Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 1 of 21 PageID: 197

BRIAN M. BOYNTON
Acting Assistant Attorney General
Civil Division
ARUN G. RAO
Deputy Assistant Attorney General
GUSTAV W. EYLER
Director
Consumer Protection Branch
ALLAN GORDUS
Assistant Director
BRIANNA M. GARDNER
Trial Attorney
U.S. Department of JusticeConsumer Protection Branch
P.O. Box 386
Washington, D.C. 20044
Tel: 202-532-4786
Brianna.M.Gardner@usdoj.gov
UNITED STATES DISTRICT COURTFOR THE DISTRICT OF NEW JERSEYUNITED STATES OF AMERICA,
Plaintiff,

Civil Action No. 2:20-cv-16016

v.
NATURAL SOLUTIONS FOUNDATION, anorganization, and RIMA LAIBOW, andRALPH FUCETOLA, individuals,

Hon. Julien X. Neals
Hon. Edward S. Kiel

Defendants.

MOTION FOR ENTRY OF CONSENT DECREE
The parties have agreed to settle this matter pursuant to the terms set forth in the attached
Consent Decree of Permanent Injunction. The United States therefore respectfully requests that
the Court enter the attached Consent Decree of Permanent Injunction.

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 2 of 21 PageID: 198

DATED this 23rd day of December, 2021.
Respectfully submitted,

OF COUNSEL:DANIEL J. BARRY
Acting General Counsel
Department of Health and Human Services

BRIAN M. BOYNTON
Acting Assistant Attorney General
Civil Division

PERHAM GORJI
Deputy Chief Counsel, Litigation
Food and Drug Administration

ARUN G. RAO
Deputy Assistant Attorney General
GUSTAV W. EYLER
Director
Consumer Protection Branch

JACLYN E. MARTÍNEZ RESLY
Associate Chief Counsel for Enforcement
Department of Health and Human Services
Office of the Chief Counsel
Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 32, Room 4397
Silver Spring, MD 20993
Phone: (301) 348-3932
Jaclyn.MartinezResly@fda.hhs.gov

ALLAN GORDUS
Assistant Director________________________BRIANNA M. GARDNER
Trial Attorney
Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044(202) 532-4786
Brianna.M.Gardner@usdoj.gov
Counsel for the United States of America2Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 3 of 21 PageID: 199

UNITED STATES DISTRICT COURTFOR THE DISTRICT OF NEW JERSEYUNITED STATES OF AMERICA,
Plaintiff,
Civil Action No. 2:20-cv-16016

v.
NATURAL SOLUTIONSFOUNDATION, an organization, and
RIMA LAIBOW, and RALPH
FUCETOLA, individuals,

Hon. Julien X. Neals
Hon. Edward S. Kiel

Defendants.
CONSENT DECREE OF PERMANENT INJUNCTION
Plaintiff, the United States of America, by its undersigned counsel, having filed aComplaint for Injunction against Natural Solutions Foundation, an organization, and Rima
Laibow and Ralph Fucetola, individuals (collectively, “Defendants”), and Defendants having
appeared and consented to entry of this Decree without contest and before any testimony has
been taken and without admitting or denying the allegations in the Complaint, and the UnitedStates 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 the parties to this2.

The Complaint states a cause of action against Defendants under the Federal

action.

Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the “Act”).
3.

The Complaint alleges that Defendants violate 21 U.S.C. § 331(d) by introducing

or causing to be introduced, or delivering for introduction or causing to be delivered forCase 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 4 of 21 PageID: 200

introduction, into interstate commerce a new drug, as defined in 21 U.S.C. § 321(p), that isneither approved pursuant to 21 U.S.C. § 355 nor exempt from approval;
4.

The Complaint alleges that Defendants violate 21 U.S.C. § 331(a) by introducing

or causing to be introduced, or delivering for introduction or causing to be delivered for
introduction, into interstate commerce a drug that is misbranded within the meaning of 21 U.S.C.
§ 352(f)(1).
5.

Upon entry of this Decree, Defendants and each and all of their directors, officers,

agents, representatives, trustees, employees, volunteers, attorneys, successors, and assigns, andany and all persons or entities in active concert or participation with any of them, who havereceived actual notice of this Decree by personal service or otherwise, are permanently enjoined
under 21 U.S.C. § 332(a), and the inherent equitable authority of this Court, from directly or
indirectly receiving, manufacturing, preparing, packing, labeling, holding, or distributing any
articles of drug, at or from 58 Plotts Road, Newton, New Jersey 07860, or at or from any otherlocation(s) at which Defendants now or in the future directly or indirectly receive, manufacture,
prepare, pack, label, hold, or distribute articles of drug (hereafter, the “Facility”), unless anduntil: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.

