## F I L E D United States Court of Appeals Tenth Circuit 

### SEP 10 1999 

### PATRICK FISHER Clerk PUBLISH
UNITED STATES COURT OF APPEALS

TENTH CIRCUIT

COTTRELL, LTD., a Colorado corporation, Plaintiff-Appellant, v. BIOTROL INTERNATIONAL, INC., a Delaware corporation, and PRO-DEX, INC., a Colorado corporation, Defendants-Appellees. No. 97-1475

Appeal from the United States District Court

for the District of Colorado (D.C. No. 97-S-1479)
Howard J. Beck (Douglas Jaffe with him on the brief s), Beck and Cassinis, P.C., Aurora, Colorado. Richard A. Johnson (Julie S. Schoenfeld with him onthe brief), Porzak Browning & Johnson LLP, Boulder, Colorado.

Before EBEL , BRISCOE and LUCERO , Circuit Judges.

EBEL , Circuit Judge.- 2 -

Cottrell, Ltd. (“Cottrell”) filed a Lanham Act clai m against Pro-Dex, Inc. (“Pro-Dex”), and its wholly-owned subsidiary, Biotr ol International, Inc. (“Biotrol”), alleging that they made false and misl eading representations with regard to their hard surface cleaning product, “Bir ex.” The district court granted the defendants-appellees’ motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6). We now reverse and remand.

BACKGROUND The parties to this litigation manufacture, adverti se, and market hard surface cleaners and disinfectants for use in medic al and dental facilities. Because the parties’ products are antimicrobial pes ticides, the cleaners and disinfectants are regulated by the Environmental Pr otection Agency (“EPA”), which must review and approve the text of all label s (“label claims”) on or accompanying the products before they can be sold. See 7 U.S.C. §§ 136 & 136a. As such, manufacturers and sellers of hard surface cleaners and disinfectants are forbidden by law from using label claims which have not been approved by and registered with the EPA. See 7 U.S.C. §§ 136a(c)(1) & 136j(a)(1)(B) (“it shall be unlawful for any person . . . to distribute, sel l, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person . . . any registered pestici de if any claims made for it as a1 Title 7 U.S.C. §§ 136-136y (“Federal Insecticide, F ungicide, and

Rodenticide Act” or “FIFRA”) and 40 C.F.R. §§ 152 p rovide a detailed regulatory framework for registering pesticides (including ant imicrobial pesticides like the parties’ hard surface cleaners and disinfectants), including provisions for approving pesticide labels and claims made therein. FIFRA prohibits, interalia , the distribution, sale, receipt or delivery of pest icides which have not complied with the registration requirements, see 7 U.S.C. § 136a(a), and makes unlawful selling “any registered pesticide if any claims mad e for it as a part of its distribution or sale substantially differ from any claims made for it as a part of the statement required in connection with its registrat ion under section 136a of this title,” 7 U.S.C. § 136j(a)(1)(B). - 3 - part of its distribution or sale substantially diff er from any claims made for it as a part of the statement required in connection with i ts registration under section 136a of this title,” which requires pesticide regis trants to file with the EPA administrator “a complete copy of the labeling of t he pesticide, a statement of all claims to be made for it, and any directions for it s use,” in order to qualify for approval). 1 Cottrell sued Pro-Dex and Biotrol (collectively “de fendants-appellees”), claiming that representations made by defendants-ap pellees regarding their hard surface cleaner and disinfectant, which is sold und er the name “Birex,” violated section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a ). Specifically, Cottrell alleged in its complaint that the defendants-appell ees’ label claims were “violative of EPA clearance” and “[a]s such . . . f alse,” and that the label claims deceptively imply that “EPA approval or clearance h as been obtained.” The- 4 -

