Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-casd-3_16-cv-02338/USCOURTS-casd-3_16-cv-02338-0/pdf.json

Nature of Suit Code: 840
Nature of Suit: Trademark
Cause of Action: 15:1125la Trademark Infringement (Lanham Act)

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UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF CALIFORNIA

NUTRITION DISTRIBUTION, LLC,

Plaintiff,

v.

NEW HEALTH VENTURES, LLC,

Defendant.

Case No.: 16-cv-02338-BTMMDD

ORDER DENYING PLAINTIFF’S 

MOTION FOR LEAVE TO 

AMEND COMPLAINT, 

GRANTING DEFENDANT’S 

MOTION TO DISMISS AND 

DENYING DEFENDANT’S 

MOTION TO STRIKE

Before the Court are Defendant New Health Ventures, LLC’s motion to 

dismiss and motion to strike, as well as Plaintiff Nutrition Distribution, LLC’s 

motion for leave to file an amended complaint. (ECF Nos. 5–6, 13.) For the 

reasons discussed below, Plaintiff’s motion for leave to amend is denied, 

Defendant’s motion to dismiss is granted and its motion to strike certain portions 

of the Complaint is denied as moot. 

I. BACKGROUND

On September 15, 2016, Plaintiff filed a Complaint against Defendant alleging 

a single cause of action of false advertisement in violation of Section 43(a)(1)(B) 

of the Lanham Act. (ECF No. 1 (“Compl.”).) Plaintiff alleges that Defendant 

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falsely advertised and marketed products containing various “Selective Androgen 

Receptor Modulators (“SARMS”)” such as “Ostarine.” (Compl. ¶ 27.) On 

October 26, 2016, Defendant filed a motion to dismiss for failure to state a claim 

and a motion to strike Plaintiff’s request for injunctive relief. In response, on 

December 12, 2016, Plaintiff filed a proposed First Amended Complaint (ECF 

No. 8 (“FAC”)) asserting three causes of action including a violation of the 

Lanham Act, a violation of the Civil Racketeer Influenced and Corrupt 

Organizations Act (“RICO”), and a violation of the California Business and 

Professions Code Section 17200. Unlike Plaintiff’s original Complaint, its 

proposed FAC is based on Defendant’s sale of products containing Dimethazine 

(“DMZ”). 

Defendant subsequently filed a request for entry of dismissal with 

prejudice, arguing that because Plaintiff did not oppose the motion to dismiss and 

instead filed an untimely FAC without leave from the Court, the case should be 

dismissed with prejudice. (ECF No. 9.) On January 3, 2017, Plaintiff filed a

motion for leave to amend its Complaint. 

II. STANDARD

A. Leave to Amend

Pursuant to Federal Rule of Civil Procedure 15(a)(2), “a party may amend 

its pleading only with the opposing party’s written consent or the court’s leave.” 

Fed. R. Civ. P. 15(a)(2). “The court should freely give leave when justice so 

requires.” Id. “Liberality in granting a plaintiff leave to amend is subject to the 

qualification that the amendment not cause undue prejudice to the defendant, is 

not sought in bad faith, and is not futile.” Bowles v. Reade, 198 F.3d 752, 757 

(9th Cir. 1999). Additionally, a court may consider the factor of undue delay. Id.

at 757–58. 

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These factors are not given equal weight. Bonin v. Calderon, 59 F.3d 815, 

845 (9th Cir. 1995). “Futility of amendment can, by itself, justify the denial of a 

motion for leave to amend.” Id. The test for futility is the same one used when 

considering the sufficiency of a pleading under Rule 12(b)(6). Miller v. RykoffSexton, Inc., 845 F.2d 209, 214 (9th Cir. 1988). 

