Azurity Pharmaceuticals, Inc. v. Edge Pharma, LLC

45 F.4th 479

• Court: Court of Appeals for the First Circuit
• Decided: August 12, 2022
• Docket: 21-1492P
• Status: Published

Opinion

United States Court of Appeals For the First Circuit

No. 21-1492

AZURITY PHARMACEUTICALS, INC.,

Plaintiff, Appellant,

v.

EDGE PHARMA, LLC,

Defendant, Appellee.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Rya W. Zobel, U.S. District Judge]

Before

Barron, Chief Judge, Howard and Thompson, Circuit Judges.

James H. Hulme, with whom Nadia A. Patel, Valerie C. Samuels, and Arent Fox LLP were on brief, for appellant. Robert J. Fluskey, Jr., with whom Linda L. Morkan, William J. Egan, Julianna M. Charpentier, Robinson & Cole LLP, and Hodgson Russ LLP were on brief, for appellee.

August 12, 2022 BARRON, Chief Judge. Azurity Pharmaceuticals, Inc.

("Azurity") is a specialty pharmaceutical company. It markets a

hydrochloride vancomycin drug that received pre-market approval

from the United States Food and Drug Administration ("FDA"). Edge

Pharma, LLC ("Edge") is a drug compounding company. It markets a

hydrochloride vancomycin drug that competes with Azurity's but has

not been given pre-market FDA approval.

In 2020, Azurity filed suit in the United States District

Court for the District of Massachusetts against Edge under both

the Lanham Act and a Massachusetts consumer protection law, Mass.

Gen. Laws. ch. 93A ("Chapter 93A"), based on statements that Edge

allegedly made on its website. The suit alleges that a number of

these statements represent or convey the impression that Edge is

not in violation of section 503B of the Food, Drug, and Cosmetic

Act ("FDCA"), which authorizes drug compounders who meet certain

conditions to market their compounded drugs without first

obtaining FDA approval. The suit alleges that these statements

are literally false and/or misleading. The suit further alleges

that another one of Edge's statements on its website is false

and/or misleading because it holds out Edge's vancomycin drug as

being superior to Azurity's.

Edge moved to dismiss Azurity's claims for, among other

things, failure to state a claim on which relief could be granted

under Federal Rule of Civil Procedure ("Rule") 12(b)(6). The

- 2 - District Court granted Edge's Rule 12(b)(6) motion as to Azurity's

Lanham Act claim on the ground that the FDCA precluded Azurity's

claim. The District Court based this ruling on the determination

that the claim would require a court to interpret the meaning of

section 503B in a way that would interfere with the FDA's authority

to administer and enforce the FDCA. Azurity Pharms., Inc. v. Edge

Pharma, LLC, 540 F. Supp. 3d 141, 144 (D. Mass. 2021). The District

Court also ruled that, because the FDCA precluded Azurity's Lanham

Act claim, Azurity's Chapter 93A claim "likewise fails as it is

premised on the same allegations" as Azurity's Lanham Act claim.1

Id. (citing Reed v. Zipcar, Inc., 883 F. Supp. 2d 329, 334–35 (D.

Mass. 2012)).2 We affirm in part (albeit on an alternative ground)

and vacate in part.

1 Azurity's complaint contains two counts, one for violation of the Lanham Act and another for unfair and deceptive trade practices under Chapter 93A. The District Court treated Azurity as having made one "claim" under each statute. See Azurity, 540 F. Supp. 3d at 144. On appeal, Azurity frames its complaint has having stated four distinct claims under the Lanham Act. Following the District Court, we use the singular "claim" to encompass all of the theories that Azurity argues for finding Edge to have violated the Lanham Act, and we do the same with respect to Chapter 93A.

2 In granting Edge's motion to dismiss, the District Court also denied Azurity's motion for a preliminary injunction as moot. Azurity, 540 F. Supp. 3d. at 145. Azurity referred to this denial in its notice of appeal, but it makes no mention of it in its briefing to us so any challenge to that ruling is waived. See United States v. Zannino, 895 F.2d 1, 17 (1st Cir. 1990).

- 3 - I.

Because this appeal is from the grant of a motion to

dismiss Azurity's complaint for failure to state a claim under

Rule 12(b)(6), we accept all well-pleaded facts in Azurity's

operative complaint as true. See Clorox Co. P.R. v. Proctor &

Gamble Com. Co., 228 F.3d 24, 30 (1st Cir. 2000). We also draw

all reasonable inferences in Azurity's favor. Id.

A.

The FDCA requires the FDA's pre-approval to market any

drug. However, the FDCA exempts "compounded" drugs -- which are

drugs that are produced by "combining, admixing, mixing, diluting,

pooling, reconstituting, or otherwise altering . . . a drug or

bulk drug substance," 21 U.S.C. § 353b(d)(1) -- from the FDCA's

pre-approval requirements in some circumstances.

The circumstances are set forth in section 503B of the

FDCA, 21 U.S.C. § 353b. That section provides that certain pre-

approval requirements "shall not apply to a drug compounded by or

under the direct supervision of a licensed pharmacist in a facility

that elects to register as an outsourcing facility if each of

the . . . conditions [set forth in section 503B] is met." 21

U.S.C. § 353b(a). The FDCA defines an "outsourcing facility" as

a facility that "is engaged in the compounding of sterile drugs;

has elected to register as an outsourcing facility; and complies

- 4 - with all of the requirements of [section 503B of the FDCA]." Id.

§ 353b(d)(4)(A)(i)-(iii).

In specifying the conditions that an outsourcing

facility must meet, section 503B provides that an "outsourcing

facility" may not compound a drug that is "essentially a copy of

one or more approved drugs." Id. § 353b(a)(5). Section 503B

defines "essentially a copy" to mean:

(A) a drug that is identical or nearly identical to an approved drug . . . unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing; or

(B) a drug, a component of which is a bulk drug substance that is a component of an approved drug . . . , unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.

Id. § 353b(d)(2).

Another portion of section 503B concerns the use by

"outsourcing facilities" of a "bulk drug substance." Id.

§ 353b(a)(2). That provision requires, as a "condition" for an

"outsourcing facility" to market a compounded drug without prior

FDA approval, that:

The drug is compounded in an outsourcing facility that does not compound using bulk drug substances . . ., unless--

- 5 - (A)(i) the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need, by--

(I) publishing a notice in the Federal Register proposing bulk drug substances to be included on the list, including the rationale for such proposal;

(II) providing a period of not less than 60 calendar days for comment on the notice; and

(III) publishing a notice in the Federal Register designating bulk drug substances for inclusion on the list; or

(ii) the drug compounded from such bulk drug substance appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing . . . .

Id.

B.

The vancomycin hydrochloride drug that Azurity markets

is called FIRVANQ. FIRVANQ is "indicated for treatment of

Clostridium difficile-associated diarrhea and enterocolitis caused

by Staphylococcus aureus, including methicillin-resistant

strains." Azurity does not purport to be an "outsourcing

facility," but it has received FDA pre-approval to market FIRVANQ.

Edge "produces and markets an oral vancomycin solution

that competes directly with Azurity's FIRVANQ." Edge markets the

drug under the generic name "Vancomycin Oral Solution." Unlike

- 6 - Azurity, Edge has not received FDA pre-approval to market this

drug. Edge is registered, however, as an "outsourcing facility".

Prior to this suit, Edge made the following statements

about its operations, each of which appeared on Edge's website:

a. "Edge Pharma is a pharmaceutical sterile and non-sterile 503B Outsourcing Facility offering high quality, innovative solutions for the health care community."

b. "As your compliance partner, we are dedicated to providing turnkey 503B outsourcing with the highest level of quality, easy ordering, simple logistics, and excellent customer support."

c. "Edge Pharma is an FDA-registered and state-licensed, 503B Outsourcing Facility providing service to hospital pharmacies, outpatient surgery Centers, and clinics."

d. "Our facility is compliant with the following state, local, and federal regulations and guidelines: USP 795, USP 797, USP 800[,] Occupational Safety and Health Administration (OSHA)[,] Food and Drug Administration (FDA)[,] US Pharmacopeia (USP)[,] Applicable Good Manufacturing Practice (GMP) Guidelines."

e. "Edge Pharma is a USP 797 and cGMP compliant FDA-Registered 503B Outsourcing Facility that specializes in a wide array of sterile and non-sterile compounded medications."

f. "As an FDA registered and inspected 503B Outsourcing facility, Edge has the ability to react quickly to customer requirements and deliver cost effective solutions."

- 7 - In addition, "Edge . . . claim[ed] to be a 'Registered

and Inspected FDA Outsourcing Facility'" in its marketing

materials. Edge also stated on its website: "commercially

available options are not ideal for use in the hospital setting."

We will refer to the statements that refer to Edge's

"compliance" with the law as the "Compliance Statements." We will

refer to the statements that refer to Edge being a "registered"

and "inspected" "Outsourcing Facility" as the "Registration

Statements." We will refer to the statement that "commercially

available options are not ideal for use in the hospital setting"

as the "Superiority Statement."

C.

On February 12, 2020, Azurity sued Edge in the District

Court for the District of Massachusetts based on the statements

just described. One count of Azurity's two-count complaint alleges

that the Compliance and Registration Statements, as well as the

Superiority Statement, constitute unfair competition and false

advertising in violation of the Lanham Act, 15 U.S.C. § 1125(a).

