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, INC.,

Defendant-Appellant,

AND

PHARMA TECH INTERNATIONAL, INC., 

PRODUCT INNOVATIONS, LLC,

NORTHWEST COSMETIC LABORATORIES, LLC,

AND R & G BUSINESS LLC,

Defendants.

______________________ 

2013-1286

______________________ 

Appeal from the United States District Court for the 

Central District of California in consolidated Nos. 07-CV1316 and 09-CV-0328, Judge James V. Selna.

______________________ 

Decided: December 30, 2013 

______________________ 
2 ALLERGAN, INC. v. ATHENA COSMETICS, INC. 

MARK A. PERRY, Gibson, Dunn & Crutcher LLP, of 

Washington, DC, argued for plaintiffs-appellees. With 

him on the brief were JEFFREY T. THOMAS and BLAINE H.

EVANSON, of Irvine, California. 

STEVEN A. ZALESIN, Patterson Belknap Webb & Tyler 

LLP, of New York, New York, argued for defendantappellant. With him on the brief were TRAVIS J. TU, 

JONAH M. KNOBLER and JANE M. METCALF. Of counsel 

was STEPHEN P. BENSON, Katten Muchin Rosenman, LLP, 

of Chicago, Illinois. 

______________________ 

Before RADER, Chief Judge, MOORE, and WALLACH, 

Circuit Judges.

MOORE, Circuit Judge. 

Athena Cosmetics, Inc. (Athena) appeals from the district court’s grant of summary judgment that Athena

violated California’s unfair competition law (UCL) by

marketing, 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 Federal 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 district court abused its discretion by entering an overbroad 

injunction, and thus vacate the injunction and remand. 

BACKGROUND

The products at issue in this appeal are formulations 

of Athena’s RevitaLash line, all of which contain a 
ALLERGAN, 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 regulated, the 

products at issue. Allergan sells 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)

§ 1115501 by “marketing, selling, and distributing [its] 

hair and/or eyelash growth products without [a new drug] 

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). 

The 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, giving 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 [California Health Department] has approved a new drug 

application for that new drug . . . .” 

 
4 ALLERGAN, INC. v. ATHENA COSMETICS, INC. 

JURISDICTION

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 appellate court 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 omitted). Therefore, we ordered supplemental briefing on our 

jurisdiction. 

Athena argued that we have jurisdiction over this appeal. 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. 

Christianson v. Colt Indus. Operating Corp., 486 U.S. 800, 

809 (1988); 28 U.S.C. § 1295(a)(1). In some circumstances, 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, 

1189–90 (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 funda-
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 5

mental basis of our jurisdiction.” Chamberlain, 381 F.3d 

at 1190.

In this case, following the district court’s issuance of a 

Final Claim Construction Order, the parties proposed 

that the court grant summary judgment of noninfringement of the ’105 patent, while preserving their full appellate 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 parties were not left in the same legal position 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 summary judgment ruling—which the court did not vacate. 

Indeed, Allergan, whose decision it is whether to reassert 

the ’105 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 alteration in legal status, 

and therefore we have jurisdiction over this appeal pursuant to 28 U.S.C. § 1295(a)(1).2

2 Athena contends that the district court altered the 

legal status of the parties with respect to each of the other 

 
6 ALLERGAN, INC. v. ATHENA COSMETICS, INC. 

ANALYSIS

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 grants of 

summary judgment and determinations 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 permanent injunction, as well as its scope, for abuse of discretion, and underlying factual findings for clear error. 

Columbia Pictures Indus., Inc. v. Fung, 710 F.3d 1020, 

1030 (9th Cir. 2013). 

I. Preemption 

The California Health Code incorporates various provisions 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 determine 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 Allergan’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 other patents. 

 
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 7

Athena argues that the FDCA impliedly preempts Allergan’s UCL claim. It contends that, under Buckman Co. 

v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), a state 

law claim is impliedly preempted 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 misrepresentations to the FDA about a medical device was impliedly 

preempted because it would have impermissibly circumvented the agency’s exclusive enforcement authority. Id. 

at 926–30. Athena argues that Allergan’s claim interferes

with the FDA’s discretionary authority whether to regulate 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 determinations about the products at issue. 

Allergan responds that the FDCA does not impliedly 

preempt its UCL claim. It argues that the FDCA contains

express preemption provisions for “certain narrow topics 

inapplicable,” including medical devices and nonprescription drugs. Resp. Br. at 17–18 (citing 21 U.S.C. 

§§ 360k(a), 379r). Allergan argues that there are no 

similar preemption provisions for prescription 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 is no implied preemption where simul-
8 ALLERGAN, INC. v. ATHENA COSMETICS, INC. 

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 compliance 

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)). “‘In all pre-emption cases, and 

particularly in those in which Congress 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 Congress.’” Id. (quoting Medtronic, 518 U.S. at 485) (alterations omitted). 

The fact that the California Health Code parallels certain FDCA provisions does not mean that it does not 

implicate an 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 safety,” Buckman, 531 U.S. at 348, 

which is precisely the California Health Code’s subject 

matter. 

We do not 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-prescription drugs and medical devices. 

Allergan’s contention, however, is that the products at 

issue must ultimately be regulated as prescription 

drugs—about which Congress “declined to enact such a 
ALLERGAN, 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 attempt to clearly define the scope of preemption under the 

FDCA.”). Moreover, the California Health Code is not an

obstacle to realizing federal objectives. To the contrary, it

contains provisions that parallel the FDCA, such that the 

statutes have consistent goals.

