MacuHealth, LP v. Vision Elements, Inc.

UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF FLORIDA

TAMPA DIVISION

MACUHEALTH, LP,

Plaintiff,

v. Case No. 8:22-cv-199-VMC-UAM

VISION ELEMENTS, INC.,

Defendant.

/

ORDER

This matter comes before the Court upon consideration of

Plaintiff MacuHealth LP’s request for permanent injunctive

relief (Doc. # 146), filed on November 29, 2023. Defendant

Vision Elements, Inc. responded on December 27, 2023. (Doc.

# 150). MacuHealth filed a reply on January 19, 2024. (Doc.

# 153). For the reasons that follow, the Motion is granted in

part and denied in part.

I. Background

A. Products and the False Advertisement

MacuHealth and Vision Elements sell competing

nutritional supplements intended to maintain or improve eye

health. (Doc. # 78-5 at 24:13-22, 43:13-44:5); (Doc. # 78-1

at 33:11-19). MacuHealth’s product is called “MacuHealth,”

while Vision Elements’ product is called “Early Defense.”

(Doc. # 78-5 at 24:13-22); (Doc. # 78-1 at 33:11-19).

Both companies’ nutritional supplements contain the same

amount of three active ingredients called LMZ carotenoids:

lutein, zeaxanthin, and mesozeaxanthin. (Doc. # 78-5 at

24:13-25); (Doc. # 78-1 at 33:22-34:9). The LMZ carotenoids

are extracted and derived from marigold flower petals using

solvents. (Doc. # 63-5 at 132:2-14). The industry uses hexane,

methanol, and acetone as solvents for this process. (Id. at

132:2-5); (Doc. # 78-5 at 18:22-19:3). While the solvents are

largely removed from the LMZ carotenoids during the

production process, residual amounts remain in the final

product. (Doc. # 63-4 at 43); (Doc. # 63-5 at 123:22-124:25).

Between January 2021 and November 2022, Vision Elements

promoted its supplement “using marketing materials that

stated it is free from, made without the use of, or does not

contain certain solvents including hexane, methanol and/or

acetone.” (Doc. # 150-1 at ¶ 7). The Early Defense bottle

also stated that the supplement did not contain hexane,

methanol, or acetone. (Doc. # 63-2 at 15). This claim was

repeated at trade shows, in personal product pitches, and in

emails to potential customers. (Doc. # 78-1 at 198:21-199:2);

(Doc. # 78-4 at 292-93, 297).

Vision Elements also created the following advertisement

comparing its product to “Competitor A”:

VISION ici

- CLEAN-LABEL vs KNOWN ISSUES Vision Elements, Inc.

ELEMENTS

zs Vision Elements Early Defense is FREE FROM:

Early Defense nor. Zinc, beta-carotene, class 2 solvents (hexane, methanol, and acetone), soy, synthetic

Comparison to = surfactants (polysorbate/tween, PEG), gelatin, plasticizers, gluten, wheat, egg, GMOs,

Competitor A = titanium dioxide, polyvinlypyrrolidone (PVP), artificial colors, flavors, and sweeteners.

frond Vion Esence ces Why clean-label is important:

Defence

Carotengid Formula: Int Arch Allergy Immunol 2001:126:218-225 eee □□□

tutes: tom v Vv Identification of |IgE-Binding Proteins in Soy Lecithin

ae Vv v Conclusions: Soy lecithin contains a number of lgE-binding proteins; thus, it might representa source of hidden allergens. These

Meso-zeaxanthin 10mg Vv Vv allergens are a more significant concern for soy-allergic individuals consuming lecithin products as a health supplement.

Carotenoid Source Non-GMo Marigold Marigold flower

(Origin) ese ee eae See Published in final edited form as:

Extraction Technique Supercritical CO, Solvent extraction: J Allergy Clin dmmuno! Pract. 2019; 7(5): 1533-1540.8. doi: 10.101 64 ,jaip.2018.12.003_

eco-friendly hexane, methonel, ocetonet

Pore eae SEE Sofigel (Revine gelatin) Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates:

— a More Common Than We Have Recognized

pecans ones Suniower cl Results: Skin and provocation testing demonstrated symptomatic reactivity in both cases to PEG 3350 and polysorbate 80.

Surfactant Nor-GMO sunflower Tween 80° [polysorbate} Conclusions: Immediate hypersensitivity to PEG 3350 with cross-reactive polysorbate 80 hypersensitivity may be under recognized in

lecithin Soy lecithin (allergen)! clinical practice and can be detected with clinical skin testing. Our studies raise the possibility of an IgE mediated Type |

Soy Allergen None V hypersensitivity mechanism in some cases,

Gluten Free Vv Vv

ery V sen nl tata inept an ean Memento sik A nme Pe 8

aes Apsinesary Sate “_ sonoueaanit tishowienumunnit

eee

(Doc. # 78-4 at 299).

Matthew Brannen Hinton, owner and Chief Executive

Officer of Vision Elements, acknowledges that he created the

Competitor A bottle using a photo of the MacuHealth bottle.

