2 3 4 IN THE CIRCUIT COURT OF THE STATE OF OREGON 5 FOR THE COUNTY OF MULTNOMAH 150V28591 6 STATE OF OREGON, ex rel. ELLEN F. Case No. ROSENBLUM, in her official capacity as 7 Attorney General for the State of Oregon, COMPLAINT 8 Plaintiff, Oregon Unlawful Trade Practices Act 9 ORS 646.605 62? seq. v. CLAIM NOT SUBJECT 10 GENERAL NUTRITION CORPORATION, TO MANDATORY ARBITRATION 11 Defendant. ORS 20.140 - State fees deferred at ?ling 12 INTRODUCTION 13 This is a lawsuit by Ellen F. Rosenblum, Attorney General of Oregon, against General 14 Nutrition Corporation or ?Defendant?) for violations of Oregon?s Unlawful Trade 1 5 Practices Act Defendant repeatedly violated the UTPA by misrepresenting that 16 various products that GNC sold in Oregon were lawful dietary supplements when in fact these 17 products were adulterated and unlawful because they contained either picamilonl or 1 8 potentially dangerous ingredients that do not meet the legal de?nition of a dietary ingredient and 19 may not be lawfully used in dietary supplements. Picamilon is a chemical designed to 20 cross the blood brain barrier and is a prescription drug used in some countries but not the United 21 States to treat various neurological conditions. BMPEA is a chemical similar to 22 23 1 Picamilon is also known as nicotinoyl-GABA, pycamilon, picamilone, pikatropin, and 24 pikamilon. 25 2 BMPEA is also known as R-beta- l-amino?2? 26 alpha-benzylethylamine, 1- phenyl?lmethyl?Z?aminoethane, 2- phenyl?l ?propanamine. Page 1 - I Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 amphetamine that is banned by the World Anti-Doping Organization. In addition to selling I 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 l. 7 Ellen F. Rosenblum is the Attorney General for the State of Oregon and sues in her 9 of?cial capacity pursuant to ORS 646.605(5) and ORS 646.6320). 10 2. General Nutrition Corporation is incorporated under the laws of with 11 its principal place of business located at 300? Sixth Avenue, Pittsburgh, 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 l7 3. Theclaims 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 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 UTPA 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 26 Page 2 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 1 7. Venue is proper pursuant to ORS 646.6320) and ORS 14.080 because Defendant is 2 alleged to have committed violations of the UTPA 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. prohibits 6 unconscionable and deceptive acts and practices in commerce. The Attorney General is authorized 7 under ORS 646.6320) 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 prohibition on unconscionable and deceptive 10 acts and practices in commerce. 1 1 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 Actionable representations under 13 the UTPA can be express or implied. 14 11. Violations of the UTPA are willful if a person knew or should have known that their 15 conduct was a violation of the law. ORS 646.6050 0). 16 E34215. 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 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 requirements and expectations. Suppliers are expected to make 26 labeling changes?o?such as adding GNC-approved warnings?as necessary. Page 3 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673?1880 Fax: (971) 673-5000 1 14. GNC reviews the scienti?c literature on many of the ingredients used in third- 2 party products. For example, on December 8, 2014, an e?mail exchange between Jennifer akel, 3 Senior Project Manager for Technical Research, and Christina Middleton, Associate 4 Project Manager, discussed the scienti?c literature ?regarding the ingredients from 3rd party 5 products.? Based on Ms. Middleton?s review of the literature, Ms. akel decided which 6 ingredients ?looked promising? for possible development by Nutra Manufacturing (?Nutra?), 7 manufacturing arm. Nutra manufactures and supplies Vitamins and supplements to 8 General Nutrition Centers and to other third-party companies. 9 15. 