NORTH AMERICAN DIETARY SUPPLEMENTS

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1 NORTH AMERICAN DIETARY SUPPLEMENTS Prepared by: CPL Business Consultants The Manor House, Howbery Park, Wallingford, Oxfordshire, OX10 8BA Tel: , Dr Robert Harwood Ms Megha Chugh MSc Dr Esther Hunter Dr Steve Lisansky April 2010

2 North American Dietary Supplements - Contents - i TABLE OF CONTENTS OBJECTIVE AND BACKGROUND... 8 METHOD... 9 PRINCIPAL FINDINGS MARKETS VALUE CHAIN SALES CHANNELS COMPETITION PLAYERS Retail channel Direct-marketing channel Practitioner channel PRODUCTS US Canada Mexico VIEWS OF CONTACTS Cholesterol-Lowering Market Phytosterols Marketing Regulations and claims R&D Views on Product A CASE STUDIES Product A case Product B case REGULATIONS US Canada Mexico NEWS PHARMACEUTICALS CONCLUSIONS MARKETS SALES CHANNELS COMPETITION MARKETING AND PROMOTION PRODUCTS VIEWS OF CONTACTS CASE STUDIES Product A case Product B case REGULATIONS NEWS PHARMACEUTICALS SOME SUMMARY THOUGHTS ON THE MARKET RECOMMENDATIONS KEY SUCCESS FACTORS SWOT FOR CLIENT IN DIETARY SUPPLEMENTS SUMMARY OF SPREADSHEET RESULTS... 47

3 North American Dietary Supplements - Contents - ii MARKETS SEGMENTATION Vitamins Minerals Herbs & Botanicals Specialty Supplements Meal Supplements Sports Nutrition SALES CHANNELS Retail Channels Direct Channels SIZE IN VOLUME AND VALUE Heart Health Supplements THE SUPPLEMENTS VALUE CHAIN SUPPLY CHAIN - THE SUPPLEMENTS INDUSTRY VALUE CHAIN US NUTRITION INDUSTRY SUPPLY CHAIN US NUTRITION INDUSTRY SALES CHANNELS Retail Channels Non-Retail Channels PLAYERS SUMMARY Direct marketing channel Practitioner Sales channel RETAIL SUPPLEMENT COMPANIES companies DIRECT SELLING SUPPLEMENT COMPANIES companies PRACTITIONER CHANNEL SALES IN US companies CHOLESTEROL-LOWERING AGENTS PRESCRIPTION DRUGS Statins (also known as HMG CoA reductase inhibitors) Bile Acid Sequestrants (or also called Resins) Nicotinic Acid Fibrates Ezetimibe SUPPLEMENTS Artichoke leaf extract Fenugreek Fibre Fish oil Garlic Ginseng Guggul Niacin Red yeast rice Soy protein PHYTOSTEROL/STANOL SUPPLIERS PRODUCTS INTRODUCTION US PRODUCTS products CANADIAN PLAYERS & PRODUCTS MEXICO Players

4 North American Dietary Supplements - Contents - iii Sales Channels REGULATIONS IADSA FRAMEWORK US Background Labelling of Supplements Containing Sterols and Stanols CANADA Scope of the Natural Health Products Regulations Main Components of the Natural Health Products Regulations Guidance Documents List of Included Substances List of Excluded Substances Dosage Form and Bulk Herbs Hybrid Products Activities Covered by the Natural Health Products Regulations MEXICO Background Import Permits CONTACT REPORTS OVERVIEW Market size and growth Marketing Regulations and claims Case Study Product A CONTACT REPORTS contacts CASE STUDIES COMPANY X Overview The Product A Story COMPANY Y Innovation, Protection, Communication Product Quality COMPANY Z Marketing Opportunities for application Consumer Awareness Role of Science Implication of Market data NEWS ARTICLES SUMMARY Market Recent Scientific Studies Statins a potential OTC threat Competition Consumer education & awareness New product formulations Brand recognition PRESS ARTICLES articles PATENTS WORLD PATENTS patents US PATENTS patent

