CHK Nutition, NeuroResearch Clinics, and
Martin Hinz, M.D., Charged with Illegal Marketing

Stephen Barrett, M.D.


In 2011, the U.S. Food and Drug Administration (FDA) initiated a federal lawsuit to stop Martin Hinz, M.D., his daughter, and their companies from illegally marketing products. The complaint (shown below) stated:

The case was settled with a consent agreement under which the defendants were required to (a) remove from their product labels, labeling, promotional material, websites, and other media all representations that their products or the ingredient combinations in their products cure, mitigate, treat, or prevent disease, (b) notify all previous customers that the products could not be sold for such purposes, and (c) pay the cost of any subsequent inspections. Quackwatch has additional information about Dr. Hinz and his activities.


IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MINNESOTA

UNITED STATES OF AMERICA,

Plaintiff,

v.

WEST DULUTH DISTRIBUTION COMPANY,
a corporation doing business as CHK NUTRITION,
NEURORESEARCH CLINICS, INC., a corporation,
and MARTIN C. HINZ and
AMY M. GUNTHERT-HINZ, individuals,

Defendants.

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Civil No. 11-2590 (PJS/LIB)

 

 

 

 

COMPLAINT FOR PERMANENT INJUNCTION

Plaintiff, the United States of America, by its undersigned attorneys, respectfully represents to this Honorable Court:

INTRODUCTION

1. This action is brought on behalf of the United States Food and Drug Administration ("FDA"), under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the "FDC Act"), to enjoin Defendants from:

A. Violating the FDC Act, 21 U.S.C. § 331(d), by introducing or delivering for introduction, and causing to be introduced or delivered for introduction, into interstate commerce new drugs within the meaning of 21 U.S.C. § 321(p) that are neither approved pursuant to 21 U.S.C. § 355(a), nor exempt from approval pursuant to 21 U.S.C. § 355(i); specifically, by distributing in interstate commerce products with claims that they can cure, mitigate, treat, or prevent disease;

B. Violating the FDC Act, 21 U.S.C. § 331(a), by introducing or delivering for introduction, and causing to be introduced or delivered for introduction, into interstate commerce drugs that are misbranded within the meaning of 21 U.S.C. § 352(f)(l) in that their labeling fails to bear adequate directions for use; and

C. Violating the FDC Act, 21 U.S.C. § 33 l(k), by doing or causing to be done any act with respect to drugs, while the drugs are held for sale after shipment in interstate commerce, that results in the drugs being misbranded within the meaning of 21 U.S.C. § 352(f)(l).

JURISDICTION AND VENUE

2. This Court has jurisdiction pursuant to 21 U.S.C. § 332(a) and 28 U.S.C. §§ 1331, 1337, and 1345, and personal jurisdiction over all parties.

3. Venue in this District is proper under 28 U.S.C. §§ 1391(b) and (c).

DEFENDANTS

4. Defendant West Duluth Distribution Company, which operates under the name CHK Nutrition, was incorporated under the law of the state of Minnesota in 2005. CHK Nutrition sells products containing amino acids. The business is located at 8721 Falcon Street, Duluth, Minnesota, within the jurisdiction of this Court.

5. Defendant NeuroResearch Clinics, Inc. ("NeuroResearch"), promotes products containing amino acids to treat a variety of serious diseases, in accordance with treatment protocols created by Defendant Martin C. Hinz. NeuroResearch was incorporated under the laws of the state of Minnesota in 2002 and, in 2010, became incorporated in the state of Florida. The firm maintains a Minnesota office, located in the same building as CHK Nutrition, at 1150 88th A venue West, Duluth, Minnesota, within the jurisdiction of this Court.

6. Defendant Martin C. Hinz is the owner and president of NeuroResearch. He is responsible for overseeing all operations of the firm and maintains the content of NeuroResearch's website. He conducts his business from NeuroResearch's corporate office in Florida and, several times a year, is onsite at the Minnesota office at 1150 88th A venue West, Duluth, Minnesota, within the jurisdiction of this Court.

7. Defendant Amy M. Gunthert-Hinz is the chief executive officer of CHK Nutrition. She is responsible for the operations of the firm, including ordering products from its contract manufacturer, overseeing employees, and handling complaints. She directs the activities of CHK Nutrition from a home office in Duluth, Minnesota, and makes periodic visits to CHK Nutrition's office at 8721 Falcon Street, Duluth, Minnesota, within the jurisdiction of this Court.