(Doc. # 99 at 6); (Doc. # 150-1 at @ 2). Frederic Jouhet,

MacuHealth’s CEO, testified that consumers would recognize

the Competitor A bottle as that of MacuHealth. See (Doc. #

78-5 at 44:22-45:3) (“There is a marketing document that shows

a Vision Element or Vision Essence bottle side by side with

a MacuHealth bottle that has been blurred slightly, but not

enough to not convince the doctors what we’re discussing.”).

While Vision Elements was advertising using this claim,

the company sold its supplement to fourteen customers or eye

care professionals. (Doc. # 150-1 at ¶ 9). Nearly all sales

of Early Defense are to eyecare physicians, though 1% are

direct to consumers. (Id. at ¶ 6).

Vision Elements ceased publishing these claims in

November and December 2022 to avoid further litigation and

hired a consultant to change its marketing materials to omit

the claim. (Id. at ¶ 10-11); see (Doc. # 66-2 at ¶ 16) (“In

an effort to avoid further litigation regarding the

Advertisements, Vision Elements has stopped publishing the

Advertisements on its website or brochures. The

advertisements have been removed from [the] Vision Elements

website at https://www.visionelements.com. Bottles of Early

Defense for future production lots will have new labels that

do not include the Advertisements.”). “Since using the New

Label [without the claim], every one of the fourteen (14) eye

care professionals that previously purchased bottles with the

Old Label, [has] run out of Early Defense and repurchased

bottles with the New Label several times over, and any new

customers purchased bottles with the New Label.” (Doc. # 150-

1 at ¶ 12).

Mr. Hinton previously testified that his solvent claims

were “highly important” to customers choosing an ocular

supplement and that the claim that Early Defense uses a

“solvent free” extraction process was a way that Vision

Elements distinguished the product. (Doc. # 78-1 at 118:6-

20); (Id. at 196:23-197:2). Even so, the two doctors

MacuHealth identified as those from whom they had lost sales

based on the advertisements (Doc. # 150-2 at 14) testified at

trial that Vision Elements’ claims about using a solvent-free

process did not influence their decision to switch from

MacuHealth to Early Defense. (Doc. # 150-3 at 189:6-15,

206:19-21). Instead, the doctors switched products for other

reasons, including that the two supplements had the same

amounts of the LMZ carotenoids and Early Defense was sold at

a lower price. (Id. at 187:5-16, 205:14-206:18). Vision

Elements now states that it has no intention of republishing

the claim, and the company’s sales have improved since the

claim was removed from its advertising. (Id. at ¶¶ 13-14).

Though Vision Elements has stopped advertising the

claim, Mr. Jouhet still receives one to two questions about

this topic during trade shows. (Doc. # 146-2 at 189:9-12).

B. Procedural History

MacuHealth initiated this action on January 25, 2022.

(Doc. # 1). In its complaint, MacuHealth alleged unfair

competition under 15 U.S.C. § 1125(a)(1)(B) (Count I),

misleading advertising under Fla. Stat. § 817.41(1) (Count

II), unfair competition under Florida common law (Count III),

and deceptive and unfair trade practice under Fla. Stat. §

501.201 (Count IV). (Id. at ¶¶ 41-81). As part of its prayer

for relief, MacuHealth requested “an injunction ordering

Vision Elements to retract the False Advertisements, to

publish a corrective statement, and for Vision Elements and

all those who are in active concert with them to refrain from

publishing false advertisements in the future.” (Id. at 14).

MacuHealth did not explicitly plead the elements it is

required to prove to obtain injunctive relief in its

complaint.

In the order on MacuHealth’s motion for summary

judgment, the Court determined that the evidence demonstrated

that there was no dispute of material fact as to the elements

of MacuHealth’s claims, except as to whether MacuHealth

suffered any injury based on Vision Elements’ actions. (Doc.

# 99 at 24-35). The case proceeded to trial on each claim as

to this remaining issue.

At trial, the jury determined that MacuHealth has been,

or is likely to be, injured as a result of the false

advertising, but that MacuHealth had not suffered any actual

monetary damages. (Doc. # 141 at 1). The jury further

determined that Vision Elements’ conduct was not willful and

deliberate, Vision Elements was not unjustly enriched as a

result of the false or misleading advertising, and an award

of Vision Elements’ profits was not necessary to deter future

conduct. (Id. at 2). The jury found that Vision Elements did

not make a profit from sales made due to the false or

misleading advertising. (Id.). Even so, the jury awarded

MacuHealth nominal damages in the amount of $5,000.00. (Id.).

Now, MacuHealth moves for permanent injunctive relief.

(Doc. # 146). Specifically, MacuHealth seeks a permanent

injunction that orders that Vision Elements:

1) Refrain from making any claim that its product

does not use or does not contain class 2 solvents,

hexane, methanol, and/or acetone.

2) Within ten (10) days of the order, issue the

letter attached as Exhibit 1 [to the Motion], to

the eye care professionals to whom it has sold or

directly promoted its product.

3) Within ten (10) days of the order, issue a notice

of recall to all current and former customers of

Vision Elements demanding the return of any bottles

of Early Defense which state that the product does

not contain class 2 solvents – hexane, methanol,

acetone within ten (10) days. All returned bottles

are to be relabeled with a label without the

statement that the product does not contain class

2 solvents - hexane, methanol, acetone, before

being sold again.

