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Choline: The Issues, the Urgency. Overall Summary: Choline, The Urgency Choline may well represent one of the largest untapped nutritional opportunities.

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Presentation on theme: "Choline: The Issues, the Urgency. Overall Summary: Choline, The Urgency Choline may well represent one of the largest untapped nutritional opportunities."— Presentation transcript:

1 Choline: The Issues, the Urgency

2 Overall Summary: Choline, The Urgency Choline may well represent one of the largest untapped nutritional opportunities of recent times. Rarely, has a nutrient recognized by the Institute of Medicine (IOM) as essential – and with such a widespread deficiency in the U.S. population - gone unaddressed by the nutraceutical and functional food industries. In 1998, The Institute of Medicine - the public health arm of the National Academy of Sciences – documented choline as an essential nutrient needed by humans, and critical for proper fetal and child development. They set a recommended Adequate Intake (AI) level of 425 mg/day for women and 550 mg/day for men. About 90% of the U.S. population is not consuming enough choline. Analysis of USDA’s National Health and Nutrition Examination Survey (NHANES) showed that only 10 percent or fewer had usual intakes at or above the AI; only young children typically consumed the recommended amount. Choline intakes also decrease with age and adults over 71 years of age consumed on average 264 mg/day, which is about half of their requirement. During pregnancy, recommended choline levels increase to 450 mg/day; during lactation the AI rises to 550 mg/day. The Nurses’ Health Study, reported in 2010, found that 95% of pregnant women consumed less than 411 mg of choline/day. In fact, the average consumption was 337 mg/day.

3 Benefits for Every State of Life Pregnancy: Brain/Memory Development Liver Health Heart Health Mental Cognition Sports Performance Supplements are a Good Way to Get Enough Choline Overall Summary: Choline, The Urgency

4 Lack of Recognition There appears to be a paradoxical lack of health professional and media attention to this vital nutrient. The 2010 Dietary Guidelines called out choline as a nutrient that is currently under- consumed and has significant health effects. However, the final recommendations did not include choline. Awareness of choline’s health benefits among the professional community is so low that relatively few choline supplements exist, although it is added to some B-complex vitamin formulas. Only 15% of consumers were aware of choline in Dec Only 2% of consumers were making a strong effort to get more choline. Health professional awareness is also very low—only 1% of doctors recommended choline supplements to their patients in 2013, according to Gallup. Major trackers of supplement sales have not yet begun to monitor cthe sales of choline supplements. Only Nielsen/ SPINS reported on choline sales in 2012, and only in combination with inositol. Sales in combined natural/mass channels reached $428,000, far from the million-dollar threshold.

5 Lack of Recognition – 2 Similarly, choline’s role in pregnant and lactating women has a parallel impact similar to folate - for which a national campaign was launched to include folic acid in food fortification with the objective to prevent neural tube defects. Yet, choline has not received similar attention. The European Food Safety Authority’s Panel on Dietetic Products, Nutrition and Allergies approved a health claim related to supplemental folate intake and the reduced risk of neural tube defects on July 26, 2013, but not choline. The opportunity exists to promote choline for all ages, and particularly for pregnant and lactating women, and women of reproductive age. Only 15% were aware of choline according to Gallup’s Dec survey.

6 Choline: A Missed Market Opportunity

7 Choline Market Potential Choline is currently a missed opportunity and marketers should have choline-containing supplements and fortified foods in the marketplace. They should initiate an extensive public relations effort. Choline quietly became a mass market opportunity in according to the TrendSense™ model, and has continued to accelerate in terms of its marketability ever since. With Medical Counts/research activity at this high level and growing, the marketability should be higher at this point in time. Normally, this pattern is indicative of a market “artificially” held down by other market factors. In this case, it is likely due to relatively low awareness of 15% in Dec Choline/brain is the driving health linkage and is just about to crossover into the Popularization Phase, indicating optimal timing for launch into specialty/health food channels and among condition-specific, e.g., pre-natal, kids, etc. and very health conscious shoppers. Choline and kid’s health is about to cross the Medical Threshold indicating the beginning of a long-term sustainable trend. New choline supplements nearly doubled to 555 in the global marketplace in 2012, up from 292 in 2011; new choline supplement introductions are falling in the U.S., creating an ever bigger opportunity for savvy marketers..

8 Choline Can Be Marketed For… Prenatal support for normal brain development and development of the memory center in utero Supporting prenatal nutrition Brain development in infants Memory development in children Prevent neural tube defects in fetal development Support normal liver health and function Promoting heart health Promoting brain health

9 Medical Threshold Medical/NutritionConsumer Commercialization – Level 1 Popularization Copyright Sloan Trends, Inc NOT TO BE COPIED, PUBLISHED, DIVULGED WITHOUT PRIOR WRITTEN PERMISSION FROM SLOAN TRENDS TrendSense™ Predictive Model: Choline Mass Market Op Since TrendSense™ Predictive Model Medical/NutritionConsumer Choline & Brain is the Top Health Linkage

10 10 The 2010 Dietary Guidelines for Americans Advisory Committee considered choline as “Nutrient of Concern” that is under consumed, but failed to call it out in their final report. Choline: Nutrient of “Concern”

11 Institute of Medicine Priority Nutrients Nutrients Nominated as IOM Priority Nutrients for 2013 are: Arachidonic acid (AA) Choline Chromium Docosahexaenoic acid (DHA) Eicosapentaenoic acid (EPA) Fiber: Viscous and fermentable fibers Magnesium Niacin Potassium Protein Saturated fat Stearic acid Sodium Vitamin B6 Vitamin E Zinc

