United States of America v. Fusion Health and Vitality LLC et al

Filing 5

CONSENT DECREE OF PERMANENT INJUNCTION. Signed by Judge William T. Moore, Jr on January 7, 2021. (jrb)

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 1 of 25

IN THE UNITED STATES DISTRICT COURT FOR
THE SOUTHERN DISTRICT OF GEORGIA
SAVANNAH DIVISION

UNITED STATES OF AMERICA,

Plaintiff,
CASE NO. CV420-296

V.

FUSION HEALTH AND VITALITY LLC,

a Limited Liability Company
doing business as Pharm
Origins; FUSION lONZ LLC, a
Limited Liability Company doing
business as Pharm Origins; and
MATTHEW RYNCARZ, an Individual;
Defendants.

CONSENT DECREE OF PERMANENT INJUNCTION

Plaintiff, the United States of America, by its undersigned

attorneys,

having

filed

a

Complaint

for

Injunctive

Relief

{"Complaint") against Fusion Health and Vitality LLC and Fusion
lonz LLC, limited liability companies organized in the state of

Georgia,

and

Matthew

Ryncarz,

an

individual

(collectively,

"Defendants"), and Defendants having appeared and having consented
to the entry of this Consent Decree of Permanent Injunction (the
"Decree") without contest and before any testimony has been taken,

and the United States of America having consented to this Decree:
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED as follows:

1. This Court has jurisdiction over the subject matter and
all parties to this action.

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 2 of 25

2. The Complaint states a cause of action against Defendants

under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301
et seq. {the '"Act").

3. Defendants 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.
4. Defendants 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(f)(1), and food (dietary supplements,
as defined in 21 U.S.C. § 321(ff)) that is adulterated within the

meaning of 21 U.S.C. § 342(a)(2)(C)(i) and misbranded within the
meaning of 21 U.S.C. § 343.
5. Defendants violate 21 U.S.C. § 331(k) by causing drugs to

become misbranded within the meaning of 21 U.S.C. § 352(f)(1), and
by causing food (dietary supplements, as defined in 21 U.S.C.
§ 321(ff)) to become adulterated within the meaning of 21 U.S.C.
§ 342(a)(2)(C)(i) and misbranded within the meaning of 21 U.S.C.
§ 343, while they are held for sale after shipment of one or more
of their components in interstate commerce.

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

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 3 of 25

A. """Facility" means 1360 Union Hill Road, Suite IIB,

Alpharetta, Georgia, 30004, or any other location(s) at which
Defendants

now

or

in

the

future

directly

or

indirectly

manufacture, process, pack, label, hold, and/or distribute
any drug or articles of drugs or food (including but not
limited to dietary supplements and their components).
B.

""Current

Websites" means

the

following

websites:

www.pharmorigins.com,www.pharmorigins.co, www.americanraws.
net, www.immune-shot.com, www.freecoreoffer.online, www.imm

une-boost.net,

and

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.

C. ""Future

Websites" means

any future

website(s)

or

social media account(s) registered to, owned by, controlled
by, or under the direction of any Defendant.
D. ""Vitamin D Products" refers to Defendants' products
called

Immune Shot, Immune

Boost, CORE, and

any other

of

Defendants' products that contain vitamin D.
E. ""Hordenine HCl Products" refers to any of Defendants'

products that contain hordenine HCl, including Defendants'
CORE product.

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

directors,

officers,

agents,

representatives,

employees.

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 4 of 25

attorneys, successors and assigns, and any and all persons or
entities

in

active

concert

or

participation

with

any

of

them

(^'Associated Persons") are permanently restrained and enjoined
under 21 U.S.C. § 332(a) and the inherent equitable authority of
this Court from directly or indirectly manufacturing, processing,
packing,

labeling,

holding,

and/or

distributing

any

drug

or

articles of drugs or food (including but not limited to dietary

supplements and their components), including but not limited to
Vitamin D Products and Hordenine HCl Products, unless and until:

A. For all of Defendants' drugs, either:
i. 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(1), for such drugs; or
ii. Defendants meet the following requirements:
a.

