Criminal Prosecution of General Nutrition (1984-1986)

Stephen Barrett, M.D.


In 1984, General Nutrition, Inc., three of its officers, and two of its retail store managers were charged with conspiring to defraud the FDA and violating provisions of the Food, Drug, and Cosmetic Act which require that drug products be approved by the FDA as safe and effective prior to marketing. The indictment alleged:

In motions to stop the prosecution, the defendants claimed: (a) their right to free speech was being violated, (b) the prosecution was unfair because many other companies making health claims in advertising had not been criminally prosecuted, (c) Gammaprim should not be considered a drug because it is not inherently toxic, and (d) the laws under which they were being prosecuted were too vague. In 1986, these motions were dismissed by a federal judge who noted that the defendants were aware, or should have been aware, that they were breaking the law. A few months later, General Nutrition pled guilty to four counts of misbranding a drug and agreed to pay $10,000 to the government as reimbursement for costs of prosecution. Daum (who was no longer its president) pled guilty to one count of misbranding and was fined $1,000. The remaining charges against other employees were dismissed.


In the District Court of the United States
For the Western District of New York

THE UNITED STATES OF AMERICA

-vs-

GENERAL NUTRITION, INCORPORATED,
GARY A. DAUM, DAVID E. WALSH,
GEORGE E. McTURK, ILENE M.
FENICCHIA, and JESSIE M. COPIA

JANUARY 1984 SESSION
(Impanelled January 9, 1984)
 
Vio.
Title 18, United States Code
Section 371
Title 21, United States Code
Sections 331(k), 333(a)
352(f), and 353(b)

COUNT !

The Grand Jury charges:

1. The Federal Food/Drug, and Cosmetic Act, Title 21, United States Code, Sections 301 et seq. (hereinafter, "the Act"), is administered by the Food and Drug Administration of the United States Department of Health and Human Services (hereinafter, "FDA.").

2. One of the functions of the Act is the protection of the American public from drugs which have not been proven to be safe and effective for their intended uses. Thus, the Act requires that before a new drug may be marketed, an application must be submitted to, and approved by, FDA.. The Act and regulations promulgated thereunder further require that each drug bear labeling which provides adequate directions for use. In the case of a drug to be sold over-the-counter, those directions must be adequate for use of the drug by the layman. In the case of a drug to be dispensed on the prescription of a licensed practitioner, the labeling must contain adequate information for use by the practitioner in prescribing the drug, and further, the labeling of the drug must bear the following statement: "Caution: Federal law prohibits dispensing without prescription."

3. Defendant, GENERAL NUTRITION, INCORPORATED, at all times hereinafter alleged, was a corporation organized and existing under the laws of the Commonwealth of Pennsylvania, headquartered at 921 Penn Avenue, Pittsburgh, Pennsylvania, doing business through its subsidiary corporations, General Nutrition Center, Inc. and General Nutrition Corporation, and doing business under the names General Nutrition Center and GNC, all collectively referred to hereinafter as GENERAL NUTRITION, INCORPORATED.

4. Defendant, GENERAL NUTRITION, INCORPORATED, at all times hereinafter alleged, was doing business within the Western District of New York at retail stores located at Boulevard Mall, Amherst, New York (hereinafter, "Boulevard Mall"), Summit Park Mall, Wheatfield, New York (hereinafter, " Summit Park Mall"), Chautauqua Mall, Lakewood, New York (hereinafter, "Chautauqua Mall"), Towne Mall, Greece, New York (hereinafter, "Towne Mall"), and elsewhere.

5. Defendant, GENERAL NUTRITION, INCORPORATED, from in or about October 1980 through in or about October 1981, was engaged in, among other things, the business of purchasing oil of evening primrose from Efamol Limited, London, England and holding the same for sale as a product known as Gamma-prim Oil of Evening Primrose (hereinafter, "Gammaprim").

6. Defendant, GARY A. DAUM, at all times hereinafter alleged, was the President of GENERAL NUTRITION, INCORPORATED.

7. Defendant, DAVID E. WALSH, at all times hereinafter alleged, was a Vice President of GENERAL NUTRITION, INCORPORATED.

8. Defendant, GEORGE E. McTURK, at all times hereinafter alleged, was a Vice President of GENERAL NUTRITION, INCORPORATED.

