ORIGINA 1 2 IN THE UNITED STATES OF AMERICA 3 BEFORE THE FEDERAL TRADE COMMISSION OFFICE OF ADMINISTRATIVE LAW JUDGES 4 5 In the Matter of ) Docket No.: 9329 6 DANIEL CHAPTER ONE, ) ) 7 a corporation, and ) PUBLIC DOCUMENT ) 8 JAMES FEIJO, ) individually, and as an offcer of ) 9 Daniel Chapter One ) 10 ) ) 11 12 RESPONDENTS' STIPULATED MOTION TO INCLUDE EXHIBIT IN HEARING RECORD 13 14 On May 5, 2009, Complaint Counsel and Respondents' Counsel agreed - pending 15 approval by the hearing officer - that the attached THE JOURNAL OF THE AMERICAN BOTANICAL 16 COUNCIL, "HerbaIGram," No. 81 (Feb-Apr 2009) constitutes the correct and complete Exhibit 1 17 to Exhibit R18 (Deposition Transcript of James A. Duke), which was provided to the reporter at 18 the deposition but may not have been included in the final hearing record. 19 Respectfully submitted, 20 Dated: May~, 2009 21 22 ~;: 71 lJ Leonard L. Gordon, Esq. J mes S. Turner, Esq. 23 Theodore Zang, Jr., Esq. Michael McCormack, Esq Carole A. Paynter, Esq. 24 Betsy E. Lehrfeld, Esq. David W. Dulabon, Esq. Chrstopher B. Turner, Esq. 25 Elizabeth N ach, Esq. Swankin & Turner Wiliam H. Efron, Esq. 1400 16th Street, NW, Suite 101 26 Federal Trade Commission - Northeast Region Washington, DC 20036 27 One Bowling Green, Suite 318 New York, NY 10004 28 Complaint Counsel Counsel for Respondents 1 2 (PROPOSED) ORDER 3 The parties having agreed that Exhibit 1 to Exhibit R18 consists of THE JOURNAL OF THE 4 AMERICAN BOTANICAL COUNCIL, "HerbaIGram," No. 81 (Feb-Apr 2009), 5 6 IT is ORDERED that 7 To the extent it is necessary to change the hearing record such that Exhibit 1 to Exhibit 8 R18 shall consist of THE JOURNAL OF THE AMERICAN BOTANICAL COUNCIL, "HerbaIGram," No. 9 81 (Feb-Apr 2009), the hearing record shall be so changed. 10 ORDERED: 11 12 D. Michael Chappell 13 Administrative Law Judge 14 15 Dated: May _, 2009 16 17 18 19 20 21 22 23 24 25 26 27 28 CERTIFICATE OF SERVICE I HEREBY CERTIFY that on May 6,2009, I served the attached RESPONDENTS' STIPULATED MOTION TO INCLUDE EXHIBIT IN HEARIG RECORD upon the following: The original and two paper copies via hand delivery to: Donald S. Clark, Secretar Federal Trade Commission 600 Pennsylvana Ave., N.W., Room H-159 Washington, DC 20580 Two paper copies via hand delivery to: The Honorable D. Michael Chappell Administrative Law Judge 600 Pennsylvana Ave., N.W., Room H-528 Washington, DC 20580 ~ ti l/ '~ , ,. Ginseng for ED .__~~cf~ Bl~od Pr~~~~:~ Turmeric;1I Pancreatic Cancer. Medicinal Trees of . Virgin Islands .The Journal of the American Botanical Council Number 81 I February - April 2009 BILBERRY Continued from page 1 bilberry extracts to treat diabetic retinopathy, blindness, cataracts, Their Uses. London: Dorling Kindersley Ltd.; 200L. glaucoma, and macular degeneration, with retinopathy showing the 3. Kathe W, Honnef S, Heym A. Medicinal and Aromatic Plants in Alba­ most promise.13 In a meta-analysis of 30 clinical trials on bilberry nia, Bosnia-Herzegovina, Bulgaria, Croatia and Romania: A study of the collection of and trade in medicinal and aromatic plants (MAs), extract for vision in reduced light, the 4 most recent randomized relevant legislation and the potential of MA use for financing nature controlled trials (RCTs) had negative outcomes. However, one conservation and protected areas. Bonn, Germany: German Federal RCT and 7 non-randomized controlled trials reported positive Agency for Nature Conservation; 2003. effects on outcome measures relevant to night vision.1 However, 4. Medicinal and Aromatic Herbs: Manual and Monographs fot Collec­ the use ofbilberry extract for vision in reduced light has been based tors according to the Ptinciples of Organic Production. Skopje, mainly on anecdotal experience during the Second World War and Macedonia: Swiss Import Promotion Otganization; 2004. Available today is generally dismissed. at: http://ww.sippo.ch/internet/ osee! en/home/import/ publications/ File. pdf/ pubjood_ The primary application of anthocyanoside-enriched bilberry food.-ContentSlot- 5180- ItemList- 23399- File. monomk.pd£ extracts in ophthalmology focuses on diabetic retinopathy, where 5. Fostet S. Medicinal Plants of Montenegro. HerbalGram. 