Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 1 of 17

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.
____________________________________/

[PROPOSED] ORDER OF PERMANENT INJUNCTION

Plaintiff, the United States of America, by its undersigned attorneys, having filed a

Complaint for Injunction against Genesis II Church of Health and Healing (“Genesis”),

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

Court having considered such arguments and supporting evidence filed by Defendants,

and it appearing that Defendants are violating the Federal Food, Drug, and Cosmetic Act

(“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., and, unless restrained by order of this

Court, will continue to violate the Act:

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

that:

1. This Court has jurisdiction over this action under 21 U.S.C. § 332(a) and

28 U.S.C. §§ 1331, 1337, and 1345.

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2. The Complaint states a cause of action against Defendants under the

FDCA, 21 U.S.C. §§ 301 et seq.

3. Defendants violate the FDCA, 21 U.S.C. § 331(d), by introducing or

delivering for introduction into interstate commerce and/or causing the introduction or

delivery for introduction into interstate commerce unapproved new drugs.

4. Defendants violate the FDCA, 21 U.S.C. § 331(a), by introducing or

delivering for introduction into interstate commerce and/or causing the introduction or

delivery for introduction into interstate commerce drugs, as defined by 21 U.S.C.

§ 321(g), that are misbranded within the meaning of 21 U.S.C. § 352(a) and (f)(1).

5. Defendants violate the FDCA, 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 such

drugs are held for sale after shipment of components or the finished product in interstate

commerce.

6. For the purposes of this Order, the following definitions shall apply:

“The Facility” means 2014 Garden Lane, Bradenton, Florida

34205-5274.

“Current Websites” means the following websites:

genesis2church.ch, newg2sacraments.org, g2churchnews.org, g2voice.is,

mmstestimonials.co, and g2worldwidemissions.org, as well as any other website(s) and

social media account(s) currently in existence that are registered to, owned by, controlled

by, or under the direction of any Defendant.

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“Future Websites” means any future website(s) or social media

account(s) that are registered to, owned by, controlled by, or under the direction of any

Defendant.

“MMS products” refers to Defendants’ products called MMS,

Sacramental Cleansing Water, Miracle Mineral Solution, MMS1, G2Church Sacramental,

G2Church Sacrament, products sold as part of Defendants’ “g2kit2,” and any other of

Defendants’ products that, when used as directed, contain chloride dioxide.

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

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

and all persons or entities in active concert or participation with any of them who have

received actual notice of this Order by personal service or otherwise are permanently

restrained and enjoined under 21 U.S.C. § 332(a), and the inherent equitable authority of

this Court, from directly or indirectly labeling, holding, and/or distributing any drug,

including but not limited to MMS, unless and until:

A. For all of Defendants’ drugs, Defendants have an approved new

drug application (“NDA”) or an abbreviated new drug application (“ANDA”), pursuant to

21 U.S.C. § 355(b), (j), or an investigational new drug application (“IND”) in effect

pursuant to 21 U.S.C. § 355(i), for such drugs;

B. Within eight (8) calendar days after the entry of this Order,

Defendants shall submit to FDA for its review and approval a recall strategy for all of

Defendants’ MMS products, including components, raw and in-process materials, and

finished products, that were distributed by Defendants from January 1, 2010, through and

including the date of entry of this Order. The recall strategy shall include, but not be
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limited to, customer notifications, public warning, methods for conducting effectiveness

checks, and plans for the disposition of recalled products. Within five (5) calendar days

after receiving FDA’s approval of the recall strategy, Defendants shall initiate a recall of

all MMS distributed product in accordance with such recall strategy. Within thirty (30)

calendar days after initiating the recall, Defendants will complete the recall and shall

destroy, under FDA’s supervision (which may be done by e-mail or other virtual means as

FDA determines to be appropriate) and in accordance with the procedures provided in

Paragraph 8, all of their MMS products, including components, raw and in-process

materials, and finished products that are held and/or were distributed by Defendants from

January 1, 2010, through and including the date of entry of this Order. Defendants shall

bear the costs of destruction and the costs of FDA’s supervision;

C. If FDA determines it to be necessary, FDA representatives inspect

the Facility to determine whether the requirements of this Order have been met and

whether Defendants are operating in conformity with this Order, the Act, and its

implementing regulations;

D. Defendants have reimbursed FDA for the costs of all FDA

inspections, investigations, supervision, analyses, examinations, and reviews that FDA

deems necessary to evaluate Defendants’ compliance with Paragraph 7, at the rates set

forth in Paragraph 15; and

E. FDA notifies Defendants in writing that they appear to be in

compliance with the requirements set forth in Paragraphs 7.A – B and 7.D of this Order.