Athena’s principal authorities are 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 352–

53. The Court described fraud on the FDA as—unlike 

state regulation of health and safety—“hardly a field 

which the States have traditionally occupied . . . such as 

to warrant a presumption against finding federal preemption of a state law cause of action.” Id. at 347 (internal quotation marks omitted). PhotoMedex concerned an 

issue that does not involve federal preemption of a state 

law claim: “whether the FDCA limits 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 

medical device, which implicated the Medical Device 

Amendments of 1976 to the FDCA. Id. at 922, 924–28. 

We see no error in the district court’s determination 

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 

the 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. 
10 ALLERGAN, INC. v. ATHENA COSMETICS, INC. 

§ 201.128. Objective intent “is determined by such persons’ 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 structure of eyelashes—i.e., as drugs. The court found that 

Athena’s founder, a physician, developed an initial formulation 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 discussed 

eyelash appearance, but concluded this did not negate an

objective intent to cause growth. 

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

intent should turn only on labeling and marketing materials 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

that, within a year of its founding, it limited its marketing 

to claims about eyelash appearance. It argues that 

statements by resellers about eyelash growth do not 

reflect Athena’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 eyelash 

growth. 

Allergan responds that there is no genuine factual 

dispute that Athena objectively intends for the products 
ALLERGAN, 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 formulations 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 founder 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, 687. 

Allergan argues that Athena’s marketing consistently 

references eyelash length, which depends on growth. 

We agree with Allergan and hold that there is no genuine 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” & “49”, 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. Athena’s website collectively refers to the RevitaLash “line-up 

of products,” and describes formulation changes as “improve[ments]” to the intended use of “one or more of our 

products.” J.A. 878. 

Athena’s marketing of the products at issue consistently discusses physical changes to eyelashes. There 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. Instead, the company continued to suggest that the products at issue 

change eyelash structure. For example, the company’s 

website contained a message from the founder referring to 
12 ALLERGAN, INC. v. ATHENA COSMETICS, INC. 

his wife’s “fragile, sparse and thin” eyelashes, and his

development of a formula to achieve “the look of renewed

health, strength and beauty.” J.A. 875 (emphasis added). 

An advertisement about the most recent formulation 

states that the product is “both dermatologist and ophthalmologist reviewed,” and describes “improved appearance” 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 “maintenance program” to retain “the desired length” after 

“achiev[ing] longer, fuller-looking eyelashes.” J.A. 822. 

She stated that “eyelashes will grow naturally or with 

RevitaLash.” J.A. 824. One reseller’s marketing materials 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 benefits fails. We need not decide whether the products at 

issue could also be cosmetics—it is sufficient to resolve 

this case that there is no dispute that Athena objectively 

intends that the products at issue be used as drugs. We 

therefore affirm the district court’s grant of summary 

judgment. 

III. 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.” Allergan, No. 8:07-cv-1316, slip op. at 15 (C.D. Cal. Mar. 6, 

2013). It determined that nationwide coverage was 
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 13

justified because Athena’s UCL violation resulted from 

sales and advertising “throughout the United States,” and

“wherever the unfair competition occurs, it affects Allergan in California.” Id. at 7–8. The court concluded 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 “substantial indications that other jurisdictions define ‘drug’” like

the California 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 [it] 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 violation of California law. Athena argues 

that the injunction violates the Commerce Clause by 

regulating commerce that occurs wholly outside of California. It emphasizes that California is not part of the

supply chain for the most recent formulation of the products at issue.

Allergan responds that the court did not abuse its discretion. 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. Allergan 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 contends that, in any event, other states could not adopt laws 
14 ALLERGAN, INC. v. ATHENA COSMETICS, INC. 

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 California 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 operate extraterritorially.” Sullivan v. Oracle Corp., 254 P.3d 

237, 248 (Cal. 2011). The injunction impermissibly imposes the UCL on entirely extraterritorial conduct regardless of whether the conduct in other states causes harm to 

California. This injunction is so broad 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. Superior 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 Norwest 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 nonCalifornia 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 

purely 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 being shipped into California 

or to sales emanating from California. 

Neither the California courts nor the California legislature are permitted to regulate commerce entirely out-
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 15

side of the state’s borders. 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. This rule applies 

regardless of whether Athena can demonstrate that the 

laws of other states do—or even could—conflict 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 alone—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 authori3 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 Entertainment, 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. 

 
16 ALLERGAN, INC. v. ATHENA COSMETICS, INC. 

ty to stand in the shoes of the FDA to determine whether 

Athena’s sale of the products at issue amounts to the sale 

of an unapproved drug under the FDCA. This enforcement authority relies exclusively with the FDA. California has chosen to enact the UCL, which prevents 

marketing, distributing, and selling, without 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 laws 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 products at issue. 

In short, imposing the UCL on other states would violate 

their sovereignty, and usurp the discretionary enforcement authority of the FDA. 

Allergan’s reliance on Athena’s purported failure to 

voluntarily cease sales of the products at issue in California does not justify a nationwide injunction. After summary judgment, Athena offered to voluntarily cease sales 

to California. An attorney for Allergan submitted a 

declaration stating that, after Athena’s purported cessation of sales in California, she 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 these sales were isolated occurrences. 

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 entirely 
ALLERGAN, INC. v. ATHENA COSMETICS, INC. 17

stop sales in California pursuant to its voluntary efforts 

cannot, as Allergan argues, justify a nationwide injunction that violates the Commerce Clause.

We vacate the permanent injunction. On remand, the 

district court should limit the scope of the injunction to 

regulate conduct occurring within California.4 

CONCLUSION

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 abused 

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 express 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.