Defendants

remove

from

product

labeling

(including but not limited to labels, promotional
material. Current Websites, and Future Websites)
and other promotional/informational material: (1)
all

representations

diagnose,

disease,

cure,

and

all

that

mitigate,

Defendants'
treat,

representations

or

that

products
prevent

otherwise

cause any of their products to be a drug within the

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 5 of 25

meaning of the Act; and (2) all references, direct
or

indirect,

to

other

sources

representations

that

diagnose,

mitigate,

cure,

that

Defendants'
treat,

contain

products
or

prevent

disease, and representations that otherwise cause

any of Defendants' products to be a drug within the
meaning of the Act.
b. Defendants retain, at Defendants' expense,

an

independent

person

or

persons

(the

''Drug

Expert") who is without any personal or financial
ties

(other

than

a

retention

agreement)

to

Defendants and/or their families, and who by reason

of background, training, education, or experience
is qualified to review Defendants' product labeling
(including but not limited to labels, promotional
material.

and

other

Current Websites, and

Future Websites)

promotional/informational

material

to

determine whether: (1) Defendants' claims cause any

of the

products that they manufacture,

process,

pack, label, hold, and/or distribute, including but
not limited to Vitamin

D Products, to be a drug

within the meaning of 21 U.S.C. § 321(g)(1); and
(2) Defendants' product labeling complies with the
Act and its implementing regulations. Defendants

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 6 of 25

shall notify FDA in writing of the identity and
qualifications of the Drug Expert within three (3)
business days after retaining such expert.
c.

The

Drug

comprehensive
labeling

Expert

review

(including

of

but

shall

perform

Defendants'

not

limited

a

product

to

labels,

promotional material, Current Websites, and Future

Websites)

and

other

promotional/informational

material and certifies in writing to FDA that: (1)
he

or

she

has

identified

all

of

Defendants'

products and reviewed Defendants' representations

for

each

product

on

labeling

and

other

promotional/informational material; (2) Defendants
have removed all representations that cause any of

Defendants' products to be drugs within the meaning
of the Act, 21 U.S.C. § 321(g); and (3) based upon

the Drug Expert's inspection and review. Defendants
are operating, in compliance with this Decree, the
Act,

and its implementing

regulations.

The

Drug

Expert's written certification shall include the

specific

results

of

his

or

her

inspection

and

review, including references to product names and
copies of all materials reviewed.

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 7 of 25

d. For all products for which Defendants have
removed claims that caused Defendants' products to

be drugs within the meaning of the Act, and such

products

meet

the

definition

of

a

dietary

supplement in 21 U.S.C. § 321(ff) Defendants shall
.
comply with the requirements in Paragraph 7.B of
this

Decree

provisions

and

and

the

Act's

dietary

implementing

supplement

regulations,

before

introducing such products into interstate commerce.
B.

For

all

of

Defendants'

food

products

(dietary

supplements):
i. Defendants retain, at Defendants' expense, an

independent person or persons (the '"Dietary Supplement

Expert") who is without any personal or financial ties

(other than a retention agreement) to Defendants and/or
their families, except that this person may be the same

as the Drug Expert described in Paragraph 7.A, and who,
by

reason

of

background,

training,

education,

or

experience, is qualified to inspect the Facility and
review Defendants' labeling (including but not limited
to labels, promotional material. Current Websites, and

Future

Websites)

material

to

and

determine

other

promotional/informational

whether

Defendants'

methods,

processes, and controls, are adequate to ensure that the

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 8 of 25

dietary

supplements

that

they

manufacture,

process,

pack, label, hold, and/or distribute are in compliance
with

this

Decree,

the

Act,

and

its

implementing

regulations, including, but not limited to, whether: (1)
Defendants'

methods,

processes,

and

controls,

are

adequate to ensure that none of the dietary supplements

that

they

and/or

manufacture,

distribute,

process,

including

pack,

but

not

label,

hold,

limited

to

Hordenine HCl Products, contain a food additive that is

unsafe within the meaning of 21 U.S.C. § 348(a); and (2)

Defendants' dietary supplement labeling complies with 21
U.S.C. § 343 and applicable regulations.
ii. Defendants shall notify FDA in writing of the
identity and qualifications of the Dietary Supplement
Expert within three (3) business days after retaining
such expert.

iii. The Dietary Supplement Expert shall perform a

comprehensive

inspection

of

the

Facility

and

the

methods, processes, and controls used to manufacture,
process, pack, label, hold, and/or distribute dietary
supplements and a comprehensive review of Defendants'
labeling