8. Defendants have been, and are now, engaged in distributing amino-acid products and promoting their use in combination to treat a variety of neurotransmitter-related diseases.

DEFENDANTS' OPERATIONS

9. NeuroResearch and Martin ("Marty") Hinz, a physician, promote the use of 5- hydroxytryptophan ("5-HTP"), L-tyrosine, and levodopa ("L-dopa") in combination to treat diseases including Alzheimer's disease, Parkinson's disease, depression, obsessive-compulsive disorder, attention-deficit hyperactivity disorder, and fibromyalgia, which they refer to as "neurotransmitter diseases."

10. NeuroResearch' s website, www.neuroassist.com, describes the treatment protocols developed by Dr. Martin Hinz for using amino-acid products, e.g., the specific amino-acid combinations, their dosages, and general instructions for administration, to treat "neurotransmitter diseases."

11. CHK Nutrition's website, www.chknutrition.com, sells products that contain 5-HTP, L-tyrosine, and/or mucuna puriens (a source of L-dopa). The products are named NeuroReplete, Neuro-R, Replete Extra, Neuro-RE, D5, Neuro-D, D5 Extra, Neuro-DE, D5 Mucuna, Neuro-M, 5-HTP, Neuro-5, Tyrosine Replete, Neuro-T, CysReplete, and Neuro-C.

12. CHK Nutrition and NeuroResearch operate in tandem. When healthcare providers contact NeuroResearch about treatment protocols, NeuroResearch recommends the use of CHK Nutrition's products. When healthcare providers contact CHK Nutrition to ask questions about treating diseases or to report adverse events, they are referred to NeuroResearch.

13. CHK Nutrition's website directs customers to the NeuroResearch office on the web pages containing the online product catalog, which refers to NeuroResearch as a source of assistance and provides its telephone number.

14. NeuroResearch's website is accessible from CHK Nutrition's website byway of the web page that names the recipients of its "medical education grants." NeuroResearch is the first grant recipient listed, and the name links directly to NeuroResearch's website.

15. Numerous pages on NeuroResearch's website facilitate access to papers authored by Dr. Martin Hinz. The link to Dr. Hinz's papers connects directly to hinzmd.com - which bears the NeuroResearch name and logo. Once on hinzmd.com, a link called "amino acids from CHK nutrition" leads directly to CHK Nutrition's website.

DEFENDANTS' VIOLATIONS OF THE ACT

16. Defendants' amino-acid products are drugs within the meaning of the FDC Act because, as indicated in their labeling and promotional materials, they are articles intended for use in the cure, mitigation, treatment, or prevention of disease. 21 U.S.C. § 321 (g)(l )(B).

17. Defendants' amino-acid products are new drugs within the meaning of the FDC Act because they are not generally recognized as safe and effective for their recommended uses, namely the treatment of diseases including Alzheimer's disease, Parkinson's disease, depression, obsessive-compulsive disorder, attention-deficit hyperactivity disorder, and fibromyalgia. 21 U.S.C. § 321(p)(l).

18. Defendants' amino-acid products are not the subject of approved new drug applications or abbreviated new drug applications. 21 U.S.C. § 355(b), U). Further, Defendants' amino-acid products do not qualify for exemption from the premarket approval process as investigational new drugs under 21 U.S.C. § 335(i). Therefore, Defendants' amino-acid products are unapproved new drugs within the meaning of the FDC Act. 21 U.S.C. § 355(a).

19. Defendants' amino-acid products are misbranded within the FDC Act because their labeling fails to bear adequate directions for use. 21 U.S.C. § 352(f)(l). "Adequate directions for use" means "directions under which the layman can use a drug safely and for the purposes for which it is intended." 21 C.F.R. § 201.5.

20. Defendants' amino-acid products are contract-manufactured by a firm in Chandler, Arizona, which ships the finished products to Defendants in Duluth, Minnesota. The products are held at CHK Nutrition until orders are placed. Most of Defendants' customers are located outside Minnesota, e.g., in Texas, Utah, and California.

21. Defendants' interstate distribution of misbranded and unapproved new drugs violates the FDC Act, 21 U.S.C. §§ 331(a), (d).

22. Defendants' misbranding of drugs that have been distributed in interstate commerce violates the FDC Act, 21 U.S.C. § 331(k).