B. Rule 12(b)(6)

A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) should 

be granted only where a plaintiff's complaint lacks a "cognizable legal theory" or 

sufficient facts to support a legal claim. Balistreri v. Pacifica Police Dept., 901 

F.2d 696, 699 (9th Cir. 1988). When reviewing a motion to dismiss, the 

allegations of material fact in plaintiff’s complaint are taken as true and construed 

in the light most favorable to the plaintiff. Parks Sch. of Bus., Inc. v. Symington, 

51 F.3d 1480, 1484 (9th Cir. 1995). Although detailed factual allegations are not 

required, factual allegations “must be enough to raise a right to relief above the 

speculative level.” Bell Atlantic v. Twombly, 550 U.S. 544, 555 (2007). “A 

plaintiff’s obligation to prove the ‘grounds’ of his ‘entitle[ment] to relief’ requires 

more than labels and conclusions, and a formulaic recitation of the elements of a 

cause of action will not do.” Id. “[W]here the well-pleaded facts do not permit the 

court to infer more than the mere possibility of misconduct, the complaint has 

alleged - but it has not show[n] that the pleader is entitled to relief.” Ashcroft v. 

Iqbal, 556 U.S. 662, 679 (2009) (internal quotation marks omitted). Only a 

complaint that states a plausible claim for relief will survive a motion to dismiss. 

Id.

C. Rule 9(b)

Under Federal Rule of Civil Procedure 9(b), a plaintiff “must state with 

particularity the circumstances constituting fraud or mistake.” Fed. R. Civ. Proc. 

9(b). A plaintiff alleging fraud “must state the time, place, and specific content of 

the false representations as well as the identities of the parties to the 

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misrepresentations.” Alan Neuman Prods., Inc. v. Albright, 862 F.2d 1388, 

1392–93 (9th Cir. 1988) (quoting Schreiber Distrib. Co. v. Serv-Well Furniture 

Co., 806 F.2d 1393, 1401 (9th Cir. 1986)). 

II. DISCUSSION

A. Plaintiff’s Motion to Amend

Defendant opposes Plaintiff’s motion for leave to file its FAC on grounds of 

bad faith, undue prejudice, and futility. First, Defendant argues that Plaintiff 

acted in bad faith because it completely abandoned its original claim and evaded 

an unfavorable ruling and possible attorney’s fees. Second, Defendant argues 

that it would be prejudiced if an amendment is permitted because the original 

claims will never be adjudicated and it would be deprived of seeking its attorneys’ 

fees. Finally, Defendant contends that the Court should deny Plaintiff leave to 

amend because the proposed amendments are futile. 

At this juncture, no ENE has taken place and discovery has not yet 

commenced. Though the motion is procedurally defective, given the early stage 

of this litigation, the Court does not find that Plaintiff acted in bad faith, caused 

undue delay, or that granting Plaintiff leave to file an FAC would prejudice 

Defendants. Therefore, leave to amend turns on whether the proposed 

amendments would be futile. 

1. Lanham Act Claim

Defendant argues that Plaintiff’s Lanham Act claim is futile because it is

barred under the primary jurisdiction doctrine and fails to satisfy Rules 12(b)(6) 

and 9(b). 

Section 43(a) of the Lanham Act “allows one competitor to sue another if it 

alleges unfair competition arising from false or misleading product descriptions.” 

POM Wonderful LLC v. Coca-Cola Co., __ U.S. __, 134 S. Ct. 228, 1879 (2017). 

A plaintiff seeking to establish a prima facie case under the Lanham Act must 

show that: 

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(1) the defendant made a false statement either about the plaintiff’s or its 

own product; (2) the statement was made in commercial advertisement or 

promotion; (3) the statement actually deceived or had the tendency to 

deceive a substantial segment of its audience; (4) the deception is material; 

(5) the defendant caused its false statement to enter interstate commerce; 

and (6) the plaintiff has or is likely to be injured as a result of the false 

statement, either by direct diversion of sales from itself to the defendant, or 

by a lessening of goodwill associated with the plaintiff’s product. 

Newcal Indust. V. Ikon Office Solution, 513 F.3d 1038, 1052 (9th Cir. 2008). 

i. Futility Under the Primary Jurisdiction Doctrine 

Defendant argues that Plaintiff’s Lanham Act claim—based on its failure to 

disclose DMZ’s health effects—is futile because it is barred under the primary 

jurisdiction doctrine. 

