EXHIBIT 3

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UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF FLORIDA

CASE NO. 20-21601-CIV-WILLIAMS

UNITED STATES OF AMERICA,

Plaintiff,

vs.

GENESIS II CHURCH OF HEALTH 

AND HEALING;

MARK GRENON;

JOSEPH GRENON;

JORDAN GRENON; and

JONATHAN GRENON,

Defendants.

ORDER ON PRELIMINARY INJUNCTION

1. Plaintiff has filed a Complaint for Injunction against Genesis II Church 

of Health and Healing (“Genesis”), and individual defendants Mark Grenon, Joseph 

Grenon, Jordan Grenon, and Jonathan Grenon (collectively, “Defendants”) 

pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. 

§ 332(a), alleging that Defendants directly or indirectly:

A. Violate 21 U.S.C. § 331(d), by introducing or delivering for 

introduction into interstate commerce new drugs, as defined in 21 U.S.C. § 321(p), 

that are neither approved pursuant to 21 U.S.C. § 355 nor exempt from approval;

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B. Violate 21 U.S.C. § 331(a), by introducing or delivering for 

introduction into interstate commerce drugs, as defined in 21 U.S.C. § 321(g), that 

are misbranded within the meaning of 21 U.S.C. § 352(a) and (f)(1); and

C. Violate 21 U.S.C. § 331(k), by causing drugs to become 

misbranded within the meaning of 21 U.S.C. § 352(a) and (f)(1) while they are held 

for sale after shipment of one or more of their components in interstate commerce.

2. This Court has jurisdiction over the subject matter of this case and 

over all persons and parties to this action under the FDCA, 21 U.S.C. § 332(a). 

3. The Complaint for injunction states a cause of action under FDCA, 21 

U.S.C. § 301 et seq. 

4. Because the United States’ motion is based on 21 U.S.C. § 332(a), 

which expressly authorizes injunctive relief to protect the public interest, no specific 

finding of irreparable harm is necessary, no showing of any inadequacy of other 

remedies at law is necessary and no balancing of interests of the parties is required 

prior to the issuance of a preliminary injunction in this case. To obtain a preliminary 

injunction, the United states must demonstrate a substantial likelihood that it will 

succeed on the merits of its claim, and some cognizable danger of recurrent 

violation. See Gresham v. Windrush Partners, Ltd., 730 F.2d 1417, 1423 (11th Cir. 

1984); United States v. Livdahl, 356 F. Supp. 2d 1289, 1290–91 (S.D. Fla. 2005); 

United States v. BioAnue Labs, Inc., 2014 WL 3696662, at *5 (M.D. Ga. July 23, 

2014); United States v. S. Serra Cheese Co., 2015 WL 6156961, at *6 (E.D. Mich. 

Oct. 20, 2015). 

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5. The Court finds that United States has demonstrated a substantial 

likelihood of success on the merits that Defendants are violating various sections 

of the FDCA. Specifically, the Court finds that United States has demonstrated a 

substantial likelihood of success on the merits that Defendants are: 

A. Violating 21 U.S.C. § 331(d), by introducing or delivering for 

introduction into interstate commerce new drugs, as defined in 21 U.S.C. 

§ 321(p), that are neither approved pursuant to 21 U.S.C. § 355 nor exempt 

from approval. In support of this finding, the United States has presented 

evidence showing that: 

1. MMS is a “drug” as defined by 21 U.S.C. § 321(g). Defendants 

have posted content on their websites claiming that MMS is 

intended for curing, mitigating, treating, or preventing COVID19, Alzheimer’s, autism, brain cancer, HIV / AIDS, and multiple 

sclerosis. (DE 3-1 at Exs. 3-12, 14-16, 18-20.)

2. MMS is a “new drug” as defined in 21 U.S.C. § 321 (p)(1) and 

(p)(2). Affiant Dr. Arthur F. Simone (Senior Medical Advisor in 

the Office of Unapproved Drugs and Labeling Compliance at 

the Center for Drug Evaluation and Research at the FDA) 

explained that after conducting “comprehensive searches of the 

publicly available medical and scientific literatures for MMS and 

its alias,” he found “that there are no published adequate and 

well-controlled studies demonstrating that MMS is GRASE for 

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its intended use. Because there are no adequate and wellcontrolled studies for the intended uses of MMS, qualified 

experts cannot come to a consensus of opinion concerning its 

safety and effectiveness for such uses.” (DE 3-3 at ¶ 22.) 