The other count alleges that the Compliance and Registration

Statements, as well as the Superiority Statement, constitute

unfair or deceptive acts or practices under Chapter 93A, Mass.

Gen. Laws. ch. 93A, § 2(a).

To prove a Lanham Act claim for unfair competition and

false advertising, a plaintiff must demonstrate that

- 8 - (1) the defendant made a false or misleading description of fact or representation of fact in a commercial advertisement about his own or another's product; (2) the misrepresentation is material, in that it is likely to influence the purchasing decision; (3) the misrepresentation actually deceives or has the tendency to deceive a substantial segment of its audience; (4) the defendant placed the false or misleading statement in interstate commerce; and (5) the plaintiff has been or is likely to be injured as a result of the misrepresentation, either by direct diversion of sales or by a lessening of goodwill associated with its products.

Cashmere & Camel Hair Mfrs. Inst. v. Saks Fifth Ave., 284 F.3d

302, 310–11 (1st Cir. 2002).

A description or representation of fact in an

advertisement may be either literally false or "true or ambiguous

yet misleading." Id. at 311. Literal falsity and misleadingness

represent two "independent" theories of recovery under the Lanham

Act. Clorox, 228 F.3d at 36.

In assessing a Lanham Act claim for unfair competition

and false advertising, a determination first must be made as to

what the statement by the defendant that grounds the claim

communicates. Id. at 34. A determination then must be made about

whether that statement, given what it communicates, is either false

and/or misleading. See id. at 34, 36. The Lanham Act prohibits

only "false or misleading description[s] of fact." 15 U.S.C.

§ 1125(a)(1) (emphasis added).

- 9 - The plaintiff bears the burden of proving that the

statement at issue is false and/or misleading. Clorox, 228 F.3d

at 33. That question is typically for the factfinder to determine.

Id. at 34, 37.

If the statement is alleged to be literally false, "a

violation [of the Lanham Act] may be established without evidence

of consumer deception." Cashmere & Camel Hair Mfrs. Inst., 284

F.3d at 311. If the statement is alleged to be only misleading,

rather than literally false, there is generally "an additional

burden . . . placed upon the plaintiff to show that the

advertisement . . . conveys a misleading message to the viewing

public."3 Id. (second alteration in original) (quoting Clorox,

228 F.3d at 33).

"[F]actfinders usually base literal falsity

determinations upon the explicit claims made by an advertisement."

Clorox, 228 F.3d at 34-35. However, "they may also consider any

claims the advertisement conveys by 'necessary implication.'" Id.

at 35 (quoting Southland Sod Farms v. Stover Seed Co., 108 F.3d

1134, 1139 (9th Cir. 1997)). We have explained that "[a] claim is

conveyed by necessary implication when, considering the

3 "[A] plaintiff alleging an implied falsity claim, however, is relieved of the burden of demonstrating consumer deception when there is evidence that defendants intentionally deceived the consuming public." Cashmere & Camel Hair Mfrs. Inst., 284 F.3d at 311 n.8. No such argument is made here.

- 10 - advertisement in its entirety, the audience would recognize the

claim as readily as if it had been explicitly stated." Id.

When the Lanham Act claim is predicated on finding the

advertisement to be misleading, the question is whether "the

advertisement, though explicitly true, nonetheless conveys a

misleading message to the viewing public." Id. at 33. In other

words, in that circumstance, the question is whether the

advertisement, though "literally true or ambiguous," nonetheless

is "likely to mislead and confuse consumers" into believing a

"false . . . representation of fact." Id. 33 & n.6. Moreover,

when the plaintiff is pursuing a claim based on a statement's

misleadingness, "the plaintiff must show how consumers have

actually reacted to the challenged advertisement, rather than

merely demonstrating how they could have reacted." Id. at 33.

Chapter 93A provides that "[u]nfair methods of

competition and unfair or deceptive acts or practices in the

conduct of any trade or commerce are hereby declared unlawful."

Mass. Gen. Laws ch. 93A, § 2(a). The elements of a Chapter 93A

claim "overlap[]" with those of a Lanham Act false advertising

claim. See Cashmere & Camel Hair Mfrs. Inst., 284 F.3d at 320.

D.

Edge moved to dismiss Azurity's complaint on March 20,

2020, pursuant to Rule 12(b)(6) and Rule 12(b)(1). Edge gave the

following grounds for dismissal.

- 11 - First, Edge contended that Azurity had not plausibly

alleged a claim under the Lanham Act based on any of the statements

described above because the complaint plausibly alleges no more

than that each of the statements contains "non-actionable puffery,

opinion, and generalized comments about compliance with

administrative law." Edge asserted in support of that contention

that Azurity's complaint lacked the factual allegations necessary

to plausibly allege a Lanham Act claim for either literal falsity

or misleadingness, insofar as the claim relies on the Compliance

or Registration Statements.

Edge contended in the alternative that, under the

analysis set forth in POM Wonderful, the FDCA precludes Azurity's

Lanham Act claim in any of its variants. Thus, Edge contended,

Azurity's Lanham Act claim must be dismissed even if the complaint

plausibly alleges that any or all of the statements at issue are

literally false or misleading.

Relatedly, Edge contended that Azurity's Lanham Act

claim -- again, even if based on plausible allegations of literal

falsity or misleadingness, and no matter on which of the statements

that claim is based -- must be dismissed under the doctrine of

primary jurisdiction. That doctrine requires a federal court

presented with an issue that falls within the primary jurisdiction

of a regulatory agency to "defer any decision in the action before

it until the agency has addressed the issue that is within its

- 12 - primary jurisdiction." Ass'n of Int'l Auto. Mfrs., Inc. v. Comm'r,

Mass. Dep't of Env't Prot., 196 F.3d 302, 304 (1st Cir. 1999)

(quoting 2 Kenneth Culp Davis & Richard J. Pierce, Jr.,

Administrative Law Treatise 271 (3d ed. 1994)).

Finally, Edge asserted that Azurity's Chapter 93A claims

must be dismissed. That was so, according to Edge, "because the

allegedly false statements cited by Azurity are not actionable"

under the Lanham Act, Cashmere & Camel Hair Mfrs. Inst., 284 F.3d

at 320 (explaining there that if "plaintiffs were unable to satisfy

the requirements of a Lanham Act claim, they would not be able to

prove their state law claims, as the two have overlapping

requirements"), and because "to the extent that Azurity's state

law claims mirror its Lanham Act claims, they are preempted by the

FDCA."

Azurity filed an opposition to the motion to dismiss.

The opposition addressed each of Edge's asserted grounds for

dismissal.

E.

The District Court granted Edge's motion and dismissed

the complaint per Rule 12(b)(6) on May 18, 2021. Azurity, 540 F.

Supp. 3d at 145. The District Court began by explaining its ruling

as to the Lanham Act claim. The District Court relied solely on

FDCA preclusion to dismiss the Lanham Act claim.

- 13 - In POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102

(2014), the Supreme Court of the United States rejected the

defendant's contention that the FDCA precluded a Lanham Act claim

that involved a challenge to a statement that had been made in a

label on a food item that was regulated by FDA pursuant to its

authority to administer the FDCA's food labeling provisions. POM

Wonderful, 573 U.S. at 121.

In so deciding, the Court reversed the Ninth Circuit's

holding that the claim was precluded by the FDCA. See POM

Wonderful LLC v. Coca-Cola Co. ("POM I"), 679 F.3d 1170 (9th Cir.

2012), rev'd, 573 U.S. 102 (2014). The Ninth Circuit had found

the claim precluded based on its own precedent establishing that

"a Lanham Act claim may not be pursued if the claim would require

litigating whether [the underlying] conduct [to which the alleged

misstatement refers] violates the FDCA" when the FDA itself has

not determined a violation occurred. See id. at 1176-78 (citing

PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924 (9th Cir. 2010)).

This was so, the Ninth explained in that prior case, because "the

FDCA may be enforced only by the [federal government]," id. at

1175 (citing 21 U.S.C. § 337(a)), and "allowing such a suit would

undermine" that exclusive enforcement authority, id. at 1176.

The Supreme Court thought differently. In POM

Wonderful, the Court reasoned that "the centralization of FDCA

enforcement authority in the Federal Government does not indicate

- 14 - that Congress intended to foreclose private enforcement of other

federal statutes." POM Wonderful, 573 U.S. at 117. Thus, because

the plaintiff there sought to "enforce the Lanham Act, not the

FDCA or its regulations," the FDA's exclusive enforcement

authority did not itself warrant preclusion of the plaintiff's

Lanham Act claim. Id.

In so concluding, the Court did not rule out the

possibility that the FDCA might preclude a Lanham Act claim in

some circumstances, id. at 118, and it specifically noted that the

case before it did not involve a claim of preclusion regarding a

statement about a drug, id. at 109, 116 ("Unlike other types of

labels regulated by the FDA, such as drug labels, it would appear

the FDA does not preapprove food and beverage labels under its

regulations and instead relies on enforcement actions, warning

letters, and other measures." (internal citation omitted)). But,

the Court did not purport to identify any circumstance in which

the FDCA would preclude a Lanham Act claim, and it noted that "the

FDCA and the Lanham Act complement each other in the federal

regulation of misleading food and beverage labels." Id. at 106.