The primary jurisdiction doctrine allows federal courts, under limited 

circumstances, to defer to a relevant agency “when a claim is cognizable in 

federal court but requires resolution of an issue of first impression, or of a 

particularly complicated issue that Congress had committed to a regulatory 

agency.” Syntek Semiconductor Co. v. Microchip Tech. Inc., 307 F.3d 775, 780 

(9th Cir. 2002) (citations omitted). Though discretionary, in evaluating primary 

jurisdiction a court should consider “(1) the need to resolve an issue that, (2) has 

been placed by the United States Congress within the jurisdiction of an 

administrative body having regulatory authority, (3) pursuant to a statute that 

subjects an industry or activity to a comprehensive regulatory authority that, (4) 

requires expertise or uniformity in administration.” Id. at 781. 

Relying on Aaronson v. Vital Pharmaceuticals, Incorporation, No. 9–cv1333-W, 2010 WL 625337, at *2–3 (S.D. Cal. Feb. 17, 2010), Defendant argues 

that Plaintiff’s allegations concerning Defendant’s omissions about DMZ’s health 

effects falls within the FDA’s primary jurisdiction. In Aaronson, the court 

determined that the plaintiff’s claims rested on the question of whether the 

product was in fact safe. Id. at * 2. The court, therefore, dismissed the plaintiff’s 

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claims under the primary jurisdiction doctrine and deferred to the FDA because it 

found that the agency was in a better position to make that determination. Id. at * 

3. 

Unlike the claims in Aaronson, Plaintiff’s claim does not depend on whether 

DMZ is safe or not. Plaintiff alleges that “Defendant markets DMZ to body 

builders, gym users, fitness enthusiasts and athletes, promising consumers 

numerous purported physical benefits without mentioning the overwhelming 

clinical evidence that such products pose extreme health risks.” (FAC ¶ 18.) 

Here, Plaintiff’s claim instead requires the Court to determine whether Defendant 

misled consumers by failing to disclose the alleged severe health effects 

associated with taking DMZ. Therefore, the FDA’s technical and policy expertise 

is not necessary to determine whether Defendant’s advertisements are 

misleading. See Nutrition Distribution LLC v. Custom Nutraceuticals LLC, 194 F. 

Supp. 3d 952, 955–956 (D. Ariz. 2016) (holding that nearly identical allegations, 

including whether Defendant made false and misleading statements about 

Ostarine’s side effects, were not barred under the primary jurisdiction doctrine); 

see also Thermolife Int’l, LLC v. Gaspari Nutrition Inc., 648 Fed. Appx. 609, 612 

(9th Cir. Apr. 14, 2016) (finding that whether a nutritional supplement distributor 

“falsely advertised its product as ‘safe’ and ‘natural’ require[d] no interpretation of 

the FDCA”). 

Accordingly, Plaintiff’s claim based on Defendant’s alleged omission of 

DMZ’s side effects is not barred by the primary jurisdiction doctrine. 

ii. Futility under 12(b)(6) 

Defendant also argues that Plaintiff has not sufficiently alleged a claim 

under the Lanham Act. 

First, Defendant maintains that Plaintiff fails to allege how DMZ is a 

“controlled substance” under the Controlled Substance Act (“CSA”), 21 U.S.C. § 

802(41)(C). The CSA classifies more than a dozen drugs and hormonal 

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substances as Schedule III controlled substances. § 802(41)(A). Additionally, it 

provides that:

a drug or hormonal substance . . . that is not listed in subparagraph (A) and 

is derived from, or has a chemical structure substantially similar to, 1 or 

more anabolic steroids listed in subparagraph (A) shall be considered to be 

an anabolic steroid for purposes of this Act if—(I) the drug or substance 

has been created or manufactured with the intent of producing a drug or 

other substance that either (aa) promotes muscle growth; or (bb) otherwise 

causes a pharmacological effect similar to that of testosterone; or (II) the 

drug or substance has been, or is intended to be, marketed or otherwise 

promoted in any manner suggesting that consuming it will promote muscle 

growth or any other pharmacological effect similar to that of testosterone.

§ 802(41)(C). 

Plaintiff alleges that DMZ is a controlled substance because it is derived 

from, and structurally similar to, Methastorone—a chemical already deemed to 

be an anabolic steroid under the Act. (FAC ¶ 14.) It claims that DMZ is 

“composed of two Methastorone molecules ba bonded at the center by two 

nitrogen atoms.” (Id.) DMZ breaks down into Methastorone when it gets in 

contact with stomach acid. (Id.) As a result, the two molecules of Methastorone 

act on your body as they would if you had taken the drug on its own. (Id.) At this 

stage, the Court finds that Plaintiff has sufficiently pled that DMZ falls within the 

definition of a “controlled substance” under Section 802(41)(C) of the CSA. 