3. MMS has not been approved by the FDA. Dr. Simone 

explained that after conducting “diligent searches” on various 

databases to “determine whether any Defendant has sought 

approval for MMS and to determine whether MMS has been 

approved by the FDA,” his searches “did not identify any NDA 

or ANDA for Defendants’ MMS product. Because none of the 

Defendants sought FDA approval for MMS, and neither an NDA 

nor an ANDA for MMS has been approved by FDA, I conclude 

that the MMS, associated with any Defendant, is an unapproved 

new drug.” (DE 3-3 at ¶¶ 32-35.)

4. Defendants have introduced MMS into interstate commerce. 

Affiant Tiffany Petty (Program Analyst in the Health Fraud 

Branch in the Office of Regulatory Affair’s Division of 

Enforcement, FDA) explained that on March 27, 2020, she 

visited Defendants’ website and “[u]sing an undercover credit 

card and a fictitious name, I placed an order for: one (1) bottle 

of MMS 2 oz. (Sodium Chlorite); one (1) bottle of MMS2 powder 

2.5 oz; and one (1) pack of clear capsules.” (DE 3-1 at ¶¶ 16-

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18.) Affiant Jason Humbert (Director of the Health Fraud 

Branch) explained that on March 30, 2020, he “traveled 

undercover” to the “mailbox in Ashburn, Virginia that is 

associated with the fictitious identity Petty used to purchase 

Defendants’ MMS products. I collected the shipment with 

USPS Tracking number 9405511298370940883574 for order 

28665 that was made by Petty. The package containing the 

product contained the return address of 2014 Garden Lane, 

Bradenton, Florida 34205.” (DE 3-2 at ¶ 11.) Plaintiffs also 

provided screenshots of the online order and confirmation 

emails, as well as photographs of the package and its contents. 

(DE 3-1 at exs. 13, 17; DE 3-2 at ex. 2). 

B. Violating 21 U.S.C. § 331(a), by introducing or delivering for 

introduction into interstate commerce drugs, as defined in 21 U.S.C. 

§ 321(g), that are misbranded within the meaning of 21 U.S.C. § 352(a) and 

(f)(1). In support of this finding, the United States has presented evidence 

showing that: 

1. MMS is mislabeled because “it’s labeling is false or misleading 

in any particular” under 21 U.S.C. § 352(a). Defendants have 

claimed that MMS is intended for curing, mitigating, treating, or 

preventing COVID-19, Alzheimer’s, autism, brain cancer, HIV / 

AIDS, and multiple sclerosis. (DE 3-1 at exs. 3-12, 14-16, 18-

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20.) Dr. Simone explained that there are no adequate and wellcontrolled studies demonstrating that MMS can safely or 

effectively treat these diseases. (DE 3-3 at ¶ 22.)

2. MMS is misbranded because its labeling does not include 

“adequate directions for use” as defined by 21 U.S.C. § 352(a), 

because it lacks “directions under which the layman can use a 

drug safely and for the purposes for which it is intended.” Dr. 

Simone explained that “Defendants’ drug is a prescription drug 

because it is intended for curing, mitigating, treating, or 

preventing coronavirus, and many other serious diseases. . . 

that require diagnosis and management by a physician. 

Specifically, medical expertise and special clinical testing are 

necessary to diagnose these serious disease. . . 

Consequently, adequate directions under which a layman can 

safely use Defendants’ MMS product to cure, mitigate, treat, or 

prevent coronavirus, or other serious diseases . . . cannot be 

written.” (DE 3-3 at ¶ 37.)

C. Violating 21 U.S.C. § 331(k), by causing drugs to become misbranded 

within the meaning of 21 U.S.C. § 352(a) and (f)(1) while they are held for 

sale after shipment of one or more of their components in interstate 

commerce. In support of this finding, the United States has presented 

evidence showing that:

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1. MMS is “held for sale” because it is intended for purposes other 

than Defendants’ personal consumption. See United States v. 

US Stem Cell Clinic, LLC, 403 F. Supp. 3d 1279 (S.D. Fla. 

2019). The United States has introduced screenshots of 

Defendants’ sales website demonstrating Defendants’ intent to

sell MMS to others. (DE 3-1 at ex. 13.)

6. The Court finds that the United States has shown a cognizable danger that 

Defendants will continue to violate the FDCA in the future unless a 

preliminary injunction is issued. In their written response to the FDA’s April 

8, 2020 cease and desist letter demanding corrective action regarding MMS 

distribution and mislabeling (DE 3-2 at ex. 8), Defendants state that “There 

will be NO corrective actions on our part,” “You have no authority over us! . 