12 Awareness of Choline 15% in 12/2013; 1% Strong Effort To Get More Choline Multi-sponsor Survey’s 2-13 Gallup Study of Nutrient Knowledge & consumption

13 Sales of Choline Supplements Choline is so new that major trackers of supplement sales e.g., Nutrition Business Journal, Nielsen, SymphonyIRI have not yet started tracking sales of choline supplements. Nielsen/SPINS: Choline in combination with inositol $428,000; NOT $1 million

14 Choline Can Play a Key Role in the Following Condition Specific Supplement Markets Nutrition Business Journal Data Sheets 2013; includes multi-level marketing, practitioner channels, etc.; Children’s Supplement Sales: Combined Channel (Natural + Conventional AOC Channel 52 we 3/16/1352 we 3/17/12$ % Chg CALCIUM & CALCIUM FORMULAS $1,568$ % CHILDREN'S VITAMINS & MINERALS $247,874,182$245,318,8701.0% FIBER PRODUCTS & LAXATIVES $4,738,970$7,435, % MULTI-VITAMINS $6,384$5, % OTHER MISCELLANEOUS SUPPLEMENTS $1,850,478$1,316, % POWDERED MEAL REPLACEMENTS & SUPPLEMENTS $74,537$74,2650.4% PREBIOTICS & PROBIOTICS $21,409,084$15,138, % READY TO DRINK MEAL REPLACEMENTS $259,151,852$237,858,5619.0% VITAMINS A & D & K $539,507$738, % Nielen/SPINS Year Ended 3/16/13 Children’s U.S. Supplement Sales $555.2M Combined Channels 2013/2012 Condition Specific Supplements ($ million) >2011 Growth % 2013 E If available 2013>2012 Growth (e) General Health $4,407$4,555$4,6793.4%-__ Heart health $2,000$2,133$2,2946.6%$2,4245.7% Brain Mental $540$580$6267.3%$6605.4% Liver & Detox $45$88$ %--

15 Product Development Finds It Too Difficult to Work With

16 Choline: Inadequate Intake, 90% Deficiency

17 Overall Summary: Choline Dietary Intake: 90% Deficiency in the U.S. About 90% of the U.S. population is not consuming enough choline. Data from the NHANES Evaluation showed that only 10% or fewer had usual intakes at or above the AI; only young children typically consumed the AI. Choline intake also decreased with age, with those over age 71 years, averaging 264 mg/day, or about half of their requirement. Choline deficiency is associated with non-alcoholic fatty liver in adults. Dietary intakes in pregnant women ranged from less than 300 mg to over 550 mg/day. Intakes at the lower end of this spectrum increase the risk of neural tube defects and potentially compromised memory and cognitive development in newborns and functions later in life. Liver, eggs, egg yolks and a variety of meats are the richest sources of choline, but their consumption has decreased in recent years.

18 Actual Choline Intake vs. Requirements Institute of Medicine, Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B 6, Folate, Vitamin B 12. Pantothenic Acid, Biotin, and Choline. Jan USDA

19 Foods Rich in Choline (mg/100g) USDA Database for Choline in Common Foods, Release Two, USDA-ARS, Jan 2008.

20 Choline Requirements by Age (mg/day) Infants 0-6 months: 125mg/day 7-12 months: 150mg/day Boys 9-13 Years: 375 mg/day Years: 550 mg/day Girls 9-13 Years: 375 mg/day Years: 400 mg/day Infants 0-6 months: 125mg/day 7-12 months: 150mg/day Boys 9-13 Years: 375 mg/day Years: 550 mg/day Girls 9-13 Years: 375 mg/day Years: 400 mg/day Years: 450 mg/day Years: 450mg/day Years: 450 mg/day Years: 450 mg/day Years: 450mg/day Years: 450 mg/day Years: 550 mg/day Years: 550mg/day Years 550 mg/day Years: 550 mg/day Years: 550mg/day Years 550 mg/day Men Years: 550 mg/day Years: 550 mg/day Years: 550 mg/day >70 Years: 550 mg/day Women Years: 425 mg/day Years: 425 mg/day Years: 425 mg/day >70 Years: 425 mg/day Men Years: 550 mg/day Years: 550 mg/day Years: 550 mg/day >70 Years: 550 mg/day Women Years: 425 mg/day Years: 425 mg/day Years: 425 mg/day >70 Years: 425 mg/day Infants/Children Pregnancy Lactation Men/Woman USDA Database for Choline in Common Foods, Release. USDA Database for Choline in Common Foods, Release Two, USDA-ARS, Jan 2008.

21 Choline & Fortified Foods Nine in 10 (88%) consumers regularly eat fortified foods and beverages. Milk, bread, cold cereal and pasta are among the most regularly consumed fortified foods (Gallup, 2012). Seven in 10 moms are making a strong/some effort to buy fortified foods for their children (MSI, 2012). U.S. retail sales of kid-specific foods/beverages reached $23B in 2013 and are projected to reach $30B by 2018 (Packaged Facts, 2012). Four in 10 (41%) of America’s 32 million moms say they always buy healthy foods/drinks for their kids - 88% at least sometimes (Packaged Facts, 2014). Improving heart health and having more energy are the two most important conditions affecting food shoppers’ food choices, for 72% and 68% respectively in 2014 (FMI, 2014). Six in 10 (58%) of adults use sports nutrition products (MSI, 2012b). Sales of sport and energy drinks reached $17.1 billion in 2013, meal replacements $3.3 billion and nutrition bars $3.6 billion (NBJ, 2014).