Second, Defendant argues that Plaintiff’s claim regarding Defendant’s 

alleged failure to disclose that DMZ is banned by anti-doping organizations is 

legally insufficient because it is not an actionable omission. 

Under the Lanham Act, a statement is actionable “if it is affirmatively 

misleading, partially incorrect, or untrue as a result of a failure to disclose a 

material fact.” U.S. Healthcare, Inc. v. Blue Cross of Greater Phila., 898 F.2d 

914, 921 (3d. Cir. 1990) (quoting J. Thomas McCarthy, Trademarks and Unfair 

Competition, § 27.7B (2d ed. 1984)). Federal courts have held that while 

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omissions can be actionable under the Lanham Act if they render affirmative 

statements false or misleading, a plaintiff must point to such statements at the 

pleading stage. See id.; see also Casper Sleep, Inc. v. Mitcham, 204 F. Supp. 

3d 632, 638 (S.D.N.Y. 2016); Oil Heat Ins. V. Northwest Natural Gas, 708 F. 

Supp. 1118, 1123 (D. Or. 1988) (holding that a reasonable fact finder could 

reasonably conclude that Northwest failed to disclose material facts about its 

product, making the statement untrue). 

Defendant contends that the proposed FAC fails to state how the alleged 

omission contradicts a representation made by Defendant or that Defendant was 

obligated to disclose such omission. Plaintiff alleges that Defendant marketed its 

product, Fury DMZ, as “hands down the strongest anabolic Pre-Workout on the 

market today!” (FAC ¶ 21.) Defendant advertised that “Fury DMZ is an 

extremely potent, high-intensity, high-stimulant and highly anabolic pre-workout 

concoction.” (Id.) However, Plaintiff fails to point to any statement that would be 

rendered misleading or untrue as a result of Defendant’s alleged omission that 

DMZ is banned by competitive anti-doping organizations. Accordingly, to the 

extent that Plaintiff’s Lanham Act claim is based on this alleged omission, it 

would not survive a motion to dismiss under Rule 12(b)(6). 

iii. Futility Under Rule 9(b)

Lastly, Defendant argues that Plaintiff’s Lanham Act claim is futile because 

it fails to meet Rule 9(b)’s particularity requirements. 

Lower federal courts have applied this heightened pleading standard to 

claims under the Lanham Act that are grounded in fraud. See Seoul Laser 

Dieboard Sys. Co. v. Serviform, S.R.L., 957 F. Supp. 2d 1189, 1200 (S.D. Cal. 

2013); see also EcoDisc Tech. AG v. DVD Format/Logo Licensing Corp., 711 F. 

Supp. 2d 1074, 1085 (C.D. Cal. 2010). Though the standard is somewhat 

relaxed for claims that are based on fraudulent omissions, a plaintiff must still 

plead the omission or concealment with particularity. Kearns v. Ford Motor Co., 

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567 F.3d 1120, 1127 (9th Cir. 2009) (dismissing fraudulent omission claim under 

Rule 9(b) where plaintiff’s claims of nondisclosure were couched in general 

pleadings); see Davidson v. Apple, Inc., 16-cv-04942-LHK, 2017 WL 976048, at 

*9–10 (N.D. Cal. Mar. 14, 2017) (dismissing plaintiffs’ fraudulent omission claims 

as “too vague to provide Defendants with the ‘who, what, when, and where’ of 

the allegedly fraudulent omissions, as required by Rule 9(b).”). 

Here, Plaintiff alleges that “Defendant has purposely made false and 

misleading descriptions of fact concerning the nature, characteristics and 

qualities of its DMZ products by . . . failing to disclose their status as controlled 

substances and failing to disclose the overwhelming clinical evidence that such 

products pose extreme health risks.” (FAC ¶ 25.) Plaintiff fails to plead with 

particularity Defendant’s alleged misleading advertisement. Rather than describe 

with particularity Defendant’s alleged misleading descriptions of its DMZ 

products, Plaintiff merely makes general allegations about its advertisements—

which are insufficient under Rule 9(b). 

