , Chief Judge

, M OORE , and W ALLACH , Ci r cuit Judges.

M OORE , Circuit Judge

. Athena Cosmetics , Inc. (Athena) appeals from the di strict court’s grant of summary judgment that Athena violated California’s unfair competition l aw (UCL) by market in g, distributing and selling, without regulatory approval

, products that qualify as drugs

. Athena also challenges the court’s entry of a nationwide injunction and the denial of a motion for judgment on the pleadings that the F ederal Food, Drug, and Cosmetic Act (FDCA) preempts Allergan, Inc.’s (Allergan) UCL claim

. We hold that the FDCA does not preempt Allergan’s UCL claim and that there is no genuine dispute that the products at issue are drugs under California law , and thus affirm the grant of summary judgment. We also hold that the di strict court abuse d its discretion by entering an overbroad injunction , and thus vacate the injunction and remand

.

B ACKGROUND

The products at issue in this appeal are formulations of Athena’s RevitaLa sh line

, all of which contain aALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 3

prostaglandin derivative as an active ingredient

. The Food and Drug Administration (FDA) has not taken enforcement action against

, or otherwise regulat ed, the products at issue

. Allergan se lls a product called Latisse

, which also contains a prostaglandin derivative. Latisse is

a FDA

- approved prescription drug used for the treatment of a condition that affects eyelash growth.
Allergan sued Athena for patent infringement and a violation of the UCL, California Business and Professions Code § 17200 et seq

. Allergan alleged that Athena competed unfairly by violating

, inter alia

, California’s Health and Safety Code (California Health Code) § 111550 1 by “marketing, selling, and distributing [its] hair and/or eyelash growth products without [a new d rug] application approved by the FDA or California State Department of Health Services.” Complaint at ¶¶ 82, 84

, Allergan, Inc. v. Athena Cosmetics, Inc. , No. 8:07

- cv

- 1316 (C.D. Cal. Sept. 30, 2011 )

. T he district court denied Athena’s motion for judgment on the pleadings that the FDCA preempts Allergan’s UCL claim

. Allergan moved for summary judgment that the products at issue qualify as new drugs that lack the requisite approval under the California Health Code, givin g rise to a UCL violation. The court granted summary judgment and entered a permanent injunction. Athena appeals.

1 “No person shall sell . . . any new drug . . . unless it satisfies either of the following: (a) It is . . . [a] new drug, and a new drug application has been approved for it and that approval has not been withdrawn or suspended under Section 505 of the [FDCA] . . . . [or] (b) The [Cal ifornia Health Department] has approved a new drug application for that new drug . . . .”ALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 4

J URISDICTION While this appeal does not present any patent issues, Allergan’s amended complaint alleged infringement of three patents of which it is the exclusive licensee, including U.S. Patent No. 6,262,105. The parties did not initially contest our jurisdiction, but “every federal appe llate cou rt has a special obligation to satisfy itself

. . . of its own jurisdiction .” Bender v. Williamsport Area Sch. Dist.

, 475 U.S. 534, 541 (1986) ( internal quotation marks omi tted)

. Therefore, we ordered supplemental briefing on our jurisdiction.
Athena argued that we have jurisdiction over this a ppeal. Sept. 20, 2013 Supp. Br. It argued that, as a result of actions in the underlying district court litigation, the parties’ legal relations were altered with respect to the patent claims. Id. Allergan disputed our jurisdiction. Sept. 20, 2013 & Oct. 11, 2013 Supp

. Brs. We have exclusive jurisdiction over an appeal from a final decision of a district court (including one unrelated to patent issues) when “ patent law is a necessary element of one of the well

- pleaded claims ” in the complaint. Christ ianson v. Colt Indus. Operating Corp. , 486 U.S. 800, 8 09 (1988) ; 28 U.S.C. § 1295(a)(1). In some circumstan ces, a district court’s dismissal without prejudice of a patent claim serves as a constructive amendment to the complaint, effectively removing the patent claim. See Chamberlain Grp. v. Skylink Techs., Inc. , 381 F.3d 1178, 11 89