Defendants report to FDA in writing: (i) the actions they have taken tocorrect the violations brought to Defendants’ attention by FDA and any other source; and (ii) theactions they have taken to ensure that the claims on Defendants’ product labels; labeling;2

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 5 of 21 PageID: 201

promotional material; websites and social media pages owned, created by, controlled by, or
related to Defendants or their products, including, but not limited to, www.nsfmarketplace.com;
www.drrimatruthreports.com; www.inhere.org; www.opensourcetruth.com; andwww.truthaboutcoronavirus.com; and any other media over which Defendants have control do
not cause any of their products to be a drug within the meaning of 21 U.S.C. § 321(g)(1) unlessthe drug is the subject of an FDA-approved new drug application, abbreviated new drug
application, investigational new drug application, or is exempt from approval, and do not cause
any of their products to be misbranded within the meaning of 21 U.S.C. § 352(f)(1);C.

As FDA determines it to be necessary, FDA representatives inspect

Defendants’ Facility, including buildings, equipment, products, labeling, and all relevant records
contained therein; and/or Defendants’ product labels; labeling; promotional material; websites
and social media pages owned, created by, controlled by, or related to Defendants including, but
not limited to, www.nsfmarketplace.com; www.drrimatruthreports.com; www.inhere.org;
www.opensourcetruth.com; and www.truthaboutcoronavirus.com; and any other media overwhich Defendants have control, 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;D.

Defendants have reimbursed FDA for the costs of all FDA inspections,investigations, supervision, analyses, examinations, and reviews that FDA deems necessary toevaluate Defendants’ compliance with Paragraph 5, at the rates set forth in Paragraph 14; andE.

FDA notifies Defendants in writing that they appear to be in compliancewith the requirements set forth in Paragraph 5.A-B and 5.D of this Decree. In no circumstanceshall FDA’s silence be construed as a substitute for written notification.

3

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 6 of 21 PageID: 202

6.

Within six (6) business days after the entry of this Decree, Defendants shallsubmit to FDA for its review and approval a recall plan for Dr. Rima Recommends Nano Silver
10PPM (“nano silver product”) that was distributed to consumers from January 22, 2020,
through and including the date of entry of this Decree. The recall plan shall be submitted to
FDA’s Office of Regulatory Affairs/Office of Human and Animal Food Operations Division
East 2 Recall Coordinator at orahafeast2recalls@fda.hhs.gov and shall include, but not be limited
to, customer notifications, public warning, methods for conducting effectiveness checks, andplans for the disposition of recalled products. Defendants shall promptly implement any changes
that FDA directs in such plan. Within six (6) business days after receiving FDA’s approval of
the recall plan, Defendants shall initiate a recall of their nano silver product in accordance withthe approved recall plan. Within twenty-two (22) business days after initiating the recall,Defendants shall complete the recall. Defendants shall bear the costs of the recall. Defendants
shall destroy the recalled product and all their nano silver product, including components andraw and in-process materials and finished product, in Defendants’ possession, custody, or control
in accordance with the procedures provided in Paragraph 7.
7.

Within fifteen (15) business days after completing the recall of Defendants’ nanosilver product as described in Paragraph 6, Defendants shall give notice to FDA that, under
FDA’s supervision (which may be done by email or other means as FDA determines to beappropriate), Defendants are prepared to destroy all their nano silver product, including
components and raw and in-process materials and finished product, in Defendants’ possession,custody, or control. Defendants’ notice shall specify the proposed time, place, and method ofdestruction (“Destruction Plan”). Defendants shall not commence or permit any other person tocommence destruction until they have received written authorization from FDA to commence the4Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 7 of 21 PageID: 203

destruction. Within fifteen (15) business days after receiving written authorization from FDA tocommence destruction, Defendants shall, under FDA’s supervision (which may be done by email
or other means as FDA determines to be appropriate), complete the destruction in compliancewith the FDA-authorized Destruction Plan. Defendants shall not dispose of any of their nanosilver product (including components and raw and in-process materials and finished product) in amanner 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 articles of nano silver product are disposed.
Defendants shall bear the costs of destruction and FDA’s supervision thereof at the rates set forthin Paragraph 14.
8.

