Choline: The Issues,
the Urgency
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 2003-2004 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.
Overall Summary:
Choline, The Urgency
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
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 underconsumed 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. 2013. 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.
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. 2013 survey.
Choline: A Missed
Market Opportunity
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 2009-2010 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. 2013.
•
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.
.
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
TrendSense™ Predictive Model: Choline
Mass Market Op Since 2009-10
Medical/Nutrition
9000
Consumer
1600
Medical/Nutrition
8000
Consumer
1400
7000
1200
6000
1000
5000
TrendSense™
Predictive Model
4000
3000
800
Commercialization – Level 1
600
2000
400
1000
Popularization
Medical Threshold
200
0
00
01
02
03
04
05
06
07
08
09
10
11
12
13
0
00
Choline
Choline & Brain
Choline & Pregnancy
Choline & Children
Choline & Cognition
Choline & Heart
01
02
03
04
05
Choline
Choline & Brain
Choline & Pregnancy
06
07
08
09
10
11
12
13
Choline & Children
Choline & Cognition
Choline & Heart
Choline & Brain is the Top Health Linkage
Copyright Sloan Trends, Inc. 2013 NOT TO BE COPIED, PUBLISHED, DIVULGED WITHOUT PRIOR WRITTEN PERMISSION FROM SLOAN TRENDS
Choline: Nutrient of “Concern”
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.
10
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
Awareness of Choline 15% in 12/2013;
1% Strong Effort To Get More Choline
Gender & Age
18.0%
13.1%
17.1%
13.0%
16.0%
12.0%
14.0%
12.0%
Region
14.0%
13.2%
12.8%
11.6%
12.0%
12.1%
11.4%
11.0%
10.0%
10.7%
East
Mid-West South
West
10.0%
7.3%
8.0%
20.0%
6.0%
17.7%
15.0%
4.0%
Income
12.2%
11.0%
8.7%
10.0%
2.0%
5.0%
0.0%
Male Female 18-34
35-49
50-64
65+
0.0%
75K+
Multi-sponsor Survey’s 2-13 Gallup Study of Nutrient Knowledge & consumption
50-74.9K 30-49.9K
Less
than 30K
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 $1 million
Choline Can Play a Key Role in the Following
Condition Specific Supplement Markets
Condition
Specific
Supplements
($ million)
General Health
Heart health
Brain Mental
Liver & Detox
2010
2011
2012
2012 >2011
Growth
%
$4,407
$2,000
$540
$45
$4,555
$2,133
$580
$88
$4,679
$2,294
$626
$111
3.4%
6.6%
7.3%
95.7%
2013 E
If available
2013>2012
Growth (e)
$2,424
$660
-
__
5.7%
5.4%
-
Children’s U.S. Supplement Sales
$555.2M Combined Channels 2013/2012
Children’s Supplement Sales: Combined Channel (Natural + Conventional AOC Channel
CALCIUM & CALCIUM FORMULAS
CHILDREN'S VITAMINS & MINERALS
FIBER PRODUCTS & LAXATIVES
MULTI-VITAMINS
OTHER MISCELLANEOUS SUPPLEMENTS
POWDERED MEAL REPLACEMENTS &
SUPPLEMENTS
PREBIOTICS & PROBIOTICS
READY TO DRINK MEAL REPLACEMENTS
VITAMINS A & D & K
52 we 3/16/13
52 we 3/17/12
$ % Chg
$1,568
$247,874,182
$4,738,970
$6,384
$1,850,478
$440
$245,318,870
$7,435,817
$5,263
$1,316,278
256.4%
1.0%
-36.3%
21.3%
40.6%
$74,537
$74,265
0.4%
$21,409,084
$259,151,852
$539,507
$15,138,218
$237,858,561
$738,852
41.4%
9.0%
-27.0%
Nutrition Business Journal Data Sheets 2013; includes multi-level marketing, practitioner channels, etc.; Nielen/SPINS Year Ended 3/16/13
Product Development Finds It Too
Difficult to Work With
Choline: Inadequate
Intake, 90% Deficiency
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
2007-2008 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.
Actual Choline Intake vs. Requirements
550
550
600
396
337
400
300
450
425
500
550
200
216
337
264
260
200
100
0
Average Intake (mg/day)
Required (mg/day)
Institute of Medicine, Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12. Pantothenic Acid, Biotin, and Choline.
Jan 2008. USDA
Foods Rich in Choline (mg/100g)
USDA Database for Choline in Common Foods, Release Two, USDA-ARS, Jan 2008.
Choline Requirements by Age
(mg/day)
Infants/Children
Pregnancy
Lactation
Infants
•
•
0-6 months:
125mg/day
7-12 months:
150mg/day
Boys
•
•
9-13 Years:
375 mg/day
14-18 Years:
550 mg/day
Men
14-18 Years:
450 mg/day
14-18 Years:
550 mg/day
19-30 Years:
450mg/day
19-30 Years:
550mg/day
31-50 Years:
450 mg/day
31-50 Years
550 mg/day
Girls
•
•
Men/Woman
9-13 Years:
375 mg/day
14-18 Years:
400 mg/day
USDA Database for Choline in Common
Foods,for
Release
USDA-ARS,
Jan
2008.
USDA Database
CholineTwo,
in Common
Foods,
Release.