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 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 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 requires its vendors 23 to be honest, ethical, reliable and capable of providing products that meet our high standards of 24 quality.? Unfortunately, representations are untrue. As described below, GNC sells 25 prodticts obtained from third?party vendors that GNC knows or should know contain unlawful 26 Page 4 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673?1880 Fax: (971) 673-5000 1 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 7 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 modi?ed in order to facilitate its translocation across the blood-brain barrier. 9 Picamilon is formed by 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 201(ff)(1) of the Act is 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 21 U.S.C. ?321(ff)(1). 16 20. Picamilon does not ?t any of the dietary ingredient categories in section 17 of the Act. (EX.1, Decl. 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 2 1 adulterated. 22 21. 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, Senior Project Manager for Technical Research Jennifer akel, Page 5 Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 1 whose responsibilities include ensuring that labeling and scienti?c claims are accurate, reviewed the 2 available literature regarding picamilon. 3 23. All the documents reviewed by Ms. akel had been translated from Russian. Among 4 the documents reviewed by Ms. akel 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 ?nding 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. akel also learned from this same document that picamilon was in 10 1969 by the All-Union Scienti?c Research Institute and studied in the N11 pharmacological RAN. 11 By chemical structure picamilone is a derivative of the gamma?amino-butvric acid and nicotinic 12 m? (Underlined by Ms. akel). Thus, as early as early as May 22, 2007, GNC knew that 13 picamilon was a 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. akel documented in the GNC library ?le on picamilon: ?No NDI that 17 I could 18 26. An NDI or new dietary ingredient noti?cation 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. akel again looked for an NDI for picamilon and documented 25 in her ?le ?still no NDI found.? (EX. 3.) 26 Page 6 Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 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 ful?ll dietary ingredient categories in section 201 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 1 1 June 2015, GNC sales of products that contain picamilon were as follows: 12 Picamilon Sales in Oregon, anuarv 2013?June 2015 13 Description Vendor Total Units Sold (Web) Charge Extreme Energy Booster Labrada Bodybuilding Nutrition 4 14 Lean Body for Her Fat Burner Labrada Bodybuilding Nutrition 9 Lean Body Hi Energy Fat Burn Labrada Bodybuilding Nutrition 8 15 Testek QNT International, Inc. 13 (8) 16 Riptek V2 QNT International, Inc. 2 (1) Tru Mangodrin Truderma, LLC 26 (4) 17 Turbo Shred Swole Sports Nutrition 12 (9) Jacked Pack BD Health Partners 100 (3) 13 Mr. Hyde Fruit Punch Prosupps USA LLC 808 (7) 19 Mr. Hyde Watermelon Prosupps USA LLC 1,037 (6) Dr. Jekyll Power Punch Prosupps USA LLC 226 (3) 20 Dr. Jekyll Watermelon Prosupps USA LLC 218 Mr. Hyde Orange Guava Prosupps USA LLC 1 21 Vanish Bonus Prosupps USA LLC 25 (14) 22 Mr. Hyde Red Razz Prosupps USA LLC 48 Mr. Hyde RTD Blue Razz Prosupps USA LLC 65 23 Mr. Hyde Blue Razz Prosupps USA LLC 120 Mr. Hyde RTD Fruit Punch Prosupps USA LLC 69 24 Nirvana Sensatus Group LLC 18 25 ENGN Fruit Punch Evlution Nutrition 5 8 (5) 7 ENGN Blue Raz Evlution Nutrition 88 (4) 26 ENGN Green Apple Evlution Nutrition 55 TOTAL 3,010 (64) Page 7 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 31. On June 16, 2015, pursuant to ORS 646.618, Plaintiff issued an Investigative 1 2 Demand to GNC Holdings, Inc., (Defendant?s parent company) which demanded production of 3 documents and information relating to Defendant?s sale of picamilon. 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 17 33. BMPEA is a chemical similar to amphetamine. It was ?rst 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 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 (BMPEA): A Case Report; Ann Intern Med. Published online 12 May 2015 Page 8 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673?5000 1 supplement that contains BMPEA is deemed to be adulterated and may not be lawfully sold in the 2 United States. 