Upon entry of this Decree, Defendants, and all of their directors, officers, agents,

representatives, trustees, employees, volunteers, attorneys, successors and assigns, and any andall persons or entities in active concert or participation with any of them, are permanently
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 causing to be introduced,

or delivering for introduction or causing to be delivered for introduction, into interstate
commerce a new drug, as defined in 21 U.S.C. § 321(p), that is neither approved pursuant to
21 U.S.C. § 355 nor exempt from approval;
B.

Violating 21 U.S.C. § 331(a) by introducing or causing to be introduced,

or delivering for introduction or causing to be delivered for introduction, into interstate
commerce a drug, as defined in 21 U.S.C. § 321(g)(1), that is misbranded within the meaning of
21 U.S.C. § 352(f)(1); and5Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 8 of 21 PageID: 204

C.

Failing to implement and continuously maintain the requirements of thisDecree, the Act, and its implementing regulations.
9.

After complying with the requirements of Paragraph 5.A-B and 5.D and receiving

the notification from FDA pursuant to Paragraph 5.E, Defendants shall retain, at their expense,
an independent person or persons (the “Auditor”) who may or may not be the same person as theLabeling Expert and who is qualified by education, training, and experience to determine
whether Defendants’ labels, labeling, promotional material, and websites cause Defendants’products, including but not limited to Defendants’ nano silver product, to be unapproved new
drugs and misbranded drugs; and whether Defendants are directly or indirectly responsible forreceiving, manufacturing, preparing, packing, labeling, holding, or distributing unapproved new
drugs and misbranded drugs, including but not limited to their nano silver product. The Auditor
shall be without personal or financial ties (other than a consulting agreement between the parties)
to any Defendant or any of Defendants’ employees, trustees, volunteers, or families. Defendants
shall notify FDA in writing of the identity of the Auditor within ten (10) business days ofretaining such Auditor. Thereafter:
A.

Defendants shall ensure that the Auditor shall inspect Defendants’ productlabels; labeling; promotional material; websites and social media pages owned, created by,controlled by, or related to Defendants or their products, including, but not limited to,www.nsfmarketplace.com; www.drrimatruthreports.com; www.inhere.org;
www.opensourcetruth.com; and www.truthaboutcoronavirus.com; and any other locations 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 than6Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 9 of 21 PageID: 205

five (5) years (the “Audit Inspections”). The first Audit Inspection shall occur no more than six(6) months after Defendants’ receipt of FDA’s written notification pursuant to Paragraph 5.E;
B.

At the conclusion of each Audit Inspection, Defendants shall ensure that

the Auditor prepares a detailed written audit report (“Audit Report”) analyzing whether
Defendants are in compliance with this Decree, the Act, and its implementing regulations, andidentifying any deviations from such requirements (“Audit Report Observations”) and shallprovide a list of all materials reviewed, including all websites and social media, as well as copiesof all such materials.
C.

Defendants shall ensure that each Audit Report contains a written

certification that the Auditor has personally reviewed all of Defendants’ product labels; labeling;promotional material; websites and social media pages owned, created by, controlled by, or
related to Defendants including, but not limited to, www.nsfmarketplace.com;
www.drrimatruthreports.com; www.inhere.org; www.opensourcetruth.com; andwww.truthaboutcoronavirus.com; and any other locations at which Defendants, now or in the
future, directly or indirectly engage in labeling, holding, and/or distributing drugs, and personallycertifies (1) whether they contain claims that cause any of Defendants’ products, including but
not limited to their nano silver product, to be drugs within the meaning of the Act and, if so,whether those drugs are unapproved new drugs within the meaning of the Act; and (2) whether
Defendants are directly or indirectly receiving, manufacturing, preparing, packing, labeling,holding, or distributing their nano silver product or other products that are misbranded within themeaning of the Act.
D.

Defendants shall ensure that the Audit Reports are delivered

contemporaneously to Defendants and FDA by courier service or overnight delivery service, no7

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 10 of 21 PageID: 206

later than ten (10) business days after the date the Audit Inspection is completed. Additionally,
Defendants shall maintain the Audit Reports in separate files at Defendants’ Facility and shallpromptly make the Audit Reports available to FDA upon request; andE.