None of the statements at issue in this case appear on

any label that must be approved by the FDA. The statements are

all ones that Edge allegedly made on its website. Nonetheless,

the District Court concluded that the FDCA precluded Azurity's

Lanham Act claim -- seemingly in all its variants -- on the ground

- 15 - that the evaluation of the merits of the claim necessarily "would

require the court to determine whether defendant is violating the

FDCA and the FDA's interim policies." Azurity, 540 F. Supp. 3d at

143-44. The District Court explained that the FDA had not itself

made those determinations and that "[e]nforcement of the FDCA and

the detailed prescriptions of its implementing regulations is

largely committed to the FDA," id. at 144 (quoting POM Wonderful,

573 U.S. at 115), such that "[i]t would be inappropriate . . . to

resolve plaintiff's Lanham Act claim, which necessitates

resolution of 'thorny questions that may require the FDA's

expertise,'" id. (quoting Allergan USA Inc. v. Imprimis Pharms.,

Inc., No. 17-1551, 2017 WL 10526121, at *7 (C.D. Cal. Nov. 14,

2017)); see also id. ("Because the FDCA forbids private rights of

action . . . [a] Lanham Act [claim] may not be pursued when, as

here, the claim would require litigation of the alleged underlying

FDCA violation where the FDA has not itself concluded that there

was such a violation." (quoting PhotoMedex, Inc., 601 F.3d at

924)). The District Court went on to explain that, because the

FDCA precluded the Lanham Act claim, Azurity's Chapter 93A claim

had to be dismissed as well. Id.

Azurity timely filed this appeal. We review de novo the

District Court's grant of Edge's Rule 12(b)(6) motion to dismiss

Azurity's Lanham Act and Chapter 93A claims. See Clorox, 228 F.3d

at 30.

- 16 - II.

We start with Azurity's challenge to the District

Court's dismissal of the variant of Azurity's Lanham Act claim

that alleges that Edge's Compliance and Registration Statements

communicate the message that Edge is not "in violation of"

section 503B of the FDCA. Azurity contends that its complaint

plausibly alleges in this variant of its Lanham Act claim that

Edge has engaged in conduct that is barred by the portion of

section 503B that restricts the marketing of compounded drugs that

are "essentially a copy" of approved drugs, 21 U.S.C. § 353b(a)(5).

Accordingly, Azurity contends, it has plausibly alleged that the

Compliance Statements are literally false and the Registration

Statements are misleading due to the messages that those statements

communicate concerning Edge's purported compliance with the

"essentially a copy" portion of section 503B and what conditions

that portion of that section of the FDCA sets forth. Azurity

further contends that, given that this variant of its Lanham Act

claim is otherwise actionable, the District Court erred in

dismissing it, because the FDCA does not preclude it.

We reject Azurity's challenge to the District Court

order of dismissal as to this variant of Azurity's Lanham Act

claim. We do not do so, however, based on FDCA preclusion, even

though Edge urges us to affirm the ruling below on that basis. We

do so because, as we will explain, we are persuaded by the

- 17 - alternative ground that Edge advances to us on appeal for affirming

the District Court's order of dismissal for this variant of

Azurity's Lanham Act claim. See Lin v. TipRanks, Ltd., 19 F.4th

28, 36 (1st Cir. 2021) ("We, of course, may affirm the District

Court's ruling on any ground manifest in the record.").

We begin with Edge's assertion that, FDCA preclusion

aside, Azurity fails to state a claim on which relief can be

granted in the variant of its Lanham Act claim that alleges that

the Compliance Statements, insofar as they communicate that Edge

is not in violation of the "essentially a copy" provision of

section 503B, make a literally false representation of fact.4 In

advancing this non-preclusion-based ground for dismissal, Edge

relies chiefly on two out-of-circuit precedents that set forth a

framework for assessing when a statement that concerns whether an

entity is in violation of a law is actionable under the Lanham

Act. The two precedents are Coastal Abstract Service, Inc. v.

Azurity mentions in passing that the Compliance Statements 4

"mislead health care providers and other customers into believing that Edge's vancomycin product complies with state and federal law, and that it is safe, effective, and legal." But, Azurity develops no argument as to whether, or why, the Compliance Statements are misleading as to the "safe[ty], effective[ness], and legal[ity]" of Edge's vancomycin product if the assertion that Edge is not in violation of section 503B is not literally false. Thus, any such argument is waived for lack of development. See Zannino, 895 F.2d at 17.

- 18 - First American Title Insurance Co., 173 F.3d 725 (9th Cir. 1999),

and Dial A Car, Inc. v. Transportation, Inc., 82 F.3d 484 (D.C.

Cir. 1996).5

In Coastal Abstract, the Ninth Circuit considered

whether a plaintiff could state a Lanham Act claim based on a

defendant's statement that the plaintiff "was not licensed in

California as an escrow company," 173 F.3d at 729, and the fact

that the defendant "stated or clearly implied" that such a license

was "required [by California law] . . . for [the plaintiff's]

activities in connection with refinancing California property,"

id. at 731. The Ninth Circuit concluded that, "[a]bsent a clear

and unambiguous ruling from a court or agency of competent

jurisdiction, statements by laypersons that purport to interpret

the meaning of a statute or regulation are opinion statements, and

not statements of fact," and, as such, are "not generally

actionable under the Lanham Act." Id. The Ninth Circuit ruled on

5In its briefing to us, Edge also cites to a district court case that presented a similar situation to Dial A Car, in which that court adopted the reasoning of the D.C. Circuit in that case, Greenwich Taxi, Inc. v. Uber Techs., Inc., 123 F. Supp. 3d 327, 335-36 (D. Conn. 2015), as well as several other cases in which the district courts there concluded that a legal opinion could not form the basis of a Lanham Act claim, see Metro. Reg'l Info. Sys., Inc. v. Am. Home Realty Network, Inc., 948 F. Supp. 2d 538, 554 (D. Md. 2013); Language Line Servs., Inc. v. Language Servs. Assocs., LLC, No. 10-02605, 2011 WL 5024281, *11 (N.D. Cal. Oct. 13, 2011). These cases accord with our understanding that Edge is asking us to apply the analytic framework that Dial A Car and Coastal Abstract adopt.

- 19 - that basis that the plaintiff had not sufficiently plead that the

statement at issue was false or misleading in violation of the

Lanham Act, because "the correct application of [the statutory

licensing requirement] was not knowable to the parties at the time

that [the defendant] made the licensure statement." Id. at 732.

In Dial A_Car, the D.C. Circuit considered a plaintiff's

contention that the defendants "violat[ed] the Lanham Act by

misrepresenting to [the plaintiff]'s actual and potential . . .

customers that [the defendants'] taxicabs can legally provide

within [Washington, D.C.]" point-to-point transportation to

corporate clients using taxicabs licensed in Virginia or Maryland,

but not D.C. 82 F.3d at 486. The plaintiff argued there that an

order by the D.C. Taxicab Commission Office prohibited the

defendants' taxicabs from providing the service in question to or

from D.C. unless their passengers' origin or destination was in

the county of the taxicabs' licensure. Id. The D.C. Circuit held

that the defendants' representations at issue were not actionable

under the Lanham Act, because "there must be a clear and

unambiguous statement from the Taxicab Commission regarding [the

defendants'] status before a Lanham Act claim can be entertained"

based on the defendants' statements "that they lawfully may

perform" a particular service and there was none in that case.

Id. at 485, 489 (emphasis in original).

- 20 - The D.C. Circuit did acknowledge that it was possible

that "a regulation might conceivably be drafted that would be so

clear on its face that no good faith doubt concerning its

interpretation would be possible, even without an explicit

statement from the [relevant regulatory entity]." Id. at 489 n.3.

In such a circumstance, the court posited, the meaning of the

regulation in question could be "so clear as to be a fact for

Lanham Act purposes," id., such that a representation concerning

the meaning of that law in advertising -- as a representation as

to whether the defendant was violating a law would necessarily

make -- might be actionable as a "false or misleading

representation of fact," 15 U.S.C. § 1125(a)(1). But, the D.C.

Circuit explained, the regulation at issue in that case was not of

that sort. Dial A Car, 82 F.3d at 489 n.3. It thus held the

Lanham Act claim there could not go forward on that basis. Id.

Azurity does not take issue with the framework for

analysis that Coastal Abstract and Dial A Car set forth. Azurity

also makes no argument that the framework is inapplicable here.

It contends instead that, even under that framework, it has

plausibly alleged an actionable Lanham Act claim based on the

literally false representation or description of fact that it

contends that the Compliance Statements make in communicating a

message regarding the relationship between Edge's conduct and the

"essentially a copy" provision of section 503B. Azurity contends

- 21 - that is so because "the section 503B requirements," unlike the

regulation involved in Dial A Car, "are explicit in the statute,

and the FDA has issued clear and unambiguous guidance on how to

apply those requirements."