In no circumstance shall FDA’s silence be construed as a substitute for written

notification.
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8. Within fifteen (15) business days after completing the recall of all

distributed MMS products as described in Paragraph 7.B, Defendants shall give notice to

FDA that, under FDA’s supervision (which may be done by e-mail or other virtual means

as FDA determines to be appropriate), Defendants are prepared to destroy all MMS

products (including components, raw and in-process materials, and finished products) in

Defendants’ possession, custody, or control. Defendants’ notice shall specify the

proposed time, place, and method of destruction. Defendants shall not commence or

permit any other person to commence destruction until they have received written

authorization from FDA to commence the destruction. Within fifteen (15) business days

after receiving authorization from FDA to commence destruction, Defendants shall, under

FDA supervision (which may be done by e-mail or other virtual means as FDA

determines to be appropriate), complete the destruction in compliance with this Order.

Defendants shall not dispose of any such products in a manner contrary to the provisions

of the Act, any other federal law, or the laws or any state or Territory, as defined in the

Act, in which the products are disposed. Defendants shall bear the costs of destruction

and FDA’s supervision.

9. Defendants shall retain, at their expense, an independent person or persons

(the “Auditor”) who is qualified by education, training, and experience to determine

whether Defendants’ labels, labeling, promotional material, Current Websites, and Future

Websites cause Defendants’ drugs, including but not limited to MMS, to be unapproved

new drugs and misbranded drugs; whether Defendants are directly or indirectly

responsible for labeling, holding, or distributing drugs, including but not limited to MMS;

and whether Defendants directly or indirectly do any acts that causes drugs to become
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misbranded while they are held for sale after shipment of one or more of their

components in interstate commerce. The Auditor shall be without personal or financial

ties (other than a consulting agreement between the parties) to any Defendant or any of

Defendants’ affiliates (including, but not limited to, any entities that Defendants identify

as “chapters”), officers or employees, or immediate families. Defendants shall notify

FDA in writing of the identity of the Auditor within ten (10) business days after retaining

such Auditor.

A. The Auditor shall conduct audit inspections of Defendants’ Current

Websites, Future Websites, the Facility, and any other location(s) at which Defendants,

now or in the future, directly or indirectly engage in labeling, holding, and/or distributing

drugs, no less frequently than once every six (6) months for a period of no less than five

(5) years. The first audit shall occur not more than six (6) months after entry of this

Order.

B. At the conclusion of each audit inspection, the Auditor shall

prepare a detailed written audit report (“Audit Report”) analyzing whether Defendants are

in compliance with this Order and identifying any deviations from such requirements and

shall provide a list of all materials reviewed, including all websites and social media, as

well as copies of all such materials (“Audit Report Observations”).

C. Each Audit Report shall contain a written certification that the

Auditor: (1) has personally reviewed all of Defendants’ product labels, labeling, Current

Websites, and Future Websites; (2) personally certified whether the product labels,

labeling, Current Websites, and Future Websites make claims that cause Defendants’

MMS products or other products to be drugs within the meaning of the Act;
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(3) personally certified whether Defendants are directly or indirectly labeling, holding, or

distributing Defendants’ MMS products or other products that are drugs within the

meaning of the Act; and (4) personally certified whether Defendants are directly or

indirectly doing any acts that cause drugs to become misbranded while they are held for

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

D. The Audit Reports shall be delivered contemporaneously to

Defendants and FDA by courier service, overnight delivery service, or e-mail, no later

than ten (10) business days after the date the Audit Report is completed. In addition,

Defendants shall maintain the Audit Reports in separate files at Defendants’ Facility and

at any other location(s) at which Defendants, now or in the future, directly or indirectly

engage in labeling, holding, and/or distributing drugs, and shall promptly make the Audit

Reports available to FDA upon request; and

E. If an Audit Report contains any observations indicating that

Defendants are violating any provision of this Order or the Act or its implementing

regulations, Defendants shall immediately cease such activity.