4) Serve a declaration, signed by Mr. Hinton,

within thirty (30) days attesting to the

satisfaction of items (2) and (3) above, including

(i) identification of all eye care professionals to

whom Vision Elements sent the letter required by

item (2), and (ii) the number of bottles Vision

Elements received in response to its recall notice

and the names of the eye care professionals from

whom it received the bottles.

(Id. at 1-2). Vision Elements has responded to the Motion.

(Doc. # 150). MacuHealth has replied. (Doc. # 153). The Motion

is ripe for review.

II. Analysis

MacuHealth argues that it is entitled to permanent

injunctive relief based on its Lanham Act, Florida Deceptive

and Unfair Trade Practices Act (“FDUTPA”), and Florida common

law unfair competition claims. (Doc. # 146 at 3). The Court

determines that MacuHealth is entitled to a permanent

injunction under FDUTPA, the Lanham Act, and Florida common

law.

A. Florida Deceptive and Unfair Trade Practices Act

MacuHealth brought a claim under FDUTPA, asserting that

Vision Elements’ false advertisements constituted a deceptive

act and unfair practice under the statute. (Doc. # 1 at ¶¶

74-81). MacuHealth did not succeed on its claim for damages

under FDUTPA, pursuant to Florida Statute § 501.211(2). See

(Doc. # 141 at 1) (determining that MacuHealth had not

suffered actual monetary damages). However, MacuHealth

asserts that it is still entitled to injunctive relief under

FDUTPA based on the jury’s determination that MacuHealth has

been, or is likely to be, injured as a result of Vision

Elements’ false advertising. (Doc. # 146).

MacuHealth is entitled to injunctive relief under

FDUTPA. FDUTPA provides that, “[w]ithout regard to any other

remedy or relief to which a person is entitled, anyone

aggrieved by a violation of this part may bring an action .

. . to enjoin a person who has violated, is violating, or is

otherwise likely to violate this part.” Fla. Stat. §

501.211(1). “Accordingly, regardless of whether an aggrieved

party can recover ‘actual damages’ under section 501.211(2),

it may obtain injunctive relief under section 501.211(1).”

Wyndham Vacation Resorts, Inc. v. Timeshares Direct, Inc.,

123 So. 3d 1149, 1152 (Fla. 5th DCA 2012).

Courts have interpreted this provision as establishing

a lower threshold for injunctive relief than that under

federal law and other state statutes. In re Mednax Servs.,

Inc., Customer Data Sec. Breach Litig., No. 21-MD-02994-RAR,

2022 WL 3550045, at *2 (S.D. Fla. Aug. 18, 2022); Gastaldi v.

Sunvest Cmtys. USA, LLC, 637 F. Supp. 2d 1045, 1057 (S.D.

Fla. 2009). Under FDUTPA, “[t]here is no requirement that a

plaintiff show an ongoing practice or irreparable harm, and

. . . relief is available regardless of whether an adequate

remedy at law also exists.” Gastaldi, 637 F. Supp. 2d at 1057.

Further, the provision “is broadly worded to authorize

declaratory and injunctive relief even if those remedies

might not benefit the individual consumers who filed the

suit.” Davis v. Powertel, Inc., 776 So. 2d 971, 975 (Fla. 1st

DCA 2000). As such, “an aggrieved party may pursue a claim

for declaratory or injunctive relief under [FDUTPA], even if

the effect of those remedies would be limited to the

protection of consumers who have not yet been harmed by the

unlawful trade practice.” Id.

Vision Elements first argues that MacuHealth is not

entitled to injunctive relief under FDUTPA because MacuHealth

does not qualify as an “aggrieved” party. (Doc. # 150 at 11-

12). “The term ‘aggrieved’ is not defined in FDUTPA.” Ahearn

v. Mayo Clinic, 180 So. 3d 165, 171 (Fla. 1st DCA 2015).

Because of this, Florida circuit courts have adopted

different definitions of “aggrieved.” Importantly, several

courts have adopted or referenced the definitions of

“aggrieved” in Black’s Law Dictionary. The second definition

states that “aggrieved” means “([o]f a person) angry or sad

on grounds of perceived unfair treatment.” Id. at 172 (quoting

Aggrieved, Black’s Law Dictionary (10th ed. 2014)); see also

O’Keefe v. Pick Five Imports, Inc., No. 8:18-cv-1496-MSS-AEP,

2019 WL 13083614, at *10 (M.D. Fla. June 14, 2019). “This

definition of ‘aggrieved’ [is] more expansive than ‘damaged’

or ‘suffered a loss.’” Ahearn, 180 So. 3d at 172. Interpreting

this caselaw, the Middle District of Florida has stated that

“a plaintiff is ‘aggrieved’ under FDUTPA when the deceptive

conduct alleged has caused a non-speculative injury that has

affected the plaintiff beyond a general interest in curbing

deceptive or unfair conduct.” Superior Consulting Servs.,

Inc. v. Shaklee Corp., No. 6:16-cv-2001-GAP-GJK, 2017 WL

2834783, at *7 (M.D. Fla. June 30, 2017) (citing Ahearn, 180

So. 3d at 173).