2006;72:48­ bilberry can be used as an adjuvant in combination with conven­ 54. tional pharmaceutical therapies. Bilberry extract improves capil­ 6. Lonnet J, Thomas M. A Harvesters Handbook on the Sustainable Wild lary fragility, reducing vessel proliferation through an anti-angio­ Collection of Medicinal Plants in Kosovo. USAD Agribusiness Devel­ genetic mechanism related to the high content of delphinidin. opment Sector - Circular 007. August 2003. Available at: http://ww. This appears to be a unique property of bilberry compared to gowildconsulting.com/ pdfs/harvesters_handbook. pdf . A, Steidle M. Overview of Word j most other anthocyanoside-containing, fruit-derived extracts. In 7. Censkowsky U, Helberg U, Nowack Production and Marketing of Organic Wild Collected Products. Geneva, diabetic patients bilberry extract improves cicatrisation (healing Switzerland: International Trade Centre UNCTAD / WTO. 2007. '. of a wound by producing scar tissue) of leg ulcers, combining a Available at: http://ww.intracen.otg/Organics/documents/World_ proteases inhibitory effect with anti-edema (anti-inflammatory) Production_and_Marketing.oL Organic_ Wild_Collected_Products. properties. pd£ A recent uncontrolled trial found that a standardized bilberry 8. Grieve M. A Modern Herbal. Vol 2. New York: Dover Books; 1971. .' extract (Myrtoselect", Indena, Milan, Italy) combined with 9. Foster S. Bilberry Vaccinium myrtillus. The Steven Foster Web site. f a patented French maritime pine bark extract (Pycnogenol", Available at: http://ww.stevenfoster.com/education/ monograph/ ; Horphag Research, Geneva, Switzerland) called Mirtogenol" was bilberry.html. Accessed November 24,2008. able to lower ocular pressure in non-glaucoma patients with ocular 10. Morazzoni P, E Bombardelli. Vaccinium myrtillus L. Fitoterapia. 1996;67(1):329. hypertension.1S Additional clinical trials have documented the 11. Braun R, Surmann P, Wendt R, Wicht! M, Ziegenmeyer J (eds.). benefits of bilberry extracts in treating venous insuffciency.13 The Heidelbeeren. In: Standardzulasungen fUr Fertigarzneimittel Text und concentrated txtract also has been evaluated for its possible effects Kommentar, 12. Ergänzungslieferung. Stuttgart, Germany: Deutscher in treating inflamed oral and pharyngeal membranes12 as well as Apotheker Verlag; 1996. on painful menstruation.19 12. Blumenthal M, Busse WR, Goldbetg A, Gruenwald J, Hall T, Riggins CW; Rister RS, eds. Klein S, Rister RS, trans. The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines. FUTRE OUTLOOK Austin, TX: America Botanica Council; Boston: Integrative Medi- ,l Bilberry is currently commercially harvested in several countries cine Commnq.ication; 1998. including the Russian Federation, Bulgaria, Romania, Sweden, 13. Blumenthal M, Hall T, Goldbetg A, Kunz T, Dinda K, Brinckrann Poland, Ukraine, Finland, Bosnia and Herzegovina, Croatia, J, Wollschlaeger B. The ABC Clinical Guide to Herbs. Austin, TX: American Botanical Council; 2003. Serbia and Montenegro, and Kosovo, among other eastern Euro­ 14. Health Canada Natutal Health Products Directorate (NHPD). -; pean countries.20 Most bilberry (fruit and leaf) is still collected Bilberry. In: NHPD Compendium of Monographs. Ottawa, Ontario: via wild harvest, much of it under organic wild certification (J. Natural Health Products Directorate. Januar 17, 2008. Available at: Brinckmann, e-mail to M. Blumenthal, November 21, 2008). http://ww.hc-sc.gc.caldhp-mps/ alcformats/hpfb-dgpsalpdf/ pro dna­ o. Some attempts are being made to commercially cultivate the crop rur / mono _bilberry- myrtile-eng. pdf in the Northwestern United States; however, most have been 15. European Pharmacopoeial Commission. European Pharmacopoeia, 6th unsuccessful thus far.21 Large-scale efforts to grow bilberry are edition, 5th supplement. Strasbourg, France: European Directorate for the Quality of Medicines (EDQM). 2008. considered risky and are not recommended; small-scale agricul­ 16. United States Pharmacopeial Convention. Powdered Bilberry Extract. tural trials are appropriate depending on the site.21 In: USP 32-NF 27. Rockvile, MD: United States Pharmacopeial Owing to the relatively high commercial value of bilberry Convention. 2008:964. extracts, intentional adulteration has been detected, not only with 17. Canter PH, Ernst E. Anthocyanosides of Vaccinium myrtillus anthocyanosides obtained from other plant sources, but even with (bilberry) for night vision-a systematic review of placebo-controlled synthetic dyes, e.g., amaranth dye, a synthetic dye used in foods trials. Surv Ophthalmol. 2004;49:38-50. (not related to what is often called "grain amaranth" (Amaranthus 18. Steigerwalt RD, Gianni B, Paolo M, et al. Effects of Mirtogenol" spp., AmaranthaceaeJ, the increasingly popular food cultivated and on ocular blood flow and inttaocular hypertension in asymptomatic subjects. Molecular Vision. 2008; 14:1288-1292. marketed for its relatively high protein content.) Analytical meth­ 19. Colombo D, Vescovini R. Controlled clinica trial of anthocyanosides ods have been developed to determine such adulteration for use by from Vaccinium myrtillus in primar dysmenorrheal. G ¡tal Obstet 22 responsible manufacturers. GinecoL 1985;7:1033-1038. -Gayle Engels 20. Bilberry. Research. Sandpoint R & E Center. University of Idaho College of Agricultural