defendants-appellees filed a motion to dismiss purs uant to Fed. R. Civ. P. 12(b)(6), which the magistrate judge recommended gr anting, stating: Plaintiff’s allegations that the claims are false a re based on the allegation that the claims violate the EPA clearanc e of the product. The complaint does not specifically allege, however , that Defendants’ claim that the efficacy of Birex contin ues for seven days after mixing is actually false or misleading. Thus , resolution of Plaintiff’s claims would involve the determination of whether the claim that the efficacy of the product continues fo r seven days after mixing violates the EPA clearance. Similar to the Mylan [Labs., Inc. v. Matkari , 7 F.3d 1130 (4th Cir. 1993)] case, for purposes o f a Lanham Act misrepresentation claim, it cannot be implied from the fact that the product has been placed on the marketthat the EPA has approved Defendants’ label claims. An affirmative representation is required. Mylan , 7 F.3d at 1139. Based on the above case law, absent an allegation that the Defendants’ claim reg arding the efficacy of Birex is false, Plaintiff has failed to state a claim under section 43(a) of the Lanham Act. Cottrell objected to the magistrate judge’s recomme ndation, but “agreed that an expansion of the existing factual predicate for its claims is warranted.” Accordingly, Cottrell filed a motion for leave to f ile an amended complaint. Cottrell’s proposed amended complaint alleged that the defendants-appellees affirmatively misrepresented that the EPA gave “cle arance and/or approval” to claims made in Birex literature that “proper use is to discard weekly,” and that “Biotrol’s product is not known to be effective forthat period of time [one week], nor has it been demonstrated to be effective under those use conditions [weekly discarding].”- 5 -

The district court accepted the magistrate judge’s recommendation to grant the defendants’ motion to dismiss and denied Cottre ll’s motion for leave to file an amended complaint despite recognizing that “Fed. R. Civ. P. 15(a) requires leave to amend be given freely,” on the ground “that the Proposed Amended Complaint suffers from the same defect as the original compla int.” The district court identified the “defect” it found in Cottrell’s orig inal and proposed amended complaint as follows: “[T]his complaint seeks a de termination whether the label claims [of the defendants] violate the EPA clearanc e. Resolution of the Plaintiff’s complaint would require the court to in terpret and apply regulations that are exclusively within the province of the EPA .” Cottrell now appeals the district court’s grant of the motion to dismiss and denial of its motion for leave to file an amended c omplaint. We reverse and remand.

DISCUSSION Whether the District Court Erred in Dismissing Cott rell’s Lanham Act Claim. A. Standard of Review “We review de novo a district court’s dismissal of a cause of action for failure to state a claim upon which relief can be g ranted.” Chemical Weapons Working Group, Inc. v. United States Dep’t of the A rmy , 111 F.3d 1485, 14902 Because we reverse the district court’s dismissal o f Cottrell’s original

complaint, we do not reach issues concerning the pr oposed amended complaint. - 6 - (10th Cir. 1997). “We uphold a dismissal under Fed . R. Civ. P. 12(b)(6) only when it appears that the plaintiff can prove no setof facts in support of the claims that would entitle him to relief, accepting the wel l-pleaded allegations of the complaint as true and construing them in the light most favorable to the plaintiff.” Yoder v. Honeywell Inc. , 104 F.3d 1215, 1224 (10th Cir.) (quotations omitt ed), cert. denied , 118 S. Ct. 55 (1997). “[T]he Federal Rules of Ci vil Procedure erect a powerful presumption against rejecting pleadings for failure to state a claim.” Cayman Exploration Corp. v. United Gas Pipe Line Co

. , 873 F.2d 1357, 1359 (10th Cir. 1989) (quotations omitted). Granting de fendant’s motion to dismiss is “a harsh remedy which must be cautiously studied, n ot only to effectuate the spirit of the liberal rules of pleading but also to protec t the interests of justice.” Id. (quotations omitted).