Where a plaintiff is a business entity, and not a person,

some courts have instead referred to the first definition of

aggrieved in Black’s Law Dictionary: “([o]f a person or

entity) having legal rights that are adversely affected;

having been harmed by an infringement of legal rights.”

Stewart Agency, Inc. v. Arrigo Enters., Inc., 266 So. 3d 207,

213-14 (Fla. 4th DCA 2019); e.g., Westgate Resorts, Ltd. v.

Reed Hein & Assocs., LLC, No. 6:18-cv-1088-GAP-DCI, 2020 WL

3265972, at *3 (M.D. Fla. Apr. 27, 2020) (noting that “the

plaintiff is ‘aggrieved[’ when] ‘its rights have been, are

being, or will be adversely affected’” (quoting Stewart

Agency, Inc., 266 So. 3d at 214)). This definition “is not

synonymous with the requirement to show entitlement to actual

damages under section 501.211(2), because entities frequently

do not suffer actual damages from unfair and deceptive

practices of competitors.” Stewart Agency, Inc., 266 So. 3d

at 214. “Instead, their damages are frequently special or

consequential damages, and thus, not compensable under

section 501.211(2).” Id.

MacuHealth qualifies as an aggrieved party under FDUTPA.

FDUTPA recognizes non-monetary harm, the type of harm that

the jury determined MacuHealth had experienced or was likely

to experience as a result of Vision Element’s claims. See Id.

(recognizing that the damages suffered by business entities

are frequently special or consequential, and not actual);

Global Tech Led, LLC v. Hilumz Int’l Corp., No. 2:15-cv-553-

JES-CM, 2017 WL 588669, at *8 n.13 (M.D. Fla. Feb. 14, 2017)

(“The FDUTPA allows ‘anyone aggrieved by a violation of [the

Act to] bring an action to obtain a declaratory judgment . .

. and to enjoin [the accused],’ . . . and Defendants’

allegations of commercial and reputational harm show that

Defendants may be ‘aggrieved.’” (citations omitted)).

Additionally, in contrast to Vision Elements’ assertions

(Doc. # 150 at 11-12), the harm to MacuHealth caused by the

false statements is not speculative. The jury determined

that, while MacuHealth had not suffered any actual monetary

damages, the company has been, or is likely to be, injured as

a result of the false advertising. (Doc. # 141 at 1). This

determination establishes that MacuHealth did suffer harm or

is sufficiently likely to suffer harm that entitles it to a

permanent injunction under FDUTPA. See Fla. Stat. §

501.211(1) (providing that a plaintiff can seek “to enjoin a

person who has violated, is violating, or is otherwise likely

to violate this part”). Further, the jury’s determination was

supported by sufficient evidence, such as Mr. Jouhet’s

testimony that he must field questions about solvent-free

production at trade shows. (Doc. # 146-2 at 189:9-12).

Vision Elements further asserts that MacuHealth is not

entitled to injunctive relief under FDUTPA because there is

no likelihood that the advertisements with the comparisons to

MacuHealth based on false information will be republished.

(Doc. # 150 at 12-13). “Under Florida law ‘an injunction will

not be granted where it appears that the acts complained of

have already been committed and there is no showing by the

pleadings and proof that there is a reasonably well grounded

probability that such course of conduct will continue in the

future.’” Off Lease Only, Inc. v. LeJeune Auto Wholesale,

Inc., 187 So. 3d 868, 870 (Fla. 3d DCA 2016) (quoting City of

Jacksonville v. Wilson, 27 So. 2d 108, 111 (1946)).

Vision Elements has taken several steps to remove the

false advertisements, including no longer publishing the

advertisements, replacing the supplement’s label with one

that omitted that false statement, and hiring a consultant to

assist with changes to marketing materials about the

supplement, “to avoid further advertising disputes.” (Doc. #

150 at 3-4); (Doc. # 150-1 at ¶¶ 10-11). However, as

MacuHealth highlights, Vision Elements has not issued any

corrective advertising. And “[t]he mere voluntary cessation

of conduct alleged to be in violation of FDUTPA does not

necessarily foreclose [a plaintiff] from pursuing an action

for injunctive relief.” Off Lease Only, Inc., 187 So. 3d at

870. Importantly, Vision Elements stopped publishing the

advertisements in an effort to avoid further litigation.

(Doc. # 66-2 at ¶ 16). The Court concludes that there is a

reasonable probability that Vision Elements may continue its

false advertisements in the future, especially when Mr.

Hinton has refused to concede that Vision Elements’ product

contains the solvents at issue. (Doc. #146-4 at 34:21-25).

This demonstrates that Mr. Hinton still believes that the

product is solvent-free, as previously advertised and proved

false.

In sum, the Court believes that injunctive relief is

still warranted despite Vision Elements’ efforts to remove

the false statements. MacuHealth may continue to suffer harm

without corrective advertising and any harm could be

increased if Vision Elements decides to republish the

statements. Accordingly, MacuHealth is entitled to injunctive

relief under FDUTPA.

B. Lanham Act

MacuHealth asserts that it is also entitled to a

permanent injunction based on its claim under the Lanham Act

for unfair competition, misrepresentation, and false

advertising, pursuant to 15 U.S.C. § 1125(a)(1)(B). (Doc. #

1 at 8); (Doc. # 146 at 7). The Court agrees.

