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IN THE CIRCUIT COURT OF THE STATE OF OREGON 

FOR THE COUNTY OF MULTNOMAH 15CV28591 

STATE OF OREGON, ex rel. ELLEN F. 

ROSENBLUM, in her official capacity as 

Attorney General for the State of Oregon, 

Plaintiff, 

v. 

Case No. 

COMPLAINT 

Oregon Unlawful Trade Practices Act 

ORS 646.605 et seq. 

CLAIM NOT SUBJECT 

10 GENERAL NUTRITION CORPORATION, TO MANDATORY ARBITRATION 

11 Defendant. ORS 20.140 - State fees deferred at filing 

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INTRODUCTION 

This is a lawsuit by Ellen F. Rosenblum, Attorney General of Oregon, against General 

Nutrition Corporation ("GNC" or "Defendant") for violations of Oregon's Unlawful Trade 

Practices Act ("UTP A"). Defendant repeatedly violated the UTP A by misrepresenting that 

various products that GNC sold in Oregon were lawful dietary supplements when in fact these 

products were adulterated and unlawful because they contained either picamilon 1 or BMPEA, 2 

potentially dangerous ingredients that do not meet the legal definition of a dietary ingredient and 

may not be lawfully used in dietary supplements. Picamilon is a synthetic chemical designed to 

cross the blood brain barrier and is a prescription drug used in some countries but not the United 

States to treat various neurological conditions. BMPEA is a synthetic chemical similar to 

1 Picamilon is also known as nicotinoyl-GABA, pycamilon, picamilone, pikatropin, and 

pikamilon. 

2 BMPEA is also known as , BMePEA, R-beta-methylphenethylamine, R-betamethylphenethylamine HCl, Beta-methylphenethylamine, B-methylphenethylamine, 1-amino-2-

phenylpropane, 2-phenylpropan-1-amine, 2-phenylpropylamine, alpha-benzylethylamine, 1-

phenyl-1 methyl-2-aminoethane, Beta-methylbenzeneethanamine., Beta-phenylpropylamine, 2-

phenyl-1-propanamine. 

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Department of Justice 

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Portland, OR 97201 

(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 1 of 30
1 amphetamine that is banned by the World Anti-Doping Organization. In addition to selling 

2 products that were labeled as containing picamilon and BMPEA, Defendant sold products that it 

3 knew or should have known had been spiked with BMPEA, without disclosing in the product's 

4 label that the product contained this unlawful ingredient. 

5 As a result of its repeated violations of the UTPA, GNC is liable for civil penalties, 

6 injunctive relief, restitution, disgorgement, and other appropriate relief, as set forth below. 

7 PARTIES 

8 1. . Ellen F. Rosenblum is the Attorney General for the State of Oregon and sues in her 

9 official capacity pursuant to ORS 646.605(5) and ORS 646.632(1). 

10 2. General Nutrition Corporation is incorporated under the laws of Pennsylvania with 

11 its principal place of business located at 300 Sixth Avenue, Pittsburgh, Pennsylvania. GNC 

12 describes itself as a leading global retailer of health and wellness products, including vitamins, 

13 minerals, dietary supplement products, sports nutrition products and diet products. Its products are 

14 sold under GNC proprietary names and under third-party names in company owned retail stores and 

15 in franchise stores located across the United States, including in Oregon. 

16 JURISDICTION AND VENUE 

17 3. The claims described in this Complaint arise from sale in Oregon by GNC of 

18 putative dietary supplements. 

19 4. This Court has personal jurisdiction over Defendant pursuant to ORCP 4 A( 4) and 

20 ORCP 4 L. Defendant has engaged in substantial activity in this state, and jurisdiction is not 

21 inconsistent with the Oregon Constitution or the United States Constitution. 

22 5. Defendant was given the notice required by ORS 646.632(2) that it has allegedly 

23 violated the UTP A and the relief to be sought. 

24 6. Defendant failed to deliver an Assurance of Voluntary Compliance that complies 

25 with the requirements of ORS 646.632(3). 

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(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 2 of 30
1 7. Venue is proper pursuant to ORS 646.632(1) and ORS 14.080 because Defendant is 

2 alleged to have committed violations of the UTP A in Multnomah County and conducts regular 

3 business in Multnomah County. 

4 STATUTORY FRAMEWORK 

5 8. The Unlawful Trade Practices Act, ORS 646.605 et seq. ("UTPA") prohibits 

6 unconscionable and deceptive acts and practices in commerce. The Attorney General is authorized 

7 under ORS 646.632(1) to sue to enforce the UTPA. 

8 9. Deceptive advertising and marketing, including the misrepresentation of facts and 

9 the omission of material facts, violates the UTPA's prohibition on unconscionable and deceptive 

10 acts and practices in commerce. 

11 10. Under the UTPA, a representation is any manifestation of an assertion by words or 

12 conduct, including a failure to disclose a fact. ORS 646.608(2). Actionable representations under 

13 the UTP A can be express or implied. 

14 11. Violations of the UTP A are willful if a person knew or should have known that their 

15 conduct was a violation of the law. ORS 646.605(10). 

16 FACTS 

17 GNC Controls and is Responsible for Third-Party Products Sold in GNC Stores 

18 12. GNC reviews and pre- approves all labels, packaging, advertising and marketing 

19 materials for third-party products sold in its stores. Third-party vendors may not make changes 

20 to a product's formula, label, or store advertising without GNC's express permission. On 

21 occasion, GNC approves changes in a third-party vendor's product ingredients. For example, on 

22 one occasion, GNC approved a third-party vendor's proposal to reformulate a product by 

23 substituting acacia rigidula for ephedra. 

24 13. GNC works closely with third-party vendors to ensure that labeling and marketing 

25 materials comply with GNC's requirements and expectations. Suppliers are expected to make 

26 labeling changes-such as adding GNC-approved warnings-as necessary. 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 3 of 30
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1 14. GNC reviews the scientific literature on many of the ingredients used in third2 party products. For example, on December 8, 2014, an e-mail exchange between Jennifer Jakel, 

3 GNC's Senior Project Manager for Technical Research, and Christina Middleton, Associate 

4 Project Manager, discussed the scientific literature "regarding the ingredients from 3rd party 

5 products." Based on Ms. Middleton's review of the literature, Ms. Jakel decided which 

6 ingredients "looked promising" for possible development by Nutra Manufacturing (''Nutra"), 

7 GNC's manufacturing arm. Nutra manufactures and supplies vitamins and supplements to 

8 General Nutrition Centers and to other third-party companies. 

9 15. GNC's third-party vendor agreement provides that the "Vendor Warrants that the 

10 Goods covered by this purchase order have been manufactured, packaged, stored and shipped in 

11 accordance with the applicable standards of Good Manufacturing Practices promulgated under 

12 the Food, Drug and Cosmetic Act (21 U.S.C.§301 ET SEQ, hereinafter "the Act") and 

13 requirements of all applicable federal, state and local laws, rules and regulations." Based on this 

14 language, GNC maintains that it is not liable for unlawful third-party vendor products sold at 

15 GNC stores or sold by GNC over the Internet. However, at least for products that contain 

16 picamilon or BMPEA, although GNC received guarantees from third-party vendors that products 

17 containing these ingredients complied with legal requirements, GNC did not rely on these 

18 guarantees in good faith, because GNC knew or should have known that these ingredients were 

19 unlawful, and that products containing these ingredients are deemed to be adulterated. 

20 16. GNC represents on its website that "GNC sets the standard in the nutritional 

21 supplement industry by demanding truth in labeling, ingredient safety and product potency, all 

22 while remaining on the cutting-edge of nutritional science," and that "GNC requires its vendors 

23 to be honest, ethical, reliable and capable of providing products that meet our high standards of 

24 quality." Unfortunately, GNC's representations are untrue. As described below, GNC sells 

25 products obtained from third-party vendors that GNC knows or should know contain unlawful 

26 

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Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 4 of 30
and potentially unsafe ingredients and GNC sells third-party products that GNC knows, or 

2 should know, have labels that are deceptive. 