22 Choline & Supplements With awareness of choline’s health benefits very low in the professional community, it’s not surprising that there is a relatively limited presence of dietary supplements in the market today; but the potential is enormous. The U.S. multivitamin market is projected to approach $6 billion in 2014 (NBJ, 2014). Half (52%) of consumers took a multivitamin in 2013; 70% of users took a supplement simply to boost their general health (CRN, 2013; Mintel, 2013). In 2013, consumers spent $2.4billion on heart and $660 million on brain health supplements (NBJ, 2014b). Just under half (45%) of supplement users took a supplement to keep their heart healthy in 2013; 28% to boost their brain function/memory (Mintel, 2013). With sales of sports nutrition supplements reaching $4.5 billion in 2013, up 13%, it remains among the fastest growing supplement sectors AHSA, 2014). Half (46%) of children < age 4 take a supplement; 70% age 4-6 (Multi-Sponsor’s Survey’s 2011 Gallup Study of Children’s Supplement Use). In 2012, 3.8M women in the U.S. used prenatal supplements. Four of the top 10 best- selling women’s supplements were prenatal (Pkg. Facts’ Supplements/IRI, 2012). While liver is still a relatively small supplement category, sales of liver/detox supplements topped $111M in 2012, up 95.7% vs Rx medications, especially statins are also raising concern for liver health. New choline supplements nearly doubled to 555 in the global marketplace in 2012, up from 292 in 2011.

23 Cognitive Function

24 Choline: Memory & Cognition Choline is linked to fetal and infant brain development and enhanced memory and cognition in adults. It is a precursor to the neurotransmitter, acetylcholine. Choline also functions as part of phosphatidylcholine, a structural component of all cell membranes. Choline is important to the integrity of the communication systems for cells within the brain and rest of the body. Before birth, choline is needed to help form the membranes of the nervous system. Insufficient choline in the fetal brain affects the development of the areas of the brain that regulate memory. Choline may also support the brain during aging and help prevent changes in brain chemistry that result in cognitive decline and failure. Maintaining mental sharpness as we age is the #1 consumer health concern U.S. and in the top 10 concerns across all ages globally. Mental/intellectual development ranks #6 among mom’s top health concerns for their children. Lack of mental sharpness and Alzheimers is among their fastest growing health concerns. Consumers are most interested in improved memory among mental health performance benefits. Mental/healthy aging is a mega mass market opportunity; aging /mental /memory is a strong level 2 mass market, on a par with vitamin D and omega-3s. Alzheimer’s is not yet a viable supplement market. Ulrey et al, 2005; Kang, 1996; Gilette-Guyonnet et al, 2007, Berry and Lockwood, 2004.

25 Memory & Cognitive Supplement Opportunity 66% of consumers believe that supplements are effective at preventing or delaying the onset of normal age related memory loss, 14% extremely effective, 52% somewhat effective. 60% of consumers believe that supplements are effective at preventing or delaying the onset of Alzheimer’s disease; 13% believe they are extremely effective, and 47% somewhat effective. In 2013, consumers spent $660 million on brain health supplements; 28% took a supplement to boost their brain function/memory. 4 in 10 moms are looking to supplements to boost cognitive development/brain health for their children, moms with children aged 205 are the most active.

26 Top 10 U.S. Health Concerns U.S. Adults Very/Extremely Concerned About: 1.Continue with Normal Activities as I Age 2.Retaining Mental Sharpness as I Age 3.Bone Health/Strength 4.Eye Health 5.Tiredness/Lack of Energy 6.Stress 7.Cancer 8.Coronary Heart Disease 9.Lack of Mental Sharpness 10. Muscle (Tied) 10. Reduced Physical Activity Due to Age (Tied) HealthFocus, Global & U.S. Consumer Health Survey, 2012 U.S. Kids Health Concerns: Moms Strong Bones/Teeth Protection against disease later in life Growth/Development Health appearance Dental cavities Mental/Intellectual Development Resistance disease Eye sight Lack concentration at school Reduced physical activity with aging

27 Retaining Mental Sharpness as they Age Important Concern Across All Age Groups Globally HealthFocus International, 2012 Global Consumer Health & Nutrition Survey Top 10 Health Concerns - Extremely/Very Concerned about in 2012 in North America, South America, Europe, Asia Pacific, Australia, China, & India Top Health Concerns by Age

28 Mental Sharpness Among Fastest Growing Health Concerns HealthFocus, 2010; Hartman Group, Reimagining Health & Nutrition % Households member treating MillennialsGen X Baby Boomers Memory/mind health 26%33%36%

29 Interest in Mental Performance Benefits DSM Global Consumer Survey,

30 TrendSense™: Mental Healthy Aging & Memory, Not Supplements for Alzheimer’s Consumer Medical Threshold Medical/Nutrition Commercialization – Level 2 Commercialization – Level 1 Popularization The 2012 Gallup Study of Nutrient Knowledge & Consumption; Sloan Trends, Inc % Consumers Think Supplements are Very Effective for Age-related Memory Loss, 52% Somewhat Effective

31 TrendSense™: Mental & Healthy Aging Consumer Medical Threshold Medical/Nutrition Sloan Trends Inc Commercialization – Mega Market Commercialization – Level 3 TrendSense™ Predictive Model: Mental and Healthy Aging is an Excellent High Potential Mega Mass Market Opportunity