The Lanham Act allows courts “to grant injunctions,

according to the principles of equity and upon such terms and

the court may deem reasonable, . . . to prevent a violation

under subsection (a), (c), or (d) of section 1125 of [the]

title.” 15 U.S.C. § 1116(a). “[A] plaintiff who brings an

action pursuant to section 1125(a) is entitled to permanent

injunctive relief if the plaintiff succeeds on the merits of

his or her claim and if the equities involved favor injunctive

relief.” Neva, Inc. v. Christian Duplications Int’l, Inc.,

743 F. Supp. 1533, 1548 (M.D. Fla. 1990) (citation omitted).

Before a court may grant a permanent injunction under

the Lanham Act, a plaintiff seeking a permanent injunction

must satisfy the following four-factor test: “(1) that it has

suffered an irreparable injury; (2) that remedies available

at law, such as monetary damages, are inadequate to compensate

for that injury; (3) that, considering the balance of

hardships between the plaintiff and defendant, a remedy in

equity is warranted; and (4) that the public interest would

not be disserved by a permanent injunction.” eBay Inc. v.

MercExchange, L.L.C., 547 U.S. 388, 391 (2006). “The decision

to grant or deny permanent injunctive relief is an act of

equitable discretion by the district court . . . .” Id. The

Court will address each factor in turn.

1. Irreparable Injury

As to the first factor, “[a]n injury is ‘irreparable’

only if it cannot be undone through monetary remedies.” Ne.

Fla. Chapter of Ass’n of Gen. Contractors v. Jacksonville,

896 F.2d 1283, 1285 (11th Cir. 1990). “[G]rounds for

irreparable injury include loss of control of reputation,

loss of trade, and loss of goodwill.” Ferrellgas Partners,

L.P. v. Barrow, 143 F. App’x 180, 190 (11th Cir. 2005)

(quoting Pappan Enters., Inc. v. Hardee’s Food Sys., Inc.,

143 F.3d 800, 805 (3d Cir. 1998)). Further, the statute

provides that “[a] plaintiff seeking any such injunction

shall be entitled to a rebuttable presumption of irreparable

harm upon a finding of a violation identified in this

subsection in the case of a motion for a permanent

injunction.” 15 U.S.C. § 1116(a). “This presumption, it

appears, is based upon the judgment that it is virtually

impossible to ascertain the precise economic consequences of

intangible harms, such as damage to reputation and loss of

goodwill, caused by such violations.” Abbott Lab’ys v. Mead

Johnson & Co., 971 F.2d 6, 16 (7th Cir. 1992). Importantly,

“[p]roof of falsity [in false advertising cases] is generally

. . . sufficient to sustain a finding of irreparable injury

when the false statement is made in the context of comparative

advertising between the plaintiffs’ and defendant’s

products.” N. Am. Med. Corp. v. Axiom Worldwide, Inc., 522

F.3d 1211, 1227 (11th Cir. 2008).

Here, Vision Elements specifically made its false

statement in the context of comparative advertising. (Doc. #

78-4 at 299). Additionally, while Vision Elements asserts

that MacuHealth’s harm is monetary in nature based on Mr.

Jouhet’s testimony about the decrease in the closing rates,

the jury specifically found that MacuHealth had suffered

harm, but no monetary damages. See (Doc. # 141 at 1) (finding

that “MacuHealth [has] been, or is likely to be, injured as

a result of the false advertising,” but that MacuHealth did

not suffer actual monetary damages). Vision Elements’

arguments to the contrary do not sufficiently rebut the

presumption of irreparable injury. Accordingly, MacuHealth

has established an irreparable injury.

2. Inadequate Remedies at Law

MacuHealth also does not have adequate remedies at law

for the harms. “[A] remedy at law for . . . reputational

damage is ordinarily inadequate, given ‘the potential

difficulty of proof of plaintiff’s damages’ and ‘the

impairment of intangible values.’” Boulan S. Beach Master

Ass’n, Inc. v. Think Props., LLC, 617 F. App’x 931, 934 (11th

Cir. 2015) (citation omitted).

“The terms ‘inadequate remedy at law’ and ‘irreparable

harm’ describe two sides of the same coin. If the harm being

suffered by plaintiff . . . is ‘irreparable’ then the remedy

at law (monetary damages) is ‘inadequate’.” Anhing Corp. v.

Thuan Phong Co., CV 13-05167 BRO (MANx), 2015 WL 4517846, at

*23 (C.D. Cal. July 24, 2015) (quoting 4 McCarthy on

Trademarks and Unfair Competition § 30:2 (5th ed.)).

As noted above, MacuHealth’s harm cannot be compensated

for through monetary remedies. Therefore, MacuHealth has

established that it has inadequate remedies at law.

3. Balance of Hardships

Further, the balance of hardships weighs in favor of

granting an injunction. Vision Elements does not have a

legitimate interest in the false statements. See PBM Prods.,

LLC v. Mead Johnson & Co., 639 F.3d 111, 127 (4th Cir. 2011)

(“Mead Johnson ‘simply has no equitable interest in

perpetuating the false and misleading claims in the Mailer.’”