3 Picamilon 

4 17. Picamilon was developed by researchers in the former Soviet Union and is 

5 currently a prescription drug in Russia used to treat a variety of neurological conditions. It has 

6 never been approved as a prescription or over-the-counter drug in the United States. 

7 18. Picamilon is a neurotransmitter (gamma-aminobutyric acid or GABA) that has 

8 been synthetically modified in order to facilitate its translocation across the blood-brain barrier. 

9 Picamilon is formed by synthetically combining nicotinic acid (niacin) with GABA. There is no 

10 indication in the literature that this compound is found in nature. 

11 19. A "dietary ingredient" under section 20l(ff)(l) of the Act is "(A) a vitamin; (B) a 

12 mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by 

13 man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, 

14 metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), 

15 (C), (D), or (E)." 21 U.S.C. §32l(ff)(l). 

16 20. Picamilon does not fit any of the dietary ingredient categories in section 

17 201(ff)(A)-(F) of the Act. (Ex.1, Deel. of FDA Acting Deputy Director, Division of Dietary 

18 Supplement Programs, Dr. Cara Welch.) Thus picamilon is not a lawful dietary ingredient and 

19 products that contain picamilon are not lawful dietary supplements and may not be lawfully sold 

20 in the United States. Under the Act, products that contain picamilon are deemed to be 

21 adulterated. 

22 21. GNC's manufacturing arm Nutra does not manufacture products that contain 

23 picamilon, presumably because GNC knows that picamilon is not a lawful dietary ingredient. GNC 

24 obtains products that contain picamilon for sale in GNC stores through third-party vendors. 

25 22. As early as May 22, 2007, GNC knew that picamilon is not a lawful dietary 

26 ingredient. On that date, GNC's Senior Project Manager for Technical Research Jennifer Jakel, 

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(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 5 of 30
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1 whose responsibilities include ensuring that labeling and scientific claims are accurate, reviewed the 

2 available literature regarding picamilon. 

3 23. All the documents reviewed by Ms. Jakel had been translated from Russian. Among 

4 the documents reviewed by Ms. Jakel was a review of picamilon, which among other things 

5 describes picamilon as one of "a new class of medicinal preparations called nootropics which are 

6 finding increasingly wider applications in various areas of medicine. Nootropic medications are 

7 adopted successfully for breakdowns of memory, attention, learning, and for treatment of loss of 

8 brain blood circulation, brain trauma, chronic alcoholism and other disorders." (Ex. 2.) 

9 24. Ms. Jakel also learned from this same document that picamilon was "synthesized in 

10 1969 by the All-Union Scientific Research Institute and studied in the NII pharmacological RAN. 

11 By chemical structure picamilone is a derivative of the gamma-amino-butvric acid and nicotinic 

12 acid." (Underlined by Ms. Jakel). Thus, as early as early as May 22, 2007, GNC knew that 

13 picamilon was a synthetic drug created by Soviet investigators and was not a lawful dietary 

14 ingredient in the United States. 

15 25. GNC also knew that picamilon is not a lawful dietary ingredient because as part of 

16 her May 2007 review, Ms. Jakel documented in the GNC library file on picamilon: "No NDI that 

17 I could find." 

18 26. An NDI or new dietary ingredient notification is required by federal law before a 

19 dietary ingredient not used in the United States before 1994, may be used in a dietary 

20 supplement. The NDI must be submitted 75 days before the ingredient is sold and must include 

21 information that supports the manufacturer or distributors belief that the product is safe. Only if 

22 FDA takes no action during the 75-day period may the new dietary ingredient be used in dietary 

23 supplements sold in the United States. 

24 27. In April 2014, Ms. Jakel again looked for an NDI for picamilon and documented 

25 in her file "still no NDI found." (Ex. 3.) 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 6 of 30
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1 28. Even if GNC did not actually know that picamilon is not a lawful dietary ingredient 

2 (and it did), had GNC conducted a reasonable due diligence review, GNC would have known that 

3 picamilon did not fulfill dietary ingredient categories in section 201(ff)(A)-(F) of the Act. 

4 29. When GNC sells products that contain picamilon in Oregon, GNC represents that 

5 the product is a lawful dietary supplement that contains lawful dietary ingredients. 

6 30. Despite the fact that GNC knew, or should have known, that picamilon was a 

7 prescription drug used in Russia and not a lawful dietary ingredient in the United States, and that 

8 products that contain picamilon are not lawful dietary supplements, GNC sold thousands of units 

9 of products in Oregon that contained picamilon. These products were falsely labeled and sold as 

10 if they were lawful dietary supplements when in fact, they were not. Between January 2013 and 

11 June 2015, GNC sales of products that contain picamilon were as follows: 

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p· 1cam il on SI. a es ID O re1?:on. J anuarv 2013 - J une 

Description Vendor 

Charge Extreme Energy Booster Labrada Bodybuilding Nutrition 

Lean Body for Her Fat Burner Labrada Bodybuilding Nutrition 

Lean Body Hi Energy Fat Burn Labrada Bodybuilding Nutrition 

Testek QNT International, Inc. 

Riptek V2 QNT International, Inc. 

Tru Mangodrin Truderma, LLC 

Turbo Shred Swole Sports Nutrition 

Jacked Pack BD Health Partners 

Mr. Hyde - Fruit Punch Prosupps USA LLC 

Mr. Hyde- Watermelon Prosuoos USA LLC 

Dr. Jekyll - Power Punch Prosupps USA LLC 

Dr. Jekyll- Watermelon Prosupps USA LLC 

Mr. Hyde - Orange Guava Prosupps USA LLC 

Vanish Bonus Prosupps USA LLC 

Mr. Hvde - Red Razz Prosupps USA LLC 

Mr. Hyde RTD Blue Razz Prosupps USA LLC 

Mr. Hyde - Blue Razz Prosupps USA LLC 

Mr. Hyde RTD Fruit Punch Prosupps USA LLC 

Nirvana Sensatus Group LLC 

ENON Fruit Punch Evlution Nutrition 

ENON Blue Raz Evlution Nutrition 

ENON Green Apple Evlution Nutrition 

TOTAL 

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Department of Justice 

1515 SW Fifth Ave, Suite 410 

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2015 

Total Units Sold (Web) 

4 

9 

8 

13 (8) 

2 (1) 

26 (4) 

12 (9) 

100 (3) 

808 (7) 

1,037 (6) 

226 (3) 

218 

1 

25 (14) 

48 

65 

120 

69 

18 

58 (5) 

88 (4) 

55 

3,010 (64) 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 7 of 30
L~-~ -_ -

1 31. On June 16, 2015, pursuant to ORS 646.618, Plaintiff issued an Investigative 

2 Demand to GNC Holdings, Inc., (Defendant's parent company) which demanded production of 

3 documents and information relating to Defendant's sale ofpicamilon. The Investigative Demand 

4 clearly discussed the likelihood that picamilon was not a lawful dietary ingredient. Defendant was 

5 aware that GNC Holdings, Inc., was in receipt of the demand, and Defendant produced documents 

6 and information in response to the demand. Despite this additional notice to GNC that picamilon is 

7 an unlawful ingredient and that products which contain picamilon are adulterated, GNC continued 

8 to sell products that contain picamilon nationally and in Oregon. GNC did not cease selling such 

9 products until after Plaintiff issued a document entitled "Notice of Unlawful Trade Practices and 

10 Proposed Resolution" on September 21, 2015. It was only after this document was served on 

11 Defendant, that GNC stopped selling products that contain picamilon. 

12 32. In addition to the sales listed above, between May 22, 2007 (when GNC knew that 

13 picamilon was not a lawful dietary ingredient) and January 1, 2013, and between June 2015 and the 

14 September 21, 2015, GNC sold a yet to be determine number of products that contained picamilon 

15 in Oregon. 