– 90 (Fed. Cir. 2004) . We have explained, however, that “[d]ismissals divest this court of jurisdiction only if ‘[t]he parties were left in the same legal position with respect to [all] patent claims as if they had never been filed.’” Id. at 1190 (quoting Nilssen v. Motorola, Inc. , 203 F.3d 782, 785 (Fed. Cir. 2000)). Moreover, “[n]either the specific rule under which the District Court dismissed the claims nor the wording of the dismissal alters the fund a-ALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 5

mental basis of our jurisdiction.” Chamberlain , 381 F.3d at 1190.
In this case, f ollowing the district court’s issuance of a Final Claim Construction Order, the parties proposed that the court grant summary judgment of noninf ring ement of the ’105 patent, while preserving their full appe llate rights regarding claim construction. Allergan, No. 8:07

- cv

- 1316, ECF No. 679 (C.D. Cal. May 9, 2012). The court entered summary judgment “in accordance with the terms of the Stipulation

. ” Id. , ECF No. 691 (C.D. Cal. May 29, 2012). Thereafter, pursuant to the parties’ further agreement, the court dismissed all of the patent claims “without prejudice.” Id. , ECF No. 1075 (C.D. Cal. Mar. 28, 2013).
We have jurisdiction over this case because the pa rties were not left in the same legal posit ion as if the ’105 patent claim had never been filed. The court’s dismissal “without prejudice” merely reflects the parties’ agreement that the ’105 patent claim could be re

- filed in future litigation between these parties. Should that occur, however, the parties will be bound by the court’s su mmary judgment ruling

— which the court did not vacate. Indeed, Allergan, whose decision it is whether to reassert the ’10 5 patent against Athena, concedes on appeal that the summary judgment ruling “would bind the parties in future district court litigation against each other.” Oct. 11, 2013 Supp. Br. at 2. The court’s dismissal of the ’105 patent claim did not undo this a lteration in legal status, and therefore we have jurisdiction over this appeal pu rsuant to 28 U.S.C. § 1295(a)(1). 2

2 Athena contends that the district court altered the le gal status of the parties with respect to each of the otherALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 6

A NALYSIS Where an issue is not unique to patent law, we apply the law of the regional circuit from which the case arises

. Sulzer Textil A.G. v. Picanol N.V. , 358 F.3d 1356, 1363 (Fed. Cir. 2004). The Ninth Circuit reviews grant s of summary judgment and d eterminations regarding preemption de novo

. Engine Mfrs. Ass’n v. S. Coast Air Quality Maint. Dist. , 498 F.3d 1031, 1035 (9th Cir. 2007)

. The Ninth Circuit reviews the decision to grant a perm anent injunction , as well as its scope, for abuse of discr etion , and underlying factual findings for clear error

. Columbia Pictures Indus., Inc. v. Fung , 710 F.3d 1020, 1030 (9th Cir. 2013).

I. Pr eemption

The California Health Code incorporates various pr ovisions of the FDCA , which does not itself allow a private right of action

. See 21 U.S.C. § 337(a). The district court held that the FDCA did not preempt Allergan’s UCL claim

. It stated that “mentions of the FDCA throughout” its order were “referential” because “[i]n order to dete rmine if the [California Health Code] is violated, the Court looks to whether the federal regulations incorporated therein are violated.” Allergan

, No. 8:07

- cv

- 1316
, slip op. at 4 (C.D. Cal. Oct. 11, 2012)

. On appeal, the parties agree that the FDCA does not expressly preempt Alle rgan’s claim

— the dispute before us concerns implied preemption

.

two patent claims. Sept. 20, 2013 Supp. Br. at 2

– 3. Because the change in legal status with respect to the ’105 patent claim is sufficient to supply our jurisdiction, we need not address the oth er patents.ALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 7

Athena argues that the FDCA impliedly preempts A llergan’s UCL claim

. It contends that, under Buckman Co. v. Plaintiffs’ Legal Committee

, 531 U.S. 341 (2001), a state law claim is impliedly preempt ed if it does not implicate a traditional state law tort principle and exists solely by virtue of a federal statute. Athena argues that Allergan’s claim involves the violation of a California statute that simply incorporates FDCA provisions and is not rooted in
state law tort principles