9. From in or about May 1980 and continuing through in or about October 1981, in the Western District of New York and elsewhere, the defendants,

GENERAL NUTRITION, INCORPORATED,
GARY A. DAUM,
DAVID E. WALSH, and
GEORGE E. McTURK

both as individuals and, in the cases of GARY A. DAUM, DAVID E. WALSH and GEORGE E. McTURK, as officers and employees of GENERAL NUTRITION, INCORPORATED, and other persons known and unknown to the Grand Jury, did unlawfully, willfully and knowingly conspire, combine, confederate and agree together and with each other to:

(a) defraud FDA, an agency of the United States, by impairing, obstructing and defeating a lawful function of FDA that is, the regulation of Gammaprim as a drug under the Federal Food, Drug, and Cosmetic Act; and

(b) commit offenses against the United States, to wit, violations of the Federal Food, Drug, and Cosmetic Act, specifically violations of Title 21, United States Code, Sections 331(k), 333(a), 352(f) and 353(b).

10. It was a part of the conspiracy that the defendants would promote, market, distribute and sell Gammaprim, and would cause the same to be promoted, marketed, distributed and sold, for the prevention, mitigation, treatment and cure of various diseases, such as hypertension, arthritis and multiple sclerosis, by virtue of which Gammaprim became a drug within the meaning of Title 21, United States Code, Section 321(g). This promotion, marketing, distribution and selling was accomplished by the following means:

(1) media publicity;
(2) publication and/or distribution of booklets, leaflets and other literature; and
(3) oral representations.

11. It was a further part of the conspiracy that the defendants failed to list Gammaprim as a drug with FDA as required by Title 21, United States Code, Section 360(j) and labeled Gammaprim as a food supplement.

12. By the actions and omissions of the defendants as set forth in paragraphs 10 and 11 above, the defendants sought to disguise Gammaprim as a food supplement while marketing it as a drug. As a consequence, FDA's program of regulating drugs was intended by the defendants to be impaired, obstructed and defeated in several respects, including but not limited to the following: (a) FDA would be impeded from a determination as to whether the drug Gammaprim was misbranded under Title 21, United States Code, Sections 352 and 353; and (b) FDA would be impeded from a determination as to whether the drug Gammaprim was subject to premarket testing and approval as required by Title 21, United States Code, Section 355, including a determination as to whether it was generally recognized as safe and effective for use in the cure, mitigation, treatment or prevention of the diseases for which it was intended to be used.

13. It was a further part of the conspiracy that the defendants would cause the misbranding, within the meaning of Title 21, United States Code, Section 352(f), of Gammaprim, while Gammaprim was held for sale after shipment in interstate commerce at their facilities within the Western District of New York at Boulevard Mall, Summit Park Mall, Chautauqua Mall and Towne Mall, in that the defendants would promote Gammaprim for the prevention, mitigation, treatment and cure of hypertension, arthritis and multiple sclerosis, among other diseases of man, but fail to provide in the labeling of Gammaprim adequate directions for the use of Gammaprim in such diseases, in violation of Title 21, United States Code, Sections 331(k) and 333(a).

14. It was a further part of the conspiracy that the defendants would cause the misbranding, within the meaning of Title 21, United States Code, Section 353(b), of Gammaprim, while Gammaprim was held for sale after shipment in interstate commerce at their facilities within the Western District of New York at Boulevard Mall, Summit Park Mall, Chautauqua Mall and Towne Mall, in that when intended for use in the cure, mitigation, treatment and prevention of hypertension in man, Gammaprim would he a drug which, because of the collateral measures necessary to its use, was not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, and defendants would dispense said drug without the written or oral prescription of such a practitioner, and further, the label of the Gammaprim would fail to bear the statement "Caution: Federal law prohibits dispensing without prescription", in violation of Title 21, United States Code, Sections 331(k) and 333(a).

All in violation of Title 18, United States Code, Section 371.

OVERT ACTS

In furtherance of the said conspiracy and to effect the objects there-of, the following overt acts were committed in the Western District of New York and elsewhere:

1. On or about May 9, 1980, David F. Horrobin wrote a letter to defendant DAVID E. WALSH, proposing the test marketing of Efamol primrose oil "without FDA approval", and referring to the effects of Efamol on blood pressure, arthritis and alcoholism, among other conditions and diseases: stating, "obviously you could not advertise Efamol for these purposes but equally obviously there are ways of getting the information across."