16 BMPEA 

17 33. BMPEA is a chemical similar to amphetamine. It was first synthesized in the 1930s 

18 as a replacement for amphetamine, but for unknown reasons it was never studied in humans. There 

19 are anecdotal reports that BMPEA is associated with hemorrhagic stroke.3 Because of its 

20 amphetamine-like qualities, BMPEA is banned for use by athletes by the World Anti-Doping 

21 Agency. 

22 34. BMPEA is not a lawful dietary ingredient because it does not fit any of the dietary 

23 ingredient categories in Section 201(ff)(A)-(F) of the Act. Under federal law, any dietary 

24 

25 

26 3 P. Cohen et al, Hemorrhagic Stroke Probably Caused by Exercise Combined with a Sports 

Supplement Containing ~-Methylphenylethymaline (BMPEA): A Case Report; Ann Intern Med. 

Published online 12 May 2015 doi;10.7326L15-0106 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 8 of 30
supplement that contains BMPEA is deemed to be adulterated and may not be lawfully sold in the 

2 United States. 

3 35. GNC's manufacturing arm Nutra does not manufacture products that contain 

4 BMPEA, presumably because GNC knows that BMPEA is not a lawful dietary ingredient. 

5 However, GNC obtains products that contain BMPEA for sale in GNC stores through third-party 

6 vendors. 

7 36. BMPEA is synthetically produced and not found naturally. Although there is one 

8 published report4 that BMPEA is found naturally in the acacia rigidula ("AR") plant, this report 

9 provides little information regarding how the identification was made, and in 2013, FDA conducted 

10 a more credible analysis using a verified and well-accepted testing methodology that found AR does 

11 not, in fact, contain BMPEA. The FDA study also found that 43% of the dietary supplements tested 

12 that were labeled as containing AR had been "spiked" with BMPEA. 5 Among other things, the 

13 2013 study reported that BMPEA is a synthetic substance similar to amphetamine. Thus, anyone 

14 aware of the 2013 FDA study would know that BMPEA is not a lawful dietary ingredient and that 

15 products labeled as containing acacia rigidula were at significant risk of being spiked with BMPEA. 

16 37. Even before the 2013 FDA study, GNC should have known that BMPEA is not a 

17 lawful dietary ingredient because BMPEA does not fit any of the dietary ingredient categories in 

18 Section 20l(ff)(A)-(F) of the Act. 

19 38. GNC knew of the FDA study as early as November 2, 2013, when GNC's Senior 

20 Project Manager for Technical Research Jennifer Jakel was notified by a PubMed service that the 

21 study was available on line. 

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23 

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25 

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39. On November 18, 2013, USA Today published an article about the FDA study.6 

4 B.A. Clement et al, , Toxic amines and alkaloids from Acacia Rigidula, Phytochemistry 

491998) 1377-1380 

5 Pawar et al, determination of selected biogenic amines in acasia rigidula plant materials and 

dietary supplements us le-MS/MS methods; Journal of Pharmaceutical and Biomedical analysis 

88(2014 457466 

6 http://www. usatoday.corn/story/news/nation/20 l 3/l 1/18/fda-scientists-find-amphetamine-likecompound-in-dietary-supplements/3627963/ . 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 9 of 30
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1 40. The FDA study became widely known throughout GNC on November 19, 2013, 

2 when Ms. Jakel circulated the USA Today article to approximately 100 recipients at GNC 

3 headquarters. Among those recipients was GNC's Senior Vice President and Chief Innovation 

4 Officer Guru Ramanathan. GNC Vice President & General Counsel, Regulator Affairs David J 

5 Sullivan was another recipient of the USA Today article. 

6 41. The USA Today article stimulated significant concern and discussion within GNC. 

7 For example, within minutes ofreceiving the email from Ms. Jakel, Merchandising Manager Carter 

8 Gray wrote to GNC Director of Merchandising John Telencho, "Please tell me we won't have to get 

9 rid of acacia now." (Ex. 4.) 

10 42. Shortly after receiving the USA Today article, GNC Director of e-Commerce 

11 Nathaniel Kennedy learned of six products sold by GNC with acacia rigidula. Later that day, Brian 

12 Cavanough, GNC's Senior Vice President of Merchandising wrote to Steve Cherry, the Vice 

13 President of Purchasing, and David J. Sullivan, GNC's Vice President and General Counsel, and 

14 offered to do a "database search to find all SKUs" associated with effected products. 

15 43. Despite widespread knowledge that the AR products sold by GNC were at high risk 

16 of having been spiked with BMPEA, including knowledge by David J. Sullivan, GNC's Vice 

17 President & General Counsel, Regulatory Affairs, GNC continued to sell products that contained 

18 AR without testing these products to determine whether the product was adulterated with BMPEA 

19 or informing consumers of the risk that these products were adulterated. 

20 44. GNC also continued to sell products that were labeled as containing BMPEA even 

21 though it knew or should have known from the 2013 FDA study that BMPEA is a synthetic 

22 substance similar to amphetamine and was not a lawful dietary ingredient. 

23 45. Also after the 2013 FDA study, GNC approved inclusion of AR in products supplied 

24 to GNC by a third-party vendor. On February 21, 2014, supplier Riley Judd wrote to GNC 

25 employee Russell Barba that "Rhino Rush is currently reformulating the current ephedra version 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 10 of 30
1 shot. To replace the ephedra, they would like to use Acacia Rigidula (leaves)-is this ingredient 

2 acceptable." Barba then checked with GNC's Beth Curtin who approved Rhino Rush's use of AR. 

3 46. On March 12, 2014, the Food Standards Agency of the European Union (EU) 

4 contacted GNC and other sellers of AR products to inform them that AR was a "novel food 

5 product" and could not be sold in the EU because, among other things, its safety had not been 

6 demonstrated. 

7 47. In November 2014, the newsletter Nutralngredients-USA, reported that Danish and 

8 Swedish regulatory agencies had issued warnings that a dietary supplement labeled as containing 

9 AR that was spiked-with BMPEA may have caused a hemorrhagic stroke. This newsletter was 

10 widely distributed throughout GNC headquarters. 

11 48. In December 2014, Health Canada, (the Canadian equivalent to FDA) announced a 

12 recall of the AR labeled dietary supplement "Jet Fuel Superburn" because it was spiked with 

13 undisclosed BMPEA. At the time of the Health Canada recall, GNC sold Jet Fuel Superburn and 

14 other dietary supplements labeled as containing AR and at risk of containing BMPEA, and 

15 continued to sell those products in Oregon and the United States even after the Health Canada 

16 recall. 

17 49. In April 2015, researchers reported the results of yet another study (''the Cohen 

18 study") that found more than 50% of tested dietary supplements labeled as containing AR were 

19 spiked with BMPEA. 7 The list of products tested in the Cohen study that were found to contain 

20 undisclosed BMPEA included products sold by GNC in the United States and Oregon. 

21 50. The Cohen study received significant national media attention. On April 23, 2015, 

22 after the results of the Cohen study became widely known, FDA formally announced that BMPEA 

23 does not meet the statutory definition of a dietary ingredient and sent warning letters to 

24 manufacturers whose products contain BMPEA. 

25 

26 7 Cohen et al, An amphetamine isomer whose efficacy and safety in humans has never been 

studied /3-methylphenethylamine(BMP EA), is found in multiple dietary supplements, Drug Test 

analysis DOl.1002/dta.1793 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 11 of 30
51. It was only after FDA made its formal announcement that GNC stopped selling 

2 products which contain BMPEA, including products labeled as containing AR that were spiked with 

3 BMPEA. 

4 52. The Oregon Department of Justice (ODOJ) conducted its own testing of three 

5 dietary supplements sold by GNC in Oregon: Jetfuel Superburn, MX-LS7 and Phenyl Core Weight 

6 management. These products were labeled as containing AR but were not labeled as containing 

7 BMPEA. ODOJ's expert tested these products using a state-of-the-art methodology: rapid 

8 resolution liquid chromatography-accurate mass-quadrupole-time of flight-tandem mass 

9 spectrometry. All three products tested positive for BMPEA. 