32 Brain/Mental Supplement Sales On the Rise Nutrition Business Journal Data charts, % in 2013

33 The 2012 Gallup Study of Nutrient Knowledge & Consumption Multi-sponsor Surveys, Inc. 33 2/3rds Believe Supplements Can Help Delay or Prevent Normal Age-Related Memory Loss 60% Alzheimer’s 5.4M Americans 65+ Have Alzheimer’s, 2/3rds are Women

34 28% of Consumers Used Foods to Prevent Memory/Mind Issues in 2013; 18% to Treat The Hartman Group, Re-imagining health & Nutrition, 2013

35 Boost Cognitive Development/Brain #1 Reason Moms Give Supplement to Kids Benefits Looking ForTotal %Age 2-5Age 6-9Age Age Overall health and well-being Boost immune system To fill nutritional gaps in diet Boost cognitive development/brain Top 4: Benefits Looking for from Supplements Given to Child The 2011 Gallup Study of Children’s Supplement Use

36 Pregnancy/Lactation Supplementation

37 Choline: Critical During Pregnancy & Lactation In 1998, The Institute of Medicine - the public health arm of the National Academy of Sciences - acknowledged the important role of choline in pregnancy and lactation. They set an Adequate Intake (AI) level that was higher for pregnant and lactating women than women in general. In recognizing choline as an essential nutrient for humans, and critical for fetal and proper child development, The Institutes of Medicine recommended an AI of 425 mg per day for women. During pregnancy, AI levels increase to 450 mg per day, and during lactation the AI rises to 550 mg per day. There were 2.9 million babies born in the U.S. in 2012, the latest statistics available. Pregnant women are not consuming adequate amounts of choline. The issue is compounded because many multi-vitamins and prenatal supplements do not contain choline. The Nurses’ Health Study, reported in 2010, found that 95% of pregnant women consumed less that 411 mg of choline per day, below the recommended 450 mg. In fact, the average consumption was 337 mg per day. Choline plays a critical role in brain development in the fetus and in infants, especially in the development of the hippocampus and basal forebrain - the parts of the brain known to regulate memory. Choline also acts like folate in preventing neural tube defects (NTD) in fetal development. Folate, choline, and betaine are all important in the prevention of neural tube birth defects such as anencephaly or spina bifida. These defects occur early in pregnancy, between the 21st and 27th days after conception, when many women do not realize that they are pregnant (Pitkin, 2007). Although choline acts similar to folic acid (folate), the vitamin for which the U.S. launched a fortification program to prevent neural tube birth defects, choline was not included in the plan. Only recently has the FDA permitted choline to be added to the nutrition facts label.

38 Consuming the recommended amount of choline is also essential for lactating women. Human milk is rich in choline, so the need for choline is greatest in lactating women. The Adequate Intake level for them increases to 550 mg per day. Consumption of choline-rich foods has decreased in recent years, due to changes in American eating patterns. That’s why taking supplemental choline, including pre-natal vitamins that contain choline, benefits women who are pregnant or lactating. Choline is now mandated by the FDA in infant formula. As the benefits of choline become more evident, many infant formula manufacturers have increased the choline content of their products to achieve a similar concentration to that of breast milk. Many multi-vitamins supplements, including pre-natal vitamins, do not contain choline. Check to make sure yours do, so that you are assured of consuming adequate amounts of choline. Choline: Critical During Pregnancy & Lactation

39 3.95 Million Babies Born In the U.S The provisional count of births in the U.S. for the 12-month period ending was 3,952,841 up slightly vs 3,942,000 in The number of births has steadily declined from the historic high of 4,316,233 in 2007, but the rate of decline has slowed from 2010 through June Births: Final Data for 2012, Joyce A. Martin, et. Al., National Vital Statistics Report, Dec. 30, ADC/NCHS, 20122

40 3.8M in U.S. Use Prenatal Supplements 4 of the Top 6 Women’s Supplements = Prenatal

41 Choline & Liver Health

42 Liver Health United Kingdom Three first-time ever major government funded reports were released on liver health in Canada, the UK and the European Union in All of these reports were intended to draw attention to the growing crisis in liver health. Data support exponential growth in a wide variety of liver issues in these countries, ranging from non-alcoholic fatty liver disease to cirrhosis.

43 Choline & Liver Health There is strong evidence that adequate choline supports normal liver functions and helps to prevent nonalcoholic fatty liver disease (NAFLD) and fatty liver either as a result of choline deficiency or alcohol consumption. NAFLD is defined as a build-up of extra fat in liver cells that is not caused by alcohol. Although the liver normally contains some fat, if more than 5% to 10% of the organ’s weight is fat, then it is called a fatty liver (steatosis). NAFLD may cause the liver to swell - steatohepatitis - and over time a swollen liver may cause scarring (cirrhosis) and may lead to liver cancer or liver failure. NAFLD may affect up to 25% of the U.S. population, including 6 million children, and the incidence is on the rise. Those who are more likely to develop NAFLD include the overweight or obese, as well as those with diabetes, high cholesterol or high blood triglyceride levers, according to the Am. Diabetes Association. In addition, the incidence of NAFLD increases with age. Men are more likely to develop NAFLD than women. Mexican- America men have the highest incidence of any U.S. ethnic group. It is not surprising that the incidence of NAFLD has more than doubled in the past 20 years. In the U.S., 154 million adults are overweight ; 78.4 million are obese. Each year, 1.7 million new cases of diabetes are diagnosed, and according to 2014 Am. Heart Assn. statistics, 99 million Americans have cholesterol levels > 200 mg/dL.