2. On or about July 11, 1980, defendant DAVID E. WALSH wrote a memorandum to defendant GARY A. DAUM, with a copy to David B. Shakarian, then Chairman of the Board of defendant GENERAL NUTRITION, INCORPORATED, stating, "Dr. Horrobin and other physicians who have worked in the area of nutritional treatment of alcoholism, eczema, and arthritis are willing to write articles and work with GNC in placing news releases in magazines and newspapers as well as making appearances to support the product."

3. On or about October 1, 1980, defendant GENERAL NUTRITION, INCORPORATED entered into an agreement with Efamol Limited which provided GENERAL NUTRITION, INC with exclusive distribution rights in the United States for Efamol evening primrose oil capsules "as a dietary supplement/food product".

4. On or about October 20, 1980, defendant DAVID E. WALSH wrote a memorandum to defendant GEORGE E. McTURK, with copies to David B. Shakarian and defendant GARY A. DAUM, listing specific claims which had been made for the effectiveness of gamma linolenic acid, including reduction of blood pressure, treatment of multiple sclerosis, relieving symptoms of manic depressive psychosis, treatment of alcoholism, and lowering the risk of heart attack, among others, and stating, "Dr. Horrobin is in the process of writing a book to bring all of these symptoms and medical indications into a unified, easy to understand form which can be used to inform individuals and doctors of the potential benefits of using General Nutrition Gammaprim brand of Evening Primrose Oil."

5. On or about November 19, 1980, defendant DAVID E. WALSH wrote a memorandum to defendant GEORGE E. McTURK, with copies to David B. Shakarian and defendant GARY A. DAUM, suggesting that he consider using booklets known as "Self Help Guides" in the promotion of Gammaprim, stating "The one's I am sending you are for acne, arthritis, heart attacks and high cholesterol, menstrual problems, multiple sclerosis, obesity and schizophrenia

6. On or about January 7, 1981 a meeting was held in Pittsburgh among David F. Horrobin, defendants DAVID E. WALSH and GEORGE E. McTURK, and other persons, during which it was decided that defendant GENERAL NUTRITION, INCORPORATED would promote the sale of Gammaprim by arranging for publicity in electronic and printed media concerning the claimed therapeutic effects of the product.

7. On or about January 9, 1981 defendant DAVID E. WALSH wrote a "MEMO FOR THE RECORD" concerning the meeting described in Overt Act 6, with copies to defendants GARY A. DAUM and GEORGE E. McTURK, as well as to David B. Shakarian and David F. Horrobin.

8. On or about January 29, 1981, defendant GARY A. DAUM wrote a memorandum to defendants DAVID E. WALSH and GEORGE E. McTURK, and others, commenting upon the implementation of the marketing strategy for Gammaprim.

9. On or about February 21, 1981 David F. Horrobin wrote a letter to defendant GARY A. DAUM, enclosing a copy of a "Health Guide" titled "GLA and DGLA: the amazing nutrients found in human milk and evening primrose oil" (hereinafter, "GLA and DGLA booklet").

10. On or about March 2, 1981 defendant GARY A. DAUM wrote a letter to David F. Horrobin, with a copy to defendant DAVID E. WALSH, acknowledging receipt of Horrobin's letter of February 21, 1981, and suggesting the GLA and DGLA booklet would be more successful in defendant GENERAL NUTRITION, INCORPORATED's retail stores if the front of the booklet referenced "arthritis, heart attacks, etc." to attract consumer attention.

11. On or about May 1, 1981, defendant GARY A. DAUM wrote a letter to David F. Horrobin, agreeing with Horrobin that various "health guides" should be shipped immediately, stating, "We need these to start moving our Gammaprim product."

12. On or about June 10, 1981, defendant GEORGE E. McTURK wrote a memorandum to "Center Sales Managers" and "Sales Staff" of defendant GENERAL NUTRITION, INCORPORATED, transmitting copies of the GLA and DGLA booklet, and directing their attention particularly to that portion of the booklet describing various uses of evening primrose oil in humans.

13. On or about July 2, 1981 defendant GEORGE E. McTURK wrote a memorandum to defendant GARY A. DAUM, and others, discussing the shipment of additional supplies of Gammaprim to defendant GENERAL NUTRITION, INCORPORATED's retail stores to coincide with the expected publication of an article on Gammaprim in the National Enquirer.