10. Upon entry of this Order, Defendants, and all of their directors, officers,

agents, representatives, employees, attorneys, successors and assigns, and any and all

persons or entities in active concert or participation with any of them, are permanently

restrained and enjoined under 21 U.S.C. § 332(a) from directly or indirectly doing or

causing to be done any of the following acts:

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

introduction into interstate commerce new drugs that are neither approved pursuant to

21 U.S.C. § 355 nor exempt from approval;

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

interstate commerce drugs that are misbranded within the meaning of 21 U.S.C. § 352(a)

and/or (f)(1); and

C. Violating 21 U.S.C. § 331(k), by causing drugs that Defendants

hold for sale after shipment of components or finished product in interstate commerce to

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

D. Failing to implement and continuously maintain the requirements

of the Act, its implementing regulations, and this Order.

11. If, at any time after this Order has been entered, FDA determines, based on

the results of an inspection, a review of Defendants’ products, product labels, labeling,

Current Websites, Future Websites, a report prepared by the Auditor, or any other

information, that Defendants have failed to comply with any provision of this Order, have

violated the Act or its implementing regulations, or that additional corrective actions are

necessary to achieve compliance with this Order, the Act, or its applicable regulations,

FDA may, as and when it deems necessary, notify Defendants in writing of the

noncompliance and order Defendants to take appropriate corrective action, including, but

not limited to, ordering Defendants to immediately take one or more of the following

actions:

A. Cease labeling, holding, and/or distributing any or all drugs;

B. Recall, at Defendants’ expense, any drug that is an unapproved

new drug, a misbranded drug, or otherwise in violation of this Order, the Act, or its

implementing regulations;
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C. Revise, modify, expand, or continue to submit any reports or plans

prepared pursuant to this Order;

D. Submit additional reports or information to FDA as requested;

E. Issue a safety alert; and/or

F. Take any other corrective actions as FDA, in its discretion, deems

necessary to bring Defendants into compliance with this Order, the Act, or its

implementing regulations.

This remedy shall be separate and apart from, and in addition to, any other

remedy available to the United States under this Order or under the law.

12. Upon receipt of any order issued by FDA pursuant to Paragraph 11,

Defendants shall immediately and fully comply with the terms of FDA’s order. Any

cessation of operations or other action described in Paragraph 11 shall continue until

Defendants receive written notification from FDA that Defendants appear to be in

compliance with this Order, the Act, and its implementing regulations, and that

Defendants may resume operations. The cost of FDA inspections, sampling, testing,

travel time, and subsistence expenses to implement the remedies set forth in this

paragraph shall be borne by Defendants at the rates specified in Paragraph 15.

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

when FDA deems necessary, to inspect the Facility, any other location(s) at which

Defendants, now or in the future, directly or indirectly engage in labeling, holding, and/or

distributing any drug, and Defendants’ operations, collect samples, and, without prior

notice, take any other measures necessary to monitor and ensure continuing compliance

with the terms of this Order, the Act, and all applicable regulations. During such
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inspections, FDA representatives shall be permitted: immediate access to Defendants’

Facility and/or other place(s) of business, including but not limited to all buildings or

other structures, equipment, raw ingredients, in-process or unfinished and finished

materials and products, containers, labeling, and other promotional material therein; to

take photographs and make video recordings; to take samples of Defendants’ raw

ingredients, finished and unfinished materials and products, containers, and labeling; and

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

any and all of Defendants’ products 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 Act, 21 U.S.C. § 374.

14. Defendants shall promptly provide any information or records to FDA

upon request regarding the labeling, holding, or distributing (directly or indirectly) of

Defendants’ drugs, including MMS. Defendants shall submit to FDA, at the street

addresses specified in Paragraph 22 and within ten (10) calendar days after such request,

a copy of the materials FDA requests, on CD-ROM or DVD. Such requested materials

may include, but are not limited to: a list of all locations where any of Defendants’

products, including MMS, are held; a list of all of Defendants’ websites and any other

media that are registered to, owned by, controlled by, or under the direction of any

Defendant; and/or downloaded copies of any and all of Defendants’ websites, product

labeling and promotional materials, and any other media that are registered to, owned by,

controlled by, or under the direction of any Defendant.