(citation omitted)); Homeland Housewares, LLC v. Euro-Pro

Operating LLC, No. CV 14-03954 DDP (MANx), 2014 WL 4187982,

at *5 (“As a general matter, ‘there is no harm to a defendant

from an injunction which prevents continuing dissemination of

false statements.’” (citation omitted)); Osmose, Inc. v.

Viance, LLC, 612 F.3d 1298, 1323 (11th Cir. 2010) (“[I]t is

well settled that false commercial speech is not protected by

the First Amendment and may be banned entirely.” (quoting

Castrol Inc. v. Pennzoil Co., 987 F.2d 939, 949 (3d Cir.

1993))). Accordingly, Vision Elements will suffer little

hardship in being prohibited from making the false claims

again. Additionally, “[a] district court has broad powers in

equity to direct parties who have engaged in unfair

competition to take affirmative steps to eliminate possible

consumer confusion,” including by issuing corrective

statements. Energy Four, Inc. v. Dornier Med. Sys., Inc., 765

F. Supp. 724, 735 (N.D. Ga. 1991).

Further, Vision Elements is unlikely to suffer any

hardship from being enjoined from publishing false statements

that it has already ceased to publish and allegedly has no

intention of publishing again. See (Doc. # 150-1 at ¶¶ 10,

14). Affirmative steps to correct the false advertising are

also appropriate to address any consumers who have already

been exposed to the false statements. See Handsome Brook Farm,

LLC v. Humane Farm Animal Care, Inc., 700 F. App’x 251, 264

(4th Cir. 2017) (“Requiring HFAC to issue a retraction email,

sent to its initial list of recipients, is a reasonably

related requirement to ensure that those who received the

first email will also receive the retraction email that

mitigates the harm the first email caused.”). In contrast,

MacuHealth has a great interest in not having to counter false

statements, particularly those made in comparative

advertisements with the company’s product. While the Court

will further discuss the appropriate scope of the permanent

injunction below, the balance of harms weighs in favor of

injunctive relief.

4. Public Interest

Finally, injunctive relief is in the public interest.

“The Eleventh Circuit has explained that []the public

interest relevant to the issuance of [an]... injunction is

the public’s interest in avoiding unnecessary confusion.’”

It’s a 10, Inc. v. Beauty Elite Grp., Inc., 932 F. Supp. 2d

1325, 1333 (S.D. Fla. 2013) (internal quotation marks

omitted) (quoting Angel Flight of Ga. v. Angel Flight Am.,

Inc., 522 F.3d 1200, 1209 (11th Cir. 2008)). Further, “it is

self evident that preventing false or misleading advertising

is in the public interest in general.” PBM Prods., LLC, 639

F.3d at 127 (citation omitted). As modified, the relief would

not interfere with the public’s enjoyment of Early Defense

nor Vision Elements’ ability to compete fairly with

MacuHealth.

In sum, injunctive relief is warranted under the Lanham

Act.

C. Florida Common Law for Unfair Competition

Because injunctive relief is warranted under the Lanham

Act as explained above, it is also warranted under Florida

common law. The legal analysis is the same for violations of

the Lanham Act, FDUPTA, and Florida common law for unfair

competition. See Suntree Techs., Inc. v. Ecosense Int’l,

Inc., 693 F.3d 1338, 1345 (11th Cir. 2012) (“Courts may use

an analysis of federal infringement claims as a ‘measuring

stick’ in evaluating the merits of state law claims of unfair

competition.”). The Lanham Act and the Florida common law for

unfair competition are coextensive, and injunctive relief is

therefore appropriate under both. See Am. United Life Ins.

Co. v. Am. United Ins. Co., 731 F. Supp. 480, 486 (S.D. Fla.

1990) (holding that the Lanham Act analysis also proved a

common law unfair competition claim, entitling plaintiff to

injunctive relief under both); see also Nat. Answers, Inc. v.

SmithKline Beecham Corp., 529 F.3d 1325, 1332–33 (11th Cir.

2008) (“Since Natural Answers is unable to bring an unfair

competition claim under the Lanham Act under the theory of

either false advertising or trademark infringement, it

follows that the common law claims based on unfair competition

and trademark infringement must fail as well.”).

D. Scope of Permanent Injunction

As noted above, MacuHealth requests injunctive relief

composed of four elements. (Doc. # 146 at 1-2).

1. Refrain from Making False Statements

The Court determines that the first element, requiring

that Vision Elements “[re]frain from making any claim that

its product does not use or does not contain class 2 solvents,

hexane, methanol, and/or acetone,” is warranted. (Id. at 1).

The Court acknowledges that Vision Elements has stopped

advertising using the false statement and states that it has

no intention to republish this statement. (Doc. # 150-1 at ¶¶

10-11, 14). But Vision Elements only stopped making this claim

to avoid further litigation on this issue (Doc. # 66-2 at ¶

16), a fact that leaves this Court with a reasonable

expectation that the false advertising may be resumed in the

future. Accordingly, the Court believes that injunctive

relief is still appropriate. See Nat’l Ass’n of Bds. of Pharm.