Azurity refers here to a document cited in its complaint

that the FDA issued in January 2018. See Compounded Drug Products

That Are Essentially Copies of Approved Drug Products Under Section

503b of the Federal Food, Drug, and Cosmetic Act Guidance For

Industry, 2018 WL 953053 (Jan. 2018) [hereinafter "Essentially a

Copy Guidance"]. That document purports to provide non-binding

guidance about how the FDA "intends to consider" a "compounded

drug" with respect to whether it is "identical or nearly identical

to an approved drug" pursuant to the "essentially a copy" provision

of section 503B, see 21 U.S.C. § 353b(d)(2).

The document states that the

FDA intends to consider a compounded drug product to be identical or nearly identical to an approved drug if the compounded drug product and the FDA-approved drug have the same: • active ingredient(s), • route of administration, • dosage form, • dosage strength, and • excipients.

Essentially a Copy Guidance, 2018 WL 953053, at *5.

Azurity asserts that, in light of this document, its

complaint plausibly alleges that "FIRVANQ and Edge's vancomycin

- 22 - product satisfy each of the applicable factors" for making a

compounded drug "identical or nearly identical" to an approved one

under section 503B's "essentially a copy" provision. And, that is

so, according to Azurity, because its complaint plausibly alleges

that its vancomycin drug and Edge's each has the same active

ingredient, is administered orally, and is liquid.6

Azurity acknowledges that its complaint does not allege

that Vancomycin Oral Solution has the same "excipients" as FIRVANQ.

But, Azurity points out that its complaint plausibly alleges that

information about the "excipients" in FIRVANQ is not publicly

available. Thus, Azurity contends, the absence of any allegation

in its complaint about the two drugs sharing the same excipients

is of no concern, given that the FDA's Essentially a Copy Guidance

expressly states that when information about the approved drug's

excipients is not publicly available the agency "does not intend

to consider whether the compounded drug has the same excipients

that the approved drug is labeled to contain in determining whether

a compounded drug is identical or nearly identical to an approved

drug." Id. at *5 n.15.

6 Azurity's complaint does not allege that the two products' dosage strengths are the same, but Azurity did argue to the District Court that its product is administered in the same dosage strength as Edge's. Additionally, Edge argues that the products have different "dosage form[s]" because FIRVANQ is made and sold as "powder and diluent" for oral administration, whereas "Edge's product is a single-dose syringe of oral solution."

- 23 - Azurity does not deny, however, that it is premising

this variant of its Lanham Act claim on the complaint plausibly

alleging that, in the Compliance Statements, Edge made a false

representation or description of fact about the meaning of the

"essentially a copy" provision of section 503B. And yet, to

support the contention that the complaint does plausibly so allege,

Azurity is not relying on any ruling by the FDA, or any court,

that Edge has in fact violated section 503B by engaging in conduct

barred by the "essentially a copy" provision. See Coastal Abstract

Serv., 173 F.3d at 731. Nor is Azurity relying even on a binding

ruling by an agency or a court about the meaning of the

"essentially a copy" provision itself with respect to what the

"applicable factors" are for determining whether two drugs are

identical or nearly identical under that provision of

section 503B. Instead, Azurity is relying solely on a guidance

document from the FDA that the FDA itself describes as "only

recommendations" that are non-binding, see Essentially a Copy

Guidance, 2018 WL 953053, at *1, and that states only that the FDA

"intends to consider" a compounded drug to be "identical or nearly

identical" within the meaning of the "essentially a copy" portion

of section 503B to an approved drug when the five-factor test set

forth above is satisfied, id. at *5 & n.15.

Moreover, Azurity is relying solely on that non-binding

guidance document to support the contention that it has plausibly

- 24 - alleged that, in the Compliance Statements, Edge has made a

literally false representation or description of fact about the

meaning of the "essentially a copy" provision of section 503B even

though the text of section 503B does not itself make clear, on its

face, that two drugs can be "identical or nearly identical" even

if they have divergent "excipients." Indeed, the relevant

statutory text does not refer to any of the five factors set forth

in the FDA's non-binding guidance document, see 21 U.S.C.

§ 353b(d)(2) -- let alone suggest that fewer than all of them need

to be satisfied for a compounded drug to be "essentially a copy"

of an FDA-approved one for purposes of section 503B.

Thus, Azurity does not explain how there is the kind of

"clear and unambiguous ruling" from a court or agency -- either

that Edge specifically is in violation of the relevant provisions

of law, or that interprets the "essentially a copy" provision of

section 503B -- that could ground the variant of the claim that is

at issue under the framework for determining whether this variant

of the claim is actionable that Azurity accepts applies. See

Coastal Abstract Serv., 173 F.3d at 731; Dial A Car, 82 F.3d at

489 & n.3; cf. Metro. Reg’l Info. Sys., Inc. v. Am. Home Realty

Network, Inc., 948 F. Supp. 2d 538, 554 (D. Md. 2013) ("any

statements made by [the counterclaim-defendants] regarding the

copyrightability of [particular information] were nonverifiable

legal opinions that are not actionable under the Lanham Act");

- 25 - Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 230

(3d Cir. 1990) (rejecting a Lanham Act false labeling

claim -- premised on the argument that FDA regulations required a

label that the defendant's product lacked -- on the grounds that

the plaintiff "has not proved that [the defendant's] labeling is

false" because "interpretation of FDA regulations, absent direct

guidance from the promulgating agency, is not as simple as [the

plaintiff] proposes" and therefore did not compel the conclusion

that the defendant's labeling was false). Nor can Azurity argue

that the text of section 503B, given what that text sets forth, is

clear enough on its face to make up for the absence of there being

any such ruling. Cf. Dial A Car, 82 F.3d at 489 n.3. Thus, we

agree with Edge that this variant of Azurity's Lanham Act claim

cannot survive the motion to dismiss under Rule 12(b)(6) because

it fails plausibly to allege that Edge made any literally false

description or representation of fact.

We recognize that Azurity does attempt to fend off Edge's

non-preclusion-based ground for affirming the District Court's

dismissal of this variant of the Lanham Act claim by directing our

attention to a different portion of the "essentially a copy"

provision of section 503B from the "identical or nearly identical"

one that has been our concern thus far. That portion of section

503B reads:

- 26 - The term 'essentially a copy of an approved drug' means . . . a drug, a component of which is a bulk drug substance that is a component of an approved drug . . ., unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable approved drug.

21 U.S.C. § 353b(d)(2)(B).

Azurity contends that the Compliance Statements are

literally false because they communicate that Edge is not engaging

in conduct barred by section 503B based on this "prescribing

practitioner" portion of it. Azurity points as support for that

contention to a different portion of the FDA's non-binding

Essentially a Copy Guidance:

If an outsourcing facility compounds a drug, the component of which is a bulk drug substance that is a component of an approved drug, there must be a change that produces a clinical difference for an individual patient as determined by the prescribing practitioner. If an outsourcing facility intends to rely on such a determination to establish that a compounded drug is not essentially a copy of an approved drug, the outsourcing facility should ensure that the determination is noted on the prescription or order (which may be a patient-specific prescription or a non- patient specific order) for the compounded drug.

FDA is aware that a health care practitioner who orders a compounded drug from an outsourcing facility for office stock will not know the identity of the individual patients who will receive the compounded drug at the time of the order. In that case, the outsourcing facility should obtain a statement

- 27 - from the practitioner that specifies the change between the compounded drug and the comparable approved drug and indicates that the compounded drug will be administered or dispensed only to a patient for whom the change produces a clinical difference, as determined by the prescribing practitioner for that patient. Such assurances should be provided by the health care practitioner or a person able to make the representation for the health care practitioner.

2018 WL 953053, at *7 (emphasis added).

Azurity's complaint, however, is bereft of allegations

that support the prescriber documentation theory for permitting

its Lanham Act claim based on the literal falsity of the Compliance

Statements to go forward that Azurity now presses on appeal. Its

complaint alleges that "the vancomycin [Edge] sells is essentially

a copy of an FDA-approved drug," but the complaint refers in doing

so only to facts and statutory language that bear on the "identical

or nearly identical" portion of that provision of section 503B.

Indeed, Azurity conceded at oral argument to us that no allegations

in its complaint bore on its prescriber documentation theory

specifically. Accordingly, we agree with Edge that Azurity has

not pleaded its "prescribing practitioner" theory of noncompliance

with the "essentially a copy" provision, such that the Compliance

Statements are plausibly alleged to violate the Lanham Act.7

7 Azurity argues in the alternative that if its complaint cannot support its prescriber documentation theory, it should be

- 28 - B.