If an Audit Report contains any Audit Report Observations indicating that

Defendants’ products are not in compliance with this Decree, the Act, or its implementing
regulations, Defendants shall immediately cease such activity.
10.

If, at any time after this Decree has been entered, FDA determines, based on the

results of an inspection, a review of Defendants’ products, product labels, labeling, websites, or
social media pages owned or controlled by Defendants, a report prepared by Defendants’
Auditor, or any other information, that Defendants have failed to comply with any provision ofthis 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 implementing
regulations, FDA may, as and when it deems necessary, notify Defendants in writing of theirnoncompliance and order Defendants to take appropriate corrective actions, including, but notlimited to, ordering Defendants to immediately take one or more of the following actions:A.

Cease receiving, manufacturing, preparing, processing, packing, labeling,holding, and/or distributing any or all drugs;
B.

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

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

8Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 11 of 21 PageID: 207

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, theAct, or its implementing regulations.
The provisions of this paragraph shall be separate and apart from, and in addition to, all otherremedies available to FDA. Defendants shall pay all costs of recalls and other corrective actions,
including the costs of FDA’s supervision, inspections, investigations, analyses, examinations,review, travel, and subsistence expenses to implement and monitor recalls and other corrective
actions, at the rates specified in Paragraph 14.
11.

Upon receipt of any order issued by FDA pursuant to Paragraph 10, Defendants

shall immediately and fully comply with the terms of the order. Any cessation of operations orother action described in Paragraph 10 shall continue until Defendants receive written
notification from FDA that Defendants appear to be in compliance with this Decree, the Act, andits implementing regulations, and that Defendants may resume operations.
12.

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

FDA deems necessary, to inspect Defendants’ Facility and, without prior notice, take any othermeasures necessary to monitor and ensure continuing compliance with the terms of this Decree,
the Act, and its implementing regulations. During such inspections, FDA representatives shallbe permitted to: have immediate access to buildings, including but not limited to 58 Plotts Road,
Newton, New Jersey 07860, equipment, raw ingredients, in-process materials, finished products,
containers, packaging material, labeling, and other promotional material therein; takephotographs and make video recordings; take samples of Defendants’ in-process materials or
unfinished and finished products, containers, packaging material, labeling, and other promotional
material; and examine and copy all records relating to the receiving, manufacturing, preparing,9Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 12 of 21 PageID: 208

packing, labeling, holding, or distributing of any and all drugs and their components. The
inspections shall be permitted upon presentation of a copy of this Decree and appropriate
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.
13.

Defendants shall promptly, and no later than ten (10) business days after any FDA

request, provide any information or records to FDA regarding Defendants’ labels, labeling,promotional materials, websites or social media pages, and any other media over which
Defendants have control, containing representations about the intended use(s) of Defendants’products; as well as the receipt, manufacture, preparing, packing, repacking, labeling, holding,and distribution of Defendants’ products, including components.
14.

Defendants shall reimburse FDA for the costs of supervision, inspection,

investigation, review, examination, and analyses conducted pursuant to this Decree or that FDA
deems necessary to evaluate Defendants’ compliance with this Decree at the standard rates
prevailing at the time the activities are accomplished. As of the date this Decree is entered, these
rates are: $102.39 per hour and fraction thereof per representative for inspection and supervision
work; $122.71 per hour and fraction thereof per representative for laboratory and analytical
work; $0.56 per mile plus tolls for travel expenses for travel by automobile; the government rateor equivalent for travel by air or other means; and the published government per diem rate forsubsistence expenses, where necessary. In the event that the standard rates generally applicableto FDA supervision, inspection, review, examination, or analysis are modified, these rates shallbe increased or decreased without further order of the Court. Defendants shall pay any suchcosts within ten (10) business days after being presented with an invoice for such costs from
FDA.

10

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 13 of 21 PageID: 209

15.

Within seven (7) business days after the entry of this Decree, Defendants shallpost a copy of this Decree (a) on the homepage of their websites www.nsfmarketplace.com;
www.drrimatruthreports.com; www.inhere.org; www.opensourcetruth.com; andwww.truthaboutcoronavirus.com, and on the homepage of any other website at which
Defendants conduct business, and (b) in a common area at Defendants’ Facility and at any otherlocation at which Defendants conduct business, and shall ensure that the Decree remains posted
for as long as the Decree remains in effect. Within fifteen (15) business days after entry of thisDecree, Defendants shall provide to FDA an affidavit, from a person with personal knowledge ofthe facts stated therein, stating the fact and manner of compliance with this paragraph, including
but not limited to the identification of the websites on which the Decree was posted.
16.