5 North American Dietary Supplements - Contents - iv FOCUS ON THE UNDERSTANDING OF CORONARY HEART DISEASE INTRODUCTION HOW CORONARY HEART DISEASE ORIGINATES INCIDENCE OF CHD CAUSES OF CHD DIAGNOSIS OF CHD Signs & Symptoms Diagnostic Techniques TREATMENTS FOR CHD CLINICAL TRIALS FOCUS ON CHOLESTEROL AND CHOLESTEROL-LOWERING DRUGS HYPERCHOLESTEROLEMIA AND CORONARY HEART DISEASE (CHD) Cholesterol Guidelines Cholesterol in the Population High blood pressure Cholesterol Management CLINICAL TRIALS OF CHOLESTEROL-LOWERING DRUGS SUMMARY NEWS ON PHARMACEUTICALS OVERVIEW OF MOST RECENT NEWS NEWS ARTICLES articles EXAMPLES OF RESEARCH & PATENTS items APPENDIX 1 FTC GUIDANCE ON ADVERTISING DIETARY SUPPLEMENTS INTRODUCTION APPLICATION OF FTC LAW TO DIETARY SUPPLEMENT ADVERTISING Identifying Claims and Interpreting Ad Meaning Substantiating Claims Other Issues Relating to Dietary Supplement Advertising CONCLUSION For More Information ENDNOTES

6 North American Dietary Supplements - Contents - v TABLES TABLE 1 GLOBAL NUTRITION INDUSTRY SALES & GROWTH: TABLE 2 SUPPLEMENTS SALES & GROWTH BY REGION: TABLE 3 US CONSUMER SALES OF FOODS AND SUPPLEMENTS IN $M: TABLE 4 VALUE OF THE US CONDITION SPECIFIC SUPPLEMENTS MARKET ($B) TABLE 5 US CONDITION SPECIFIC SUPPLEMENTS MARKET VALUE TABLE 6 US CONSUMER SALES OF SPECIALTY SUPPLEMENTS: TABLE 7 MARKET SHARE OF KEY PRODUCT TYPES IN THE US HEART HEALTH MARKET (RETAIL SALES 2008) TABLE 8 RAW MATERIAL SALES OF US HEALTH INGREDIENTS: TABLE 9 VALUE OF RETAIL, WHOLESALE AND RAW MATERIAL SALES FOR SPECIALTY SUPPLEMENTS IN THE US, TABLE 10 SALES VALUE GROWTH FOR SPECIALTY SUPPLEMENTS IN THE US (CAGR) TABLE 11 US SPECIALTY SUPPLEMENTS VALUE CHAIN % GROWTH YEAR ON YEAR TABLE 12 US SPECIALTY SUPPLEMENTS VALUE CHAIN WHOLESALE AND RAW MATERIAL SALES VALUE AS % OF CONSUMER SALES TABLE 13 PER CENT MARK-UP FOR SPECIALTY SUPPLEMENTS RETAILERS AND WHOLESALERS IN THE US TABLE 14 SUPPLEMENT SALES BY CATEGORY OF STORE IN THE US, TABLE 15 COMPARISON OF % OF TOTAL STORES TO % OF SALES FOR US SUPPLEMENTS RETAIL CHANNELS, TABLE 16 WEEKLY AND PER ANNUM SUPPLEMENT SALES BY STORE TYPE IN THE US, TABLE US NUTRITION AND SUPPLEMENT SALES BY RETAIL CHANNEL TABLE US SUPPLEMENT SALES: RETAIL VERSUS NON-RETAIL TABLE US SUPPLEMENT SALES IN NON-RETAIL CHANNELS TABLE 20 NCEP S RECOMMENDED THERAPY FOR LDL-LOWERING TABLE 21 PRACTITIONER CHANNEL SUPPLEMENT SALES AND YEAR ON YEAR GROWTH TABLE 22 PRACTITIONER CHANNEL SALES IN THE US: TOP 10 COMPANIES IN TABLE 23 TOP 50 US SUPPLEMENT COMPANIES TABLE 24 COMPANY 1 NET SALES (PRELIMINARY & UNAUDITED) TABLE 25 COMPANY 1 PROFIT, PROMOTION AND SG&A AS % OF SALES, TABLE 26 COMPANY 1 NET INCOME STARTEMENT DATA, ($K) TABLE 27 COMPANY 1 GROSS PROFIT DATA BY SEGMENT, ($K) TABLE 28 COMPANY 1 ADVERTISING, PROMOTION AND CATALOG DATA BY SEGMENT, ($K) TABLE 29 COMPANY 1 SELLING, GENERAL AND ADMINISTRATIVE EXPENSES, ($K) TABLE 30 TOP DIRECT-SELLING SUPPLEMENT COMPANIES IN US BY SALES, TABLE 31 COMPANY 2 RANGE OF DIETARY SUPPLEMENTS TABLE 32 COMPANY 3 - CONSOLIDATED STATEMENTS OF OPERATIONS DATA TABLE 33 COMPANY 3 - NET SALES IN DOLLARS AND AS A PERCENTAGE OF CONSOLIDATED NET SALES.. 91 TABLE 34 COMPANY 3 S PRODUCT PORTFOLIO TABLE 35 COMPANY 4 - SUBSIDIARIES TABLE 36 STATEMENT OF OPERATIONS DATA (IN 000): TABLE 37 TOP COMPANIES FOR PRACTITIONER CHANNEL SALES IN US IN TABLE 38 DESIGNS FOR HEALTH - LIST OF STEROL CONTAINING SUPPLEMENTS SOLD TABLE 39 DESIGNS FOR HEALTH SUPPLEMENTS - CARDIO VASCULAR HEALTH TABLE 40 COMPANY 5 - LIST OF STEROL CONTAINING SUPPLEMENTS SOLD TABLE 41 COMPANY 6 - PRODUCTS CONTAINING PLANT STEROLS TABLE 42 COMPANY 7 PRODUCTS AVAILABLE FOR CARDIOVASCULAR SUPPORT TABLE 43 COMPANY 8 PRODUCT CONTAINING STEROL TABLE 44 COMPANY 9 NUMBER OF PRODUCTS SOLD FOR DIFFERENT CARDIOVASCULAR CONDITIONS TABLE 45 COMPANY 9 S SUPPLEMENTS FOR CHOLESTEROL MANAGEMENT TABLE 46 COMPANG 10 S STEROL CONTAINING PRODUCTS TABLE 47 COMPANY 10 S SUPPLEMENTS TARGETED AT CARDIOVASCULAR SUPPORT TABLE 48 POPULAR INGREDIENTS USED IN DIETARY SUPPLEMENTS FOR CHOLESTEROL-LOWERING TABLE 49 COMMERCIAL SUPPLIERS OF PHYTOSTEROLS, STANOLS AND/OR THEIR ESTERS TABLE 50 MAIN HEALTH CLAIMS FOR STEROL / STANOL CONTAINING SUPPLEMENTS TABLE 51 EXAMPLE SUPPLEMENT PRODUCTS CONTAINING STEROLS AND/OR STANOLS TABLE 52 COMPANY 11 S PRODUCT LABEL DETAILS TABLE 53 COMPANY 12 S PRODUCT DETAILS