14. On or about August 3, 1981 defendant GEORGE E. McTURK wrote a memorandum to defendants GARY A. DAUM and DAVID E. WALSH, and others, advising that an advertisement for Gammaprim was scheduled to appear in the September 22, 1981 issue of the National Enquirer, and stating "This is good timing in that the article should have already appeared by the time this ad runs."

15. On or about August 7, 1981 defendant GEORGE E. McTURK wrote a memorandum to defendants GARY A. DAUM and DAVID E. WALSH, and others, providing an update on publicity for evening primrose oil, including upcoming articles in the National Star and the National Enquirer; a talk show on a radio station featuring David F. Horrobin; and radio appearances by Horrobin and Dr. Robert Zurrier of the University of Pennsylvania.

16. On or about August 11, 1981 defendant GEORGE E. McTURK wrote a memorandum to "All Centers Sales Managers" of defendant GENERAL NUTRITION, INCORPORATED in which he told them that the GLA and DGLA booklet "does a great selling job on the merits of Evening Primrose Oil", and told them to "inform everyone in the store that' Yes, GNC has Evening Primrose Oil, it is called Gammaprim capsules, and we have it in our stores now.'"

17. On or about August 24, 1981 at the Towne Mall facility, defendant GENERAL NUTRITION, INCORPORATED, through its employee, Ilene M. Fennichia, sold Gammaprim to FDA. Investigator Donald G. Gordon, who was posing as a customer, showing Investigator Gordon a copy of the GLA and DGLA booklet.

18. On or about September 4, 1981 at the Boulevard Mall facility, defendant GENERAL NUTRITION, INCORPORATED, through its retail sales employees, promoted Gammaprim with the GLA and DGLA booklet, and sold Gammaprim and a copy of the booklet to FDA Investigator Penny E. Glebowski, who was posing as a customer.

19. On or about September 7, 1981 defendant GEORGE E. McTURK wrote a memorandum to "All Center Sales Managers" of defendant GENERAL NUTRITION, INCORPORATED, transmitting an article from Bestways magazine titled "The Powerful Healing Magic of the Evening Primrose", and stating, "Please read this article and be familiar with the many benefits that Evening Primrose Oil has to offer."

20. In or about September 1981, defendant GENERAL NUTRITION, INCORPORATED, through its employee, Ronald W. Thompson, Director of Nutrition Education, wrote a memorandum to "Center Sales Managers" and "Center Sales Associates" in which Gammaprim was related to "today's major health problems", and they were urged to read the article "Evening Primrose Oil—Miracle Worker of the Eighties" by David F. Horrobin in the September/October 1981 issue of The Health Quarterly.

21. On or about September 8, 1981 defendant GENERAL NUTRITION, INCORPORATED, through its employee, Ronald W. Thompson, wrote a memorandum to "Center Sales Managers" and "Center Sales Associates" of defendant GENERAL NUTRITION, INCORPORATED in which they were advised that Robert Zurrier and David F. Horrobin would discuss evening primrose oil in a series of radio programs, and they were told to keep certain "Self Help Glides" in stock, including the GLA and DGLA booklet.

22. On or about September 23, 1981, defendant GENERAL NUTRITION, INCORPORATED responded through its attorney to Notice of Adverse Findings BUF 81-288 dated September 10, 1981, issued by FDA to defendants GARY A. DAUM and GENERAL NUTRITION, INCORPORATED, concerning promotion of Gammaprim at the Towne Mall facility.

23. On an unknown date prior to October 4, 1981, defendant GENERAL NUTRITION, INCORPORATED caused to appear in the October 4, 1981 issue of the Parade magazine supplement to the Courier-Express newspaper in Buffalo, New York, an advertisement for Gammaprim, promoting the product as follows:

... A NEW GNC EXCLUSIVE! Gammaprim OIL OF EVENING PRIMROSE capsules... Made from the Oil of the Evening Primrose—one of the world's richest sources of Gamma Linolenic Acid, the essential fatty acid which is the direct predecessor for the body's manufacture of prostaglandins. Prostaglandins help regulate and control an unusually wide range of body functions including blood pressure and cholesterol levels. Also new studies are being conducted on the effects of Oil of Evening Primrose on premenstrual syndrome, arthritis, heart disease, and asthma.

24. On October 7, 1981 at the Boulevard Mall facility, defendant GENERAL NUTRITION, INCORPORATED, through its retail sales employees, sold Gammaprim to FDA Investigators Mark P. Prusak and Patricia L. Jahnes, who were posing as customers, telling them that evening primrose oil would reduce high blood pressure, and providing them with copies of the GLA and DGLA booklet and the September/October 1981 issue of The Health Quarterly.