B. Merits Cottrell argues that both its original and proposedamended complaint properly alleged all the elements necessary to make out a claim under the Lanham
Act. 2 Section 43(a) of the Lanham Act as amended reads, in relevant part:

(1) Any person who, on or in connection with any g oods or services, or any container for goods, uses in comme rce any word,3 The Act “principally provides for two distinct caus es of action: false

designation of origin or source, known as ‘product infringement,’ and false description or representation, known as ‘false adve rtising.’” Resource Developers, Inc. v. Statute of Liberty-Ellis Island Found., Inc

. , 926 F.2d 134, 139 (2d Cir. 1991) (quoting Johnson & Johnson v. Carter-Wallace, Inc. , 631 F.2d 186, 188 (2d Cir. 1980)); see also Stanfield v. Osborn Indus., Inc. , 52 F.3d 867, 873 (10th Cir. 1995) (“There are two distinct bases of liability u nder section 1125: (1) false representation in advertising concerning the qualit ies of goods (false advertising claims); and (2) false representations concerning the origin or endorsement of goods (false association or product infringement cl aims).”). - 7 - term, name, symbol, or device, or any combination t hereof, or any false designation of origin, false or misleading de scription of fact, or false or misleading representation of fact, which — (A) is likely to cause confusion, or to cause mistake, or to deceive as to the affiliation, connection, or assoc iation of such person with another person, or as to the origin, sp onsorship, or approval of his or her goods, services, or commerci al activities by another person, or (B) in commercial advertising or promotion, misreprese nts the nature, characteristics, qualities, or geograph ic origin of his or her or another person’s goods, services, or commercial activities, shall be liable in a civil action by any person who believes that he or she is or is likely to be damaged by such act. 15 U.S.C. § 1125(a). Thus, as the district court r ecognized, in order to state a claim under § 43(a) of the Lanham Act, 3 a plaintiff must allege: (1) that defendant made material false or misleading represe ntations of fact in connection with the commercial advertising or promotion of its product, see Abbott Labs. v. Mead Johnson & Co. , 971 F.2d 6, 13 (7th Cir. 1992) (“Section 43(a)(2) of the4 Cottrell’s complaint sufficiently alleged the otherthree elements. In

paragraph 20 of the complaint, Cottrell alleged mis representations in commerce. (“The misrepresentations made by the Defendants Bio trol and Pro-Dex have been made in commerce.”) In paragraph 16, Cottrell alle ged that “customers have been actually deceived by advertising and promotional materials published by and continuing to be published by Biotrol and Pro-Dex [ by falsely implying EPA approval of the label].” Finally, in paragraphs 19 and 21, Cottrell alleged sufficient injury. (“Defendants Biotrol and Pro-De x’s material misrepresentations injure Cottrell by causing Cottrell to lose custome rs and sales, resulting in business losses . . . .”); (“The actions of Defenda nts Biotrol and Pro-Dex have and are likely to continue to cause Cottrell irreparabl e harm.”) - 8 - [Lanham] Act prohibits the use of false or misleadi ng statements or representations of fact in commercial advertising, and establishes a private remedy for any violation thereof.”); Sandoz Pharms. v. Richardson-Vicks, Inc. , 902 F.2d 222, 231 (3d Cir. 1990); (2) in commerce; (3) that are either likely to cause confusion or mistake as to (a) the origin, as sociation or approval of the product with or by another, or (b) the characterist ics of the goods or services; and (4) injure the plaintiff. See generallyCharles E. McKenney & George F. Long III, Federal Unfair Competition: Lanham Act § 43(a) , § 6 (11th release 1998). The dispute in this case involves only whether the plaintiff properly alleged the first requirement. 4 As the Second Circuit has explained, “Section 43( a) of the Lanham Act encompasses more than literal falsehoods ,” because otherwise, “clever use of innuendo, indirect intimations, and ambiguous suggestions could shield the advertisement from scrutiny precisely wh en protection against such sophisticated deception is most needed.” American Home Prods. Corp. v.5 We note that on appeal the defendants-appellees ass ert that: “In fact, Birex