INSPECTIONAL HISTORY

23. Based on a review of Defendants' website, www.neuroreplete.com, FDA issued a Warning Letter, dated October 18, 2005, to Martin Hinz stating that the claims on the website that promote Defendants' amino-acid products to treat diseases caused the products to be drugs within the meaning of the FDC Act. The Warning Letter also stated that the products were unapproved new drugs within the meaning of the FDC Act that could not be legally marketed, and were misbranded because they lacked adequate directions for use.

24. In a letter dated November 21, 2005, Dr. Martin Hinz responded to the Warning Letter, promising, among other things, to "refrain from making drug claims."

25. During a review of CHK Nutrition's website, www.chknutrition.com, on July 7, 2010, FDA investigators observed a page titled "Brain Diseases," which stated that numerous diseases, including Parkinson's disease, Alzheimer's disease, depression, obsessive-compulsive disorder, attention-deficit hyperactivity disorder, and fibromyalgia, "can be treated effectively with the neurotransmitter optimization approach developed by NeuroResearch Clinics."

26. FDA conducted an inspection of CHK Nutrition and NeuroResearch on July 20 and 22, 2010. During that inspection, an FDA investigator observed evidence of the coordination of the sale of CHK Nutrition's products with claims by NeuroResearch and Dr. Martin Hinz that such products are effective treatments for "neurotransmitter diseases." For example, the inspection revealed that:

A. CHK Nutrition sent informational handouts, written by Dr. Martin Hinz, along with shipments of products to customers. The materials, entitled "Depression Treatment," "Inducing Appetite Suppression -An Overview," and "Two Systems Intertwined," promoted CHK Nutrition's products for parkinsonism, depression, and weight loss; and

B. A NeuroResearch consultation form, with Martin Hinz's name, recommended specific CHK Nutrition products to a physician to treat a patient with depression.

27. The July 2010 inspection revealed additional information about NeuroResearch's and Dr. Martin Hinz's connection with CHK Nutrition. For example:

A. Dr. Martin Hinz informed the FDA investigator that he intends to change the marketing approach for CHK Nutrition's products;

B. The FDA investigator observed Dr. Hinz givmg instructions to CHK Nutrition's employees through a NeuroResearch employee, and holding a staff meeting with employees from NeuroResearch, CHK Nutrition, and DBS Labs, Inc. (the laboratory conducting urinary neurotransmitter tests on individuals taking CHK Nutrition's products under NeuroResearch / Dr. Hinz's treatment protocols);

C. CHK Nutrition's product catalog, "Serotonin/Catecholamine Resource Guide," provided NeuroResearch's telephone number, with instructions to call if "you are experiencing problems with side effects or are not getting the outcomes desired" and for "technical support";

D. A CHK Nutrition employee informed the FDA investigator that, when CHK Nutrition received a call from a healthcare provider about product complaints involving adverse events, the caller may be referred to Dr. Hinz, and that some physicians contacted NeuroResearch directly if they have product complaints; and

E. The FDA investigator heard a NeuroResearch employee referring a caller to CHK Nutrition to order products.

28. In an electronic mail message, dated September 2, 2010, from Dr. Martin Hinz to the FDA investigator, Dr. Hinz stated "The only link between NeuroResearch and CHK Nutrition is a patent license agreement . . . . " and "When NeuroResearch or I interact with CHK it is based solely on the patent license."

29. On that day (September 2, 2010), FDA investigators reviewed the websites for CHK Nutrition and NeuroResearch and observed the following:

A. On CHK Nutrition's website, www.chknutrition.com, the online catalog referred customers to NeuroResearch by:

(1) Providing NeuroResearch's telephone number, with instructions to call if "you have a patient with difficult to manage side effects"; and

(2) Marketing the products as "patented and patent pending products of NeuroResearch" and offering that NeuroResearch (along with its telephone number) "can help you [the healthcare providers ordering products in 10,000-pill drums] with sources for pill bottles and labels";

B. NeuroResearch's website, www.neuroassist.com, is accessible from CHK Nutrition's website by a link in the name "NeuroResearch Clinics, Inc.," which is listed as an awardee of one of CHK Nutrition's "medical education grants"; and

C. Extensive discussions were available on NeuroResearch's website, www.neuroassist.com, discussing "amino-acid therapy" and the treatment protocols developed by Dr. Martin Hinz for using amino-acid products, e.g., specific amino-acid combinations, their dosages, and their sequence of administration, for the treatment of Parkinson's disease, Alzheimer's disease, depression, obsessive-compulsive disorder, attention-deficit hyperactivity disorder, fibromyalgia, and others.

