Court Order
Court Order
Plaintiff,
vs.
Defendants.
____________________________________/
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
that:
1. This Court has jurisdiction over this action under 21 U.S.C. § 332(a) and
delivering for introduction into interstate commerce and/or causing the introduction or
delivering for introduction into interstate commerce and/or causing the introduction or
§ 321(g), that are misbranded within the meaning of 21 U.S.C. § 352(a) and (f)(1).
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:
34205-5274.
social media account(s) currently in existence that are registered to, owned by, controlled
account(s) that are registered to, owned by, controlled by, or under the direction of any
Defendant.
G2Church Sacrament, products sold as part of Defendants’ “g2kit2,” and any other of
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,
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
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 4 of 17
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
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
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;
deems necessary to evaluate Defendants’ compliance with Paragraph 7, at the rates set
compliance with the requirements set forth in Paragraphs 7.A – B and 7.D of this Order.
notification.
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 5 of 17
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
products (including components, raw and in-process materials, and finished products) in
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
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
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
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 6 of 17
misbranded while they are held for sale after shipment of one or more of their
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
FDA in writing of the identity of the Auditor within ten (10) business days after retaining
such Auditor.
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.
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
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;
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 7 of 17
(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
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
Defendants are violating any provision of this Order or the Act or its implementing
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
introduction into interstate commerce new drugs that are neither approved pursuant to
interstate commerce drugs that are misbranded within the meaning of 21 U.S.C. § 352(a)
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
11. If, at any time after this Order has been entered, FDA determines, based on
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:
new drug, a misbranded drug, or otherwise in violation of this Order, the Act, or its
implementing regulations;
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 9 of 17
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
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
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
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 10 of 17
Facility and/or other place(s) of business, including but not limited to all buildings or
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,
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,
15. Defendants shall reimburse FDA for the costs of all FDA inspections,
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
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
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 12 of 17
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
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
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
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 13 of 17
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
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 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
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 14 of 17
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
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
some or all of the records shall be filed with Court within twenty (20) business days of
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
Websites, and provide it by mail to all persons and entities that have purchased MMS by
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.
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.
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 16 of 17
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.
immediately refrain from disposing of or transferring any assets that may interfere with
making unavailable any documents and records in electronic format or otherwise within
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-
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
Case 1:20-cv-21601-KMW Document 53-1 Entered on FLSD Docket 07/07/2020 Page 17 of 17
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
______________, 2020.
____________________________________
KATHLEEN M. WILLIAMS
UNITED STATES DISTRICT JUDGE