10 53. When GNC sold products in Oregon that contained BMPEA, GNC misrepresented 

11 that the product was a lawful dietary supplement that only contained lawful dietary ingredients. 

12 54. From January 1, 2013, until May 2015, GNC sold in Oregon 340 units of seven 

13 different products that were labeled as containing AR. All but one of these products tested 

14 (Green Coffee Bean+Energy) tested positive for the presence ofBMPEA. 

15 55. Whether Green Coffee Bean+Energy was adulterated with BMPEA is unknown 

16 because before it could be independently tested, the product was reformulated. On November 

17 19, 2013, in an email that included a USA Today news article following up on the November 

18 18th report about the FDA study, Charlie Chiaverini, the National Brand Manager for Rightway 

19 Nutrition (manufacturer of Green Coffee Bean+ Energy), wrote to GNC employee Bob Emilian 

20 asking, "[O]bviously you would like us to reformulate as fast as possible and replace the 

21 inventory in the stores in warehouse with new inventory yes." Mr. Emilian replied, "Yes for 

22 starters." 

23 56. After November 2013, when GNC knew that AR products were at significant risk 

24 of having been adulterated with BMPEA, GNC sold at least 27 AR products in Oregon that were 

25 in fact adulterated with BMPEA. 

26 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 12 of 30
57. In addition, GNC sold at least 105 AR products in Oregon after November 2013 

2 without disclosing that these products were at significant risk of having been adulterated with 

3 BMPEA. 

4 58. The AR products sold in Oregon between January 2013 and May 2015 are as 

5 follows: 

6 Acacia Ri!?:idula Sales in Ore1wn. Januarv 2013 - Mav 2015 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

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Description Vendor Total Units Units Sold 

Sold (Web) 12/2013 & 

After 

Hit Fastin XR Hi Tech Pharmaceuticals 20 0 

Lipodrene XR Hi Tech Pharmaceuticals 1 0 

Fastin XR DMAA Free Hi Tech Pharmaceuticals 37 6 

Jetfuel Superburn World Health Products LLC 71 (10) 16 

Green Coffee Bean + Energy Rightway Nutrition 200 (5) 78 

MX-LS7 !satori Global Technologies 8 2 

Phenylcore 3 (3) 3 

TOTAL 340 (18) 105 

59. In addition to the AR products sold by GNC that contained undisclosed BMPEA, 

GNC also sold products that were labeled as containing BMPEA. These products were falsely 

labeled as if they were a lawful dietary supplement, when in fact, they were not dietary 

supplements because BMPEA is not a lawful dietary ingredient. Between January 1, 2013, and 

May 2015, GNC sold the following products in Oregon that were labeled as contained BMPEA: 

BMPEA Sales in Ore!!on Januarv 2013-Mav 2015 2 

Description Vendor Total Units Units Sold 

Sold (Web) 12/2013 & 

After 

Fastin Hi Tech Pharmaceuticals 17 0 

Fastin DMAA Free Hi Tech Pharmaceuticals 126 (39) 79 

Meltdown Watermelon VPX Sports, Inc. 142 (4) 61 

Meltdown Peach Mango VPX Sports, Inc. 9 0 

Meltdown Exotic Fruit VPX Sports, Inc. 4 0 

Lipo 6 Black Nutrex Research 20 0 

Meltdown VPX Sports, Inc. 27 6 

Redline Ultra Hardcore Twinpk VPX Sports, Inc. 2 0 

Redline Ultra Hardcore Bonus VPX Sports, Inc. 23 0 

Redline Ultra Hardcore VPX Sports, Inc. 430 (11) 287 

Redline Hardcore Blister Pak VPX Sports, Inc. 82 0 

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Portland, OR 97201 

(971) 673-1880 /Fax: (971) 673-SOOO 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 13 of 30
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

! I 

Fruit N.O. Shotgun VPX Sports, Inc. 41 8 

Grp Bgum Shotgun V3 VPX Sports, Inc. 9 1 

Craze - Candy Grape Driven Sports 331 0 

Vanish Bonus Prosupps USA LLC 25 (14) 25 

Shredz Burner Shredz Supplements 49 (21) 49 

Iso Lean 2 Advanced Nutrition Systems 1 (1) 1 

Iso Lean 3 Advanced Nutrition Systems 1 (1) 1 

Methyl Drive 2.0 Advanced Nutrition Systems 1 (1) 1 

TOTAL 1,340 (92) 519 

60. Prior to January 1, 2013, GN C sold a yet to be determined number of products in 

Oregon that contained BMPEA. 

CLAIMS FOR RELIEF 

61. All of Defendant's violations of the UTP A set forth below were willful because 

Defendant knew or should have known that their conduct was in violation of the UTP A. 

FIRST CLAIM FOR RELIEF: ORS 646.608(1)(e) 

62. ORS 646.608(1)(e) makes it an unlawful trade practice to represent that goods have 

approval, characteristics, uses, benefits, or qualities that the goods do not have. 

COUNTl 

Misrepresenting that Products Containing Picamilon are Lawful Dietary Supplements 

63. Plaintiff realleges and incorporates each and every allegation contained in the 

preceding paragraphs as though set forth herein. 

64. Defendant offered products for sale in Oregon that contained picamilon, and in so 

doing, represented that these products had the approval, characteristics, uses, benefits, or qualities of 

a lawful dietary supplement, when in fact, products that contain picamlon are not lawful dietary 

supplements. 

65. Each and every instance in which Defendant offered a product for sale in Oregon as 

a dietary supplement when the product contained picamilon is a separate and distinct violation of 

ORS 646.608(l)(e). 

Page 14 - Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 I Fax; (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 14 of 30
. ~'I I 

1 COUNT2 

2 Misrepresenting that Products Containing BMPEA are Lawful Dietary Supplements 

3 66. Plaintiff realleges and incorporates each and every allegation contained in the 

4 preceding paragraphs as though set forth herein. 

5 67. Defendant offered products for sale in Oregon that contained BMPEA, and in so 

6 doing, represented that these products had the approval, characteristics, uses, benefits, or qualities of 

7 a lawful dietary supplement, when in fact, products that contain BMPEA are not lawful dietary 

8 supplements. 

9 68. Each and every instance in which Defendant offered a product for sale in Oregon as 

10 a lawful dietary supplement when the product contained BMPEA is a separate and distinct violation 

11 of ORS 646.608(1)(e). 

12 COUNT3 

13 Misrepresenting that Picamilon is a Lawful Dietary Ingredient 

14 69. Plaintiff realleges and incorporates each and every allegation contained in the 

15 preceding paragraphs as though set forth herein. 

16 70. Defendant listed picamilon as an ingredient in a product's label as if picamilon had 

17 the approval, characteristics, uses, benefits or qualities of a lawful dietary ingredient, when in fact, 

18 picamilon is not a lawful dietary ingredient. 

19 71. Each and every instance in which Defendant sold a product in Oregon that listed 

20 picamilon as an ingredient is a separate and distinct violation of ORS 646.608(1 )( e ). 

21 COUNT4 

22 Misrepresenting that BMPEA is a Lawful Dietary Ingredient 

23 72. Plaintiff realleges and incorporates each and every allegation contained in the 

24 preceding paragraphs as though set forth herein. 

25 

26 

Page 15 - Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 15 of 30
1 73. Defendant listed BMPEA as an ingredient in a product's label as if BMPEA had the 

2 approval, characteristics, uses, benefits or qualities of a lawful dietary ingredient, when in fact, 

3 BMPEA is not a lawful dietary ingredient. 

4 74. Each and every instance in which Defendant sold a product that listed BMPEA as an 

5 ingredient is a separate and distinct violation of ORS 646.608(l)(e). 

6 COUNTS 

7 Failure to Disclose that a Product Contained BMPEA 

8 75. Plaintiff realleges and incorporates each and every allegation contained in the 

9 preceding paragraphs as though set forth herein. 