30. FDA conducted a follow-up review of www.chknutrition.com on February 9, 2011, which documented the ongoing connection between CHK Nutrition and NeuroResearch. For example, FDA observed that CHK Nutrition's website directed customers to the NeuroResearch office on the web pages containing the online product catalog in the same manner described in paragraph 29(A)(2) and that NeuroResearch's website was accessible through a link on www.chknutrition.com in the same manner described in paragraph 29(B).

31. On February 9, 2011, FDA investigators also reviewed www.neuroassist.com and documented that:

A. The site consisted of the same or similar claims regarding amino-acid therapy and the use of specific amino-acid combinations for disease treatment as those identified by FDA during the previous website review; and

B. The site contained numerous links to Dr. Hinz's papers. Those links connected directly to another NeuroResearch website, hinzmd.com, which, in turn connected to www.chknutrition.com.

32. Plaintiff believes that, unless restrained by this Court, Defendants will continue to violate 21 U.S.C. §§ 331(a), (d), and (k) in the manner set forth above.

PRAYER FOR RELIEF

WHEREFORE, Plaintiff respectfully requests that this Court:

I. Permanently restrain and enjoin Defendants and each and all of their officers, agents, employees, successors, assigns, and attorneys, and all persons in active concert or participation with any of them who receive notice of the Court's order, from directly or indirectly:

A. Violating the FDC Act, 21 U.S.C. § 331(d), by introducing or delivering for introduction, or causing to be introduced or delivered for introduction, into interstate commerce a new drug within the meaning of 21 U.S.C. § 321(p) that is neither approved under 21 U.S.C. § 355(a), nor exempt from approval pursuant to 21 U.S.C. § 355(i);

B. Violating the FDC Act, 21 U.S.C. § 331(a), by introducing or delivering for introduction, or causing to be introduced or delivered for introduction, into interstate commerce a drug that is misbranded within the meaning of 21 U.S.C. § 352(f)(l) in that its labeling fails to bear adequate directions for use; and

C. Violating the FDC Act, 21 U.S.C. § 33 l(k), by doing or causing to be done any act with respect to a drug, while the drug is held for sale after shipment in interstate commerce, that results in the drug being misbranded within the meaning of 21 U.S.C. § 352(f)(l);

II. Permanently restrain and enjoin Defendants and each and all of their officers, agents, employees, successors, assigns, and attorneys, and all persons in active concert or participation with any of them who receive notice of the Court's order, from introducing and delivering for introduction into interstate commerce, and causing to be introduced and delivered for introduction into interstate commerce, any new drug unless and until Defendants have an approved new drug application or abbreviated new drug application filed pursuant to 21 U.S.C. § 355(a) that is effective for the product or, alternatively, an investigational new drug application filed pursuant to 21 U.S.C. § 355(i) that is in effect for the product; and

III. Award the United States its costs herein, including costs of investigation to date, and such other equitable relief as the Court may deem just and proper.

Dated this 8th day of September, 2011.

 

Respectfully submitted,

B. TODD JONES
United States Attorney

TONY WEST
Assistant Attorney
General Civil Division


Of Counsel:

WILLIAM B. SCHULTZ
Acting General Counsel

RALPH S. TYLER
Associate General Counsel
Food and Drug Division

ERIC M. BLUMBERG
Deputy Chief Counsel for Litigation

CLAUDIA J. ZUCKERMAN
Senior Counsel
U.S. Department of Health and Human Services
Office of General Counsel
Food and Drug Administration
10903 New Hampshire Avenue
White Oak 31, Room 4550
Silver Spring, MD 20993-0002

By: s/ _____________________
MARK L. JOSEPHS
Assistant Director
U.S. Department of Justice Consumer
Litigation Branch
P.O. Box 386
Washington, D.C. 20044
202-305-3630
mark.josephs@usdoj.gov

By: s/________________________
CHAD A. BLUMENFIELD
Assistant U.S. Attorney
Attorney ID No. 387296
600 U.S. Courthouse
300 S. Fourth Street
Minneapolis, MN 55415
612-664-5600
chad.blumenfield@usdoj.gov

This page was posted on February 15, 2018.