7 North American Dietary Supplements - Contents - vi TABLE 54 COMPANY 13 PRODUCT TABLE 55 COMPANY 14 PRODUCT TABLE 56 COMPANY 15 PRODUCT TABLE 57 COMPANY 16 S PRODUCT TABLE 58 COMPANY 17 S PRODUCT TABLE 59 COMPANY 17 S PRODUCT TABLE 60 COMPANY 18 S PRODUCT TABLE 61 COMPANY 19 S PRODUCT TABLE 62 COMPANY 19 S PRODUCT TABLE 63 COMPANY 20 S PRODUCT TABLE 64 COMPANY 21 S PRODUCT TABLE 65 COMPANY 21 S PRODUCT TABLE 66 COMPANY 21 S PRODUCT TABLE 67 COMPANY 21 S PRODUCT TABLE 68 COMPANY 22 S PRODUCT TABLE 69 COMPANY 23 S PRODUCT TABLE 70 COMPANY 24 S PRODUCT TABLE 71 COMPANY 25 S PRODUCT TABLE 72 COMPANY 25 S PRODUCT TABLE 73 COMPANY 25 S PRODUCT TABLE 74 COMPANY 26 S PRODUCT TABLE 75 COMPANY 26 S PRODUCT TABLE 76 COMPANY 26 S PRODUCT TABLE 77 COMPANY 27 S PRODUCT TABLE 78 COMPANY 28 S PRODUCT TABLE 79 COMPANY 28 S PRODUCT TABLE 80 COMPANY 29 S PRODUCT TABLE 81 COMPANY 30 S PRODUCT TABLE 82 COMPANY 31 S PRODUCT TABLE 83 COMPANY 32 S PRODUCT TABLE 84 COMPANY 33 S PRODUCT TABLE 85 COMPANY 34 S PRODUCT TABLE 86 COMPANY 34 S PRODUCT TABLE 87 COMPANY 35 S PRODUCT TABLE 88 COMPANY 35 S PRODUCT TABLE 89 COMPANY 36 S PRODUCT TABLE 90 COMPANY 37 S PRODUCT TABLE 91 COMPANY 38 S PRODUCT TABLE 92 COMPANY 39 S PRODUCT TABLE 93 COMPANY 40 S PRODUCT TABLE 94 COMPANY 41 S PRODUCT TABLE 95 COMPANY 42 S PRODUCT TABLE 96 COMPANY 43 S PRODUCT TABLE 97 COMPANY 44 S PRODUCT TABLE 98 LICENSED DIETARY SUPPLEMENT PRODUCTS IN CANADA CONTAINING STEROLS TABLE 99 COMPANY 45 S PRODUCT INGREDIENTS TABLE 100 REQUIREMENTS FOR CANADIAN NATURAL HEALTH PRODUCTS DIRECTORATE LICENCE TABLE 101 IMPORT PERMITS - PRODUCTS AND SERVICES TABLE 102 SALES AND NET REVENUE FOR COMPANY X, ($K) TABLE 103 RISK OF AMI IN OVERALL POPULATION TABLE 104 CAUSES OF CHD TABLE 105 DIAGNOSIS OF CHD TABLE 106 TREATMENTS FOR CHD TABLE 107 US CLINICAL TRIALS DATABASE TABLE 108 US CLINICAL TRIALS DATABASE TABLE 109 HEART OUTCOMES PREVENTION EVALUATION-3 (HOPE-3) TRIAL TABLE 110 RECOMMENDED CHOLESTEROL GUIDELINES TABLE 111 SALES OF ALL DRUGS ON THE US MARKET ($B) TABLE 112 STATIN DRUGS & AVERAGE EFFECTS ON LDL & HDL AT MAXIMUM DAILY DOSE TABLE 113 STATIN BRAND NAMES AND PRODUCTION METHOD