3 35. 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 produced and not found naturally. Although there is one 8 published report4 that BMPEA is found naturally in the acacia rigidula plant, this report 9 provides little information regarding how the identi?cation was made, and in 2013, FDA conducted 10 a more credible analysis using a veri?ed 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 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 law?il dietary ingredient because BMPEA does not fit any of the dietary ingredient categories in 18 Section of the Act. 19 38. GNC knew of the FDA study as early as November 2, 2013, when Senior 20 Project Manager for Technical Research Jennifer akel was notified by a PubMed service that the 21 study was available on line. 22 39. On November 18, 2013, USA Today published an article about the FDA study.6 23 4 BA. Clement et al, Toxic amines and alkaloids ?om Acacia Rigidula, Phytochemistry 24 491998) 1377?1380 5 Pawar et al, determination of selected biogenic amines in acasia rigidula plant materials and 25 dietary supplements us methods; Journal of Pharmaceutical and Biomedical analysis 88(2014 457466 26 6 1/ 1 . Page 9 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673?5000 1 40. The FDA study became widely known throughout GNC on November 19, 2013, 2 when Ms. akel circulated the USA Today article to approximately 100 recipients at GNC 3 headquarters. Among those recipients was Senior Vice President and Chief Innovation 4 Of?cer Guru Ramanathan. GNC Vice President General Counsel, Regulator Affairs David 5 Sullivan was another recipient of the USA Today article. 6 41. The USA Today article stimulated signi?cant concern and discussion within GNC. 7 For example, Within minutes of receiving the email from Ms. akel, 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.) I 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, Senior Vice President of Merchandising wrote to Steve Cherry, the Vice 13 President of Purchasing, and David J. Sullivan, Vice President and General Counsel, and 14 offered to do a ?database search to ?nd all 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, 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 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 26 Page 10 Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673?1880 Fax: (971) 673?5000 1 shot. To replace the ephedra, they would like to use Acacia Rigidula (leaves)?is this ingredient 2 acceptable.? Barba then checked with Beth Curtin who approved Rhino RushMarch 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 NutraIngredients?USA, reported that Danish and 8 Swedish regulatory agencies had issued warnings that a dietary supplement labeled as containing 9 AR that was spikediwith 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 1 6 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 signi?cant 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 de?nition 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 e??icacy and safety in humans has never been studied is found in multiple dietary supplements, Drug Test analysis DOI.1002/dta.1793 Page 11 Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 1 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: etfuel Superburn, MX-LS7 and Phenyl Core Weight 6 management. These products were labeled as containing AR but were not labeled as containing 7 BMPEA. expert tested these products using a state?of-the-art methodology: rapid 8 resolution liquid chromatography-accurate mass?quadrupole-time of ?ight-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 of BMPEA. 