. Athena argues that the Ninth Circuit’s application of Buckman in PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir. 2010) governs this case. In that case , the court found that the plaintiff’ s claim based on alleged misrepresent ations to the FDA about a medical device was impliedly preempted because i t would have impermissibly circu mvent ed the agency’s exclusive enforcement authority

. Id.
at 926

– 30

. Athena argues that Allergan’s claim interferes with the FDA’s discretionary author ity whether to reg ulate an article in interstate commerce as a drug

. Athena also argues that

, under the prudential doctrine of primary jurisdiction, the district court abused its discretion by declining to stay this case pending the FDA’s determin ations about the products at issue

. Allergan responds that the FDCA does not impliedly preempt its UCL claim. It ar gues t hat the FDCA contains

express preemption provisions for “cer tain narrow topics inapplicable ,” including medical devices and non

prescription drugs

. Resp. Br. at 17

– 18 (citing 21 U.S.C. §§ 360k(a), 379r). Allergan argues that there are n o similar preemption provisions for prescrip tion drugs, indicating that Congress intended that the FDCA should
not preempt by implication state law claims related to this category

. Allergan argues that, under Wyeth v. Levine , 555 U.S. 555 (2009), there i s no implied preemp tion where simu l-ALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 8

taneous compliance with state and federal law is possible

, and the state law is not an obstacle to the realization of federal goals

. It argues that the California Health Code ’s requirements parallel the FDCA’s, making co mpliance with both regimes possible. Allergan also argues that the district court did not abuse its discretion by retaining jurisdiction because the resolution of this case did not require the FDA’s specialized knowledge

. We agree with Allergan and hold that the FDCA does not impliedly preempt its UCL claim

. “[T]he purpose of Congress is the ultimate touchstone in every pre -emption case.” Id. at 565 (quoting Medtronic, Inc. v. Lohr , 518 U.S. 470, 485 (1996)). “‘I n all pre

- emption cases, and partic ularly in those in which Con gress has legislated in a field which the States have traditionally occupied, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Co ngress. ’ ” Id. ( quoting Medtronic

, 518 U.S. at 485) (alter ations omitted)

. The fact that the California Health Code parallels certain FDCA provision s does not mean that it does not implicate a n historic state power that may be vindicated under state law tort principles

. The Supreme Court acknowledged “the historic primacy of state regulation of matters of health and safe ty
, ” Buckman

, 531 U.S. at 348
, which is precisely the California Health Code’s subject
matter

. We do no t find a clear purpose by Congress to preempt the state law claim at issue

. Congress expressed its intent to preempt state

- law causes of action regarding, for example, non

- prescri ption drugs and medical devices. Allergan’s contenti on, however, is that th e products at issue must ultimately be regulated as prescription drugs

— about which Congress “declined to enact such aALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 9

provision .” Wyeth , 555 U.S. at 567 ; see also Farm Raised Salmon Cases

, 175 P.3d 1170, 1179 (Cal. 2008) (“[D] eference should be paid to Congress’s detailed a ttempt to clearly define the scope of preemption under the FDCA

. ”)

. Moreo ver, the California Health Code is not an obstacle to realizing federal objectives . To the contrary, it contains provisions that paral lel the FDCA , such that th e statutes have consistent goals.

Athena’s principal authorities a re distinguishable

. Buckman involved a claim based on fraud before the FDA

, which existed— unlike Allergan’s claim —“ solely by virtue of the FDCA disclosure requirements .” 531 U.S. at 35 2– 5 3. The Court described fraud on the FDA as

— unlike
state r egulation of health and safety

— “hardly a field which the States have traditionally occupied . . . such as to warrant a presumption against finding federal pre

emption of a state law cause of action. ” Id. at 347 (inte rnal quotation marks omitted)

. PhotoMedex concerned a n issue that does not involve federal p reemption of a state law claim: “whether the FDCA lim its claims under the [federal] Lanham Act .” 601 F.3d at 924

. The decision was limited to “particular circumstances” that are also not before us: alleged misrepresentations to the FDA about a medi cal device

, which implicated the Medical Device Amendments of 1976 to the FDCA. I d. at 922 , 9 24 –2 8.

We see no error in the district court’s determi nation that the FDCA does not preempt Allergan’s UCL claim.