44 Choline & Liver Health - 2 NAFLD affects half of obese males and 11% of children. In the U.S., 23.9 million children ages two to 19 are overweight, and 12.7 million are obese. If current trends continue for another 20 years, the prevalence of NAFLD is expected to increase by 50%. While many of the top market research/scanner sales firms are not yet tracking sales of liver dietary supplements, there is sound evidence that it is a fast-emerging market. In 2012, sales of liver/detox supplements reached $111 million, up 96% over the previous year and 26% over the year before that sales of liver/detox supplements topped $111 million in 2012, up 95.7% vs (2013 data not available yet). NAFLD affects one-third of U.S. adults; one-half of obese men; and 11% of adolescents. One in 10 have liver disease. Obesity, Rx medications, especially statins, and very high incidence of cirrhosis of the liver, especially in Europe, will continue to draw attention to liver health. Canada, the EU and the UK published government warning reports on liver health in Alcohol consumption in the U.S. is at an all-time high.

45 Many as 25% May Have NAFLD NHANES: hepatic steatosis 21.4%; NAFLD 19.0% in 1994 Incidence NAFLD more than doubled past 20 years Affects 11% of adolescents, half of obese males If current trends continue for another 20 years, prevalence expected to increase by 50% The American Liver Foundation/CDC, 2012 Causes of Death in the U.S. 1.Heart disease 2.Cancer 3.Stroke 4.Chronic lung disease 5.Accidents 6.Alzheimer’s 7.Diabetes 8.Influenza/Pneumonia 9.Kidney disease 10.Blood Poisoning 11.Suicide 12.Liver Disease/Cirrhosis Liver Disease #4 Cause of Death Age 45-54

46 Liver Problems Underestimated for Long Time Due to Screening Techniques Prior to the 3 rd NHANES Survey, Previous estimates of the prevalence of NAFLD in the U.S. population relied on measures of liver enzymes, potentially underestimating the burden of this disease. CDC/NIH now defines NAFLD as the presence of hepatic steatosis on ultrasonograph in the absence of elevated alcohol consumption. Liver has > 500 Critical Functions Largest Organ in the Body → Fights infections/disease Detoxifies inc. drugs, poisons Filters and cleans blood Control amount of cholesterol Produces/maintains hormone balance Produces enzymes/proteins responsible for blood clotting and repairing tissue Produces bile to help break down food in gut Store energy that can be used rapidly when needed Store sugars, vitamins, minerals including iron Repairs damage and renews itself The American Liver Foundation/CDC, 2012

47 NAFLD Increases with Age, Men > Women, Mexican Am. Men Highest Incidence Race NAFLD Mexican Am. 24.1% Whiles 17.8% Blacks 13.5% Men: 20.2% < Age 30 – 8.3% 30 – 40; 15.9% 40 – 50; 22.2% 50 – 60; 28.0% > 60; 28.1% Women: 15.8% < Age 30 – 9.5% 30 – 40; 11.1% 40 – 50; 15.0% 50 – 60; 20.5% > 60; 25.7% Weight Status: Underweight – 10.1% Normal weight – 6.7% Overweight – 20.0% Obese – 38.8% Obese class 2 – 57% Heart disease Cancer Accidents Stroke Diabetes Suicide Pulmonary Disease Liver Disease Top Causes of Death U.S. Hispanics CDC/NHS – NHANES 3, 2012

48 Risk Factors FOR NAFLD More likely to develop a fatty liver if: Overweight, obese Have diabetes Huge weight circumference High cholesterol High blood pressure Diagnosed with insulin resistance Diagnosed with Metabolic Syndrome Millions (20+) % Pop HBP77.934% Pre-hyper67.030% Cholest > % Cholest > % LDL>130 mg/dL71.033% HDL< % Triglycerides27.212% Overweight % Obese78.434% Diabetes (Diag) 19.79% Pre-diabetes87.326% Met Syndrome % The American Liver Foundation/CDC, 2012; Am. Heart Assn. Statistics, 2014

49 Choline & Heart Health

50 Choline is a little-known but essential nutrient that helps ensure heart health in unique ways. Choline supports heart health in a variety of ways. It lowers the levels of homocysteine, which causes oxidative stress and damage to LDL cholesterol, leading to plaque formation. Choline also works to support a strong heart muscle with regular contractions. This, in turn, leads to a controlled and lower heart rate with less stress to the heart over time. Heart disease ranks 8 th among the health concerns that consumers are very/extremely concerned about. Heart disease ranks in the top 10 health concerns for all ages in around the globe. Preventing diseases later in life, e.g., heart disease, diabetes, is now mom’s #2 health concern for their children million – or 37% of the U.S. adult population has have coronary vascular disease. Heart disease is the #1 cause of death in the U.S. Incidence of Stroke on the Rise: A New Health Heart Button Stroke is the #4 killer of all Americans, and the top preventable cause of disability. Often considered a disease of old age, stroke is declining in the elderly and increasing at younger ages. The Am. Heart Assn. has created the Am. Stroke Assn., focused on reducing the incidence/risks of stroke. Choline protects against stroke by helping to protect against the formation of plaque in arteries and other tissues. Every 40 seconds someone in the U.S. Has a stroke; every 4 minutes someone dies.