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 signi?cant 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 Page 12 Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 1 57. In addition, GNC sold at least 105 AR products in Oregon after November 2013 2 without disclosing that these products were at signi?cant risk of having been adulterated with 3 BMPEA. I 4 58. The AR products sold in Oregon between January 2013 and May 2015 are as 5 follows: i 6 Acacia Rigidula Sales in Oregon, January 2013 May 2015 7 Description Vendor Total Units Units Sold Sold (Web) 12/2013 8 After Hit Fastin XR Hi Tech Pharmaceuticals 20 0 9 Lipodrene XR Hi Tech Pharmaceuticals 1 Fastin XR DMAA Free Hi Tech Pharmaceuticals 37 6 10 etfuel Superburn World Health Products LLC 71 (10) 16 11 Green Coffee Bean Energy Rightway Nutrition 200 (5) 78 MX-LS7 Isatori Global Technologies 8 2 12 Phenylcore 3 (3) 3 13 TOTAL 340 (18) 105 59. In addition to the AR products sold by GNC that contained undisclosed BMPEA, 14 GNC also sold products that were labeled as containing BMPEA. These products were falsely 1 5 labeled as if they were a lawful dietary supplement, when in fact, they Were not dietary 16 supplements because BMPEA is not a lawful dietary ingredient. Between January 1, 2013, and 1 7 May 2015, GNC sold the following products in Oregon that were labeled as contained BMPEA: 1 8 BMPEA Sales in Oregon, anuarv 2013?May 2015 19 Description Vendor Total Units Units Sold 20 Sold (Web) 12/2013 After 21 Fastin Hi Tech Pharmaceuticals 17 0 Fastin DMAA Free Hi Tech Pharmaceuticals 126 (3 9) 79 22 Meltdown Watermelon VPX Sports, Inc. 142 (4) 61 23 Meltdown Peach Mango VPX Sports, Inc. 9 Meltdown Exotic Fruit VPX Sports, Inc. 4 0 24 Lipo 6 Black Nutrex Research 20 0 Meltdown VPX Sports, Inc. 27 6 25 Redline Ultra Hardcore Twinpk VPX Sports, Inc. 2 26 Redline Ultra Hardcore Bonus VPX Sports, Inc. 23 Redline Ultra Hardcore VPX Sports, Inc. 430 (11) 287 Redline Hardcore Blister Pak VPX Sports, Inc. 82 0 Page 13 Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 1 Fruit N.O. Shotgun VPX Sports, Inc. 41 8 gum Shotgun V3 VPX Sports, Inc. 9 1 2 Craze Candy Grape Driven Sports 331 0 Vanish Bonus Prosupps USA LLC 25 (14) 25 3 Shredz Burner Shredz Supplements 49 (21) 49 4 Iso Lean 2 Advanced Nutrition Systems 1 (1) 1 Iso Lean 3 Advanced Nutrition Systems 1 (1) 1 5 Methyl Drive 2.0 Advanced Nutrition Systems 1 (1) 1 TOTAL 1,340 (92) 519 6 60. Prior to January 1, 2013, GNC sold a yet to be determined number of products in 7 Oregon that contained BMPEA. 8 CLAIMS FOR RELIEF 9 61. All of Defendant?s violations of the UTPA set forth below were willful because 1 0 Defendant knew or should have known that their conduct was in violation of the UTPA. 1 1 FIRST CLAIM FOR RELIEF: ORS e) 1 2 62. ORS makes it an unlawful trade practice to represent that goods have 1 3 approval, characteristics, uses, bene?ts, or qualities that the goods do not have. 1 4 COUNT 1 5 Misrepresenting that Products Containing Picamilon are Lawful Dietary Supplements 1 6 63. Plaintiff realleges and incorporates each and every allegation contained in the 1 7 preceding paragraphs as though set forth herein. 1 8 64. Defendant offered products for sale in Oregon that contained picamilon, and in so 19 doing, represented that these products had the approval, characteristics, uses, benefits, or qualities of 20 a lawful dietary supplement, when in fact, products that contain picamlon are not lawful dietary 2 supplements. 22 65. Each and every instance in which Defendant offered a product for sale in Oregon as 23 a dietary supplement when the product contained picamilon is a separate and distinct Violation of 24 ORS 25 26 Page 14 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 1 COUNT 2 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 12 COUNT 3 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, bene?ts 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 21 COUNT 4 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 Fax: (971) 673-5000 1 73. Defendant listed BMPEA as an ingredient in a product?s label as if BMPEA had the 2 approval, characteristics, uses, bene?ts or qualities of a lawful dietary ingredient, when in fact, 3 BMPEA is not a law?il 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 6 COUNT 5 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, bene?ts, and qualities 11 that it does not have when it sold products that contained BMPEA but did not list BMPEA as an 1 2 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 16 COUNT 6 17 Failure to disclose that Acacia Rigidula Products were at 18 Signi?cant 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, bene?ts, and qualities 22 that it does not have when it sold products that contained Acacia rigidula without disclosing that the 23 product was at signi?cant 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 646.6080) Page 16 Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673?1880 /Fax: (971) 673-5000 1 SECOND CLAIM FOR RELIEF: ORS 2 81. ORS 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 COUNT 7 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, picamilon is not of this standard, quality, or grade. 