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15. Defendants shall reimburse FDA for the costs of all FDA inspections,

investigations, supervision, analyses, examinations, and reviews that FDA deems

necessary to evaluate Defendants’ compliance with any part of this Order, including all

transportation and associated costs for FDA investigators and experts, at the standard

rates prevailing at the time the costs are incurred. As of the date of entry of this Order,

these rates are: $101.00 per hour or fraction thereof per representative for inspection and

investigative work; $121.06 per hour or fraction thereof per representative for analytical

or review work; $0.575 per mile for travel expenses by automobile; government rate or

the equivalent for travel by air or other means; and the published government per diem

rate for subsistence expenses where necessary. In the event that the standard rates

applicable to FDA supervision of court-ordered compliance are modified, these rates shall

be increased or decreased without further order of the Court.

16. Within five (5) business days after the entry of this Order, 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 this Order remains posted for as

long as this Order remains in effect. Within ten (10) business days after entry of this

Order, Defendants shall provide to FDA an affidavit, from a person with personal

knowledge of the facts stated therein, stating the fact and manner of compliance with this

paragraph.

17. Within ten (10) business days after the entry of this Order, Defendants

shall provide a copy of this Order by personal service or certified mail (return receipt

requested) to each and all of their directors, officers, agents, representatives, employees,

attorneys, successors and assigns, and any and all persons or entities in active concert or
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participation with any of them (“Associated Persons”) and shall post this Order on

Current Websites and Future Websites. Within twenty (20) business days after the date of

entry of this Order, Defendants shall provide to FDA an affidavit stating the fact and

manner of their compliance with this paragraph, including identifying the names,

addresses, and positions of all persons who have received a copy of this Order and

websites on which the Order has been posted.

18. In the event that any of the Defendants becomes associated with any

additional Associated Person(s) at any time after entry of this Order, Defendants shall

within ten (10) business days after the commencement of such association: (a) provide a

copy of this Order, by personal service or certified mail (restricted delivery, return receipt

requested), to such Associated Person(s); and (b) provide to FDA an affidavit stating the

fact and manner of compliance with this paragraph, identifying the names, addresses, and

positions of all Associated Persons who received a copy of this Order pursuant to this

paragraph.

19. Defendants shall notify FDA in writing at least fifteen (15) business days

before any change in ownership, name, or character of their business that occurs after

entry of this Order, including an incorporation, reorganization, creation of a subsidiary,

relocation, dissolution, bankruptcy, assignment, sale, or any other change in the structure

or identity of Genesis II Church of Health and Healing, or the sale or assignment of any

business assets, such as the Facility, other buildings or structures, equipment, or inventory

that may affect obligations arising out of this Order. Defendants shall provide a copy of

this Order to any prospective successor or assign at least twenty (20) business days prior

to any sale or assignment. Defendants shall furnish FDA with an affidavit of compliance
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with this paragraph no later than ten (10) business days prior to such assignment or

change in ownership.

20. Defendants shall notify FDA in writing, at least ten (10) business days

before the creation of a new website or link or reference, direct or indirect, to another

website or other source that conveys information about MMS or any other of Defendants’

drugs. Defendants shall post a copy of this Order, in accordance with Paragraph 17, on

any websites created after entry of this Order that convey information about Defendants’

MMS products or other drugs. Within ten (10) calendar days after the creation of any new

websites, Defendants shall provide to FDA an affidavit of compliance, stating the fact and

manner of compliance with the provisions of this Paragraph.

21. In accordance with the procedures described in subparagraphs A-D of this

Paragraph, Defendants shall pay equitable disgorgement to an escrow fund for the

purpose of satisfying claims from all purchasers who purchased MMS from or through

Defendants since January 1, 2010.

A. Within fifteen (15) business days of the entry of this Order,

Defendants shall promptly provide, to a Special Master appointed by the Court (whose

services shall be paid by Defendants) and to Plaintiff, a financial statement disclosing the

amount of revenue Defendants have obtained from sales or distribution of MMS from

January 1, 2010, through the date of this Order, along with all supporting records

sufficient to determine: (1) the identities, addresses, and phone numbers of the individuals

and entities who purchased MMS by or through Defendants from January 1, 2010

through the date of this Order; (2) the dates and quantities of MMS ordered and the price

paid for such products, including any costs of shipping paid by the purchasers (less any
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refunds already paid by Defendants to such purchasers); and (3) an accounting of gains

and expenses related to the manufacturing, packaging, holding, distribution, sales, and

promotion of MMS. These records shall include, but not be limited to, state and federal

tax returns; bank records; shipping records; sales invoices; accounting records, including

certified financial statements; truthful and fully-executed copies of Department of Justice

Form OBD-500; and any other records as the Court may request. Within twenty (20)

business days after the entry of this Order, Defendants shall each file with the Court an

affidavit stating the fact and manner of compliance with this Paragraph. In the event such

records cannot be provided by Defendants, an affidavit explaining the inability to produce

some or all of the records shall be filed with Court within twenty (20) business days of

the entry of this Order.