. . Never going to happen,” and “We don’t have to cease anything in regard 

to our Church Sacraments!” (DE 3-2 at ex. 10).

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7. The Court finds that the conditions for granting a preliminary injunction under 

21 U.S.C. § 332(a) have been met. 

After considering the foregoing, it is therefore, ORDERED AND ADJUDGED that:

1. The United States’ motion for a preliminary injunction (DE 3) is GRANTED.

 1 The Government also submitted evidence demonstrating Defendants’ open 

refusal to comply with the Court’s April 17, 2020 Temporary Restraining Order (DE 

3). For instance, on April 26, 2020, Defendants Mark and Joseph Grenon hosted 

a website broadcast / podcast and Mark Grenon stated, “[j]ust because the FDA 

submits a TRO and the DOJ . . . signs the order, it doesn’t mean it has to be obeyed 

or even given attention.” (DE 23 at ex. 4.) 

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2. Upon entry of this Order, Defendants and each and all of their directors, 

officers, agents, representatives, employees, successors, assigns, attorneys, and 

any and all persons in active concert or participation with any of them (hereinafter, 

“Associated Persons”) who receive actual notice of this Order, shall not, during the 

pendency of this action, directly or indirectly, label, hold, and/or distribute any drug, 

including but not limited to MMS, that does not have an approved new drug 

application pursuant to 21 U.S.C. § 355(b) or abbreviated new drug application 

pursuant to 21 U.S.C. § 355(j), or an investigational new drug application in effect 

for its use pursuant to 21 U.S.C. § 355(i), or any drug that is misbranded within the 

meaning of 21 U.S.C. § 352.

3. Upon entry of this Order, Defendants and Associated Persons, shall not, 

directly or indirectly, violate 21 U.S.C. § 331(k) by causing any drug, including but 

not limited to MMS, to become misbranded within the meaning of 21 U.S.C. 

§ 352(a) and/or (f)(1) after shipment of one or more of its components in interstate 

commerce.

4. Upon entry of this Order, Defendants and Associated Persons shall 

immediately refrain from disposing of or transferring any assets that may interfere 

with implementation of payment of restitution to consumers who purchased 

Defendants’ drugs, should the Court ultimately order such restitution payments in 

its final judgment in this matter.

5. Upon entry of this Order, Defendants and Associated Persons are prohibited 

from destroying, discarding, altering, transferring or otherwise making unavailable 

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any document or record in electronic format or otherwise within their custody or 

control that are related to (a) MMS; (b) misbranded drugs; and/or (c) unapproved 

new drugs.

6. Representatives of FDA shall be permitted, without prior notice and as and 

when FDA deems necessary, to inspect Defendants’ places of business and take 

any other measures necessary to monitor and ensure continuing compliance with 

the terms of this Order. During such inspections, FDA representatives shall be 

permitted to: have immediate access to buildings, including but not limited to 2014 

Garden Ln, Bradenton, FL 34205-5274 (the “Facility”), equipment, raw ingredients, 

in-process materials, finished products, containers, packaging material, labeling, 

and other promotional material therein; take photographs and make video 

recordings; take samples of Defendants’ in-process or unfinished and finished 

products, containers, packaging material, labeling, and other promotional material; 

and examine and copy all records relating to the labeling, holding, and distribution 

of any and all drugs and their components. The inspections shall be permitted upon 

presentation of a copy of this Order and appropriate credentials. The inspection 

authority granted by this Order is separate and apart from, and in addition to, the 

authority to make inspections under the FDCA, 21 U.S.C. § 374.

7. Defendants shall bear the cost of any inspections, analytical work, and 

supervisory activities that FDA deems necessary to evaluate Defendants’ 

compliance with any of the terms of this Order.

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8. Defendants shall post a copy of this Order in a common area at the Facility 

and at any other location at which Defendants conduct business and shall ensure 

that the Order remains posted for as long as the Order remains in effect.

9. IT IS FURTHER ORDERED that the United States shall promptly provide 

notice of this action and this Order to Defendants by attempting service at last 

known email addresses and physical addresses. Pursuant Rule 65(c) of the 

Federal Rules of Civil Procedure, United States of America shall not be required 

to post security for the instant action.

DONE AND ORDERED in chambers in Miami, Florida, this 1st day of May, 2020.

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