Defendants shall notify FDA in writing, at least ten (10) business days before thecreation of a new website (or link or reference, direct or indirect, to another website or othersource) that conveys information about Defendants’ nano silver product or any other ofDefendants’ drugs (“new website”). Defendants shall post a copy of this Decree on any new
website on the first day it is accessible to consumers. Within ten (10) business days after thecreation of any new website, Defendants shall provide to FDA an affidavit, from a person withknowledge of the facts stated therein, stating the fact and manner of compliance with thisparagraph.
17.

Within fifteen (15) business days after the entry of this Decree, Defendants shallhold a general meeting or series of smaller meetings (to include telephone or video calls) for all
employees and volunteers at which they shall describe the terms and obligations of this Decree.
Within twenty (20) business days after the entry of this Decree, Defendants shall provide to FDA
an affidavit, from a person with knowledge of the facts stated therein, stating the fact and manner

11

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 14 of 21 PageID: 210of compliance with this paragraph and a copy of the agenda, list of attendees, and meeting
minutes from the meeting(s) held pursuant to this paragraph.
18.

Within fifteen (15) business days after the entry of this Decree, Defendants shallprovide a copy of the Decree by personal service, certified mail (restricted delivery, return
receipt requested), or email (delivery and read receipt requested) to each and all of theirdirectors, officers, agents, representatives, trustees, employees, volunteers, attorneys, successors
and assigns, and any and all persons or entities in active concert or participation with any of them(collectively, “Associated Person(s)”). Within twenty-five (25) business days after the date ofentry of this Decree, Defendants shall provide to FDA an affidavit stating the fact and manner of
their compliance with this paragraph, identifying the names, addresses, and positions of all
persons who have received a copy of this Decree.
19.

In the event that any Defendant 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, provide a copy of this Decree, by
personal service, certified mail (restricted delivery, return receipt requested), or email (delivery
and read receipt requested) to such Associated Person(s), and provide to FDA an affidavit stating
the fact and manner of compliance with this paragraph, identifying the names, addresses, andpositions of all Associated Person(s) who received a copy of this Decree pursuant to thisparagraph.
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 thisDecree, including an incorporation, reorganization, creation of a subsidiary, relocation,
dissolution, bankruptcy, assignment, sale, or any other change in the structure or identity of the12Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 15 of 21 PageID: 211

company, or the sale or assignment of any business assets, such as buildings, equipment, orinventory that may affect obligations arising out of this Decree. Defendants shall provide a copyof 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 thisparagraph no later than ten (10) business days prior to such assignment or change in ownership.
21.

All notifications, correspondence, and communications to FDA required by theterms of this Decree shall be prominently marked “Decree Correspondence” and reference thiscivil action by case name and civil action number, and shall be sent to: Director, ComplianceBranch, Office of Human and Animal Food Operations, Division East 2, Office of Regulatory
Affairs, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland
21215.
22.

All deadlines in this Decree may be extended or shortened by mutual consent of

FDA and Defendants in writing, without leave of Court.
23.

Should the United States bring and prevail in a contempt action to enforce theterms of this Decree, 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 befinal. 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 forthin 5 U.S.C. § 706(2)(A). Review by the Court of any FDA decision rendered pursuant to thisDecree 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.

13

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 16 of 21 PageID: 212

25.

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 additionalrelief as may be necessary or appropriate.

DONE AND ORDERED on this 27th day of December 2021.
*** The Clerk of Court is directed to list this matter as CLOSED.