We turn, then, to Azurity's challenge to the District

Court's dismissal of the Lanham Act claim insofar it rests on the

allegation that the Registration Statements "are materially

misleading to health care providers." Azurity's theory is that

while Edge's representations that it is a "registered" outsourcing

facility may be literally true, such representations give health

care providers the false impression "that Edge complies with state

and federal law," including "[section] 503B." And that is so,

according to Azurity, because despite those statements conveying

entitled to amend its complaint. We leave that determination to the discretion of the District Court on remand. See Fed. R. Civ. P. 15(a)(2); cf. Nikitine v. Wilmington Tr. Co., 715 F.3d 388, 389 (1st Cir. 2013) ("We review a district court's denial of leave to amend for abuse of discretion."). In so doing, we recognize that we leave unaddressed the question of whether a Lanham Act claim predicated on the prescriber documentation theory would be precluded by the FDCA, and if such a claim were precluded, that would render any such amendment futile. But, given that the preclusion analysis depends in large part on the precise nature of the claim brought, and Azurity has not represented to us the precise contours of its proposed amendment, we do not attempt to address the preclusion of any such amended claim here. See PDK Lab'ys Inc. v. DEA, 362 F.3d 786, 799 (D.C. Cir. 2004) (Roberts, J., concurring in part) ("[I]f it is not necessary to decide more, it is necessary not to decide more."). We do not mean in any way to suggest, by opting for this restrained approach at this juncture, what we would decide as to preclusion or that the argument for preclusion would be any stronger with respect to such an amended claim than we conclude that it is for the version of Azurity's Lanham Act claim predicated on the Compliance Statements and Section 503A's bulk drug substance provision. See infra at Part IV.

- 29 - that impression, its complaint plausibly alleges that Edge is in

violation of the "essentially a copy" provision of section 503B

due to the shared characteristics of FIRVANQ and Vancomycin Oral

Solution.8

Edge responds to this argument in part by disputing that

Azurity has plausibly alleged that the Registration Statements

convey the implicit message that Edge is not "in violation of"

section 503B for having engaged in conduct prohibited by the

"essentially a copy" provision of that statute. Edge contends

that the Registration Statements merely convey true and undisputed

facts about its status: that it is registered and inspected. But,

even if we were to conclude otherwise, the question remains as to

whether that implicit message is one that Azurity has plausibly

alleged makes a "misleading representation of fact," 15 U.S.C.

§ 1125(a) (emphasis added), under Dial A Car and Coastal Abstract,

see Coastal Abstract Serv., 173 F.3d at 731; Dial A Car, 82 F.3d

at 489 & n.3. Yet, as to that question, Azurity merely makes the

same arguments based on the non-binding FDA guidance document that

8 Azurity also asserts that the Registration Statements give the false impression "that the FDA has approved the drugs or given its seal of approval to Edge's drugs, and therefore the compounded drugs are safe and effective." However, it develops no argument as to whether, or why, that message would be false or misleading if Edge had not violated section 503B by engaging in conduct prohibited by its "essentially a copy" provision. Thus, we deem any such argument waived. See Zannino, 895 F.2d at 17.

- 30 - we found wanting in connection with its "essentially a copy"

argument with respect to the Compliance Statements. As a result,

we reject Azurity's challenge to the District Court's dismissal of

this variant of the Lanham Act claim as well, because we agree

with Edge that Azurity does not plausibly allege that the

Registration Statements, insofar as they implicitly convey a

message about Edge's compliance with the "essentially a copy"

provision of section 503B, make a misleading representation of

fact.

III.

We now turn to Azurity's challenge to the District

Court's dismissal of the variant of the Lanham Act claim that rests

on allegations about the way that Edge's Compliance and

Registration Statements implicate a different provision of

section 503B -- namely, the "bulk drug substance" provision, 21

U.S.C. § 353b(a)(2)(A). That provision "conditions" the ability

of an "outsourcing facility" to market a drug without prior FDA

approval on the facility "not compound[ing] using bulk drug

substances . . . unless" the substance in question appears on a

list of "bulk drug substances for which there is a clinical need"

promulgated by the FDA or the compounded drug appears on the drug

shortage list. Id. (emphasis added).

The District Court dismissed this variant of Azurity's

Lanham Act claim -- just as it dismissed all variants of it -- on

- 31 - the ground that it was precluded by the FDCA. Azurity argues on

appeal that the District Court was wrong to do so. But, before we

take up that argument, we first must address Edge's contention

that, even if the FDCA does not preclude this variant of Azurity's

Lanham Act claim, it still must be dismissed because Azurity's

complaint fails plausibly to allege that the Compliance and

Registration Statements are false and/or misleading. See

TipRanks, 19 F.4th at 36.

We start with Edge's contention that the viability of

this "bulk drug substance"-based variant of Azurity's Lanham Act

claim fails under the analytic framework set forth in Coastal

Abstract and Dial A Car insofar as the claim is premised on the

allegation that the Compliance Statements are literally false.

For, Edge contends, Azurity does not allege that there has been

any ruling that Edge has violated section 503B by failing to

conform to the requirements in the "bulk drug substance" provision

of that section of the FDCA, or any binding ruling from the FDA or

a court that interprets the FDCA to impose a requirement that

Edge's alleged use of bulk drug substances would violate. See

Coastal Abstract Serv., 173 F.3d at 731 ("Absent a clear and

unambiguous ruling from a court or agency of competent

jurisdiction, statements by laypersons that purport to interpret

the meaning of a statute or regulation are opinion statements, and

- 32 - not statements of fact. Statements of opinion are not generally

actionable under the Lanham Act." (internal citations omitted));

Dial A Car, 82 F.3d at 489.

Azurity responds as follows. It contends that the text

of the provision of law at issue -- namely, the "bulk drug

substance" provision of section 503B -- clearly prohibits the use

of bulk drug substances in compounding where the bulk drug

substance used does not appear on the FDA's official list of "bulk

drug substances for which there is a clinical need," or on the

operative drug shortage list. See 21 U.S.C. § 353b(a)(2)(A). It

further contends that FDA guidance confirms that same

understanding of the meaning of this statutory provision. And,

finally, Azurity argues it has plausibly alleged that Edge is using

a bulk drug substance that is not on either the bulk drug substance

list or the drug shortage list to which the "bulk drug substance"

provision of section 503B refers. Thus, Azurity contends, this

case is factually distinguishable from Dial A Car, such that this

variant of Azurity's Lanham Act claim is actionable even under the

analytic framework that precedent sets forth. And, we note, that

same contention, if it holds up, also would suffice to distinguish

this case, factually, from Coastal Abstract.

We are persuaded by Azurity's response to Edge's

argument that this variant of the Lanham Act claim must be

dismissed even if the FDCA does not preclude it. Recall that

- 33 - section 503B provides that an outsourcing facility cannot market

a compounded drug without prior FDA approval "unless" the substance

in question appears on a list of "bulk drug substances for which

there is a clinical need" promulgated by the FDA or the compounded

drug appears on the drug shortage list. Id. § 353b(a)(2)(A)

(emphasis added). Given that text, there is no interpretation

necessary to determine whether section 503B, through the "bulk

drug substance" provision, sets as a condition for the sale of a

compounded drug that is made using a bulk drug substance that the

bulk substance be on either of the lists that the statutory

provision specifies. Section 503B plainly does.

That is significant. Dial A Car itself recognized the

possibility that a law or regulation could be " so clear on its

face that no good faith doubt concerning its interpretation would

be possible, even without an explicit statement from the [relevant

regulatory entity]," such that it is "so clear as to be a fact for

Lanham Act purposes," 82 F.3d at 489 n.3. Nor are we aware of any

precedent that holds to the contrary. Cf. Dial A Car, Inc. v.

Transp., Inc., 884 F. Supp. 584, 592 (D.D.C. 1995) ("[The

d]efendants were expressing an opinion on an inconclusive question

of law and were not making representations of verifiable or 'hard

definable facts.'" (emphasis added) (quoting Licata & Co. Inc. v.

Goldberg, 812 F. Supp. 403, 408 (S.D.N.Y. 1993))), aff'd, 82 F.3d

484 (D.C. Cir. 1996). And, the statutory provision at issue is of

- 34 - a kind that is unusually susceptible of being clear enough on its

face as to what condition it establishes for the scope of the

condition to be a fact. The provision at issue specifies exactly

which substances cannot be used unless they are on readily

identifiable lists. Yet, one of these lists does not yet even

exist, while there is no dispute that Azurity has plausibly alleged

that the other list does not include the bulk drug substance in

question.

This case is also not one in which the administering

agency has purported to give the statutory provision at issue a

different construction from the one that its plain text appears to

demand. Rather, here, the FDA has merely stated its intention --

in, we add, a non-binding guidance document -- with respect to the

"action" it "intends to take" on the event the condition at issue

is not met. Nothing in that statement suggests that section 503B

does not impose the condition that it plainly imposes with respect

to the use of "bulk drug substances." Indeed, to the extent that

the FDA's interim guidance makes a representation about what

section 503B's bulk substance provision means, which is the

operative question under the framework set forth in Coastal

Abstract and Dial A Car, that guidance acknowledges both that

vancomycin hydrochloride is not on the "503B Bulks List" and that

an "outsourcing facility" that compounds a "drug product from a

bulk drug substance" that is not on the list "does not meet the

- 35 - conditions of section 503B(a)(2)," see Interim Policy On

Compounding Using Bulk Drug Substances Under Section 503b of the

Federal Food, Drug, and Cosmetic Act Guidance For Industry, 2017

WL 345598 at *4, *7 (Jan. 2017) [hereinafter "Interim Bulk Drug

Policy"], and identifies vancomycin hydrochloride as being among

them. Id. at *4, *7.