B. Within twenty-five (25) business days of entry of this Order,

Defendants shall pay to an escrow fund managed and identified by the Special Master, the

amount disclosed in subparagraph A., above. The Special Master will administer and

effectuate the payment of refunds to purchasers who request them from the escrow fund

until October 31, 2020.

C. Within twenty-five (25) business days of entry of this Order,

Defendants shall prominently display the following notice on Defendants’ Current

Websites, and provide it by mail to all persons and entities that have purchased MMS by

or through Defendants since January 1, 2010:

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NOTICE
You have been identified as an individual who has purchased MMS from
Genesis II Church of Health and Healing. The organization and certain
individuals associated with it are the defendants in a legal action brought
against them by the United States Government to enforce the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. § 301 et. seq.) in the United States District
Court for the Southern District of Florida.

The Court has found the defendants liable for unlawfully distributing MMS
because it is an unapproved new drug and is a misbranded drug. MMS is a
misbranded drug, in part, because its labeling and promotional material
falsely represented the product as safe and effective for treating various
diseases, when in fact there is no substantial evidence that MMS is safe and
effective to treat any disease whatsoever.

As a result, the Court has ordered Defendants to provide refunds to those

purchasers of MMS who request them. In order to obtain a refund, you must
request a refund from the Court-appointed Special Master by email or U.S.
mail using the contact information below, no later than October 31, 2020. In
your request, you must include the following information:

1. Name
2. Address
3. Phone Number
4. Email
5. Approximate date(s) of your MMS purchase(s)
6. Approximate amount paid for MMS purchases (less any refund
received).

CONTACT INFORMATION
XXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXX

You can expect to receive funds once your purchase information is verified.
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D. On November 15, 2020, the Special Master shall return the portion

of the remaining escrow fund that the Special Master determines represents legitimate

business expenses, that is, expenses that Defendants incurred independent of supporting

or powering Defendants’ unlawful distribution of MMS. On that same date, the Special

Master will pay any remaining funds in the escrow fund to the United States Treasury.

E. 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 this disgorgement provision. In addition, Defendants and Associated

Persons are prohibited from destroying, discarding, altering, transferring, or otherwise

making unavailable any documents and records in electronic format or otherwise within

the custody or control of Defendants or Associated Persons.

22. All notifications, correspondence, and communications to FDA required

by the terms of this Order shall be addressed to: Director, Office of Pharmaceutical

Operations Division II, 4040 North Central Expressway, Suite 300, Mail Code HFR-

SW100, Dallas, Texas 75204, and shall also be sent by e-mail to

ORAPHARM2_RESPONSES@fda.hhs.gov.

23. Should the United States bring and prevail in a contempt action to enforce

the terms of this Order, Defendants shall, in addition to other remedies, reimburse the

United States for its attorneys’ fees (including overhead), investigational and analytical

expenses, expert witness fees, and court costs relating to such contempt proceedings.

24. Defendants shall abide by the decisions of FDA, and FDA’s decisions shall

be final. All decisions conferred upon FDA in this Order shall be vested in FDA’s

discretion and, if contested, shall be reviewed by this Court under the arbitrary and
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capricious standard set forth in 5 U.S.C. § 706(2)(A). Review by the Court of any FDA

decision rendered pursuant to this Order shall be based exclusively on the written record

before FDA at the time the decision was made. No discovery shall be taken by either

party.

25. This Court retains jurisdiction over this action and the parties thereto for

the purpose of enforcing and modifying this Order and for the purpose of granting such

additional relief as may be necessary or appropriate.

DONE AND ORDERED in chambers in Miami, Florida, this ____ day of

______________, 2020.

____________________________________
KATHLEEN M. WILLIAMS
UNITED STATES DISTRICT JUDGE