II. Summary Judgment
The California Health Code incorporates the FDCA’s definition of “drugs” to include “any article other than food that is used or intended to affect the structure . . . of th e body of human beings.” Cal. Health Code § 109925(c); cf. 21 U.S.C. § 321(g)(1)(C). An article’s intended use is determined based on “the objective intent of the persons legally responsible for the labeling of drugs .” 21 C.F.R.ALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 10

§ 201.128. Objective intent “is determined by such pe rsons’ expressions or may be shown by the circumstances surrounding the distribution of the article,” including “labeling claims, advertising matter, or oral or written statements by such persons or their representatives.” Id. The district court found no genuine dispute that Athena objectively intended to market past and present formulations of the products at issue to affect the stru cture of eyelashes

— i.e. , as drugs

. The court found that Athena’s found er, a physician, de veloped an initial form ula tion using a prostaglandin derivative with the intent to cause users’ eyelashes to grow longer and fuller. It found that Athena’s marketing of subsequent formulations containing different derivatives continued to discuss eyelash growth . The court acknowledged that Athena’s marketing of the most recent formulation discuss ed eyelash appearance , but concluded this did not negate an objective intent to cause growth

. Athena argues that there is a genuine issue of mat erial fact about its objective intent

. Athena argues that its intent should turn only on labeling and marketing mat erials related to its most recent formulation , and that the physical properties of the products at issue and marketing of past formulations are irrelevant. Athena contends tha t
, within a year of its founding , it limited its marketing to claims about eyelash appearance. It argues that
statements by re sellers about eyelash growth do not reflect Athe na’s objective intent. Athena points to the testimony of a former employee that she always referred
to eyelash appearance when training resellers about the products at issue

. It argues that authorized resellers
must acknowledge that the products at issue may only be sold as cosmetics and may not be marketed for e yelash growth.
Allergan responds that there is no genuine factual dispute that Athena objectively intends for the productsALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 11

at issue to be used as drugs. It argues that the physical properties and claims about past and present formul ations are relevant, particularly because Athena has not materially altered the properties of, or marketing about, its various formulations. Allergan argues that Athena and its resellers advertise that the products at issue were developed by Athena’s found er to treat his wife’s eyelash loss. It argues that Athena’s founder testified that he had reason to think the product he developed would cause eyelashes “ to grow thick and long ,” J.A. 670

– 71
, and sought to sell the product for that purpose . J.A. 684, 68 7. Allergan argues that Athena’s marketing consistently references eyelash length, which depends on growth

. We agree with Allergan and hold that there is no ge nuine dispute that Athena objectively intends for the products at issue to be used to affect the structure of eyelashes— i.e. , as drugs. Athena’s intent as to its line

- up of products may be “derived or inferred from labeling, promotional material, advertising, or any other relevant

source. ” United States v. Storage Spaces Designated Nos. “8” & “4 9” , 777 F. 2d 1363, 1366 (9th Cir. 1985). As an initial matter, we disagree with Athena that the only relevant evidence is labeling and marketing , or that the only relevant formulation is the most recent one

. Ath ena’s website collectively refers to the Re vitaLash “ line

- up of products,” and describes formulation changes as “i mprove[ments]” to the intended use of “ one or more of our products.” J.A. 878.

Athena’s marketing of the products at issue consis tently discuss es physical changes to eyelashes. Ther e is no dispute that Athena made drug -related claims about an early formulation

— and it never expressly disavowed such claims as it reformulated its products

. I nstead, the co mpany continued to suggest tha t the products at issue change eyelash structure

. For example, the company’s website contained a message from the founder referring toALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 12

his wife’s “fragile, sparse and thin” eyelashe s , and his development of a formula to achieve “the look of renewed health

, strength and beauty.” J.A. 87 5 (emphasi s added). An advertisement about the most recent formulation
states that the product is “both dermatologist and op hthalmologist reviewed ,” and describes “improved appea rance” of eyelashes in the context of a “clinical study.” J.A. 750 ; see also J.A. 871.
Athena’s training of resellers similarly references eyelash structure. An Athena representative led a webinar for resellers in which she discussed achieving “fuller and thicker” eyelashes. J.A. 820. She discussed a “maint enance program” to retain “the d esired length” after