V. Bd. of Regents of the Univ. Sys. of Ga., 633 F.3d 1297,

1309 (11th Cir. 2011) (“[T]he voluntary cessation of

challenged conduct will only moot a claim when there is no

‘reasonable expectation’ that the accused litigant will

resume the conduct after the lawsuit is dismissed.” (citation

omitted)).

2. Issue Corrective Statement

MacuHealth also requests that the Court require that

Vision Elements issue the below letter to the eye care

professionals to whom it has sold or directly promoted its

product within ten days of this order. (Doc. # 146 at 1). The

letter reads:

Dear Eye-Care-Professional.

My name is Brannen Hinton. I am the Founder and CEO

of Vision Elements, a dietary supplement company

that sells the carotenoids-based ocular supplement

called Early Defense.

For several years, we published advertisements

stating that Early Defense was manufactured without

the use of any class 2 solvents in the process, and

that, consequently, the final product was free from

any residual amounts of such class 2 solvents. We

published this claim to elevate Early Defense and

denigrate our closest competitor, MacuHealth, by

suggesting that the MacuHealth product has purity

or safety issues.

THESE STATEMENTS WERE LITERALLY FALSE, WE SHOULD

HAVE KNOWN THEY WERE FALSE, AND WE HEREBY RETRACT

THEM. I APOLOGIZE TO YOU EYE CARE PROFESSIONALS AND

TO MACUHEALTH FOR THESE FALSE ADVERTISEMENTS.

Again, we humbly present you with this apology to

rectify the wrong done. We will now focus on

providing you with accurate information and

representations and cease to use deceptive methods

of advertising.

My humble apologies,

Brannen Hinton

Founder and CEO

Vision Element[s]

(Doc. # 146-1).

“A district court has broad powers in equity to direct

parties who have engaged in unfair competition to take

affirmative steps to eliminate possible consumer confusion.”

Energy Four, Inc., 765 F. Supp. at 735 (citation omitted).

Using these powers, courts have sometimes ordered corrective

statements or corrective advertising to offset the effects of

the false statements in addition to measures prohibiting

further false statements. See, e.g., Handsome Brook Farm,

LLC, 700 F. App’x at 264 (“[C]ompelling HFAC to issue a

retraction email is reasonably related to the State’s

interest in preventing deception of consumers. . . . Merely

refusing to further disseminate the email reduces the speed

by which the false information spreads, but provides no remedy

for those who have already read the email and those who share

the email with others.”). While Vision Elements has taken

steps to eliminate the further publication of materials with

the false statement, it has not taken any steps to correct

the advertising that has already reached consumers. Compare

Eastman Chem. Co. v. PlastiPure, Inc., 969 F. Supp. 2d 756,

771 (W.D. Tex. Aug. 30, 2013) (determining that corrective

advertising was not warranted where Defendant “ha[d] already

engaged in significant amounts of corrective advertising, and

it is unclear what additional effect a digital billboard

written by [Plaintiff] and posted on Defendants’ website

[would] have”). Accordingly, a corrective statement is

“appropriate to ‘remedy lingering confusion caused by’

Defendants’ past and ongoing deception.” Monster Energy Co.

v. Vital Pharms., Inc., EDCV 18-1882 JGB (SHKx), 2023 WL

2918724 (C.D. Cal. April 12, 2023) (quoting

TrafficSchool.com, Inc. v. Edriver Inc., 653 F.3d 820, 830

(9th Cir. 2011)).

Further, other courts have ordered more burdensome

corrective statements. See, e.g., Merck Eprova AG v. Gnosis

S.p.A, 760 F.3d 247, 264-65 (2nd Cir. 2014) (affirming an

injunction requiring that Defendants publish corrective

advertising on their homepage, the product’s sale page, and

third-party industry websites and trade magazines where they

advertised their product).

Vision Elements raises concerns about the sufficiency

with which the request for injunctive relief was pled in the

complaint, including that “the Complaint did not propose

sending [MacuHealth’s] crafted statement to all customers and

non-customers who may have been sent marketing materials but

never became customers.” (Doc. # 150 at 14). However,

MacuHealth did include a request for injunctive relief in its

prayer for relief and indicated that it would seek to have

Vision Elements retract the false statements and issue a

corrective statement. (Doc. # 1 at 14). Vision Elements has

provided no caselaw indicating that the language of the

corrective statement itself must be included in the

complaint. Additionally, other courts have found it

appropriate to send corrective statements to the audience

that previously received the false statements or advertising.

E.g., Handsome Brook Farm, LLC, 700 F. App’x at 264

(“Requiring HFAC to issue a retraction email, sent to its

initial list of recipients, is a reasonably related

requirement to ensure that those who received the first email

will also receive the retraction email that mitigates the

harm the first email caused.”).

Finally, Vision Elements asserts that the injunctive

relief sought by MacuHealth violates Vision Elements’ First

Amendment rights because the corrective statement is overly

broad. (Doc. # 150 at 14). Vision Elements does not specify

which aspects of the requested injunction are overly broad.

However, it does note that any “such relief must be narrowly

tailored to restrain no more than what is reasonably required

to protect the interest of the parties.” (Id. at 14-15); see

Keener v. Convergys Corp., 342 F.3d 1264, 1269 (11th Cir.