10 76. Defendant represented that a product had characteristics, uses, benefits, and qualities 

11 that it does not have when it sold products that contained BMPEA but did not list BMPEA as an 

12 ingredient. 

13 77. Each and every instance in which Defendant sold a product in Oregon that contained 

14 BMPEA but did not list BMPEA as an ingredient is a separate and distinct violation of ORS 

15 646.608(1 )( e ). 

16 COUNT6 

17 Failure to disclose that Acacia Rigidula Products were at 

18 Significant Risk of Adulteration with BMPEA 

19 78. Plaintiff realleges and incorporates each and every allegation contained in the 

20 preceding paragraphs as though set forth herein. 

21 79. Defendant represented that a product had characteristics, uses, benefits, and qualities 

22 that it does not have when it sold products that contained Acacia rigidula without disclosing that the 

23 product was at significant risk of adulteration with BMPEA. 

24 80. Each and every instance after Defendant learned that its acacia rigidula products 

25 were at risk of adulteration with BMPEA, but failed to disclose the risk, is a separate and distinct 

26 violation of ORS 646.608(1) (e). 

Page 16 - Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 16 of 30
1 

2 81. 

SECOND CLAIM FOR RELIEF: ORS 646.608(1)(g) 

ORS 646.608(1 )(g) makes it an unlawful trade practice to represent that a product is 

3 of a particular standard, quality, or grade if it is of another. 

4 COUNT7 

5 Misrepresenting that Picamilon is a Lawful Dietary Ingredient 

6 82. Plaintiff realleges and incorporates each and every allegation contained in the 

7 preceding paragraphs as though set forth herein. 

8 83. Each time Defendant sold a product in Oregon that listed picamilon as an ingredient 

9 on the product's label, Defendant misrepresented that picamilon had the standard, quality, or grade 

10 of a lawful dietary ingredient, when in fact, picarnilon is not of this standard, quality, or grade. 

11 84. Each and every instance in which Defendant misrepresented that picamilon is a 

12 lawful dietary ingredient is a separate and distinct violation of ORS 646.608(1)(g). 

13 COUNT 8 

14 Misrepresenting that BMPEA is a Lawful Dietary Ingredient 

15 85. Plaintiff realleges and incorporates each and every allegation contained in the 

16 preceding paragraphs as though set forth herein. 

17 86. Each time Defendant sold a product in Oregon that listed BMPEA as an ingredient 

18 on the product's label, Defendant misrepresented that BMPEA had the standard, quality, or grade of 

19 a lawful dietary ingredient, when in fact, BMPEA is not of that standard, quality or grade. 

20 87. Each and every instance in which Defendant misrepresented in Oregon that BMPEA 

21 is a lawful dietary ingredient is a separate and distinct violation of ORS 646.608(1 )(g). 

22 COUNT9 

23 Misrepresenting that Products Containing Picamilon are Lawful Dietary Supplements 

24 88. Plaintiff realleges and incorporates each and every allegation contained in the 

25 preceding paragraphs as though set forth herein. 

26 

Page 17 - Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 /Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 17 of 30
89. Each time Defendant offered for sale in Oregon a product which contained 

2 picamilon, Defendant misrepresent that the product had the standard, quality, or grade of a lawful 

3 dietary supplement, when in fact, the product was not of that standard, quality or grade. 

4 90. Each and every time that Defendant offered for sale as a dietary supplement a 

5 product that contained picamilon was a separate and distinct violation of )RS 646.608(1 )(g). 

6 COUNTlO 

7 Misrepresenting that Products Containing BMPEA are Lawful Dietary Supplements 

8 91. Plaintiff realleges and incorporates each and every allegation contained in the 

9 preceding paragraphs as though set forth herein. 

10 92. Each time Defendant offered for sale in Oregon a product that contained BMPEA, 

11 Defendant misrepresented that the product was of the standard, quality, or grade of a lawful dietary 

12 supplement, when in fact, the product was not of that standard quality or grade. 

13 93. Each and every time that Defendant offered for sale as a dietary supplement a 

14 product that contained BMPEA was a separate and distinct violation of ORS 646.608(1 )(g). 

15 TIDRD CLAIM FOR RELIEF: ORS 646.608(1)(b) 

16 94. ORS 646.608(1 )(b) makes it an unlawful trade practice to cause likelihood of 

17 confusion or of misunderstanding as to the approval or certification of goods. 

18 COUNT 11 

19 Causing Likelihood of Confusion that Picamilon is 

20 Approved or Certified as a Lawful Dietary Ingredient 

21 95. Plaintiff realleges and incorporates each and every allegation contained in the 

22 preceding paragraphs as though set forth herein. 

23 96. Defendant caused a likelihood of confusion or of misunderstanding that picamilon is 

24 approved or certified as a lawful dietary ingredient when it listed picamilon as an ingredient on a 

25 products label without disclosing that picarnilon is not a lawful dietary ingredient. 

26 

Page 18 -

Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 18 of 30
-------:r -~-- I J 

1 97. Each and every instance in which Defendant sold a product that listed picamilon as 

2 an ingredient without disclosing that picamilon is not a lawful dietary ingredient is a separate and 

3 distinct violation of ORS 646.608(1 )(b ). 

4 COUNT12 

5 Causing Confusion that Products that Contain Picamilon are 

6 Approved or Certified as Lawful Dietary Supplements 

7 98. Plaintiff realleges and incorporates each and every allegation contained in the 

8 preceding paragraphs as though set forth herein. 

9 99. Defendant caused a likelihood of confusion or of misunderstanding that products 

10 that contain Picamilon are approved or certified as lawful dietary supplements when Defendant 

11 offered for sale in Oregon any product that contained Picamilon, as if the product was a dietary 

12 supplement. 

13 100. Each and every instance in which Defendant offered for sale as a dietary supplement 

14 any product that contained picamilon was a separate and distinct violation of ORS 646.608 (1 )(b ). 

15 COUNT13 

16 Causing Confusion that BMPEA is Approved or Certified as a Dietary Ingredient 

1 7 101. Plaintiff realleges and incorporates each and every allegation contained in the 

18 preceding paragraphs as though set forth herein. 

19 102. Defendant caused likelihood of confusion or of misunderstanding that BMPEA is 

20 certified or approved as a dietary ingredient when it listed BMPEA as an ingredient on a products 

21 label without disclosing that BMPEA is not a lawful dietary ingredient. 

22 103. Each and every instance in which Defendant sold a product that listed BMPEA as an 

23 ingredient is a separate and distinct violation of ORS 646.608 (1 )(b ). 

24 

25 

26 

Page 19 -

Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 /Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 19 of 30
COUNT14 

2 Causing Confusion that Products Containing BMPEA are Lawful Dietary Supplements 

3 104. Plaintiff realleges and incorporates each and every allegation contained in the 

4 preceding paragraphs as though set forth herein. 

5 105. Defendant caused a likelihood of confusion or of misunderstanding that products 

6 that contain BMPEA are lawful dietary products when they offered for sale in Oregon any product 

7 that contains BMPEA, as if the product was a dietary supplement. 

8 106. Each and every instance in which Defendant offered for sale a product as if it were a 

9 dietary supplement when the product listed picamilon as an ingredient is a separate and distinct 

10 violation of ORS 646.608 (1 )(b ). 

11 FOURTH CLAIM FOR RELIEF: ORS 646.607(1) 

12 107. ORS 646.607(1) makes it an unlawful trade practice to engage in any 

13 unconscionable tactic in connection with the sale of goods. 

14 COUNT 15 

15 Unconscionable Sales of Acacia Rigidula Products Spiked with BMPEA 

16 108. Plaintiffrealleges and incorporates each and every allegation contained in the 

17 preceding paragraphs as though set forth herein. 

18 109. Each and every instance in which Defendant sold an acacia rigidula product when 

19 Defendant knew there was a significant risk that the product was spiked with BMPEA, without 

20 disclosing to consumers that the product was at risk of adulteration, used an unconscionable tactic. 

