Choline may represent one of the largest untapped nutritional opportunities of recent times. Rarely has such a widespread deficiency of a nutrient—recognized by the Institute of Medicine (IOM) as essential—gone unaddressed by the nutraceutical and functional food industries for so long.  

In 1998, the IOM recognized choline as an essential nutrient needed by humans that is critical for fetal and child development. The adequate intake (AI)/recommended Daily Value (DV) for choline is 550 mg/day for men and 425 mg/day for women.

About 90% of the U.S. population is not consuming enough choline. Data from the 2003-2004 National Health and Nutrition Examination Survey (NHANES) showed that only young children typically reached 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 intake among pregnant women ranged from less than 300 mg to more than 550 mg/day. Intake at the lower end of this spectrum increases the risk of neural tube defects and potentially compromises memory and cognitive function in newborns. Liver, eggs, egg yolks and a variety of meats are the richest sources of choline, but their consumption has decreased in recent years (USDA, 2012). Most foods contain some choline and other good sources include beef, pork, salmon, soybeans, wheat germ and, yes, chocolate cake.

Most important, there appears to be a paradoxical lack of health professional and media attention on this vital nutrient, which is clearly linked to fetal/infant brain development, enhanced memory/cognition, heart health and liver function for all ages.

Choline has been effectively sidelined as a nutrient of key importance for no apparent reason. For example, 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 focus on choline. 

Moreover, 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. Major trackers of supplement sales have not yet begun to monitor choline supplements. Only Nielsen/SPINS reported on choline sales last year in combination with inositol. Sales in combined natural/mass channels reached $428,000, far from the million-dollar threshold.

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 in pregnant women. 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.

Market Potential
Choline quietly became a mass market opportunity in 2009-2010 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 greater.

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. According to Multi-Sponsor Surveys’ 2012 Gallup Study of Nutrient Knowledge & Consumption, 11% of U.S. adults are aware of choline.

Choline is currently a missed opportunity and marketers should have choline-containing supplements/functional foods in the marketplace. They should initiate robust public relations support. 

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 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. 

Growth Opportunities

• General health supplement sales reached $4.6 billion in 2012, +3.4% (Nutrition Business Journal Data Sheets, 2013). 
• 46% of children under age 4 take a supplement; 70% ages 4-6 (Multi-Sponsors Surveys’ 2011 Gallup Study of Children’s Supplement Use). Kids were the largest mass market condition-specific supplement sector in 2012 (Packaged Facts, Nutritional Supplements in the U.S., Sep., 2012).
• Global DHA-fortified infant formula sales reached $10.2 billion in 2011 (Packaged Facts, Global Market for EPA/DHA Omega-3 Products, Jun., 2012).
• 3.8 million women in the U.S. used prenatal supplements in 2012. Four of the top 10 best-selling women’s supplements were prenatal; sales of prenatal supplements jumped 28% for the year ended 6/9/12 (Packaged Facts/IRI, 2012)
• 2012 sales of liver/detox supplements topped $111 million in 2012, up 95.7% vs. 2011 (NBJ, 2013). Non-alcoholic fatty liver disease is estimated to affect one-third of adults, one-half of obese adults and 11% of adolescents. Rx medications, especially statins, are also raising concern for liver health (National Liver Foundation, 2012).
• Heart supplement sales were estimated at $2.3 billion in 2012, +6.6% (NBJ). 37% say heart health is very important in choosing the food/beverages they buy; 38% somewhat (FMI, Shopping for Health, 2012). The heart market is shifting from one of prevention to risk factor reduction. In 2013, 99 million U.S. adults had cholesterol > 200mL/dL; 78 million high blood pressure; and 32% of women and 53% of men had high levels of blood plaque. One in 5 say atherosclerosis is an important health concern; stroke is a fast emerging concern under age 65. (For more on the heart health market see page 42.)
• Maintaining mental sharpness as we age is the #1 consumer concern; lack of mental sharpness is also among the top 10 concerns (HealthFocus, 2012). Mental/aging is a strong Level 2 mass market (Sloan Trends, 2013). Sales of brain/mental supplements reached $626 million in 2012, +7.3% (NBJ).   
• 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. 

Regulations
Currently, no specific health claims are available for choline in the U.S. or Europe. Structure/function claims for normal brain, memory and cognitive development; liver function; and nervous system function are available. Given the strength of the body of scientific literature, this nutrient begs for a champion to enable it to achieve a health claim of significant scientific agreement (SSA) status in the U.S. and EFSA approval in Europe.

Functional Foods & Supplements
The opportunity exists to promote choline for all ages, particularly for pregnant and lactating women, and women of reproductive age. A wide variety of forms will find a welcome market with adequate publicity.    

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Dr. A. Elizabeth Sloan and Dr. Catherine Adams Hutt are president and chief scientific and regulatory officer, respectively, of Sloan Trends, Inc., Escondido, CA, a 20-year-old consulting firm that offers trend interpretation/predictions; identifies emerging high potential opportunities; and provides strategic counsel on issues and regulatory claims guidance for food/beverage, supplement and pharmaceutical marketers. For more information: E-mail: [email protected]; Website: www.sloantrend.com.