2. RICO Claim

Defendant also argues that Plaintiff’s RICO claim is futile because it fails to 

allege facts supporting each of the claim’s elements. 

RICO under 18 U.S.C. § 1961 et seq., makes it unlawful for “any person 

employed by or associated with any enterprise engaged in . . . interstate or 

foreign commerce, to conduct or participate . . . in the conduct of such 

enterprise’s affairs through a pattern of racketeering activity.” 18 U.S.C. § 

1962(c). In order to plead a claim under RICO, a plaintiff must demonstrate that

a defendant participated in “(1) conduct (2) of an enterprise that affects interstate 

commerce (3) through a pattern (4) of racketeering activity or collection of 

unlawful debt.” Eclectic Props. E., LLC v. Marcus & Millichap Co., 751 F.3d 990, 

997 (9th Cir. 2014). The Supreme Court has clarified that while the same 

evidence may be used to prove both the existence of an “enterprise” and a 

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“pattern of racketeering,” they are separate elements that a plaintiff must prove. 

United States v. Turkette, 452 U.S. 576, 583 (1981) (“The ‘enterprise’ is not the 

‘pattern of racketeering activity’’; it is an entity separate and apart from the

pattern of activity in which it engages.”). 

First, Defendant contends that Plaintiff fails to sufficiently allege the 

enterprise element of its RICO claim. An enterprise may be a legal entity or it 

may be a group of individuals associated-in-fact. 18 U.S.C. § 1961(4). An 

associated-in-fact enterprise is defined as “a group of persons associated 

together for a common purpose of engaging in a course of conduct.” United 

States v. Christensen, 828 F.3d 763, 780 (9th Cir. 2016) (quoting United States 

v. Turkette, 452 U.S. at 583). To prove the existence of an associated-in-fact

enterprise, a plaintiff must show: (1) a common purpose, (2) an ongoing 

organization, and (3) a continuing unit. Id. Contrary to what Defendant argues, 

RICO does not require that an “associated-in-fact enterprise have a structure 

beyond that necessary to carry out its racketeering activity.” Odom v. Microsoft 

Corp., 486 F.3d 541, 551 (9th Cir. 2007). Nevertheless, the Court finds that 

Plaintiff has not pled sufficient facts to demonstrate that Defendant and its 

unknown co-conspirators constitute an ongoing and continuing enterprise. 

Second, Defendant argues that Plaintiff has failed to sufficiently allege any 

pattern of racketeering activity. A “‘pattern of racketeering activity’ requires at 

least two acts of racketeering activity . . . .” 18 U.S.C. § 1961(5). “‘Racketeering 

activity’ is any act indictable under several provisions of Title 18 of the United 

States Code . . .” Sanford v. MemberWorks, Inc., 625 F.3d 550, 557 (9th Cir. 

2010). The plaintiff must adequately plead the elements of each predicate act, 

satisfying the pleading standard that would apply if the predicate act were to 

stand-alone. Alan Neuman Prods., Inc. v. Albright, 862 F.2d 1388, 1392 (9th Cir. 

1988). The proposed FAC generally alleges that Defendant and co-conspirators

have violated 21 U.S.C. § 841 because they have sold products containing DMZ, 

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which is allegedly a controlled substance under the CSA. These general 

allegations alone are not enough to plead a RICO case. See Nutrition 

Distribution LLC, 194 F. Supp. 3d at 958 (dismissing plaintiff’s RICO claim 

because “it fail[ed] to identify any particular instance in which Defendants 

engaged in such [a pattern of racketeering] activity.”). Therefore, Plaintiff’s RICO 

claim is futile, as it would not survive a motion to dismiss. 

After reviewing the proposed FAC and finding that the proposed claims are 

futile1, the Court denies Plaintiff’s motion to amend.

B. Defendant’s Motion to Dismiss

Defendant moves to dismiss Plaintiff’s original Complaint, arguing that its 

claim is barred by the primary jurisdiction doctrine and that it fails to allege an 

actionable false statement. As already mentioned, Plaintiff filed no opposition to 

Defendant’s motion to dismiss. 