8 North American Dietary Supplements - Contents - vii TABLE 114 PATENT POSITION FOR EACH OF THE STATINS IN THE US FIGURES FIGURE 1 US HEART HEALTH SUPPLEMENT MARKET FIGURE 2 SUPPLY CHAIN FLOWCHART - SUPPLEMENTS INDUSTRY FIGURE 3 US NUTRITION INDUSTRY VALUE CHAIN, FIGURE 4 US NUTRITION INDUSTRY SUPPLY CHAIN, FIGURE 5 RAW MATERIAL SALES OF US HEALTH INGREDIENTS: FIGURE 6 US SPECIALTY SUPPLEMENTS SALES VALUE FIGURE 7 US SPECIALTY SUPPLEMENTS VALUE CHAIN % GROWTH YEAR ON YEAR FIGURE 8 US SPECIALTY SUPPLEMENTS VALUE CHAIN WHOLESALE AND RAW MATERIAL SALES VALUE AS % OF CONSUMER SALES FIGURE 9 PER CENT MARK-UP FOR SPECIALTY SUPPLEMENTS RETAILERS... AND WHOLESALERS FIGURE US NUTRITION AND SUPPLEMENT SALES BY RETAIL CHANNEL FIGURE 11 SUPPLEMENT SALES THROUGH PRACTIONERS IN THE US ($M) FIGURE 12 CORRECT REGULATORY FRAMEWORK FOR DIETARY SUPPLEMENTS FIGURE 13 AGE-ADJUSTED DEATH RATES FOR CHD AS COMPARED TO STROKE, LUNG AND BREAST CANCER FOR FEMALES (US: 2005) FIGURE 14 PERCENTAGE BREAKDOWN OF DEATHS FROM CVDS (US: 2006) FIGURE 15 ESTIMATED DIRECT/INDIRECT COSTS ($BILLION) OF MAJOR CVDS/STROKE (2009) FIGURE 16 ESTIMATED 10-YEAR CVD RISK IN YEAR-OLD ADULTS ACCORDING TO LEVELS OF RISK-FACTORS (FRAMINGHAM HEART STUDY) FIGURE 17 PREVALENCE OF CHD BY AGE/SEX

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