25. On or about October 7, 1981 at the Summit Park Mall facility, defendant GENERAL NUTRITION, INCORPORATED, through its employee, Jessie M. Copia, sold Gammaprim to FDA Investigator Mary T. Carden, who was posing as a customer, telling Investigator Carden that Gammaprim was being used to treat multiple sclerosis, and that Gammaprim would be better for treatment of high blood pressure than the prescription drug Nitrostat; and furnishing Investigator Carden with a copy of the September/October 1981 issue of GLA and DGLA.

26. On or about October 7, 1981 at the Chautauqua Mall facility, defendant GENERAL NUTRITION, INCORPORATED, through its retail sales employees, sold Gammaprim to FDA Investigator Penny E. Glebowski, who was posing as a customer, telling Investigator Glebowski that the product would aid in the treatment of high blood pressure, and that Gammaprim should be taken instead of the prescription drug Diuril.

27. On or about October 9, 1981 at the Chautauqua Mall facility, defendant GENERAL NUTRITION, INCORPORATED, through its retail sales employees, sold Gammaprim to Investigator Patricia L. Jahnes, who was posing as a customer, telling Investigator Jahnes that the product was good for arthritis and high blood pressure.

28. On or about October 9, 1981 at the Towne Mall facility, defendant GENERAL NUTRITION, INCORPORATED, through its employee, Ilene M. Fenicchia, sold Gammaprim to FDA Investigator Penny E. Glebowski, who was posing as a customer, referring Investigator Glebowski to the GLA and DGLA booklet, and telling Investigator Glebowski that Gammaprim should be taken as directed on the bottle label for the treatment of high blood pressure.

COUNT II

The Grand Jury further charges:

1. The Grand Jury realleges, reaffirms and incorporates the allegations contained in Paragraphs 1 through 8 of Count I of this Indictment with the same force and effect as if fully set forth herein. 2. Defendant, ILENE M. FENICCHIA, at all times hereinafter alleged, was the manager of the Towne Mall facility.

3. On or before August 24, 1981, defendant GENERAL NUTRITION, INCORPORATED, at its Towne Mall retail facility in the Western District of New York, received, after shipment in interstate commerce, quantities of Gammaprim.

4. Thereafter, on or about August 24, 1981, while the Gammaprim was held for sale within the Western District of New York at the Towne Mall retail facility, defendants GENERAL NUTRITION, INCORPORATED, GARY A. DAUM, DAVID E. WALSH, GEORGE E. McTURK and ILENE M. FENICCHIA did misbrand and cause the misbranding of the Gammaprim as a drug within the meaning of Title 21, United States Code, Section 32(g), as follows:

(a) within the meaning of Title 21, United States Code, Section 352(f)(1) in that they did represent and cause the representation of Gammaprim as effective in the prevention, mitigation and treatment of multiple sclerosis, hypertension and arthritis, and failed to provide in the labeling of Gammaprim adequate directions for such uses;

(b) within the meaning of Title 21, United States Code, Section 353(b)(1) in that they did represent and cause the representation of Gammaprim as useful in the prevention, mitigation and treatment of hypertension, and the collateral measures and methods necessary to the use of Gammaprim in hypertension were such that it was not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, and it was dispensed without the written or oral prescription of such a practitioner: and

(c) within the meaning of Title 21, United States Code, Section 353(b)(4) in that the Gammaprim was subject to Title 21, United States Code, Section 353(b) (1) and its label failed to bear the statement: Caution: Federal law prohibits dispensing without prescription."

All in violation of Title 21, United States Code, Sections 331(k) and 333 (a).

COUNT III

The Grand Jury further charges:

1. The Grand Jury realleges, reaffirms and incorporates the allegations contained in Paragraphs 1 through 8 of Count I of this Indictment with the same force and effect as if fully set forth herein.

2. On or before September 4, 1981, defendant GENERAL NUTRITION, INCORPORATED, at its Boulevard Mall retail facility in the Western District of New York, received, after shipment in interstate commerce, quantities of Gammaprim.