51 Choline & Heart Health Atherosclerosis/Plaque Buildup Moving into the Spotlight The slow plaque buildup in arteries is a progressive disease called atherosclerosis, which often starts in early adulthood. With atherosclerosis, the wall of the artery becomes thicker and harder and the free flow of blood is restricted. Atherosclerosis is the underlying cause of the majority of clinical cardiovascular events, e.g., heart attacks and strokes. Plaque is made up of fatty deposits and other cells that can build up in the walls of the arteries over time. Choline helps prevent plaque buildup. With the heart market shifting from one of prevention to risk factor reduction, expect blood plaque reduction to become a significant health objective. One in five Boomers now recognize that atherosclerosis is an important health concern. One-third (32%) of women - 53% of men – have undesirable levels of blood plaque. The opportunity for supplements that help to reduce the risk of blood plaque formation is a very big idea In 2013, consumers spent $2.4 billion on heart health supplements, up 5.7% over Just under half (45%) of supplement users took a supplement to keep their heart healthy in Heart is the health condition that has the greatest impact on food purchases, cited by 72% of food shoppers in 2014.

52 Top 10 U.S. Health Concerns U.S. Adults Very/Extremely Concerned: 1.Continue with Normal Activities as I Age 2.Retaining Mental Sharpness as I Age 3.Bone Health/Strength 4.Eye Health 5.Tiredness/Lack of Energy 6.Stress 7.Cancer 8.Coronary Heart Disease 9.Lack of Mental Sharpness 10. Muscle (Tied) 10. Reduced Physical Activity as we Age Am. Heart Assn. Statistics, 2014; HealthFocus, U.S. Consumer Health Survey, 2012; Mintel, Heart Disease - U.S., 2014 Incidence of Heart Related Health Issues in U.S. Population 31% Say Heart Disease “Runs in My Family” 44% Have Both High Cholesterol & High Blood Pressure

53 New Focus heart Health Heart Attack, Stroke, Circulation, Atherosclerosis Sloan Trends, Inc. 2012; Am. Heart Assn, Heart & Stroke Statistics, 2013 Annual rate 1 st intra-cerebral hemorrhage Annual rate of first heart attack Medical Threshold Commercialization – Level 1 Commercialization – Level 2 Commercialization – Level 3 Commercialization – Mega Phase Consumer Medical/Nutrition TrendSense™:

54 Stroke: Healthy Circulation, Blood Plaque Am. Heart Assn. 2014; Packaged Facts, Healthy Americans 50+, 2011; Mintel, Heart - U.S An American has a stroke every 40 seconds; every 4 minutes someone dies due to stroke, stroke 4 th leading cause of death U.S. Incidence of stroke increasing in those < age 65: incidence rate is down for those over age M U.S. adults have had a stroke, 13M silent stroke, and 5M TIAs (transient ischemic attack); Blacks, Mexican-Am., and Hispanics have the highest risk. If a parent had a stroke at less than age 65, then their children have a 4X greater risk of stroke. Estrogen use increases risk. Ref. # “I have not had one but am concerned about having one” – 30% stroke, 32% heart attack - US

55 TrendSense™ Predictive Model: Blood Plaque/Heart Mass Market Op Since 2005 Medical Threshold Commercialization – Level 1 Sloan Trends, Virginia Dare Boomer Health Survey, SPINS/Nielsen, Consumer Medical/Nutrition Popularization 32% Women & 53% Men Undesirable Blood Plaque Levels Boomers: Please indicate which health concerns listed are of personal preventative or curative concern to you Answer OptionsVery ImportantImportant Somewhat Important Atherosclerosis13.9%21.9%28.3%

56 Heart Health U.S. Supplement Sales $2.2B, +6.6% in 2012 → $2.42 In 2013 Nutrition Business Journal Data Sheets, 2013 Heart Supplements +5.7% in 2013

57 1. SymphonyIRI, OTC Medication Report, 10/2010 Potential Heart Dietary Supplements High Ref #1

58 Heart #1 Condition Influences Food/ Drink Selection, Cited by 72% in 2014 Food Marketing Institute, Shopping for Health 2014; Shopping for Health, 2012

59 The 2012 Gallup Study of the U.S. Market For Vitamins & Other Dietary Supplements Packaged Facts, Targeted Health and Wellness Foods and Beverages, Consumers Look to Supplements & Foods Help with Heart Health % Very Frequently/Occasionally Bought Condition Specific Foods Cholesterol lowering Weight loss/control HBP/hypertension Digestive Health Heart/Circulatory Bone/joint 33% 28% 23% 20% 17% 13% 8 in 10 Feel Supplements/Fx Foods Effective Blood Pressure = to Heart Health

60 Choline & Sports Performance

61 Choline & Enhanced Sports Performance Choline can enhance muscle performance during exercise and improve stamina through its activity at a cellular level. Choline supports communication with muscle fibers and promotes muscle recovery following repetitive motion, resulting in better overall training output. Choline promotes and regulates proper metabolism for increased energy and endurance. Choline controls the deposition of fat, allowing the body to store it efficiently or tap it immediately as an energy source for muscle use. Choline supports messaging between the brain and muscle fibers for more efficient and precise movements, and improved coordination. Choline aids in maintaining the nervous system, and delays the onset of central fatigue during strenuous activity. Choline also serves to protect the body’s natural pool of nitric oxide. Nitric oxide expands arterial walls, increasing oxygen-rich blood flow to exercising muscles. However, nitric oxide is a molecule that lasts for only a second in the bloodstream and then has to be replaced. Choline supports optimal nitric oxide functions in the body, which is good for all athletes, especially body builders. When athletes are deficient in choline – and the sources of choline are exhausted in the body – the body will take choline away from other key systems and organs.