(including

promotional

but

material.

not

Current

limited
Websites,

to
and

labels,
Future

Websites) and other promotional/informational material
8

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 9 of 25

and certify in writing to FDA that: (1) he or she has

inspected the Facility, and the methods, processes, and
controls

used

to

manufacture,

process,

pack,

label,

hold, and/or distribute dietary supplements; (2) he or
she

has

reviewed

Defendants'

promotional/informational

labeling

material;

and

(3)

other

Defendants'

Facility and the methods, processes, and controls used

to

manufacture,

distribute

process,

dietary

pack,

supplements

label,
are,

hold,

in

and/or

the

Dietary

Supplement Expert's opinion, in compliance

with this

Decree, the Act, and its implementing regulations; (4)
all

deviations

from

the

requirements

in

21

U.S.C.

§ 348(a) that have been brought to Defendants' attention
by FDA, the Dietary Supplement Expert, and any other
source

since

Defendants'

May

2020,

products and

have

claims

been

corrected;

are, in the

(5)

Dietary

Supplement Expert's opinion, in compliance with this
Decree, the Act, and its implementing regulations; and

(6)

Defendants'

dietary supplement

labeling

complies

with 21 U.S.C. § 343 and applicable regulations.
iv. The Dietary Supplement Expert shall prepare a
detailed report, which shall be submitted to FDA as part

of the certification described in Paragraph 7.B.iii, of
the Dietary Supplement Expert's inspection that shall

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 10 of 25

include, but not be limited to: {1) a determination that

Defendants

have

implemented

corrections

to

their

methods, processes, and controls that are adequate to
ensure

that

Defendants

none

of

the

manufacture,

dietary

process,

supplements

pack,

label,

that

hold,

and/or distribute contain a food additive that is unsafe

within the meaning of 21 U.S.C. § 348(a); (2) Defendants'

claims are, in the Dietary Supplement Expert's opinion,

in

compliance

implementing

with

this

regulations;

Decree,
and

the

(3)

Act,

and

Defendants

its
have

implemented corrections to ensure that their dietary
supplement labeling complies with 21 U.S.C. § 343 and
applicable regulations.

C. Should any Expert(s) described in Paragraphs 7.A 7.B identify any deficiencies as part of their certifications
as described in Paragraphs 7.A.ii.c and/or 7.B.iii:
i. Defendants shall report in writing to FDA and
the appropriate Expert the actions they have taken to
correct all such deficiencies; and

ii. The appropriate Expert shall certify in writing

to FDA, based upon his or her further review and/or
inspection(s)
conformity

that

with

Defendants

this

implementing regulations.
10

Decree,

are
the

operating
Act,

and

in
its

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 11 of 25

D.

If

FDA

determines

it

to

be

necessary,

FDA

representatives inspect the Facility to determine whether the
requirements

of

this

Decree

have

been

met

and

whether

Defendants are operating in conformity with this Decree, the
Act, and its implementing regulations.
E.

Defendants

recall

and

destroy,

under

FDA's

supervision and in accordance with the procedures provided in
Paragraphs 8-9, all of Defendants' Vitamin D Products and

Hordenine

HCl Products that were manufactured, processed,

packed, labeled, held, and/or distributed by Defendants from
January 1, 2020, through and including the date of entry of
this Decree.
F. Defendants have reimbursed FDA for the costs of all

FDA

inspections,

examinations,
evaluate

and

investigations,
reviews

Defendants'

that

compliance

supervision,
FDA

with

deems

analyses,

necessary

Paragraph

7,

at

to
the

rates set forth in Paragraph 16; and

G. FDA notifies Defendants in writing that they appear

to

be

in

compliance

with

the

requirements

set

forth

in

Paragraphs 7.A - 7.C and 7.E - 7.F of this Decree. In no
circumstance shall FDA's silence be construed as a substitute
for written notification.

8. Within eight (8) calendar days after entry of this Decree,
Defendants

shall

submit to

FDA

for

11

its

review

and

concurrence

a

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 12 of 25

strategy to recall all of the Vitamin D Products and Hordenine HCl
Products that were distributed by Defendants from January 1, 2020,
through and including the date of entry of this Decree. The recall
strategy shall include customer notifications, public warning,
methods for conducting effectiveness checks, and plans for product

disposition. Within five (5) calendar days after receiving FDA
concurrence of the recall strategy. Defendants shall initiate a
recall

of

all

distributed

Vitamin

D

Products

and

Hordenine

HCl

Products.