3. Thereafter, on or about September 4, 1981, while the Gammaprim was held for sale within the Western District of New York at the Boulevard Mall retail facility, defendants GENERAL NUTRITION, INCORPORATED, GARY A. DAUM, DAVID E. WALSH and GEORGE E. McTURK, did misbrand and cause the misbranding of Gammaprim as a drug within the meaning of Title 21, United States Code, Section 321(g), as follows:

(a) within the meaning of Title 21, United States Code, Section 352(f)(1) in that they did represent and cause the representation of Gammaprim as effective in the prevention, mitigation and treatment of hypertension and arthritis, and failed to provide in the labeling of Gammaprim adequate directions for such uses;

(b) within the meaning of Title 21, United States Code, Section 353(b)(1) in that they did represent and cause the representation of Gammaprim as useful in the prevention, mitigation and treatment of hypertension, and the collateral measures and methods necessary to the use of Gammaprim in hypertension were such that it was not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, and it was dispensed without the written or oral prescription of such a practitioner; and

(c) within the meaning of Title 21, United States Code, Section 353(b) (4) in that the Gammaprim was subject to Title 21, United States Code, Section 353(b) (1) and its label failed to bear the statement: "Caution: Federal law prohibits dispensing without prescription."

All in violation of Title 21, United States Code, Sections 331(k) and 333(a)

COUNT IV

1. The Grand Jury realleges, reaffirms and incorporates the allegations contained in Paragraphs 1 through 8 of Count I of this Indictment with the same force and effect as if fully set forth herein.

2. On or before September 4, 1981, defendant GENERAL NUTRITION, INCORPORATED, at its Boulevard Mall retail facility in the Western District of New York, received, after shipment in interstate commerce, quantities of Gammaprim.

3. Thereafter, on or about October 7, 1981, while the Gammaprim was held for sale within the Western District of New York at the Boulevard Mall retail facility, defendants GENERAL NUTRITION, INCORPORATED, GARY A. DAUM, DAVID E. WALSH and GEORGE E. McTURK, did misbrand and cause the misbranding of Gammaprim as a drug within the meaning of Title 21, United States Code, Section 321(g), as follows:

(a) within the meaning of Title 21, United States Code, Section 352(f)(1) in that they did represent and cause the representation of Gammaprim as effective in the prevention, mitigation and treatment of hypertension and arthritis, and failed to provide in the labeling of Gammaprim adequate directions for such uses;

(b) within the meaning of Title 21, United States Code, Section 353(b)(1) in that they did represent and cause the representation of Gammaprim as useful in the prevention, mitigation and treatment of hypertension, and the collateral measures and methods necessary to the use of Gammaprim in hypertension were such that it was not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, and it was dispensed without the written or oral prescription of such a practitioner; and

(c) within the meaning of Title 21, United States Code, Section 353(b)(4) in that the Gammaprim was subject to Title 21, United States Code, Section 353(b) (1) and its label failed to bear the statement: "Caution: Federal law prohibits dispensing without prescription."

All in violation of Title 21, United States Code, Sections 331(k) and 333(a).

COUNT V

The Grand Jury further charges:

1. The Grand Jury realleges, reaffirms and incorporates the allegations contained in Paragraphs 1 through 8 of Count I of this Indictment with the same force and effect as if fully set forth herein.

2. Defendant, JESSIE M. COPIA, at all times hereinafter alleged, was the assistant manager of the Summit Park Mall facility.

3. On or before October 7, 1981, defendant GENERAL NUTRITION, INCORPORATED, at its Summit Park Mall retail facility in the Western District of New York, received, after shipment in interstate commerce, quantities of Gammaprim.

4. Thereafter, on or about October 7, 1981, while the Gammaprim was held for sale within the Western District of New York at the Summit Park Mall retail facility, defendants GENERAL NUTRITION, INCORPORATED, GARY A. DAUM, DAVID E. WALSH, GEORGE E. McTURK and JESSIE M. COPIA, did misbrand and cause the misbranding of Gammaprim as a drug within the meaning of Title 21, United States Code, Section 321(g), as follows:

(a) within the meaning of Title 21, United States Code, Section 352(f)(1) in that they did represent and cause the representation of Gammaprim as effective in the prevention, mitigation and treatment of hypertension and arthritis, and failed to provide in the labeling of Gammaprim adequate directions for such uses;

(b) within the meaning of Title 21, United States Code, Section 353(b)(1) in that they did represent and cause the representation of Gammaprim as useful in the prevention, mitigation and treatment of hypertension, and the collateral measures and methods necessary to the use of Gammaprim in hypertension were such that it was not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, and it was dispensed without the written or oral prescription of such a practitioner; and

(c) within the meaning of Title 21, United States Code, Section 353(b) (4) in that the Gammaprim was subject to Title 21, United States Code, Section 353 (b) (1) and its label failed to bear the statement: Caution: Federal law prohibits dispensing without prescription.