1 1 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 l3 COUNT 8 l4 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 22 COUNT 9 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 1 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 6 COUNT 10 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 15 THIRD CLAIM FOR RELIEF: ORS 646.608( 1)(bl 16 94. ORS makes it an unlawful trade practice to cause likelihood of 17 confusion or of misunderstanding as to the approval or certi?cation of goods. 18 COUNT 11 19 Causing Likelihood of Confusion that Picamilon is 20 Approved or Certi?ed 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 certi?ed as a lawful dietary ingredient when it listed picamilon as an ingredient on a 25 products label without disclosing that picamilon is not a lawful dietary ingredient. 26 Page 18 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673?5000 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 4 COUNT 12 5 Causing Confusion that Products that Contain Picamilon are 6 Approved or Certi?ed 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 certi?ed as lawful dietary supplements when Defendant 1 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 15 COUNT 13 16 Causing Confusion that BMPEA is Approved or Certi?ed as a Dietary Ingredient 17 101. 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 certi?ed 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 24 25 26 Page 19 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 1 COUNT 14 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 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. Plaintiff realleges 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 signi?cant 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 COUNT 16 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 97201 (971) 673-1880 Fax: (971) 673-5000 1 1 11. Each and every instance in which Defendant sold a product with BMPEA when 2 Defendant knew that BMPEA is an unlawful dietary ingredient, without disclosing to consumers 3 that the product was unlawful, used an unconscionable tactic. 4 COUNT 17 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 13. 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. 1 1 1 2 13 WHEREFORE, Plaintiff prays for the following relief: 14 1. A judgment against Defendant for civil penalties up to $25,000 for each willful 15 violation of the UTPA, pursuant to ORS l6 2. A judgment requiring Defendant to disgorge all gains obtained as a result of their 17 violations of the UTPA, pursuant to ORS 646.636; 18 3. A judgment requiring Defendant to provide restitution to all Oregon purchasers of 19 products that contain BMPEA or picamilon for the cost of the product, pursuant to 20 ORS 646.636; 21 4. A permanent injunction prohibiting Defendant from selling products that contain 22 unlawful ingredients when Defendant knows, or should know, that the product 23 contains an unlawful ingredient. 24 5. A judgment against Defendant for reasonable attorney fees and investigative costs 25 pursuant to ORS 646.632(8) and ORCP 68; and 26 Page 21 - Department of Justice 1515 SW Fifth Ave, Suite 410 Portland, OR 97201 (971) 673-1880 Fax: (971) 673-5000 Page 22 - 6. A judgment granting any other and further relief as the court may deem appropriate. DATED October . 20 1 5. Respectfully submitted, ELLEN F. ROSENBLUM Attorney General 1 l. 1 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 Fax: (971) 673-5000 13; 1 $2357?;- . - 12?: . t, i V. I jest-77777557: ?l 5: WI fix. 6 a? C, DEPARTMENT or HEALTH AND HUMAN SERVICES ?e DECLARATION OF DR. WELCH I, Dr. Cara Welch, declare as follows: . l. I am the Acting Deputy Director, Division of Dietary 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 dietary supplement statute and regulations for the dietary supplement program office. This includes policies and programs involving regulatory compliance matters of signi?cant importance to the dietary supplement industry regarding manufacturing and ingredient safety issues. The statements made in this declaration are based upon my personal knowledge . supplement and ingredient issues. 