9. Within fifteen (15) business days after completing the
recall of all distributed Vitamin D and Hordenine HCl Products as

described in Paragraph 8, 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 Vitamin D Products and Hordenine HCl
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

email

or
12

other

virtual

means

as

FDA

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 13 of 25

determines

to

be

appropriate),

complete

the

destruction

in

compliance with this Decree. 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.

10. After Defendants have complied with Paragraphs 7.A - 7.C
and 7.E - 7.F and received FDA's written notification pursuant to

7.G, Defendants shall retain an independent person or persons who
shall meet the criteria described in Paragraphs 7.A - 7.B (the
Auditor") to conduct audit inspections of the Facility and a

comprehensive review of Defendants' labeling (including but not
limited to labels, promotional material. Current Websites, and
Future Websites) and other promotional/informational material, 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

Defendants

receive

FDA's

written

notification pursuant to Paragraph 7.G. The Auditor may be the

same

person

or

persons

retained

as

an

Expert

described

in

Paragraphs 7.A - 7.B.

A.

At

the

conclusion

of

each

audit

inspection,

the

Auditor shall prepare a detailed written audit report (^'Audit
Report") analyzing whether or not Defendants are operating in

compliance with this Decree, the Act, and its implementing
13

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 14 of 25

regulations and identifying in detail any deviations from the
foregoing {''Audit Report Observations'').
B.

Each

Audit

Report

shall

contain

a

written

certification that the Auditor: (1) has personally inspected

Defendants' Facility and operations and reviewed all product

labeling (including but not limited to labels, promotional
material. Current Websites, and Future Websites) and other

promotional/informational

material;

and

(2)

personally

certifies whether Defendants' food (dietary supplements) and

drugs are in compliance with the requirements of this Decree,
the Act, and its implementing regulations.

C. As part of every Audit Report, except the first, the
Auditor shall assess the adequacy of corrective actions taken

by

Defendants

observations.

to
The

contemporaneously

correct
Audit

to

all

previous

Reports

Defendants

and

Audit

shall
FDA,

be
at

Report

delivered

the

address

provided in Paragraph 22, by courier service or overnight
delivery service, no later than fifteen (15) days after the
date

the

Audit

inspection

is

completed.

In

addition.

Defendants shall maintain their Audit Reports and all of their

underlying data in separate files at the Facility and shall
promptly make the Audit Reports available to FDA upon request.

D.

If

an

Audit

Report

contains

any

observations

indicating that Defendants' food (dietary supplements) or
14

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 15 of 25

drugs are not in compliance with this Decree, the Act, or its
implementing regulations. Defendants shall, within fifteen
(15) calendar days after receipt of the Audit Report, correct
those observations,

unless

FDA notifies

Defendants that a

shorter time period is necessary. If, after receiving the
Audit

Report,

Defendants

believe

that

correction

of

the

deviations may take longer than fifteen (15) calendar days.
Defendants shall, within ten (10) calendar days after receipt

of the Audit Report, submit to FDA in writing a proposed

schedule

for

completing

corrections

(''Audit

Correction

Schedule"). The Audit Correction Schedule must be reviewed

and approved by FDA in writing prior to implementation by
Defendants.

In

no

circumstance

shall

FDA's

silence

be

construed as a substitute for written approval. Defendants

shall complete all corrections according to the approved
Audit Correction Schedule.

E. Immediately upon correction. Defendants shall submit
documentation

of

their

corrections

to

the

Auditor.

Within

thirty (30) calendar days after the Auditor's receipt of
Defendants' documentation of corrections, unless FDA notifies

Defendants that a shorter time period is necessary, or within
the time period provided in the Audit Correction Schedule
approved by FDA, the Auditor shall review the actions taken

by

Defendants

to

correct

the
15

Audit

Report

observations.