All in violation of Title 21, United States Code, Sections 331(k) and 333(a).

COUNT VI

The Grand Jury further charges:

1. The Grand Jury realleges, reaffirms and incorporates the allegations contained in Paragraphs 1 through 8 of Count I of this Indictment with the same force and effect as if fully set forth herein.

2. On or before October 7, 1981, defendant GENERAL NUTRITION, INCORPORATED, at its Chautauqua Mall retail facility in the Western District of New York, received, after shipment in interstate commerce, quantities of Gammaprim.

3. Thereafter, on or about October 7, 1981, while the Gammaprim was held for sale within the Western District of New York at the Chautauqua Mall retail facility, defendants GENERAL NUTRITION, INCORPORATED, GARY A. DAUM, DAVID E. WALSH and GEORGE E. McTURK, did misbrand and cause the misbranding of Gammaprim as a drug within the meaning of Title 21, United States Code, Section 321(g), as follows:

(a) within the meaning of Title 21, United States Code, Section 352(f)(1) in that they did represent and cause the representation of Gammaprim as effective in the prevention, mitigation and treatment of hypertension and arthritis, and failed to provide in the labeling of Gammaprim adequate directions for such uses:

(b) within the meaning of Title 21, United States Code, Section 353(b)(1) in that they did represent and cause the representation of Gammaprim as useful in the prevention, mitigation and treatment of hypertension, and the collateral measures and methods necessary to the use of Gammaprim in hypertension were such that it was not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, and it was dispensed without the written or oral prescription of such a practitioner: and

(c) within the meaning of Title 21, United States Code, Section 353(b)(4) in that the Gammaprim was subject to Title 21, United States Code, Section 353(b)(1) and its label failed to bear the statement:

"Caution: Federal law prohibits dispensing without prescription."

All in violation of Title 21, United States Code, Sections 331(k) and 333(a).

COUNT VII

The Grand Jury further charges:

1. The Grand Jury realleges, reaffirms and incorporates the allegations contained in Paragraphs I through 8 of Count I of this Indictment with the same force and effect as if fully set forth herein.

2. Defendant, ILENE M. FENICCHIA, at all times hereinafter alleged, was the manager of the Towne Mall facility.

3. On or before October 9, 1981, defendant GENERAL NUTRITION, INCORPORATED, at its The Mall retail facility in the Western District of New York, received, after shipment in interstate commerce, quantities of Gammaprim.

4. Thereafter, on or about October 9, 1981, while the Gammaprim was held for sale within the Western District of New York at the Towne Mall retail facility, defendants GENERAL NUTRITION, INCORPORATED, GARY A. DAUM, DAVID E. WALSH, GEORGE E. McTURK and ILENE M. FENICCHIA, did misbrand and cause the misbranding of Gammaprim as a drug within the meaning of Title 21, United States Code, Section 321(g), as follows:

(a) within the meaning of Title 21, United States Code, Section 352(f)(1) in that they did represent and cause the representation of Gammaprim as effective in the prevention, mitigation and treatment of hypertension and arthritis, and failed to provide in the labeling of Gammaprim adequate directions for such uses;

(b) within the meaning of Title 21, United States Code, section 353(b)(1) in that they did represent: and use the representation of Gammaprim as useful in the prevention, mitigation and treatment of hypertension, and the collateral measures and methods necessary to the use of Gammaprim in hypertension were such that it was not safe for use except under the supervision of a practitioner licensed by law to administer such a drug, and it was dispensed without the written or oral prescription of such a practitioner; and

(c) within the meaning of Title 21, United States Code, Section 353(b)(4) in that the Gammaprim was subject to Title 21, United States Code, Section 353(b)(1) and its label failed to bear the statement: "Caution: Federal law prohibits dispensing without prescription."

All in violation of Title 21, United States Code, Sections 331(x) and 333(a).

__________________
Salvatore S. Martoche
United States Attorney
 
A TRUE BILL
 
__________________
Stanley C. Lankiewicz
Foreman

This article was revised on September 9, 2013..

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