“ achiev[ing] long er, fuller -looking eyelash es. ” J.A. 822. She stated that “eyelashes will grow naturally or with RevitaLash .” J.A. 8 24. One reseller ’s marketing mater ials displayed a before

- and

- after photograph of eyelashes and promoted “dramatically thicker, longer , and lusher lashes.” J.A. 960. Athena’s claims invariably link eyelash appearance to physical changes caused by the products at issue.
Athena’s argument that it markets only cosmetic be nefits fails

. We need not d ecide whether the products at issue could also be cosmetics

— it is sufficient to resolve this case that t here is no dispute that Athe na objectively intends that the products at issue be used as drugs. We therefore affirm the district court’s grant of summa ry judgment.

II I. Injunction
The district court entered a permanent injunction barring Athena from manufacturing, marketing, selling, and/or offering for sale “any and all” “eyelash growth product(s)” “ anywhere within the United States. ” Alle rgan , No. 8:07

- cv

- 1316 , slip op. at 15 (C.D. Cal. Mar. 6
, 201 3 ). It determined that nationwide coverage wasALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 13

justified because Athena’s UCL violation resulted from sale s and advertising “throughout the United States,” and “wherever the unfair competition occurs, it affects Alle rgan in California.” Id. at 7 –8

. The court conclude d that the injunction’s regulation of out -of- state commerce did
not violate the Commerce Clause of the United States Constitution

. Id. at 8

– 10. Specifically, it found “substa ntial indications that other jurisdictions define ‘drug’” like the Califo rnia Health Code. Id. at 9– 10

. The court stated that Athena did not “demonstrate that there would be a conflict with other states’ laws,” and “proffer[ed] no facts to suggest that [i t] would encounter contrary” law in other
states

. Id. at 7, 9– 10. Athena argues that it was an abuse of discretion for the court to issue a nationwide injunction. It argues that the injunction impermissibly reaches outside of California to remedy a vio lation of California law. Athena argues that the injunction violates the Commerce Clause b y regulating commerce that occurs wholly outside of Cal ifornia. It emphasizes that California is not part of the supply chain for the most recent formulation of the pro ducts at issue.
Allergan responds that the court did not abuse its di scretion. It argues that the injunction properly applies to
out -of- state conduct that causes Allergan an injury under the UCL in California

. Allergan argues that the record evidence demonstrated that the injunction’s nationwide scope was a practical necessity. It argues that, after Athena volunteered to stop sales of the products at issue in California before the court issued an injunction

, such sales persisted within the state. Al lergan also argues that there is no Commerce Clause violation because the injunction does not impose obligations on Athena that conflict with another state’s law and Athena has not shown any conflict with the laws of other states. It co ntends that, in any event, other states could not adopt lawsALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 14

that are inconsistent with the California Health Code because it incorporates a regulatory floor set by the FDCA. We agree with Athena and hold that the district court abused its discretion by entering an injunction that regulates any and all out -of- state conduct

. As the Cal ifornia Supreme Court has stated, “[n]either the language of the UCL nor its legislative history provides any basis for concluding the Legislature intended the UCL to ope rate extraterri torially.” Sullivan v. Oracle Corp. , 254 P.3d 237, 248 (Cal. 2011)

. The injunction impermissibly i mposes the UCL o n entirely extraterritorial conduct regardless of whether the conduct in other states causes harm to California . This injunction is so broa d that it would bar Athena from making its product in Idaho, distributing it from a facility in Nevada

, and selling it to Connecticut

consumers

. Allergan argues that Norwest Mortgage , Inc. v. Sup erior Court of San Diego County

, 72 Cal. App. 4th 214 (1999)

, supports the court’s imposition of a nationwide injunction in this case. It does not. In Nor west Mortgage

, the California Court of Appeals held that UCL claims could be filed by California residents regardless of where they purchased their mortgage product and by non

California residents who purchased it in California, but
not by non

- California residents who purchased it outside of California (entirely extraterritorial conduct). Id. at 222