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 16 of 25

Within five (5) business days after beginning that review,
the Auditor shall report in writing to FDA whether each of
the Audit Report Observations have been corrected, and, if
not, which Audit Reports Observations remain uncorrected.
11. Upon entry of this Decree and after Defendants receive

notification under Paragraph 7.G from FDA that they are permitted
to resume operations. Defendants and all Associated Persons, 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

delivering

for

21

U.S.C.

introduction

§

331(d)

into

by

introducing

interstate

commerce

or
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.
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

supplements,

of
as

21

U.S.C. § 352(f)(1),

defined

in

21

and

food

(dietary

U.S.C. § 321(ff)) that

is

adulterated within the meaning of 21 U.S.C. § 342(a)(2)(C)(i)
or misbranded within the meaning of 21 U.S.C. § 343.
C. Violating 21

U.S.C. § 331(k) by causing drugs to

become misbranded within the meaning of 21 U.S.C. § 352(f)(1),
and by causing food (dietary supplements, as defined in 21
16

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 17 of 25

U.S.C. § 321(ff)) to become adulterated within the meaning of
21 U.S.C. § 342(a)(2)(C)(i) or misbranded within the meaning

of

21

U.S.C. § 343,

while

they

are

held

for

sale

after

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

D. Failing to implement and continuously maintain the
requirements of the Act, its implementing regulations, and
this Decree.

12. If, at any time after this Decree has been entered, FDA
determines, based on the results of an inspection, a review of
Defendants'

products,

labeling, a

report prepared

by the

Drug

Expert, the Dietary Supplement Expert, or the Auditor, or any other
information,

that

Defendants

have

failed

to

comply

with

any

provision of this Decree, have violated the Act or its implementing
regulations, or that additional corrective actions are necessary

to achieve compliance with this Decree, 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 manufacturing, processing, packing, labeling,

holding, and/or distributing any or all drugs and/or dietary
supplements;
17

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 18 of 25

B. Recall, at Defendants' expense, any product that in

FDA's judgment is adulterated, misbranded, or otherwise in
violation

of

this

Decree,

the

Act,

or

its

implementing

regulations;
C. Revise, modify, expand, or continue to submit any
reports or plans prepared pursuant to this Decree;
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 protect the public health or
bring Defendants into compliance with this Decree, 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 Decree or under the
law.

13.

Upon

receipt of any order issued

by

FDA

pursuant to

Paragraph 12, Defendants shall immediately and fully comply with
the terms of FDA's order. Any cessation of operations or other
action described in Paragraph 12 shall continue until Defendants
receive written notification from FDA that Defendants appear to be
in compliance

with this

Decree, the Act, and its implementing

regulations, and that Defendants may resume operations. The cost
of

FDA

inspections,

sampling,
18

testing,

travel

time,

and

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 19 of 25

subsistence expenses to implement the remedies set forth in this
paragraph shall be borne by Defendants at the rates specified in
Paragraph 16.

14. 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

manufacturing,

processing, packing, labeling, holding, and/or distributing any
drug

and/or

dietary

supplement,

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 Decree, the Act, and all applicable regulations.

During such 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
19

this

Decree

and

appropriate

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 20 of 25

credentials. The inspection authority granted by this Decree is
separate and apart from, and in addition to, the authority to make
inspections under the Act, 21 U.S.C. § 374.

15.

records

Defendants shall promptly

to

FDA

processing,

upon

request

packing, labeling,

provide

regarding

any information

the

or

manufacturing,

holding, and/or distributing

of

Defendants' drugs and/or dietary supplements, including but not
limited

to

Vitamin

D

Products

and

Hordenine

HCl

Products.

Defendants shall submit to FDA, at the street address specified in
Paragraph 22 and within ten (10) calendar days after such request,
a

copy

of

the

materials

FDA

requests,

on

CDROM

or

DVD.

Such

requested materials may include, but are not limited to: a list of
all locations where any of Defendants' drug or dietary supplement

products are held, including but not limited to Vitamin D Products
and Hordenine HCl Products; 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.

16. Defendants shall reimburse FDA for the costs of all FDA

inspections, investigations, supervision, analyses, examinations,
and

reviews

that

FDA

deems

necessary
20

to

evaluate

Defendants'

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 21 of 25

compliance

with

transportation

any

and

part

associated

of

this

costs

for

Decree,
FDA

including

investigators

all
and

experts, at the standard rates prevailing at the time the costs
are incurred. As of the date of entry of this Decree, 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.