2. Picamilon (pikatropin?) is a neurotransmitter acid, that has been modified in order to facilitate its translocatibn across the blood?brain barrier. Picarnilon is formed by combining niacin with GABA. There is no indication in the literature that this compound is found in nature. 3. A ?dietary ingredient? under section 1) of the Federal Food, Ding, and Cosmetic Act (the Act) is a Vitamin; (B) amineral; (C) an herb or (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or 21 U.S.C. 321(ft)(1). Picamilon is not a Vitamin. While picam?ilon may be from a yitamin (niacin), it is a different chemical entity. Picamilon is neither an organic substance nor a minor component of foods. Neither is, picamilon essential for normal physiological functions. Picamilon is not produced endogenously in amountsadequate to meet normal physiologic needs Page 1 of 3 a 3 (5 112.1 0- . v. 733%} risen: 21?: (and in fact, there is no physiologic need for picaniilon), and there is no clinically de?ned de?ciency associated with the absence or underutilization of piearniion. Thus, picamilon does not qualify as a dietary ingredient under section of the Act. 21 use. synonym. 5. Picamilon is not a mineral as it does not provide a form or source of inorganic elements to the diet. Thus, picam?on does not does not qualify as a dietary ingredient under section 201(c)(1xs) of the Act, 21 U.S.C. mun-yum). 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 201(ft)(l)(C) of the Act. 21 321(fi)(1)(C). 7. Picamilon is not an amino acid. While piCamilcn contains: an atninomoiety along ?qr: sits?Mm Vivi .. is a gammawamino acid, not an alphabmiuo carboxylic acid. Additionally, picamilon is not a constituent of proteins. Thus, picamilon does not qualify as a dietary ingredient under section 201(ff)(1)(D) of the Act. 21 321(ff)(1)(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 set/oral feed databases and scienti?c literature databases was conducted in August 2015 to, identify food usage ofpicamilon?. The search identi?ed no food use of picamilon. In the absence of sucha use, picamilon is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Thus, picainilon does not qualify as a dietary ingredient under section 201(ft)(1)(E) of the Act. 21 use. 9. Pioamilon is not a concentrate, metabolite, constituent, extract, or Combination of? any ingredient described in section to), or of the Act. 21 use, 321(ft)(1)(A), or (E). While picaimilon is a modi?ed version of niacin and GABA, both dietary ingredients On their own, it is a different chemical entity. Picamilcn is absorbed into the body and even crosses the blood?brain barrier and accumulates in Page 2 of 3 SATES EXHIBIT if PENGAD 800-631-6989 A the brain as this separate chemical entity. If pioam?on dissociates into GABA and niacin, it would be a precursor to, not a metabolite of, dietary ingredients. Therefore, pioam?on does not qualify as a dietary ingredient'under section 201(ff)(1)(F) of'the Act. 21 U.S.C. 10. Because pioamilon does not does not ?t any of the dietary ingredient categories in section dietary ingredient as set forth in section 201(ff)(1) ofthe Act. 21 U.S.C. 321(ff)(1). Pursuant to 28 U.S.C. 1746, I declare under penalty of perjuxy that the feregoing is tme and correct to the best of my information and belie? Executed on September 28, 2015 Cara Weleh, PILD. Acting Deputy Director Division of Dietary Supplement Programs Center fer Food Safety and Applied Nutrition US. Food and Drug Administration Cara Welsh 5100 Paint Branch Parkway Wiley Bldg, College Park, MD 20740 (240) 402~2333 Sworn to and subscribed before?ng this day of gleam/mew ,2015. Edema! Public eye/x? My commission ex ires: ANA 0. Rev rx W391, see? My mouse January 18, We Page .5: Tr "paw Lead.? . ?viva-?