– 24. The conduct enjoined here is exactly the sort of

pur ely extraterritorial conduct that the California Court of Appeals expressly held could not be regulated by the UCL. This injunction prevents sales that are entirely extraterritorial. It is not limited to purchases made by California residents that are be ing shipped into California

or to sales emanating from California. Neither the California courts nor the California legi slature are permitted to regulate commerce entirely ou t-ALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 15

side of the state’s border s

. To do so would violate the Commerce Clause , which “precludes” such extraterritorial application of state law “ whether or not the commerce has effects within the state .” Healy v. Beer Inst., Inc

., 491 U.S. 324, 336 (1989) (quoting Edgar v. MITE Corp. , 457 U.S. 624, 642

– 43 (1982)). The Commerce Clause “dictates that no State may force an out -of- state merchant to seek regulatory approval in one State before undertaking a transaction in another.” Id. at 337. Th is rule applies regardless of whether Athena can demonstrate that the laws of other states do

— or even could

— confli ct with the UCL or the California Health Code. In short, California may, as it has in this case, conclude that its own unfair competition law has been violated

, and it may prohibit any future conduct within its borders that would cause continued violation of its law. California is not permitted

, however, to extend its unfair competition law to other
states. 3

The FDA

— and the FDA al one

— has the power and the discretion to enforce the FDCA

. 21 U.S.C. § 337(a) (“[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States”). California does not have the author i3 There may be instances when a court in one state may issue an injunction that applies beyond the state’s boundaries such as when a federal law has been violated. The Ninth Circuit recognized such a possibility in United States v. AMC Enter tainment, Inc. , 549 F.3d 760 (9th Cir. 2008), but nonetheless vacated the nationwide injunction because the Fifth Circuit had a different interpretation of the federal law at issue. Id. at 770

– 73. Such is not the case here. California has no obligation or right to enforce the FDCA. The only law at issue here is California’s UCL.ALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 16

ty to stand in the shoes of the FDA to determine whether At hena’ s sale of the products at issue amounts to the sale of an unapproved drug under the F DCA. This enforc ement authority relies exclusively with the FDA. Califo rnia has chosen to enact the UCL

, which prevents marketing, distributing, and selling, withou t regulatory approval, products that qualify as drugs. While it is true that a state is not free to enact laws that do not meet the minimum requirements of the FDCA, a state is free to have no comparable state law if it chooses. The FDA does not require states to enact laws that parallel federal requirements. Thus, if other states have no law s that parallel relevant provisions of the UCL and California Health Code , there would be no mechanism at all in those states to challenge Athena’s sales of the prod ucts at issue

. In short, imposing the UCL on other states would violate their sovereignty, and usurp the discretionary enforc ement authority of the FDA. Allergan’s reliance on Athena’s purported failure to voluntarily cease sales of the products at issue in Califo rnia does not justify a nationwide injunction. After su mmary judgment

, Athena offered to voluntarily cease sales to California. An attorney for Allergan submitted a declaration stating that , after Athena’s purported ces s ation of sales in California, s he was still able to purchase a product at issue from Athena’s and a reseller’s website for delivery in California , as well as directly from a reseller’s store in California. See J.A. 2729

– 34. This record demonstrates that the se sale s were isolated occur r ences

. Athena recognized these infractions and instituted better procedures to ensure no further sales of the products at issue in California, instructed its online resellers not to sell those products for delivery in California, and ceased
to ship those products to brick

- and

- mortar resellers in California

. See J.A. 3098

– 101. If Athena violates a properly tailored injunction, Allergan’s remedy lies in a contempt proceeding. But Athena’s failure to en tirelyALLERGAN , INC

. v. ATHENA COSMETICS , INC

. 17

stop sales in California pursuant to its voluntary efforts cannot, as Allergan argues, justify a nationwide injun ction that violates the Commerce Clause.

W e vacate the permanent injunction

. On remand, the district court should lim it the scope of th e injunction to regulate conduct occurring with in California. 4

C ONCLUSION
We have considered the parties’ remaining arguments and do not find them persuasive.

AFFIRMED

- IN

- PART, VACATED

- IN

- PART, AND REMANDED

4 Athena also argues that the district court did not make findings to support irreparable harm, and abus ed its discretion by drafting the injunction to cover any product containing a prostaglandin derivative applied to eyelashes. We hold that the district court made an e xpress finding of irreparable harm that was not clearly

erroneous, see, e.g. , J.A. 1542

– 43 , and the scope of the products covered was not an abuse of discretion.