is notapproved for a mix and use daily label claim, it i s approved for a claim that states ‘[a]s solution becomes dirty, discard and re place with a fresh one . . . .’” And, in a motion for attorney’s fees filed by defen dants-appellees in the district court, defendants-appellees attached as an exhibit Birex’s approved label which appears to support defendants-appellees’ position. However, because this case comes to us on appeal from 12(b)(6) dismissal for f ailure to state a claim on which relief can be granted, we must accept all the well-pleaded allegations of the (continued...) - 9 - Johnson & Johnson , 577 F.2d 160, 165 (2d Cir. 1978). To assess the truth or falsity of these latter, more amorphous, misleading statements, “the courts favor testing by consumer reaction surveys, but have also found falsity based on their own independent reaction and the reaction of witnes ses testifying before the court, including testimony based on test results, c onsumer surveys, complaints received, allegations of more than a few instances of misrepresentation, and otherwise.” McKenney & Long, supra , § 6.03[2], at 6-27 to 6-28 (citing cases) (footnotes omitted). Notwithstanding the various m ethods for testing the accuracy of allegedly misleading advertising, we re iterate that when considering a motion for dismissal under 12(b)(6), we must assume all facts as alleged. In its original complaint, Cottrell alleged that th e defendants-appellees made material false or misleading representations, as follows:

12. Standardized “label claims” as to efficacy forproducts such as Birex include how long a solution may be us ed after mixing and dilution. Birex’s approved and cleared “label claims” require that it be “mixed and used daily” according to the approved labels on file with the EPA. 55 (...continued)

complaint as true. - 10 -

13. Contrary to the provisions and requirements of its “label claims” as approved by the EPA, Biotrol, through it s product information material and its sales force, has and c ontinues to assert in the context, inter alia , of commercial advertising or promotion that the efficacy of Birex continues for seven days after mixing. 15. Biotrol, under the direction and control of Pr o-Dex, has continued to advertise, market and sell its Birex p roductunder that and various other names with the full knowledge that the claims made are violative of EPA clearance . As such, these Defendants’ advertising and promotional materials and claims as included with the products themselves, as well as on product info rmation sheets and through sales persons, are false. 16. The Defendants Biotrol and Pro-Dex’s material representations in commercial advertising and promo tion has been disseminated to their customers and potential custo mers, many if not all of whom are also customers or potential custome rs of Cottrell. Such customers have been actually deceived by the a dvertising and promotional materials published by and continuing t o be published by Biotrol and Pro-Dex. Said claims and misrepresentations further deceive existing and potential customers of the parties by implying that EPA approval or clearance has been obtained th erefor

. 17. Customers for hard surface disinfectants are attracted by “label claims” which provide for “mixing and using” over longer periods of time. By making false label claims, inter alia , that Birex can [be] used for seven days after mixing , Biotrol and Pro-Dex place Cottrell at a gross, substantial and continuing competitive disadvantage. Because false and incorrect label cl aims make their products appear to be more attractive to customers and ultimately end users of these products, the Defendants misrepresentations are likely to influence the purchasing decisions of the person s and entities to whom disseminated.- 11 -

The defendants-appellees argue that “FIFRA is the e xclusive federal law that regulates the labeling of pesticides,” that “B irex is regulated as a pesticide under [FIFRA],” and that Cottrell’s allegations rel ate only to Birex’s label claims. Thus, they argue that Cottrell is attempting to do indirectly what Congress has not given it the right to do directly — i.e., enforce t he requirements of FIFRA (which only the EPA can do) by way of the Lanham Act. Mor eover, the defendantsappellees argue that resolution of Cottrell’s claim s would require a determination of whether the label claims violate EPA clearance —a determination requiring EPA expertise, which only the EPA is qualified to m ake. Accordingly, the defendants-appellees claim that Cottrell has failed to state a claim on which relief can be granted in the courts. Cottrell argues that it is not attempting to enforc e FIFRA, but rather to vindicate its rights under the Lanham Act independe nt of FIFRA. We agree. Construing Cottrell’s complaint in the light most f avorable to Cottrell, we recognize at least three allegations of false or mi sleading statements made by defendants-appellees which, for purposes of this op inion, we characterize as claims #1, #2 and #3: #1, that representations mad e in Birex’s advertisements violate the EPA clearance obtained under FIFRA by c laiming that Birex continues to be an effective cleaner and disinfectant for sev en days; #2, that Birex’s advertising deceives customers “by implying that EP A approval or clearance has6 Claims #1 and #2 are closely related but distinct. As we discuss further