____________________________________JULIEN XAVIER NEAL
UNITED STATES DISTRICT JUDGE

14

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 17 of 21 PageID: 213

We hereby consent to entry of the foregoing Decree:
FOR DEFENDANTS:

FOR PLAINTIFF:________________________RIMA LAIBOWIndividually and on behalf of
Natural Solutions Foundation

BRIAN M. BOYNTON
Acting Assistant Attorney General
Civil Division
ARUN G. RAO
Deputy Assistant Attorney General________________________RALPH FUCETOLA
Individually and on behalf of
Natural Solutions Foundation

GUSTAV W. EYLER
Director
Consumer Protection Branch
ALLAN GORDUS
Assistant Director________________________
NEIL GROSSMAN
Bronstein, Gewirtz & Grossman, LLC
144 North Beverwyck Road Lake, Ste. 187
Lake Hiawatha, New Jersey 07034(973) 335-6409
neil@bgandg.com
Attorney for Natural Solutions Foundation________________________BRIANNA M. GARDNER
Trial Attorney
Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044(202) 532-4786
Brianna.M.Gardner@usdoj.gov
Counsel for the United States of America

15Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 18 of 21 PageID: 214

OF COUNSEL:DANIEL J. BARRY
Acting General Counsel
Department of Health and Human Services
PERHAM GORJI
Deputy Chief Counsel, Litigation
Food and Drug Administration
JACLYN E. MARTÍNEZ RESLY
Associate Chief Counsel for Enforcement
Department of Health and Human Services
Office of the Chief Counsel
Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 32, Room 4397
Silver Spring, MD 20993
Phone: (301) 348-3932
Jaclyn.MartinezResly@fda.hhs.gov

16

Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 19 of 21 PageID: 215

We hereby consent to entry of the foregoing Decree:

BRIAN M. BOYNTONLAIBOW
In 1vidually and on behalf of
Natural Solutions Foundation

Acting Assistant Attorney General
Civil Division.l.'\I.U'Y.Llp.

ARUN G. RAO
Deputy Assistant Attorney General
GUSTAV W. EYLER
Director
Consumer Protection Branch

RALPH FUCETOLA
Individually and on behalf of
Natural Solutions Foundation

ALLAN GORDUS
Assistant Director

NEIL GROSSMAN
Bronstein, Gewirtz & Grossman, LLC
144 North Beverwyck Road Lake, Ste. 187
Lake Hiawatha, New Jersey 07034(973) 335-6409
neil@bgandg.com
Attorney for Natural Solutions Foundation

BRIANNA M. GARDNER
Trial Attorney
Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, D .C. 20044(202) 616-0295
Brianna.M.Gardner@usdoj.gov
Counsel for the United States of America

15Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 20 of 21 PageID: 216

We hereby consent to entry of the foregoing Decree:
FOR DEFENDANTS:

FOR PLA[NTIFF:
BRIAN M. BOYNTON
A cting Assistant Attorney General
Civil Division

RIMA LAIBOWIndividually and on behalf of
Natural Solutions Foundation

ARUN G. RAO
Deputy Assistant Attorney General

RALPHFUCETOLA
Individually and on behalf of
Natural Solutions Foundation

GUSTA V W. EYLER
Director
Consumer Protection Branch�� t�/21/1--/

ALLAN GORDUS
Assistant Director

NEIL GROSSMAN
Bronstein, Gewirtz & Grossman, LLC
144 North Beverwyck Road Lake, Ste. 187
Lake Hiawatha, New Jersey 07034(973) 335-6409
neil@bgandg.com
Attorney for Natural Solutions Foundation

BRJANNA M. GARDNER
Trial Attorney
Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044(202) 616-0295
Brianna.M.Gardner@usdoj.gov
Counsel for the United States of America

15Case 2:20-cv-16016-JXN-ESK Document 39 Filed 12/27/21 Page 21 of 21 PageID: 217

We hereby consent to entry of the foregoing Decree:
FOR DEFENDANTS:

FOR PLAINTIFF:________________________RIMA LAIBOWIndividually and on behalf of
Natural Solutions Foundation

BRIAN M. BOYNTON
Acting Assistant Attorney General
Civil Division
ARUN G. RAO
Deputy Assistant Attorney General________________________RALPH FUCETOLA
Individually and on behalf of
Natural Solutions Foundation

GUSTAV W. EYLER
Director
Consumer Protection Branch
ALLAN GORDUS
Assistant Director________________________
NEIL GROSSMAN
Bronstein, Gewirtz & Grossman, LLC
144 North Beverwyck Road Lake, Ste. 187
Lake Hiawatha, New Jersey 07034(973) 335-6409
neil@bgandg.com
Attorney for Natural Solutions Foundation________________________BRIANNA M. GARDNER
Trial Attorney
Consumer Protection Branch
Civil Division
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044(202) 616-0295
Brianna.M.Gardner@usdoj.gov Counsel
for the United States of America

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