21 COUNT16 

22 Unconscionable Sales of Products with the Unlawful Ingredient BMPEA 

23 110. Plaintiff realleges and incorporates each and every allegation contained in the 

24 preceding paragraphs as though set forth herein. 

25 

26 

Page 20 - Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 9720 I 

(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 20 of 30
-:[ ---_:1 I 

1 111. Each and every instance in which Defendant sold a product with BMPEA when 

2 Defendant ~ew that BMPEA is an unlawful dietary ingredient, without disclosing to consumers 

3 that the product was unlawful, used an unconscionable tactic. 

4 COUNT17 

5 Unconscionable Sales of Products with the Unlawful Ingredient Picamilon 

6 112. Plaintiff realleges and incorporates each and every allegation contained in the 

7 preceding paragraphs as though set forth herein. 

8 113. Each and every instance in which Defendant sold a product with picamilon when 

9 Defendant knew that picamilon is an unlawful dietary ingredient, without disclosing to consumers 

10 that the product was unlawful, used an unconscionable tactic. 

11 

12 

13 WHEREFORE, Plaintiff prays for the following relief: 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

Page 21 -

1. 

2. 

3. 

4. 

5. 

A judgment against Defendant for civil penalties up to $25,000 for each willful 

violation of the UTPA, pursuant to ORS 646.642(3); 

A judgment requiring Defendant to disgorge all gains obtained as a result of their 

violations of the UTPA, pursuant to ORS 646.636; 

A judgment requiring Defendant to provide restitution to all Oregon purchasers of 

products that contain BMPEA or picamilon for the cost of the product, pursuant to 

ORS 646.636; 

A permanent injunction prohibiting Defendant from selling products that contain 

unlawful ingredients when Defendant knows, or should know, that the product 

contains an unlawful ingredient. 

A judgment against Defendant for reasonable attorney fees and investigative costs 

pursuant to ORS 646.632(8) and ORCP 68; and 

Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 21 of 30
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

Page 22 -

6. A judgment granting any other and further relief as the court may deem 

appropriate. 

DATED October .12.,2015. 

Respectfully submitted, 

ELLEN F. ROSENBLUM 

Attorney General 

J)-\:\ cJ 

DAVID A. HART. #002750 

Senior Assistant Attorney General 

Tel (971) 673-5002 

Fax (971) 673-5000 

David.Hart@doj .state.or. us 

Attorney for Plaintiff 

Department of Justice 

1515 SW Fifth Ave, Suite 410 

Portland, OR 97201 

(971) 673-1880 I Fax: (971) 673-5000 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 22 of 30
.,,,.=,..,~,~~-~,--"~I 

('~ DEPARTMENT OF HEALTH AND HUMAN SERVICES J Pubilc Health Service 

Food and Drug _AdmlnlstraUon 

DECLARATION OF DR. CABA WELCH 

I, Dr. Cara Welch, declare as follows: 

1 . I am the Acting Deputy Director, Division ofDietary Supplement Programs 

(DDSP), Center for Food Safety and Applied Nutrition (CFSAN), United States Food and Drug 

Administration (FDA). In this capacity, I am responsible for the interpretation and application of 

relevant dietaiy supplement statute and regulations for the FDA's dietaiy supplement program 

office. This includes policies and programs involving regulatory compliance matters of 

significant importance to the dietary supplement industry regarding manufacturing and ingredient 

safety issues. TI1e statements made in this declaration are based upon my personal knowledge 

supplement and ingredient issues. 

2. Picamilon (pikatropin) is a 11eurotra11smittiyr (ganuna-aminobutyric acid, GABA) 

that has been synthetically modified in order to facilitate its translocation across the bloo<.l-brain 

barrier. Picamilon is formed by synthetically combining niacin with GABA. There fs no 

indication in the literature that this compound is fouild in nature. 

3. A "dietary ingredient" under section 201 (ff)(l) of the Federal Food,· Drug, and 

Cosmetic Act (the Act) is "(A) a vitamin; (B) a milieral; (C) an lierb or other botanfoal; (D) au 

amino acid; (E) a dietary substance for use by man to supplement the diet by incre"lsing the total 

dietary intake; or (F) a concentrate, metabolite, co11stituent, extract, or combination of any 

ingredient described in clause (A), (B), (C), (D), or (E)." 21U.S.C.§32l(ff)(1). 

4. Picamilon is l10t a vitamin. While picamilon may be synthesized from a vitamin 

(niacin). it is a different chemical entity. Pic!Ullilon is neither au organic substance nor a minor 

component of foods. Neither is. picamilon essential for normal p)lysiological functions. 

Picamilon is not produced endogenously in amounts adequate to meet normal physiologic needs 

Page 1 of3 ~ STATE'S I EXllBIT 

i I t:i. 

j 

i 

i: '' 

'! 

.I 

i I 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 23 of 30
(and in fact, there is no physiologic need for pica111ilon), and there is no clinically defined 

deficiency syndrome associated with the absen.ce or underutilization of picamilon. Thus, 

picamilon does not qualify as a dietary ingredient under section 20l(ff)(l)(A) of the Act. 21 

U.S.C. § 32l(ff)(l)(A). 

5. Picamilon is not a mineral as it does not provide a fonn or source of inorganic 

elements to tbe diet. Thus, picamilon does not does not qualify as a dietary ingredient under 

section 20l(ff)(l)(B) of the Act, 21U.S.C.§321(ff)(l)(B). 

6. Picamilon is not an herb or other botanical as it is not found in nature and is not a 

plant, alga, or fungus, nor an exudate thereof. Thus, picamilon does not .qualify as a dietary 

ingredient under section 20I(f:f)(l)(C) of the Act. 21U.S.C.§321(ff)(l)(C). 

7, Pieamilon is not an amino acid, While picamilon contains an amino moiety along 

·········--with a carboxy1tc·acid, JJtoamilon-W·lf gamm<r.oamim.r-carboxyl±c·a:citl~rrot···mr··aipmFaminu-···~·-

carboxylic acid. Additionally, picarnilon is not: a constituent of proteins. Thus, picamilon does not 

qualify as a dietary ingredient under section 20l(fi)(l)(D) of the Act. 21 U.S.C. § 32l(ff)(l)(D). 

8. Picamilon is not a dietary substance for use by man to supplement the diet by 

increasing the total dietary intake. At my request, a diligent search of several food databases and 

scientific literature databases was conducted in August 2015 to idet1tify food usage ofpicamilon. 

The search identified no food use of picamilon. In the absence of such a use, picamilon is not a 

dietary substance for use by man to supplement the diet by increasing the total dietary intake. 

Thus, picamilon does not qualify as a dietary ingredient under section 201(ff)(l)(E) of the Act. 

21 U.S.C. § 32l(ff)(l)(E). 

9. Pioamilon is not a concentrate, metabolite, constituent, extract, or combination of 

any ingredient described in section 20l(ff)(l)(A), (B), (C), (D), or (E) of the Act. 21 U.S,C. § 

32l(ff)(J)(A), (B), (C), (D), or (E). While pica:milon .is a synthetically modified version of 

niacin and GABA, both dietary ingredients on their own, it is a different chemical entity. 

Picamilon is absorbed into the body and even crosses the blood-brain barrier and accumulates in 

Page 2 of3 SrATE'S 

EXHIBIT 

\ 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 24 of 30
I : 

the brain as this separate chemical entity. If picamilon dissociates into GABA and niacin, it 

would be a precursor to, not a metabolite of, dietary ingredients. Therefore, picarnilon does not 

qualify as a dietary ingredient under section 201(ff)(l)(F) ofthe Act. 21 U.S.C. §32l(ff)(l)(F). 

10. Because picamilon does not does not fit any of the dietary ingredient categories 

in section 201(ff)(l)(A)-(F) of the Act [21 U.S.C. § 321(ff)(l)(A)-(F)], it is not a dietary 

ingredient as set forth in section 201(ff)(l) of the Act. 21 U.S.C. § 32l(fi)(l). 