below, claim (1) is an allegation that Birex’s labe l claims violate FIFRA, related regulations, and EPA actions taken pursuant to FIFRA. As such, claim #1 is an impermissible attempt under the Lanham Act to enfor ce FIFRA’s substantive provisions. Claim #2, on the other hand, focuses o n Birex’s representations directed at consumers, and asserts that Birex’s lab el claims put in commerce a false representation of EPA approval (which Cottrel l argues had not been given). - 12 - been obtained [for the seven-day efficacy claim]”; 6 and #3, that Birex’s claim that it “can be used seven days after mixing” is factual ly false. In resolving defendants-appellees motion to dismiss , the district court focused on paragraph 15 of Cottrell’s complaint, wh ich contained only allegations of the first category of falsity that we have ident ified (claim #1 in the preceding paragraph). Based on allegations contained therein , the district court “agree[d] with the Recommendation [of the magistrate judge] t hat this complaint seeks a determination whether the label claims violate the EPA clearance. Resolution of the Plaintiff’s complaint would require the court t o interpret and apply regulations that are exclusively within the province of the EPA .” According to the district court, this was contrary to the teaching of Mylan L abs., Inc. v. Matkari , 7 F.3d 1130, 1139 (4th Cir. 1993); Sandoz Pharms. , 902 F.2d at 231; Summit Tech., Inc. v. High-Line Med. Instruments, Co. , 933 F. Supp. 918, 933 n.7 (C.D. Cal. 1996); Grove Fresh Distribs., Inc. v. Flavor Fresh Foods, Inc. , 720 F. Supp. 714, 715-16 (N.D. Ill. 1989). We agree with the district courtthat claim #1 is subject to 12(b)(6) dismissal. However, in our view the distr ict court failed to recognize the- 13 -

second and third categories of alleged falsity we h ave identified (claims #2 and #3 in the preceding paragraph). We reverse the distri ct court’s dismissal of Cottrell’s case because we find that Cottrell alleg ed sufficient facts regarding claims #2 and #3 to state a claim under the Lanham Act. We find instructive an unpublished memorandum and o rder from the United States District Court for the District of Kansas wh ich addressed similar issues in a case involving the interaction between the Lanham A ct and the federal Food, Drug, and Cosmetic Act (“FDCA”). See Braintree Labs., Inc. v. Nephro-Tech,
Inc. , No. 96-2459-JWL, 1997 WL 94237 (D. Kan. Feb. 26, 1997). There, the plaintiff contended that “the ‘dietary supplement’ designation on defendants’ product [which had not obtained approval for market ing as a drug by the federal Food and Drug Administration (“FDA”)] constitute[d] a false or misleading description in violation of section 43(a) of the La nham Act. Defendants argue[d] that this claim may not stand because it merely all eges a violation of FDCA, for which no private right of action exists.” Id. at *2 (citation and footnote omitted). After discussing Sandoz Pharms. , Mylan Labs. , Grove Fresh Distribs. , and Summit Tech , the court observed that “[a] general framework may be gleaned from these cases.” Id. at *6. The court noted that: Affirmative misrepresentations . . . are generally actionable under the Lanham Act, even if the product is regulated by the FDA. Most obviously, a false statement of FDA approval is act ionable. It is also clear that, because no private right of action exis ts under the FDCA,- 14 -