In sum, Edge appears to accept -- and certainly develops

no argument to the contrary -- that the statements that reference

Edge's "compliance" with section 503B are, plausibly, understood

to make representations about the meaning of section 503B's "bulk

drug substance" provision and not merely representations about

what enforcement action the FDA will or will not take against the

company in the event the condition that is set forth in the "bulk

substance" provision is not satisfied. And, for the reasons we

have given, Azurity has plausibly alleged that, in the Compliance

Statements, Edge represents, in effect, that section 503B does not

say what it plainly says, given that there is no dispute that

Azurity plausibly alleges that the bulk drug substance used by

Edge in compounding -- vancomycin hydrochloride -- is not on either

the bulk drug substance list or the drug shortage list. Thus, we

cannot agree with Edge that we may affirm the District Court's

ruling dismissing this variant of Azurity's Lanham Act claim --

namely, the variant rooted in the Compliance Statements as they

- 36 - relate to the "bulk drug substance" provision -- on the non-

preclusion-based ground that Edge advances.9

We next address Edge's non-preclusion-based ground for

affirming the dismissal of Azurity's Lanham Act claim with respect

to the variant of that claim that alleges that the Registration

Statements are misleading in light of the "bulk drug substance"

provision of section 503B. Here, Azurity alleges that the

statements that Edge is a "registered" outsourcing facility, while

literally true, are misleading because they convey the message

that Edge is not in violation of section 503B, even though Edge is

using a bulk drug substance in a circumstance that is barred by

that provision.

Edge emphasizes that when a plaintiff alleges that an

advertisement is misleading, but not literally false, it bears an

"additional burden . . . to show that the advertisement . . .

conveys a misleading message to the viewing public." Cashmere &

Camel Hair Mfrs. Inst., 284 F.3d at 311 (quoting Clorox, 228 F.3d

9 We note that in finding this version of Azurity's Lanham Act claim viable, we do not mean to foreclose the possibility that a factfinder may conclude that Edge's Compliance Statements represented that Edge was in compliance with the FDCA as the FDA said it was going to enforce it. See Clorox, 228 F.3d at 34 ("Whether an advertisement is literally false is typically an issue of fact. . . . [A] factfinder must determine the claim conveyed by the advertisement.").

- 37 - at 33) (second omission in original). And, Edge then contends

that Azurity has not met this burden because Azurity "pleads no

facts to satisfy this burden" with respect to this variant of its

Lanham Act claim and instead sets forth conclusory allegations

"that the statements could give a misleading impression." We

agree.

Azurity's complaint contains only the allegations that

Edge's statements "are materially misleading to health care

providers and are intended to induce health care providers into

believing that Edge complies with state and federal law," and the

conclusory assertion that "[Edge]'s false and misleading

statements actually deceive and have the tendency to deceive a

substantial segment of the intended audience." Azurity makes no

allegations that explain how, or why, the Registration Statements

could mislead an audience about Edge's conduct with respect to the

"bulk drug substance" provision specifically.

Azurity does cite as support to McGrath & Co., LLC v.

PCM Consulting, Inc., No. 11-10930, 2012 WL 503629 (D. Mass. Feb.

15, 2012). But, the complaint in that case alleged a specific

misimpression that the statements at issue communicated -- that

the statements "give the incorrect impression that . . . 'PCM is

a larger company than it actually is,'" id. at *2, *5. Here, by

contrast, Azurity's complaint alleges only that the statements

"are materially misleading and are intended to induce health care

- 38 - providers into believing that Edge complies with state and federal

law." The complaint makes no allegations that the Registration

Statements actually misled their audience into believing that Edge

does not violate the "bulk drug substance" provision of

section 503B specifically.

Clorox Co. Puerto Rico v. Proctor & Gamble Com. Co., 228

F.3d 24 (1st Cir. 2000), accords with our conclusion. The

complaint there laid out in detail the nature of the misleading

impression the statements at issue conveyed. By contrast,

Azurity's complaint lacks any specific explanation as to how the

Registration Statements could mislead an audience as to Edge's

conduct related to the "bulk drug substance" provision in

particular. See id. at 36-37.

Azurity's complaint does state that the Registration

Statements "are intended to induce health care providers into

believing that Edge complies with state and federal law" (emphasis

added). But, Azurity does not argue to us that it has plausibly

pleaded that Edge made those statements with the intention of

deceiving its consumers. See Cashmere & Camel Hair Mfrs. Inst.,

284 F.3d at 311 n.8 ("[A] plaintiff alleging an implied falsity

claim, however, is relieved of the burden of demonstrating consumer

deception when there is evidence that defendants intentionally

deceived the consuming public."). Thus, any such argument is

waived. See Zannino, 895 F.2d at 17.

- 39 - Accordingly, for reasons independent of possible FDCA

preclusion, we agree with Edge that this variant of Azurity's

Lanham Act claim fails plausibly to allege a statement that is

actionably "misleading."10 Accordingly, we affirm the dismissal

of the claim on that basis. See Intermountain Stroke Ctr., Inc.

v. Intermountain Health Care, Inc., 638 F. App'x 778, 793 (10th

Cir. 2016) (affirming dismissal of Lanham Act claim in part because

"at no point during these proceedings have Plaintiffs explained

how consumers might infer" the misleading representation of fact

that the plaintiff asserted had been made).

IV.

Although we have put the preclusion issue aside up to

this point, we do need to return to it. For, Edge does also

contend that the District Court was right to dismiss the "bulk

drug substance"-based variant of Azurity's Lanham Act claim based

10 Similarly, insofar as Azurity has alleged and argued that the Compliance Statements are misleading -- rather than literally false -- because of what they communicate concerning Edge's conduct under the "bulk drug substance" provision of section 503B, that allegation, too, fails plausibly to state a claim under the Lanham Act. Azurity also asserts that the Registration Statements give the false impression "that the FDA has approved the drugs or given its seal of approval to Edge's drugs, and therefore the compounded drugs are safe and effective." But, here too, Azurity has failed to develop any argument as to why that message would be false or misleading if Edge had not been in violation of section 503B's "bulk drug substance" provision at the time the Registration Statements were made. Any such argument is therefore waived. See Zannino, 895 F.2d at 17.

- 40 - on FDCA preclusion (insofar as Azurity's complaint alleges with

respect to this variant of its Lanham Act claim that the Compliance

Statements are literally false) because the adjudication of that

claim "would undoubtedly interfere with an FDA policy judgment."

In support of that contention, Edge seizes upon the

enforcement priorities stated in the FDA's Interim Bulk Drug

Policy. Based on them, it argues that, because the FDA has

indicated that it does not intend to take action against

outsourcing facilities compounding drugs by using vancomycin

hydrochloride, the FDCA precludes the claim at issue. Interim

Bulk Drug Policy, 2017 WL 345598, at *7.

Edge contends that this conclusion follows from POM

Wonderful, which it contends establishes that the FDCA precludes

Lanham Act claims that would "directly conflict[] with the agency's

policy choice" or otherwise "undermin[e] an agency judgment," 573

U.S. at 120. But, insofar as POM Wonderful could be read to imply

that FDCA preclusion could be warranted under some circumstances,

we find no basis for dismissing this variant of Azurity's Lanham

Act claim on the ground that the FDCA precludes it.

First, like in POM Wonderful, which found no preclusion,

the FDA did not preapprove the statements by Edge that Azurity

alleges were made in violation of the Lanham Act. Thus, this case

is not one in which a finding that the statement is actionable

- 41 - under the Lanham Act calls into question the lawfulness of a

statement that the FDA has deemed proper.

Second, POM Wonderful found no preclusion even where an

FDA regulation governed some aspects of the challenged label. See

573 U.S. at 108. Here, the case for finding no preclusion would

only seem to be stronger. After all, the parties have identified

no FDA regulation that governs the statements that outsourcing

facilities may make in advertising -- let alone a regulation that

would risk subjecting Edge to inconsistent obligations if its

Compliance Statements could be the basis of Lanham Act claims.

Third, and relatedly, like in Pom Wonderful, this is not

a case in which a plaintiff is attempting to enforce the FDCA

indirectly. True, the FDCA does not furnish a private right of

action. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349

n.4 (2001); 21 U.S.C. § 337(a). But, we fail to see the import of

that observation here. For, while Edge does argue that "Azurity

seeks to enforce a 'bulk drug substance' provision of the FDCA

under circumstances in which the FDA has expressly declined to

take any enforcement action," Azurity "seeks to enforce the Lanham

Act, not the FDCA or its regulations," POM Wonderful, 573 U.S. at

117.

Section 503B does regulate how compounded drugs may be

labeled. See 21 U.S.C. § 353b(a)(10). But, neither party suggests

that section 503B or any other provision of the FDCA regulates the

- 42 - statements that outsourcing facilities may make in advertising.

So, rather than enforcing the FDCA, Azurity is merely pursuing a

private right of action under the Lanham Act. See id. at 120

(noting that "the FDA does not have authority to enforce the Lanham

Act" and finding it insufficient to preclude a Lanham Act claim

that the FDA "enacted regulations that touch on similar subject

matter but do not purport to displace that remedy or even implement

the statute that is its source").