Pursuant to 28 U.S.C. § 1746, I declare under penalty of pe.rjmy that the foregoing is true and 

correct to the best of my information and belief. 

Executed on September 28, 2015 

Sworn to and subscribed 

b"'°fore():ne this .B_ day 

n 

o.fA¥.~c~•· I n ,2~ ') 'yht"'. \._ . ; j~ 

¥ota~y Pqblic 

{/ 

My commission expires: ANA O. REYNOl.OS ~PUBUCSTATEOF~ 

l1lllf Commlssioo Expires Jal1uary 16, 21l11J 

Cara Welch, Ph,D. 

Acting Deputy Director 

Division of Dietary Supplement Programs 

Center for Food Safety and Applied Nutrition 

us "°"d'"~Z:Z Ca a 

5100 Paint Branch Parkway 

Wiley Bldg, 4D-039 

College Park, MD 207 40 

(240) 402-2333 

Page 3 of3 STATE'S 

EXHIBIT 

I 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 25 of 30
1:-•- .. ~--·:-""""_...,,.--..---:·:-·-:::·:-~"""- .-----1 

. I 

Picafr.ilone benefits 

Translated from Russian 

Picamilone 

The beginning of the 1970s and subsequent years is characterized 

by the appearance of a new class of medicinal preparations, called 

nootropics, which are finding increasingly wider applications in 

various areas of medicine. Nootropic preparations are applied 

successfully for breakdowns of memory, attention, learning, and for 

treatment of loss of brain blood circulation, brain trauma, chronic 

alcoholism and other disorders. Among the medicinal properties of 

this group a notable place is occupied by the domestic preparation 

picamilone, synthesized in 1969 by the All-Union Scientific Research 

Institute and studied in the NII pharmacological RAN. By chemical 

structure p j@ml!QngJ!>.~.~llY.9Jl~3.LtbsLg.9J:!:UTI2.:.<!X.D.in~ utY.ri c acid 

(GABA) and~!J.LqgtiniQ2...C?.t9: Picamilone was introduced in medical 

-·pract1c€nnT986, and to the present time has achieved sufficiently 

---·---··----lar_ga_experiencelo .its_aJlpJicatiQ!J ..... _ ... ___________ .... _ .. _______ ., .. ______ ·----------

The great interest of clinicians in picamilone may be attributed to the 

unique combination of its pharmacological properties. It possesses 

high cerebrovascular activity, which ·exceeds the effect of 

cinnarizine, papaverine, xanthinol niacinate, and piracetam. One of 

the most important components in the spectrum of psychotropic 

activity is its nootropic effect, which determines its clinical use to a 

significant degree. Picamilone has a unique tranquilizing effect (the 

manifestation of action is inferior to diazepam); in this case 

picamilone does not cause a myorelaxation effect. The important 

property of picamilone is the ability to quickly restore mental and 

physical fitness for work, which was lost through overstress. Clinical 

experience with application of plcamilone shows that it is effective 

for ischemic disturbances of cerebral blood circulation, discirculatory 

encephalopathy, vegetative dystonia, and for prevention and 

treatment of the simple form of migraine. Picamilone has proven an 

effective medicinal treatment for patients with disorders of a neurotic 

level, with accompanying manifestations of anxiety, fear, emotional 

and vegetative instability. Picamilone finds a use in the complex 

treatment of alcoholism and acute alcoholic intoxication. At this time 

the list of indications for prescription of picamilone is constantly 

growing. Clinical studies have shown that picamilone possesses 

favorable properties in opthalmological practice in the treatment of 

primary open glaucoma, diseases of the retina and the optic nerve 

of vascular genesis. It has been adapted also in urological practice 

for treatment of neurological disorders of urination in children and 

adults. It Is important to note that picamilone does not cause 

habituation, but its safety is proven for 10 years in wide and 

intensive clinical application. Picamilone is prescribed both in monopreparation and in combination with other medicinal agents. 

Pagel of2 

STATE'S 

EXHIBIT 

2 

t ~ \ 

CONFIDENTIAL 

http:/ /www.picamilone, org/picamilone-1.htm 

GNC PICEX2 000009 

5/22/2007 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 26 of 30
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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 27 of 30
I <::.-

Sender: Carter Gray </O=GNC/OU=EXCHANGE ADMINISTRATIVE GROUP 

(FYDIBOHF23 SPDLT)/CN=RECIPIENTS/CN=SMl CJG> 

Sent: Tuesday, November 19, 2013 12:46:50 PM 

Recipient: John R. Telencho, Jr.<John-Telencho@gnc-hq.com> 

Subject: Fwd: USA Today - FDA mum on new drug in diet pills; No warning given on 9 

products that have speedPlease tell me we won't have to get rid of acacia now ... 

Sent from my iPhone 

Begin forwarded message: 

From: Jennifer Jakell <J.~nillJer::JakelJ@gnc:h.~u::om> 

Date: November 19, 2013 at 7:22:41 AM EST 

To: David Sullivan <David-Sullivan@gnc-hg.com>, Gary Kelly <Gary-Kelly@gnc-hg.com>, 

Wendell Haymon <Wendell.Haymon@nutramfg.com>, Ali Barry <Alexandra-Barry@gnchq.com>, Alice Hirsche! <Alice-Hirschel@gnc-hq.com>, Amy Davis <Amy-Davis@gnc-hg.com>, 

Andy Drexler <f,.n_Q_rew-D~exler.@gnc-h~com>, Anthony Phillips <APJ)lony-Philljfil@_@f: 

hq.com>, April Schatschneider <April-Schatschneide~l.m.com>, Beth Kitchen <BethKitchen@gnc-hq.com>, Bob Emilian <Robert-Emilian@gnc-hg.com>, Brandi Spade <BrandiSpade@gnc-hg.com>, Brian Cavanaugh <Brian-Cavanaugh@gnc-hq.com>, Brian Tolbert <BrianTolbert@gnc-hq.com>, Brooke Place <Brooke-Place@gnc-hg.com>, Carl Seletz <CarlSeletz@gnc-hg.com>, Carmine Fortino <Carmine-Fortino@gnc-hg.com>, 'Caroline Underwood' 

<.carolinel!@,_d_iscount-supplements.qo.uk;>, Carter Gray <.Carter-Gray@gnc-hg.co111>, "Celeste E. 

Lucanish" <Celeste-Lucanish@gnc-hq.com>, Celina Petronzi <Celina-Petronzi@gnc-hq.com>, 

Cheri Mullen <Cheri-Mullen@gnc-hq.com>, Christina Middleton <Christina-Middleton@gnchq.com>, Cody Kishur <Cody-Kishur@gnc-hq.com>, CS-OpsTeam <CS-OpsTeam@gnchq.com>, Daniel Winschel <Daniel-Winschel@gnc-hq.com>, Danielle Fortunato <DanielleFortunato@gnc-hg.com>, "Darryl V. Green" <Darryl-Green@gnc-hg.com>, David Florian 

<dflorian@gncfranchising.com>, David King <David-King~-hg.corn>, "David R. Sims" 

<David-Sims@gnc-hg.com>, Dennis Magulick <Dennis-Magulick@gnc-hg.com>, Erica Price 

<Erica-Price@gnc-P.q.com>, Erin Catalina <Erjn-:Catalin~@gnc-filt.&oll!>, Fion Ge <flQJk. 

ge@gncintl.com>, "frankcostamd@msn.com" <frankcostamd@msn.com>, G Miller 

<gmiller@marketcompr.com>, Gilles Houde <Gilles-Houde@gnc-hq.com>, Glynn Perdue 

<Glynn-Perdue@gnc-hg.com>, Greg Szabo <Greg.Szabo@nutramfg.com>, Guru Ramanathan 

<yuru-R£1.ma11fl.th;:i.n.@,fil1£:h.Q,~Om>, "gy_m.Jl.ast2];>b@yahoo.com" <gymnast2b];>_@yahoo.cojp_>, 