a plaintiff may not use the Lanham Act as an altern ative vehicle by which to seek redress for an FDCA violation. Moreo ver, claims that require direct interpretation and application of th e FDCA are not properly recognized because such matters are more appropriately addressed by the FDA, especially in light of Congre ss’s intention to repose in that body the task of enforcing the FDCA. The court believes that the Tenth Circuit would embrace these general principles. Id. Ultimately, in Braintree Labs. , the court concluded that the issue of whether the defendants’ product’s claim to be a “dietary supplement” was false or misleading involved interpretation and application of the FDA definition of “dietary supplement”; thus the court granted defend ants’ motion to dismiss plaintiff’s Lanham Act claim. See id. at *7. The framework announced in Braintree Labs. serves us well in this case. As to Cottrell’s claim that we have denominated #1, we agree with the district court that it must be dismissed. First, no party c hallenges the district court’s conclusion that “FIFRA is exclusively enforced by the [EPA],” and thus we accept this proposition for the purposes of this ap peal. See Almond Hill Sch. v. United States Dep’t of Agriculture , 768 F.2d 1030, 1035-38 (9th Cir. 1985) (stating that “FIFRA does not authorize explicitly or implicitly a private cause of action to enforce the Act.”); Fiedler v. Clark , 714 F.2d 77, 79 (9th Cir. 1983) (noting that FIFRA contains no explicit provision f or private enforcement and “legislative history confirms that Congress did notintend to create a private cause of action under FIFRA,” specifically citing Congres s’ rejection of a proposed- 15 -

provision permitting private enforcement suits). T hus, this case is like Braintree Labs. because the EPA stands in a similar enforcement re lationship to FIFRA as the FDA does to the FDCA. Second, we believe that Cottrell’s claim #1 is properly characterized as an attempt to enforce FIF RA’s labeling requirements. The “EPA clearance” that Cottrell claims Birex’s ad vertisement violates was obtained pursuant to (and only because of) FIFRA. See Lowe v. Sporicidin Int’l. , 47 F.3d 124, 130 (4th Cir. 1995) (“[I]t is clear th at there is a ‘FIFRA-created duty’ to file ‘a statement of all [label] claims’ m ade for a pesticide with the EPA, § 136(c)(1)(C), and notto make ‘any claims for it as a part of its distri bution or sale’ that ‘substantially differ from any claims ma de for it as a part of th[at] statement.’ § 136j(a)(1)(B).” (first two alteratio ns ours, others in original)). Independent of FIFRA, an allegation that Birex’s cl aims of seven-day efficacy violates EPA clearance has no force because indepen dent of FIFRA no EPA clearance or approval for label claims would be nec essary. Moreover, we believe that a determination of the scope of EPA clearance, and whether Birex’s advertisement violates that clearance, would requir e EPA expertise. Finally, and most simply, even reading all inferences in Cottrel l’s favor, claim #1 fails to allege any false advertising. Accordingly, we agre e with the district court that Cottrell must not be permitted to bring a FIFRA cla im dressed up as a Lanham7 We note that an allegation of a mere implication of EPA approval

approaches the type of abstract and unspecific alle gation that courts correctly consider to be insufficient to survive 12(b)(6) dis missal. Thus, unless Cottrell demonstrates how defendants-appellees “imply” EPA approval, this claim still might be ripe for dismissal prior to trial. - 16 - Act claim, and claim #1 must be dismissed. Cf. Mylan Labs. , 7 F.3d at 1139; Sandoz Pharms. , 902 F.2d at 231. As to claims #2 and #3, however, we believe Cottrel l has alleged sufficient facts to support a Lanham Act claim independent of FIFRA. As identified above, claim #2 alleges that Birex’s advertising deceives customers “by implying that EPA approval or clearance has been obtained [for th e seven-day efficacy claim].” 7 As noted above, this claim is distinct from claim # 1 because in addition to alleging that the label claims did not comport with FIFRA regulations and EPA approval, claim #2 adds an allegation that Birex’s label claim, in the context in which the product is advertised, deceives consumers into believing, erroneously, that the EPA has approved Birex’s one-week efficacyclaim. As Braintree Labs. stated: “Most obviously, a false statement of [EPA] approval is actionable.” Braintree Labs , 1997 WL 94237, at *6; see also Mylan Labs. , 7 F.3d at 1138-39 (in general an allegation of false label claim of F DA approval is sufficient to survive dismissal under Rule 12(b)(6), but there itwas insufficiently alleged “that defendants[ explicitly] falsely represented that th eir drugs had been ‘properly approved by the FDA’” and “that fatal deficiency ca nnot be cured by contentions- 17 -