62 Sports Nutrition Category Splits: Hard Core Athletes & Mainstream Consumers The new users of sports nutrition products include those involved in recreational sports, gym workouts, weekend warriors, women with aggressive fitness and weight goals, baby boomers looking to age well, and mothers looking for enhanced nutritional support for their children. The sports nutrition/weight loss market reached sales of $30.7 billion in The sports nutrition supplement category which includes powders, pills and hardcore body-building ready-to-drink beverages topped $4.5B in 2013, +12% and is projected to reach $4.9B in The nutritional and performance drink market grew by 48% in the 5-year span between 2008 – The sports drink sector grew 30%, nutritional drinks 38%, and the protein drink market grew 333%. The nutrition and energy bar business grew 71% between (Mintel, 2014). Euromonitor projects sports nutrition is poised to outgrow all other major consumer health categories through Big players, e.g. Post Cereals & Hormel enter sector. The category of sports and fitness performance indexes higher as a health concern than most major condition-specific categories, including digestive health, joint/bone health, and immunity. Muscle strength is an important consideration for the New Actives, young and older. The latter also to prevent sarcopenia.

63 Serious numbers of adults - dubbed the “New Actives” in the sports world - are becoming more physically active and have caused the lucrative sports nutrition segment to move mainstream. Six in 10 adults are giving a lot more thought to the amount of physical activity they get, with 55 percent considering themselves moderately active and 11 percent being vigorously active. Nearly all those who describe themselves as active say they are active 3 to 5 days a week. In 2013, 48 percent of adults increased the amount of time or number of days a week that they were active. Today, 96 million people are exercise walkers, 56 million exercise with equipment, 39 million are aerobic exercisers, 36 million work out at a club, and 66 million jog. 50% of adults engage in some sort of strength training. Those aged 50+ are the fastest-growing segment of exercisers. Teen workouts also are increasing. Consumers More Active

64 Sports Nutrition Poised to Outgrow All Other Major Consumer Health Categories → 2018 Consumer Health (Growth Index, Constant, Fixed 2013 Terms) Though it accounts for just 4% of the US$206 billion global consumer health industry, sports nutrition’s impressive growth in the last decade has turned it into a major supplement category. From 2008 to 2013, the global sports supplement category grew by 8% annually (in constant, fixed 2013 terms) to US$8.8B. In 2014, Euromonitor International expects growth of nearly 10%, as both established markets like the U.S. and Australia and rapidly growing middle-income economies, like India and China, continue their impressive recent runs. Sports Nutrition to Lift Industry Growth Euromonitor: Weight, Sports Nutrition & Dietary Supplements, 7/12/14; nutrition.html

65 65 Top 3 Benefits Sought from SNP KEY BENEFITS SOUGHT BarsSatisfy hunger (54%) Energy boost (49%) Weight management (42%) DrinksEnergy boost (48%) Hydration/quench thirst (46%) Weight management (38%) Dietary Supplement Energy boost (49%) Weight management (48%) Build lean muscle (37%) Replace nutrients lost during exercise (37%) $30.7B Sports Nutrition Market; Mainstreams: Post, Hormel Enter Market New Mainstream Sports Sector Recreational Sports, Gym Workout Weekend Warriors Women: Fitness/Weight Boomers Aging Well Moms: Kids’ Nutrition Support Nutrition Busn. J., 5, 2014; 2013 Gallup Study of Sports Nutrition

66 Sports Nutrition & Weight Loss Category $30.6B in 2013 Nutrition Business Journal, March 2014

67 Sports Nutrition Supplements - Powders, Pills & Hardcore Body Building Ready-to- Drink Beverages $4.5B 2013 U.S. Sports Nutrition & Weight Loss Product & Channel Sales Matrix 2013 Nutrition Business Journal, March, 2014

68 $4.4B Sales of Sport Nutrition Weight Supplements, +12% to $4.89B 2014 Nutrition Business Journal Data Charts, 2014

69 Consumers Giving More Attention to Being Active, Exercising, Casual Sports, 6 in 10 Think A Lot about Being Active IFIC Food & Health Survey, 2014

70 66% Adults Physically Active Active 3-5 Days/Week, Duration Physical Activity, 45 Minutes IFIC, Food & Health Survey, 2013

71 Medical Threshold TrendSense™ Predictive Model: Muscle Copyright Sloan Trends, Inc NOT TO BE COPIED, PUBLISHED, DIVULGED WITHOUT PRIOR WRITTEN PERMISSION FROM SLOAN TRENDS Commercialization – Mega Market Medical/NutritionConsumer

72 2012: 1 st Time Building Physical Strength Shows Up as Having an Impact on Food/Bev Purchase: Protein Food Marketing Institute, Shopping for Health,

73 Sports Participation Total Adults in millions Women in millions Age in thousands National Sporting Goods Assn., 2013

74 Performance/Energy Reasons Hispanic Try Eat Healthy, 1 in 5 Men Sports Supplement The 2012 Gallup Study of Hispanic Nutrition & Supplement Use; HealthFocus, 2013 Energy #6 Hispanic Health Concern 51% % Hispanics Use Sports Nutrition Supplements Total Hispanics12 GENDER Male18 Female6 AGE years years years years2 ACCULTURATION SEGMENTATION Most acculturated12 Moderately acculturated14 Least acculturated10 1 in 5 Men Use Sports Nutrition Suppl. 2:1 Gen. Pop. Active