James McBride <James-McBrid.e@gnc-hq.com>, Jamie Garbowsky <Jarnie-Garbowsky@g_nc-: 

hq.com>,Jane Xu <Jane-Xu@gncintl.com>, Jason Minear <jminear@gncfranchising.com>, 

"Jeffery W. Bost (jwbpac2@gmail.com)" <jwbpac2@gmail.com>, Jeffrey Del Favero <JeffreyDelFavero@gnc-hq.com>, "Jenna R. O'Connor" <Jenna-O'Connor@gnc-hq.com>, Jennifer 

Dawson <Jennifer-Dawson@gnc-hg.com>, Jennifer Gartin <Jennifer-Gartin@gnc-hq.com>, 

Jennifer Jakell <Jennifer-Jakell@gnc-hq.com>, Jennifer Murphy <Jennifer-J'y[urphy@gnc_-hg.com>, 

Jerry Stubenhofer <Gerald-Stubenhofer@gnc-hq.com>, Jim Bums <Jim-Bums@gnc-hq.com>, Jim 

Kane <J:.am_~-~ati~fillc-Jm_,.gorp_>, Jim Terry <J:.ii:mes.Tern:_@!llitra ... wfg,co111>, Joanne Colacci 

<Joanne-Colacci@gnc-hq.com>, John Herman <John-Herman@gnc-hq.com>, "John R. Telencho, 

Jr." <John-Telencho@gnc-hg.com>, IT Smith <Joshua-Smith@gnc-hg.com>, "Judy A. Hufnagel" 

<Judy-Hufnagel@gnc-hq.com>, Justin Moore <Justin-Moore@gnc-hg.com>, Justin Villella 

<Justin-Villella@gnc-hq.com>, Kelly Merkle <Kelly-Merkle@gnc-hq.com>, Kim Borchert 

!!._orchert@.gnf_:_hq.cQm>, Kyle Wiederspan <Kyl~_-Wi.ed.erfil.@_@gQc-hgsom>, L Brophy 

<l];>_r911.hy.@_m_arketcw...Qr.com>, Lauren Green <Lm!@ll:fuQen@gn~Q.g..Q9m>, Lauren Kani c 

<Lauren-Kanick@gnc-hq.com>, Lea Alfred <Lea-Alfred@gnc-hq.com>, Lindsay McKibbe 

~ 

• EXHIBIT 

l< 

n i~ I . ?:, 

CONFIDENTIAL GNC CID 012274 

; 

Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 28 of 30
<Lindsay-McKibben@gnc-hq.com>, Mark Butera <Mark-Butera@gnc-hq.com>, Melanie Hennick 

<Melanie-Hennick@gnc-hq.com>, Michael Ford <Mike-Ford@gnc-hg.com>, Michael Hokanson 

<Michael-Hokanson@gnc-hq.com>, Michele Nickolas <Michele-Nickolas@gnc-hq.com>, Mike 

Nuzzo <Mike-Nuzzo@gnc-hq.com>, Monica Burkley <Monica-Burkley@gnc-hq.com>, Nathaniel 

Kennedy <N_~Jhani~l.:-~enn.edy@gnc-h_q,com,>, Nicholas Goodling <Nj~pola~_:_Gooq}j_gg@.gp.c-: 

hq.com>, "Nick H. Coxon" <Nick-Coxon@gnc-hq.com>, Olena Thomas <Olena-Thomas@gnchq.com>, "Peter@att.blackberry.net" <Peter@att.blackberry.net>, Rachel Jones <RachelJones@gnc-hq.com>, Rachel Kreider <Rachel-Kreider@gnc-hq.com>, Rachel Seyko <RachelSeyko@gnc-hq.com>, Richard Bender <Richard-Bender@gnc-hq.com>, Rob Schwartz <RobSchwartz@gnc-hg.com>, Russell Barba <Russell-Barba@gnc-hq.com>, "Ruth A. McGee" <RuthMcGee@gnc-hq.com>, Shawn Cupples <Shawn-Cupples@gnc-hq.com>, Shawn Freeman 

<Shawn-Freem.@@gnc-hq.com_>, Sheila Phillips <Sheila-~hillips@gnc-hq.com>, Steve Cherry 

<St~y~{:_b._m:y@gp.c-.\KJ..&Q..np, Steven Xu <§t§.ven-'lli@~intl.com>, Stuart Harris 

<stuarth@alsportsltd.com>, Sudipta Veeramachaneni <Sudipta-Veeramachaneni@gnc-hq.com>, 

Susan Bosiljevac <Susan-Bosiljevac@gnc-hq.com>, Suzanne Currier <Suzanne-Currier@gnchg.com>, Ted Deitrick <Ted-Deitrick@gnc-hg.com>, "Terry F. Papadopoulos"<~ 

~JillQQQulos@gntlq,.gorn>, Thomas Scott <Thomas-Scott@gnc-b.Q.&Plll» Tom Dowd <'.I'omDowd@gnc-hq.com>, Tracy Helfer <Tracy-Helfer@gnc-hq.com>, Vincent Mariani <VincentMariani@gnc-hg.com> 

Subject: USA Today- FDA mum on new drug in diet pills; No warning given on 9 products 

that have speed-like compound 

NEWS 

FDA mum on new drug in diet pills; No warning given on 9 products that 

have speed-like compound 

Alison Young 

Alison Young 

Alison Young, USA TODAY, 

489 words 

19 November 2013 

USA Today (Newspaper) 

USAT 

FINAL 

A.1 

English 

© 2013 USA Today. Provided by ProQuest Information and Learning. All Rights Reserved. 

For the second time in recent weeks, scientists have found a "non- natural" amphetamine-like compound in 

dietary supplements -- yet federal regulators have issued no warnings to consumers about the ingredient. 

Tests of 21 supposedly all-natural supplements by U.S. Food and Drug Administration scientists found nine 

products that contain the compound, according to their findings published in the Journal of Pharmaceutical 

and Biomedical Analysis. 

All 21 of the supplements list an ingredient called Acacia rigidula, which is a bushy plant found in Texas and 

Mexico. The FDA scientists reported they couldn't find the substance in verified samples of the plant. The 

compound appears to have never been tested for safety on humans, they said. 

FDA officials would not comment on their study or release the names of the nine supplements found to 

contain the compound, beta- methylphenethylamine. The Acacia rigidula supplements tested were marketed 

for such things as weight loss and energy, their paper said. 

CONFIDENTIAL 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 29 of 30
Cohen was part of another research team that last month reported finding a methamphetamine-like 

compound in a pre-workout supplement called Craze. Cohen expressed dismay that the FDA hasn't issued 

any warnings to the public about Craze or the nine supplements flagged in the new research paper. 

Acacia rigidula is listed as an ingredient in several weight loss and energy supplements made by Hi-Tech 

Pharmaceuticals of Norcross, Ga., including Fastin-XR, Stimerex and Lipodrene Hardcore. The company 

has had repeated run-ins over the years with federal regulators, records show. 

The FDA announced Monday it seized $2 million in supplements last week from Hi-Tech that contained a 

different stimulant ingredient: DMAA. 

Hi-Tech President Jared Wheat said he has safely used Acacia rigidula in supplements for several years 

and the FDA has never mentioned concerns about it. Wheat says a 1998 journal article by Texas A&M 

scientists proves the compound is natural. "They're just absolutely wrong," Wheat said of the FDA scientists. 

Wheat said he believes his company is the largest supplier of Acacia rigidula in the country and the chemical 

signatures published in the FDA's research paper indicate to him that six or seven of the nine flagged 

supplements are probably made by his company. 

Amy Eichner of the U.S. Anti-Doping Agency said Acacia rigidula appears to be the latest in an industry 

trend of spiking supplements with stimulants. 

Steve Mister of the Council for Responsible Nutrition a supplement industry group, said if there's a health 

risk, the FDA should name names and take swift enforcement action. 

USA Today Information Network 

Document USAT000020131119e9bj0000u 

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Case 3:15-cv-02006-PK Document 1-1 Filed 10/23/15 Page 30 of 30