17. Within five (5) business days after the entry of this
Decree, Defendants shall post a copy of this Decree in a common
area at the Facility and at any other location at which Defendants
conduct business and shall ensure that this Decree remains posted
for as long as this Decree remains in effect. Within ten (10)

business days after entry of this Decree, 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.

18. Within ten (10) business days after the entry of this
Decree, Defendants shall provide a copy of this Decree by personal
21

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 22 of 25

service or certified mail (return receipt requested) to each and
all

Associated

Persons

and

shall

post

this

Decree

on

Current

Websites and Future Websites. Within twenty (20) business days

after the date of entry of this Decree, 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
Decree.

19. In the event that any of the Defendants becomes associated
with any additional Associated Person(s) at any time after entry
of this Decree, Defendants shall within ten (10) business days
after the commencement of such association: (a) provide a copy of
this Decree, 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 Decree pursuant to this paragraph.

20. 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 Decree,

including

an

incorporation,

reorganization,

creation

of

a

subsidiary, relocation, dissolution, bankruptcy, assignment, sale,

or any other change in the structure or identity of Fusion Health
22

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 23 of 25

and Vitality LLC or Fusion lonz LLC, or the sale or assignment of
any business assets, such as the

Facility, other

buildings or

structures, equipment, or inventory. Defendants shall provide a
copy of this Decree 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 with

this paragraph no later than ten (10) business days prior to such
assignment or change in ownership.
21. 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 the Vitamin D Products or Hordenine
HCl

Products

supplements.

or

any

other

Defendants

of

shall

Defendants'

post

a

copy

drugs

of

this

or

dietary

Decree,

in

accordance with Paragraph 18, on any websites created after entry
of this Decree that convey information about Vitamin D Products or

Hordenine HCl Products or other drugs and/or dietary supplements.
Within

ten

websites.

(10)

calendar

Defendants

days

shall

after

provide

the
to

creation
FDA

an

of

any

affidavit

new
of

compliance, stating the fact and manner of compliance with the

provisions of this Paragraph.
22. All notifications, correspondence, and communications to
FDA required by the terms of this Decree shall be addressed to:

Director, Office of Pharmaceutical Operations Division II, 4040
23

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 24 of 25

North Central Expressway, Suite 300, Mail Code HFR-SWIOO, Dallas,

Texas

75204,

and

shall

also

be

sent

by

e-mail

to

ORAPHARM2_RESPONSES0fda.hhs.gov.
23. If any Defendant fails to comply with any provision of
this Decree, the Act, or its implementing regulations, including
any time frame imposed by this Decree, then Defendants shall pay
to the United States of America: (a) five thousand dollars ($5,000)

in

liquidated

damages

for

each

violation

of

the

Act,

its

implementing regulations, or this Decree; (b) an additional three
thousand

dollars

($3,000)

in

liquidated

violation, for each violation of the

damages

per

day,

per

Decree, the Act, and its

implementing regulations; and (c) an additional sum in liquidated
damages equal to twice the retail value of any product distributed
in

violation

of

the

Decree,

the

Act,

and

its

implementing

regulations. Defendants understand and agree that the liquidated

damages specified in this Paragraph are not punitive in nature,
and the remedy in this Paragraph shall be in addition to any other
remedies available to the United States under this Decree or the
law.

24. Should the United States bring and prevail in a contempt
action to enforce the terms of this Decree, Defendants shall, in
addition to other remedies, reimburse the United States for its

attorneys'

fees

(including

overhead),

24

investigational

and

Case 4:20-cv-00296-WTM-CLR Document 5 Filed 01/08/21 Page 25 of 25

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

25. Defendants shall abide by the decisions of FDA, and FDA's
decisions shall be final. All decisions conferred upon FDA in this
Decree shall be vested in FDA's discretion and, if contested, shall

be

reviewed

by this Court

under the

arbitrary and

capricious

standard set forth in 5 U.S.C. § 706(2)(A). Review by the Court of

any FDA decision rendered pursuant to this Decree 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.

26. This Court retains jurisdiction over this action and the

parties thereto for the purpose of enforcing and modifying this
Decree and for the purpose of granting such additional relief as
may be necessary or appropriate.
—

SO ORDERED this

r

day of January 2021.

^i
WILLIAM T. MOORE, JFK
UNITED STATES DISTRICT COURT
SOUTHERN

25

DISTRICT OF GEORGIA