- 7. Pica?r?n?one bene?ts Page 1 of 2 Translated from Russian Picamiione The beginning of the 19703 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. Noctropic 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 picamiione, in 1969 by the All-Union Scientific Research institute and studied in the Nil pharmacological RAN. By chemical structure pigamiigge is a derivative of the oamma-amino?butyric acid (GABA) and 3933019 Maggi?. Picamiione was introduced in medical Wit?i?h 1986, and to the present time has achieved sufficiently large experience in its application. The great interest of clinicians in picamiione may be attributed to the unique combination of its pharmacological properties. it possesses high cerebrovascular activity, which'e?xceeds the effect of cinnarizine, papaverine, xanthinoi niacinate, and piracetam. One of the most important components in the spectrum of activity is its nootropic effect, which determines its clinical use to a significant degree. Picamiione has a unique tranquilizing effect (the manifestation of action is inferior to diazepam); in this case picamiione does not cause a myorelaxation effect. The important property of picamiione is the ability to quickly restore mental and physical fitness for work, which was lost through overstress. Clinical experience with application of picamiione shows that it is effective for ischemic disturbances of cerebral blood circulation, discircuiatory encephalopathy, vegetative and for prevention and treatment of the simple form of migraine. Picamiione has proven an effective medicinal treatment for patients with disorders of a neurotic level, with accompanying manifestations of anxiety, fear, emotional and vegetative instability. Picamiione finds a use in the complex treatment of alcoholism and acute alcoholic intoxication. At this time the list of indications for prescription of picamiione is constantly growing. Clinical studies have shown that picamiione possesses favorable properties in opthaimoiogicai 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 picamiione does not cause habituation, but its safety is proven for 10 years in wide and intensive clinical application. Picamiione is prescribed both in mono- preparation and in combination with other medicinal agents. eNc I .htm 2 000009 5/22/2007 EXl-liBiT PENGAD 800-631?6989 rim: A .M .. .quattend an N03 Wk wuia RA a; 5359b?) Ema ?26 in 5 Woan?? gg?'Cicl I: I. :5 5! 3 {Ex-13rd go Nu: ?N?xcxm ?zhs?ws swam 9007 no :2 ('77 "7'57" I CONFIDENTIAL GNC PICEXZ 000001 Sender: Carter Gray ADMINISTRATIVE GROUP (FYDIBOHF23 Sent: Tuesday, November 19? 2013 12:46:50 PM Recipient: John R. Telenchon Jr. Subject: Fwd: USA Today - FDA mum on new drug in diet pills No warning given on 9 products that have speed- Please tell me we won't have to get rid of acacia Sent from my iPhone Begin forwarded message: From: Jennifer Jakell Date: November 19, 2013 at 7:22:41 AM EST T0: David Sullivan Gary Kelly Wendell Haymon Ali Barry , Alice Hirschel Amy Davis Andy Drexler Anthony Phillips hg?cgignz April Beth Kitchen , Cody Kishur CS-OpsTeam , Daniel Winschel Danielle Fortunato , Jason Minear "Jeffery W. BOst Jeffrey Del avero , Jerry Stubenhofer Jim Burns Jim Kane , Lauren Green Lauren Kanick , "Peter@attblackberrvnet? Rachel Jones , Susan Bosiljevac , Ted Deitrick "Terry F. Papadopoulos" 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. Forthe 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 of21 supposedly all?natural supplements by US. Food and Drug Administration scientists found nine products that contain the compound, according to theirfindings 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 ?nd the substance in verified samples ofthe 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 ofthe nine supplements found to contain the compound, beta? The Acacia rigidula supplements tested were marketed for such things as weight loss and energy, their paper said. "This is a brand-new drug being placed into a number of supplements under the guise of a natural ingredient," Pieter Cohen, an assistant professor at Harvard Medical School, said after reading the FD . papeh CONFIDENTIAL CONFIDENTIAL 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 orthe 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, including Fastln-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 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 ofthe nine flagged supplements are probably made by his company. i Amy Eichner of the US. Anti?Doping Agency said Acacia rigidula appears to be the latest in an industry trend ofspiking 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 TEXHIBIT it sumGNC CID 012276