Edge's only remaining argument for preclusion is that

Azurity's claim should be precluded because it depends on the

meaning of a law that the FDA administers. Such an argument may

be better understood to rest on the doctrine of primary

jurisdiction, rather than preclusion. See Pejepscot Indus. Park,

Inc. v. Me. Cen. R.R. Co., 215 F.3d 195, 205 (1st Cir. 2000)

(setting forth three factors that inform the decision to refer an

issue to an agency under the doctrine of primary jurisdiction:

"(1) whether the agency determination l[ies] at the heart of the

task assigned the agency by Congress; (2) whether agency expertise

[i]s required to unravel intricate, technical facts; and (3)

whether, though perhaps not determinative, the agency

determination would materially aid the court" (alterations in

original) (quoting Massachusetts v. Blackstone Valley Elec. Co.,

67 F.3d 981, 992 (1st Cir. 1995))). But, whatever the proper

label, the argument does not persuade us here.

- 43 - Edge relies on the Federal Circuit's holding that

a complainant fails to state a cognizable claim under [section 337 of the Tariff Act, 19 U.S.C. § 1337, based on alleged violations of the Lanham Act] where that claim is based on proving violations of the FDCA and where the FDA has not taken the position that the articles at issue do, indeed, violate the FDCA. Such claims are precluded by the FDCA.

Amarin Pharma, Inc. v. Int'l Trade Comm'n, 923 F.3d 959, 968 (Fed.

Cir. 2019). The plaintiff's argument in Amarin was that a

competitor had falsely or misleadingly labeled its dietary

supplement products because "labeling the products as 'dietary

supplements' is literally false because the products 'cannot meet

the definition of "dietary supplement" in Section 201(ff) of the

FDCA.' . . . [T]he [competitor's] products 'are actually

unapproved "new drugs" under the FDCA.'" Id. at 967 (quoting the

plaintiff's complaint). But, despite the broad language of the

excerpt that Edge quotes, Amarin was in fact concerned with a lack

of guidance from the FDA about an unclear statutory question, the

resolution of which implicated the FDA's expertise: whether

synthetically produced omega-3 products were "new drugs" as

defined in the FDCA, which would trigger a requirement that the

FDA approve them for sale and use in the United States. See id.

at 961. Indeed, the Federal Circuit explicitly stated that it was

not making the "broader ruling -- that all such claims are

- 44 - precluded regardless of whether the FDA has provided guidance."

Id. at 968.

Here, by contrast, the "bulk drug substance" provision

of section 503B is clear in the relevant respects, and that clear

statutory text is reinforced by the FDA's interim guidance. The

adjudication of Azurity's "bulk drug substance" claim thus does

not require a court to make a determination that "l[ies] at the

heart of the task assigned the agency by Congress" or requires

"agency expertise . . . to unravel intricate, technical facts."

Pejepscot Indus. Park, Inc., 215 F.3d at 205 (quoting Blackstone

Valley Elec. Co., 67 F.3d at 992 (alteration in original)).

Instead, the adjudication of this claim simply requires a court to

ascertain whether a particular drug appears on either the list of

"bulk drug substances for which there is a clinical need," or on

the drug shortage list. 21 U.S.C. § 353b(a)(2)(A); see also

Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 936, 939 (8th

Cir. 2005) ("The question of whether [the defendant's product]

has been approved as safe and effective is much different from the

question of whether [the defendant's product] should be approved

as safe and effective, and it is only the latter that requires the

FDA's scientific expertise.").

Thus, even if we were to assume that the FDCA precludes

Lanham Act claims that "directly conflict with" the FDA's "policy

choice[s]" or "undermin[e] an agency judgment," see POM Wonderful,

- 45 - 573 U.S. at 117, Azurity's bulk drug claim is not of that kind.

The plain text of the relevant portion of section 503B is clear:

one of the statutory "conditions" for "outsourcing facilit[ies]"

is that the "facility . . . does not compound using bulk drug

substances . . . unless" the substance in question appears on a

list the FDA has not yet promulgated in the manner prescribed by

statute. 21 U.S.C. § 353b(a)(2). Nothing in the FDA's guidance

suggests otherwise. See Belcher Pharms., LLC v. Hospira, Inc., 1

F.4th 1374, 1381 (11th Cir. 2021) (holding a Lanham Act claim not

precluded by the FDCA because the plaintiff "is . . . not asking

us to contradict any regulatory conclusion reached by the FDA" or

"to make any original determination that only the FDA could make—

such as whether the indications for use are safe or effective, or

whether [defendant]'s drug is approved or grandfathered").

Indeed, the FDA's interim bulk drug policy states that bulk drug

substances like vancomycin hydrochloride "[are] not on the 503B

bulks list," Interim Bulk Drug Policy, 2017 WL 345598, at *7.

That is not to deny that the FDA has made a statement

regarding the way it intends to exercise its enforcement

discretion. But, the FDA's choice not to enforce the terms of

this provision against outsourcing facilities that use such bulk

drug substances does not mean that the terms of the provision are

less than perfectly clear. See Allergan, 2017 WL 10526121, at *8

("[T]he FDA's decision to decline enforcement of certain

- 46 - . . . 503B requirements does not help [the defendant]. As an

executive agency, the FDA has discretion to enforce the law, but

the lack of enforcement does not make [the defendant's] actions

legal."). And, the Lanham Act claim at issue merely asks a court

-- with respect to the meaning of that provision -- to find that

the terms of the provision are as clear as they plainly are. Thus,

we perceive no basis for finding the kind of conflict between

Lanham Act enforcement and FDA policy discretion that Edge contends

could supply the basis for finding a Lanham Act claim to be

precluded by the FDCA.11

11 Edge does also contend, more broadly, that Azurity's "Lanham Act claims are precluded because they require litigation of alleged FDCA violations." And, Edge further argues, relying on the Ninth Circuit's pre-POM Wonderful decision in PhotoMedex, "[a] Lanham Act claim may not be pursued if the claim would require litigating whether [the underlying] conduct violates the FDCA," PhotoMedex, Inc., 601 F.3d at 924. But, while Edge is right that Azurity can only succeed on its Lanham Act claims if it can prove that Edge was not in compliance with the relevant provision of section 503B at the time the statements were made, the Supreme Court rejected in POM Wonderful the argument that because only the FDA can enforce the FDCA, Lanham Act claims based on a statement also regulated by the FDCA are categorically precluded. POM Wonderful, 573 U.S. at 117; see also ThermoLife Int'l, LLC v. Gaspari Nutrition Inc., 648 F. App'x 609, 612 n.1 (9th Cir. 2016) (acknowledging that POM Wonderful, by "explain[ing] that the FDCA's exclusive enforcement authority 'does not indicate that Congress intended to foreclose private enforcement of other federal statutes,'" rejected the core rationale underlying the Ninth Circuit's precedent that held that a Lanham Act claim may not be pursued if the claim would require litigating whether the underlying conduct violates the FDCA); JHP Pharms., LLC v. Hospira, Inc., 52 F. Supp. 3d 992, 999 (C.D. Cal. 2014) ("PhotoMedex was the primary case relied on by the lower courts in POM Wonderful,

- 47 - V.

That brings us to Azurity's contention that the District

Court erred in dismissing its challenge to the dismissal of the

variant of its Lanham Act claim that is premised on the Superiority

Statement. That statement, once present on a page of Edge's

website describing its Vancomycin Oral Solution, stated that

"commercially available options are not ideal for use in the

hospital setting."

Azurity argues that this statement by Edge constituted

"a literally false statement about vancomycin hydrochloride" in

violation of the Lanham Act. Edge responds that its statement is

"non-actionable puffery" and that we should affirm the District

Court's dismissal of this version of Azurity's Lanham Act claim on

that basis. We agree with Edge.

Azurity correctly notes that the District Court did not

specifically address the Superiority Statement-based theory in

granting Edge's motion to dismiss. We may also assume that Azurity

and although it was not specifically overruled, its precedential value may be limited."); Innovative Health Solutions, Inc. v. DyAnsys, Inc., No. 14-CV-05207, 2015 WL 2398931, at *7 n.4 (N.D. Cal. May 19, 2015) (same); Surgical Instrument Serv. Co., Inc. v. Intuitive Surgical, Inc., 571 F. Supp. 3d 1133, 1142 (N.D. Cal. 2021) ("PhotoMedex is no longer good law. . . . The 'reasoning and theory' of PhotoMedex is [] 'clearly irreconcilable with the reasoning and theory' of POM Wonderful, making PhotoMedex 'effectively overruled.'" (cleaned up, internal citations omitted)). Accordingly, we are not persuaded by Edge's broader argument.

- 48 - is right that the preclusion rationale upon which the District

Court grounded its decision does not dictate the resolution of

this version of Azurity's Lanham Act claim, because evaluating the

falsity of the Superiority Statement does not require construing

the FDCA. And, that is so because we may affirm a district court's

judgment on any ground manifest in the record, see TipRanks, 19

F.4th at 36, and we conclude that Edge's statement is nonactionable

puffery.

"Advertising claims that fall in the category of

'puffing' are considered not to constitute false advertising and

are not in violation of the Lanham Act." 5 McCarthy on Trademarks

and Unfair Competition § 27:38 (5th ed.). McCarthy's treatise

recognizes two varieties of puffery: (1) "grossly exaggerated

advertising claims . . . [that] no reasonable buyer would believe

was true," and (2) "a general claim of superiority over a

comparative product that is so vague and indeterminate that it

will be understood as a mere expression of

opinion. . . . Advertising claims that a product or service is

'better' and 'superior' fall into this category." Id. But, "[a]

specific and measurable advertisement claim of product superiority

. . . is not puffery." Clorox, 228 F.3d at 38 (alteration in

original) (quoting Southland Sod Farms, 108 F.3d at 1145).