1. Primary Jurisdiction Doctrine 

First, Defendant argues that Plaintiff’s Lanham Act claim is barred under 

the primary jurisdiction doctrine because it urges the Court to determine whether 

its Ostarine products are safe—a determination that should be made by the FDA. 

As already discussed above, the primary jurisdiction doctrine allows a federal 

court to abstain from deciding a case if it determines that the “initial 

decisionmaking responsibility should be performed by the relevant agency rather 

than the courts.” Syntek Semiconductor Co., 307 F.3d at 780. 

Here, the Court reads Plaintiff’s Lanham Act claim to be based on namely 

three issues: 1) whether Defendant engaged in false advertising by mislabeling 

its products as natural “dietary supplements;” (2) whether Defendant engaged in 

 

1 Plaintiff’s third proposed claim under California Business and Professions Code § 17200 is based on the same 

allegations set forth under its Lanham Act and RICO claims. As already discussed above, the Court finds that 

those claims are futile. As such, the Court similarly finds that Plaintiff’s California Unfair Competition Claim is 

futile. 

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false advertising by failing to disclose any of the recognized side effects and 

dangers of using SARMS; and (3) whether Defendant engaged in false 

advertising by failing to disclose that SARMS are specifically prohibited for use in 

sporting events by the World Anti-Doping Agency and the U.S. Anti-Doping 

Agency. The Court finds that the FDA’s technical and policy expertise is not 

required to determine whether Defendant’s advertisements are false and 

misleading. See Dabish v. Brand New Energy, LLC, 16-cv-400-BAS, 2016 WL 

7048319, at *5 (S.D. Cal. Dec. 5, 2016) (finding that because the FDA has 

already issued a guidance as to what a dietary supplement is and what dietary 

ingredients may be legally added to a dietary supplement and how, the issue of 

false advertising did not require the FDA’s expertise or implicate concerns about

uniformity in administration). 

Plaintiff’s Complaint does rest, in part, on Defendant’s misrepresentations

“to consumers that such products are purportedly safe and have little to no 

adverse health and safety consequences.” (Compl. ¶ 27.) However, Plaintiff’s 

claim does not require the Court to determine whether the product is safe under 

the FDA’s standards. Instead it requires a determination of whether Defendant 

made false and misleading statements by representing the product as safe while 

failing to disclose the product’s health effects—a finding that does not require the 

FDA’s expertise. As the Supreme Court stated in Pom Wonderful LLC, 134 S.Ct. 

at 2238, though both the FDCA and Lanham Act touch on food and beverage 

labeling, “the Lanham Act protects commercial interests against unfair 

competition, while the FDCA protects public health and safety.” Because a

review of the Complaint reveals that Plaintiff’s Lanham Act claim rests on 

Defendant’s alleged misleading advertisements, it is not barred under the primary 

jurisdiction doctrine. 

2. Rule 9(b)

Defendant also moves to dismiss Plaintiff’s Complaint by arguing that it 

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fails to identify any actionable false or misleading statements or explain why 

these statements are false or misleading. 

As already discussed above, Lanham Act claims that are grounded in fraud 

are subject to the heightened pleading standard under Rule 9(b). Seoul Laser 

Dieboard Sys. Co., 957 F. Supp. 2d at 1200. Here, Plaintiff fails to provide 

sufficient facts to support its claim. Though Plaintiff alleges that Defendant made 

false and misleading statements, it fails to provide the Court with any of those 

alleged misleading statements or how Defendant’s alleged omissions render

affirmative statements misleading or untrue. Thus, Plaintiff’s Lanham Act claim 

fails to satisfy Rule 9(b). As a result, Defendant’s motion to dismiss is granted. 

IV. CONCLUSION 

For the reasons discussed above, Plaintiff’s motion to amend its complaint 

(ECF No. 13) is denied. Defendant’s motion to dismiss (ECF No. 5) is granted

and motion to strike certain portions of the Complaint (ECF No. 6) is denied as 

moot. 

The Court grants Plaintiff leave to file a First Amended Complaint (“FAC”)

that complies with Local Rule 15.1(c), remedying the defects identified above. 

Plaintiff must file its FAC within 20 days of the entry of this Order. 

IT IS SO ORDERED.

Dated: June 13, 2017

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