that the very actof placing a drug on the market, with standard pac kage inserts often used for FDA-approved drugs, somehow implies (falsely) that the drug had been ‘properly approved by the FDA.’”). If Cottrel l can establish by consumer surveys or other means that Birex’s advertising is likely to confuse or actually confuses consumers, then the effect of the false “i mplication” of EPA approval that Cottrell now asserts could be as damaging for Lanham Act purposes as an express false claim of EPA approval. Thus, in the posture this case now stands, Cottrell has sufficiently alleged a material misrep resentation under the Lanham
Act. Defendants-appellees, however, would have us dismis s this case because Cottrell’s Lanham Act claim touches on issues cover ed by FIFRA. That is, because FIFRA prohibits the sale and distribution o f products with unapproved or materially altered labels, defendants-appellees cla im that FIFRA should preclude an independent Lanham Act claim. But, because FIFRA nowhere explicitly precludes Lanham Act coverage, we refuse to limit t he scope of the Lanham Act absent circumstances that inherently require interp retation of FIFRA regulations and/or EPA approvals. Cf. Marriott Corp. v. Great America Serv. Trades Council , 552 F.2d 176, 180-81 (7th Cir. 1977) (refusing to dismiss Lanham Act claim involving “labor dispute,” and rejecting argu ment that Labor Management Relations Act gives exclusive jurisdiction to the N ational Labor Relations Board- 18 -

because “[t]he fact that conduct is involved which may tangentially be covered by section 7 or 8 of the Labor Management Relations Ac t is not sufficient to preempt jurisdiction over Marriott’s [Lanham Act] trad emark action”); see also McKenney & Long, supra , § 2.02, at 2-7 to 2-10 & nn. 10-19.2 (citing conf licting cases). While there might be cases which would req uire EPA expertise to determine whether claims made for a product were ap proved by the EPA, that fact is not evident from the complaint before us in this case, and at this early stage of pleadings we will not construe Cottrell’s claim #2 to involve such an allegation. Claim #2 can be construed to contend simply that th e defendants-appellees falsely imply that the EPA has approved their claim that Bi rex is effective for seven days after mixing when in fact the EPA has not given suc h approval. We believe courts are capable of resolving such issues. Cf. Grove Fresh Distribs. , 720 F. Supp. at 715-16 (despite fact that FDA regulation p rovides definition of “orange juice from concentrate,” court was capable of resol ving plaintiff’s Lanham Act claim that defendants falsely claimed their productwas “100% orange juice from Concentrate” without reference to agency definition or expertise). Accordingly, as to claim #2, Cottrell has stated a claim under t he Lanham Act on which relief can be granted and the Rule 12(b)(6) dismissal mustbe reversed. Likewise, Cottrell’s claim #3 — that defendants-app ellees falsely represent that Birex “can be used seven days after mixing” — alleges sufficient facts to8 Because we reverse the district court’s dismissal o f Cottrell’s original

complaint, we offer no opinion as to whether the di strict court erred in denying Cottrell’s motion for leave to file an amended comp laint. - 19 - state a claim under the Lanham Act and is not the p roper subject for Rule 12(b)(6) dismissal. Admittedly, Cottrell’s assertion that “ [b]y making false label claims, inter alia , that Birex can [be] used for seven days after mix ing,” is not the most clear and direct way Cottrell could have alleged fa lsity. However, construing this claim in the light most favorable to Cottrell, we m ust conclude that it sufficiently alleges that the defendants-appellees falsely repre sent the efficacy of Birex. This type of claim — alleging that Birex’s label claims misrepresent facts concerning the quality of the product — is at the core of whatthe Lanham Act “false advertising” prohibition makes actionable. And aga in, although there may be circumstances under which EPA expertise would be ne cessary to determine the efficacy and longevity of Birex, from the naked ple adings alone we cannot say for certain that this is such a case. Accordingly, we reverse the Rule 12(b)(6) dismissal as to claim #3.

CONCLUSION We REVERSE the district court’s dismissal of Cottre ll’s complaint pursuant to Rule 12(b)(6), and REMAND this case forfurther proceedings. 8