In Clorox, for example, we held that two statements in

advertisements for laundry detergent -- "Compare with your

- 49 - detergent . . . Whiter is not possible" and "Whiter is not

possible" -- were specific and measurable claims of superiority,

rather than puffery, id. at 38–39. The challenged statements, we

explained, "invite[] consumers to compare [the defendant's

detergent]'s whitening power against either other detergents

acting alone or detergents used with chlorine bleach," id. at 39,

in part because the tag line appeared in commercials that featured

"consumers who normally used bleach to achieve white clothes . . .

who [were] favorably impressed by the results obtained from using

[the defendant's product] alone," id. at 35.

Other circuits have concluded similarly. In Pizza Hut,

Inc. v. Papa John's International, Inc., 227 F.3d 489 (5th Cir.

2000), for example, the Fifth Circuit concluded that the slogan

"Better Ingredients, Better Pizza" standing alone constituted

nonactionable puffery under the Lanham Act, because "[t]he word

'better,' when used in this context is unquantifiable" "without

further description," id. at 498-99. But, when that slogan was

accompanied by ads that compared specific ingredients, such as the

tomatoes and the water that went into the dough, the slogan was

given "quantifiable, and fact-specific meaning" such that it no

longer constituted puffery. Id. at 500.

Likewise, in Castrol Inc. v. Pennzoil Co., 987 F.2d 939

(3d Cir. 1993), the Third Circuit upheld a trial court's

determination that the defendant's statement that its motor oil

- 50 - product "outperforms any leading motor oil against viscosity

breakdown" was not puffery, because "[v]iscosity breakdown" is a

specific attribute of motor oil that is measured and graded by

performance on "an industry-recognized laboratory test that

measures the 'kinematic viscosity' of motor oils." Castrol Inc.

v. Pennzoil Co., 799 F. Supp. 424, 429 (D.N.J. 1992), aff'd, 987

F.2d 939 (3d Cir. 1993). And, while the statement did not

explicitly mention any of the defendant's competitors, the fact

that the statement represented that the product was "superior to

other brands" invited the consumer to make that comparison by

necessary implication. Castrol, 987 F.2d at 946.

Azurity argues that Edge's Superiority Statement

represents a false "claim[] that [Edge's] product was 'ideal' for

use in a hospital setting, implying that products such as FIRVANQ

are not, or was otherwise superior to FDA-approved drugs such as

FIRVANQ." But, Azurity further argues, FIRVANQ is ideal for use

in hospitals because it is FDA approved, and, "[b]y its inherent

nature, an FDA-approved product is presumed to be safer and

superior to a compounded formulation using the same active

ingredient." Therefore, Azurity contends, Edge's Superiority

Statement is not nonactionable puffery, because it is "a specific

and measurable advertisement claim of product superiority" that

can form the basis of a Lanham Act claim.

- 51 - But, even if we assume that the challenged statement by

Edge does in fact necessarily imply that Edge's product is "ideal

for use in the hospital setting" and competing products such as

FIRVANQ are not, Azurity's argument rests on the premise that when

Edge represents its product to be "ideal for use in the hospital

setting," a "reasonable consumer" of these drugs would measure the

"ideal-ness" of each drug for use in the hospital setting by

whether the drugs were FDA-approved or not. Pizza Hut, 227 F.3d

at 501. But, Azurity provides no explanation why that is so. Nor

does the Superiority Statement itself invite the consumer to

compare the drugs along that dimension.12 See, e.g., Clorox, 228

F.3d at 38 (inviting the consumer to compare the "whiteness" of

their laundry when they use the defendant's product versus when

12 Nor does the word's definition indicate that, insofar as it can be measured at all, the quality of being "ideal" is anything other than "vague or subjective." Clorox, 228 F.3d at 38. The Oxford English Dictionary defines "ideal" as, "[c]onceived or regarded as perfect or supremely excellent in its kind; answering to one's highest conception." Ideal, Oxford English Dictionary Online (Dec. 2021 update); see also ideal, Merriam-Webster's Unabridged Dictionary ("of or relating to an ideal or to perfection of kind : existing as a perfect exemplar : embodying or symbolizing an ideal"). Additionally, we note that the source that Azurity cites to support its claim that FDA approval serves as proof that a drug is "ideal" in fact belies the contention. Azurity cites the following language from the FDA: "FDA approval of a drug means that data on the drug’s effects have been reviewed . . . and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population." A determination that a drug's benefits outweigh its risks is a far cry from a determination that the drug is "ideal."

- 52 - they use bleach); Pizza Hut, 227 F.3d at 501 ("[A] reasonable

consumer would understand the slogan[, 'Better Ingredients, Better

Pizza,'] when considered in the context of the comparison ads, as

conveying the following message: Papa John's uses 'better

ingredients,' which produces 'better pizza' because Papa John's

uses 'fresh-pack' tomatoes, fresh dough, and filtered water."

(emphasis in original)). Because there are, perhaps, many other

factors that go into whether a drug is "ideal for use in the

hospital setting," such as ease of administration or reliable

supply of the drug in large quantities, that FDA approval itself

may not have a bearing on, we see no reason why FDA approval is

the only measure by which a consumer of these drugs would measure

the "ideal-ness" of them. See Impact Applications, Inc. v.

Concussion Mgmt., LLC, No. 19-3108, 2021 WL 978823, *7 (D. Md.

March 16, 2021) (rejecting the argument that a statement that

implied that the defendant's product was superior to that of the

plaintiff's was not nonactionable puffery on the ground that a

claim of superiority need not equate to a representation of FDA

approval, as "[i]t is unclear, if not unlikely, . . . that a device

that is not approved by the FDA can never be superior in any

respect to an FDA-approved device").

The claim allegedly being made in the Superiority

Statement, moreover, is not like a claim concerning a specifically

measurable attribute like motor oil viscosity (or its capability

- 53 - to prolong engine life), see Castrol, 799 F. Supp. at 427–28, or

a claim in which the advertiser suggests that an attribute, if not

measurable, is comparable, see Ferring Pharms., Inc. v. Braintree

Lab'ys, Inc., 38 F. Supp. 3d 169, 178 (D. Mass. 2014) (finding

that a claim that a drug had a "'superior cleansing efficacy,'

[when] backed up by study results, [was] not mere 'puffery'"). It

is a claim about a product being "not ideal" is not susceptible to

specific measurement. But, we discern no objective way to measure

the quintessentially "vague [and] subjective," Clorox, 228 F.3d at

38, attribute of "ideal-ness" and compare it across products, and

Azurity does not supply us with any guidance.

Thus, we agree with Edge that Edge's statement is

nonactionable puffery. See Catilina Nominees Proprietary Ltd. v.

Stericycle, Inc., No. 15-CV-10734, 2021 WL 1165087, at *6 (N.D.

Ill. Mar. 26, 2021) (concluding, on a motion to dismiss, that

defendant's statement that its products are "ideal for patient

rooms and treatment areas where security and convenience are

critical" "employ[ed] . . . vague buzzwords" and constituted

"puffery"). We therefore affirm on this ground the District

Court's grant of Edge's motion to dismiss the variant of Azurity's

Lanham Act that is premised on Edge's statement that "commercially

available options are not ideal for use in the hospital setting."

- 54 - VI.

Azurity also brings a claim under Chapter 93A, the

Massachusetts state consumer protection law, based on Edge's

Compliance and Registration Statements, as well as its Superiority

Statement. The District Court held that Azurity's "Chapter 93A

claim . . . fails as it is premised on the same allegations" as

its Lanham Act claim. Azurity, 540 F. Supp. 3d at 144 (citing

Reed, 883 F. Supp. 2d at 334–35).

On appeal, Azurity focuses on its Lanham Act claim; it

develops no argument that its Chapter 93A claim can survive if it

has not plausibly alleged Lanham Act violations. On the other

hand, Edge develops no argument for affirming the District Court's

dismissal of Azurity's Chapter 93A claim insofar as any variant of

Azurity's Lanham Act claim can survive. And, as we have explained,

one such variant of that claim can: the "bulk drug substance"-

based one that alleges the Compliance Statements are literally

false. Thus, to the same extent, and for the same reasons, that

we vacate the District Court's dismissal of Azurity's Lanham Act

claim in and affirm that dismissal in part, we vacate and affirm

in part the District Court's dismissal of Azurity's Chapter 93A

claim.13

13We do note that FDCA preemption rather preclusion would appear to be the operative doctrine to assess whether the FDCA

- 55 - VII.

For the foregoing reasons, we affirm in part and vacate

in part the District Court's grant of Edge's motion to dismiss

Azurity's lawsuit, and remand for further proceedings. The parties

shall bear their own costs.

bars a Chapter 93A claim, given that it is a state law claim. But, no such preemption argument has been advanced, and Edge does not explain how preclusion could bar a Chapter 93A claim predicated on the allegations underlying the "bulk substance"-based variant of Azurity's Lanham Act claim that is the only variant that we conclude states a claim.

- 56 -