75 Regulatory Status, Issues

76 Regulatory Status 76 Choline is Regarded as GRAS by FDA A choline-containing compound was reviewed by the Select Committee on GRAS Review (SCOGS) that convened between on an Executive Order by President Nixon to conduct a comprehensive safety review of GRAS substances. In 1975, the Committee issued an opinion for choline bitartate. They found no evidence to suggest any reasonable hazard from the compound now or in the future. There has been no suggestion since that choline compounds are not GRAS; choline-containing compounds have been granted GRAS status and are listed in FDA’s GRAS database. Choline bitartrate CFR Choline chloride CFR

77 Regulatory Status 77 Recognized Health Claims for Choline Products: The Balchem Corporation presented a dossier of the following structure- function claims for choline-containing products to the U. S. Food and Drug Administration in 2001: Prenatal use may lead to lifelong improvement of visuospatial memory in children born of the pregnancy Supplementation during infancy and childhood may lead to improved lifelong memory May help memory problems associated with aging May help reduce levels of plasma homocysteine May promote healthy liver function May reduce fatigue and increase vigor during strenuous exercise In April 2011, the European Food Safety Authority (EFSA), through its Panel on Dietetic Products, Nutrition and Allergies, issued a scientific opinion on Balchem’s proposed Article 13 (EC Regulation 1924/2006) general health claims, supporting the benefits of the nutrient choline. The dossiers submitted by Balchem in support of these claims were deemed sufficient for substantiation by EFSA. Contributes to normal lipid metabolism Contributes to the maintenance of normal liver function Contributes to normal homocysteine metabolism

78 Regulatory Status 78 Recognized Nutrient Content Claims for Choline: Nutrient content claims have been allowed since 2001 and are based on a Daily Value of 550 mg: In May, 1997, the National Research Council (NRC) Governing Board of NAS approved a policy statement regarding authoritative statements made by NAS or its subdivisions, the NRC, and the IOM. According to the policy, authoritative statements "are limited to those that represent the consensus of a duly-appointed principal investigator so that they appear explicitly as findings, conclusions, or recommendations in a report that has completed the institutional report review process." As articulated in the policy statement, the Summary in the Chapter titled Choline in Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline published by NAS qualifies as an authoritative statement. Following FDA's previously established procedures, on June 5, 2001, FDA offered NAS the opportunity to comment on the authoritative statement cited in the notification. FDA received no comment from NAS. FDA reviewed the authoritative statement from Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin and Choline in its context. FDA has not acted to prohibit or modify the claim, as amended. Accordingly, after August 29, 2001, manufacturers may use the specified claims on the label and in labeling of any food or dietary supplement product that qualifies for the claims described in the notification. Under the provisions of FDAMA, when the claims are used, they must appear exactly as stated in the notification. One example of a nutrient content claim characterizing the level of choline is "Good source of choline. Contains 55 mg of choline per serving, which is 10% of the Daily Value for choline (550 mg)."

79 Regulatory Enforcement Actions 79 Warning Letters: FDA has issued warning letters to companies marketing choline products for treating diseases conditions. Austin Nutrition Research, May 24, 2005 (CL-05-HFS ) The following statements were observed on the company’s webs ite: Phosphatidyl Choline “[H]elpful in the prevention of arteriosclerosis, heart disease, gallstones …. Medical studies have also shown that PHOSPHATIDYL Choline is beneficial in neurological disorders … and depression.” FDA’ s letter stated: [Products} “are promoted for conditions that cause these products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your web site establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.” The product risked seizure by FDA or FTC as an unapproved drug, if the website information was not removed or corrected to be appropriate structure/function claims.

80 80 These products contained acetyl-l-carnitine and was marketed to support synthesis of acethylcholine. They were marketed with the following claims for Alzheimer’s Disease and cognitive impairment on labels and the company’s website: “Cerelist and Zymenta capsule products are each labeled as a “medical food,” and the claims on your product labeling and websites represent these products as medical foods for the “nutritional management of certain metabolic processes associated with dementias of mild-to- moderate Alzheimer’s disease or mild cognitive impairment.” These products are misbranded under section 403(a)(1) of the Act because their labeling is false and misleading in that the products are labeled and marketed as medical foods but do not meet the statutory definition of a medical food in the Orphan Drug Act, 21 U.S.C. § 360ee(b)(3), or the criteria set forth in 21 CFR 101.9(j)(8)” Regulatory Enforcement Actions Warning Letters: A choline-related Warning Letter was issued to Neuroscience on December 19, 2011 (MIN 12-15) for marketing products as medical foods: “Zymenta and Cerelist products are misbranded under section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1), because their labeling is false or misleading in that they are labeled and marketed as medical foods but do not meet the statutory definition of a medical food in the Orphan Drug Act, 21 U.S.C. § 360ee(b)(3), or the criteria set forth in 21 CFR 101.9(j)(8).”

81 81 Recommended intake for choline is 550 mg for men and 425 mg for women. Toxicity occurs with intake levels at 2000 mg or 3500 mg per day. Symptoms of toxicity include a drop in blood pressure and fishy body odor. IOM NAS Overconsumption Levels


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