2003) (“Injunctive relief should be limited in scope to the

extent necessary to protect the interests of the parties.”);

Bull Motors, L.L.C. v. Brown, 152 So. 3d 32, 36 (Fla. 3d DCA

2014) (reversing and remanding a court order granting a

permanent injunction in part because “the injunction

mandating [Defendant’s] future behavior and specifying the

precise language the company must use with all future

customers [was] overly broad”). The Court does not believe

that mandating a specific corrective statement would violate

Vision Elements’ First Amendment rights. Indeed, several

courts have mandated that defendants issue corrective

statements with specified text as part of preliminary or

permanent injunctions. E.g., Energy Four, Inc., 765 F. Supp.

at 765, app. A; Monster Energy Co., 2023 WL 2918724, at *15,

Ex. A.

However, the Court acknowledges that the proposed

language includes several statements expressing an opinion on

behalf of Mr. Brannen, such as those statements apologizing

for the false statements. Therefore, while the Court will

direct Vision Elements to issue a corrective statement as

part of the permanent injunction, the Court has modified the

language to convey only the facts. This approach makes the

statement more similar to those issued in other cases. E.g.,

Energy Four, Inc., 765 F. Supp. at 765, app. A (directing

issuance of a corrective statement at the preliminary

injunction stage that provides a factual summary of the case

and the reasons for issuing the notice); Monster Energy Co.,

2023 WL 2918724, at *15, Ex. A (directing that Defendant issue

a corrective statement summarizing the case, the jury

verdict, and the permanent injunction).

The Court mandates that Vision Elements issue the

following corrective statement to the eye care professionals

to whom it has sold or directly promoted its product within

ten days of the order:

Subject: Corrective Statement Relating to Vision

Elements’ Advertising

Dear Eye Care Professional,

Vision Elements is a dietary supplement company

that sells the carotenoids-based ocular supplement

called Early Defense. In January 2022, MacuHealth,

LP filed a civil suit against Vision Elements, Inc.

alleging false and misleading advertising.

In August 2024, the United States District Court

for the Middle District of Florida issued a

permanent injunction enjoining Vision Elements,

Inc. from making any claim that Early Defense does

not use or does not contain class 2 solvents,

hexane, methanol, and/or acetone on the basis that

this claim is false.

Our records indicate that, between January 2021 and

November 2022, you received advertisements that

contained this claim.

Vision Elements retracts this claim. The company’s

packaging and advertisements have been modified to

reflect this ruling.

3. Product Recall

Next, the Court does not believe that a recall of “any

bottles of Early Defense which state that the product does

not contain class 2 solvents – hexane, methanol, acetone

within ten (10) days” is warranted. See (doc. # 146 at 2)

(requesting this relief). Importantly, Vision Elements has

provided an affidavit from Mr. Hinton stating that “[s]ince

using the New Label [without the false statements], every one

of the fourteen (14) eye care professionals that previously

purchased bottles with the Old Label, [has] run out of Early

Defense and repurchased bottles with the New Label several

times over, and any new customers purchased bottles with the

New Label.” (Doc. # 150-1 at ¶ 12). Therefore, a recall would

not result in the collection of any bottles of Early Defense

that contain the false statement and no recall is warranted.

Because the Court determines that a recall is not warranted,

the Court will not address Vision Elements’ concerns

regarding whether MacuHealth’s request for a recall was

sufficiently pled. (Doc. # 150 at 14).

4. Declaration of Compliance

Based on the prior requests, the Court determines that

it is appropriate to direct Vision Elements to serve a sworn

declaration, signed by Mr. Hinton, upon MacuHealth and the

Court within thirty (30) days of this order attesting that it

has issued the corrective statement and identifying the eye

care professionals to whom Vision Elements sent the

statement. The Lanham Act provides that “[a]ny [] injunction

[issued pursuant to the Act] may include a provision directing

the defendant to file with the court and serve on the

plaintiff within thirty days after the service on the

defendant of such injunction, or such extended period as the

court may direct, a report in writing under oath setting forth

in detail the manner and form in which the defendant has

complied with the injunction.” 15 U.S.C. § 1116(a). The Court

determines that a declaration is appropriate to verify Vision

Elements’ compliance with the terms of the permanent

injunction.

Accordingly, it is now

ORDERED, ADJUDGED, and DECREED:

(1) Plaintiff MacuHealth, LP’s Request for Permanent

Injunctive Relief (Doc. # 146) is GRANTED in part and

DENIED in part.

(2) Vision Elements is directed to:

a. Refrain from making any claim that its product does

not use or does not contain class 2 solvents,

hexane, methanol, and/or acetone.

b. Within ten (10) days of the Order, issue the above

letter to the eye care professionals to whom it has

sold or directly promoted its product.

Cc. Serve a sworn declaration, signed by Mr. Hinton,

within thirty (30) days of the Order attesting to

the satisfaction of item (b) above, including

identification of all eye care professionals to

whom Vision Elements sent the letter required by

item (b).

(3) The Clerk is directed to terminate any pending deadlines

and close this case.

DONE and ORDERED in Chambers in Tampa, Florida, this 9th

day of August, 2024.

Eigen Maca ee

VIRGINIA M. HERNANDEZ*COVINGTON

UNITED STATES DISTRICT JUDGE

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