19-30 Years:
550 mg/day
31-50 Years:
550 mg/day
51-70 Years:
550 mg/day
>70 Years:
550 mg/day
Women
19-30 Years:
425 mg/day
31-50 Years:
425 mg/day
51-70 Years:
425 mg/day
>70 Years:
425 mg/day
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).
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 bestselling 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. 20112. 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.
Cognitive Function
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.
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.
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
Retaining Mental Sharpness as they Age
Important Concern Across All Age Groups
Globally
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
HealthFocus International, 2012 Global Consumer Health & Nutrition Survey
Mental Sharpness Among Fastest Growing
Health Concerns
Benefits of Interest
96%
86%
81%
89%
80%
68%
All
Consumers
18-29 year 65+ shoppers
olds
Provides long-lasting mental energy
Helps retain mental sharpness with aging
HealthFocus, 2010; Hartman Group, Reimagining Health & Nutrition
% Households member
treating
Memory/mind health
Millennials
Gen X
Baby
Boomers
26%
33%
36%
Interest in Mental Performance Benefits
70%
% of global consumers
68%
66%
64%
62%
Men
Women
60%
50+
58%
56%
Improved
alertness and
concentration
DSM Global Consumer Survey, 2011
Improved
memory
Improved
mood
Long-lasting
mental
energy
Reduced
feelings of
stress
TrendSense™: Mental Healthy Aging & Memory,
Not Supplements for Alzheimer’s
12000
Medical/Nutrition
3000
10000
2500
8000
2000
6000
1500
4000
1000
2000
Consumer
Commercialization – Level 2
Commercialization – Level 1
500
Popularization
Medical Threshold
0
'00
'01
'02
'03
'04
'05
'06
'07
'08
'09 '10
'11 '12
13
0
'00
'01
'02
'03
'04
'05
'06
'07
'08
'09 '10
Mental Healthy Aging & Memory
Mental Healthy Aging & Memory
Mental Healthy Aging & Alzheimers
Mental Healthy Aging & Alzheimers
'11 '12
13
14% Consumers Think Supplements are Very Effective for Age-related
Memory Loss, 52% Somewhat Effective
30
The 2012 Gallup Study of Nutrient Knowledge & Consumption; Sloan Trends, Inc. 2013
TrendSense™: Mental & Healthy Aging
200000
Medical/Nutrition
90000
180000
80000
160000
70000
140000
60000
120000
Consumer
50000
100000
40000
80000
60000
30000
40000
20000
20000
0
'00
'01
'02
'03
'04
'05
'06
'07
'08
Mental Healthy Aging
'09
'10
'11
Commercialization – Mega Market
10000
Medical Threshold
'12
Proj.
0
Commercialization – Level 3
'00
'01
'02
'03
'04
'05
'06
'07
'08
'09
'10
'11
Mental Healthy Aging
TrendSense™ Predictive Model: Mental and Healthy Aging is an Excellent High
Potential Mega Mass Market Opportunity
Sloan Trends Inc. 2012
'12
Proj.
Brain/Mental Supplement Sales On the Rise
Supplement Sales
700
662
Supplement
Growth
626
+5.4% in 2013
600
580
7.0%
540
509
500
461
Millions
401
400
353
308
300
286
265
225
244
208
221
200
100
'99
'00
'01
'02
'03
Nutrition Business Journal Data charts, 2013
'04
'05
'06
'07
'08
'09
'10
'11
'12
'13e
'11-'12
2/3rds Believe Supplements Can Help Delay or
Prevent Normal Age-Related Memory Loss
60% Alzheimer’s
The 2012 Gallup Study of Nutrient Knowledge & Consumption
Multi-sponsor Surveys, Inc.
5.4M Americans 65+ Have Alzheimer’s,
2/3rds are Women
33
28% of Consumers Used Foods to
Prevent Memory/Mind Issues in
2013; 18% to Treat
The Hartman Group, Re-imagining health & Nutrition, 2013
Boost Cognitive Development/Brain #1 Reason
Moms Give Supplement to Kids
Top 4: Benefits Looking for from Supplements Given to Child
Benefits Looking For
Total %
Age 2-5
Age 6-9
Age 1012
Age 1317
Overall health and well-being
76
79
78
72
74
Boost immune system
70
72
64
75
70
To fill nutritional gaps in diet
62
64
56
64
63
Boost cognitive
development/brain
42
51
40
41
35
The 2011 Gallup Study of Children’s Supplement Use
Pregnancy/Lactation
Supplementation
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.
Choline: Critical During Pregnancy
& Lactation
•
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.
3.95 Million Babies Born In the U.S. 2012
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 2011. 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 2012.
Births: Final Data for 2012, Joyce A. Martin, et. Al., 2013. National Vital Statistics Report, Dec. 30, 2013. ADC/NCHS, 20122
3.8M in U.S.
Use Prenatal
Supplements
4 of the Top 6
Women’s
Supplements
= Prenatal
Choline & Liver Health
Liver Health
Three first-time ever major government funded reports were released on liver
health in Canada, the UK and the European Union in 2013. 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.
United Kingdom
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. MexicanAmerica 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.
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.
•
2012 sales of liver/detox supplements topped $111 million in 2012, up 95.7% vs. 2011
(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
2013. Alcohol consumption in the U.S. is at an all-time high.
Many as 25% May Have NAFLD
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
• 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%
Liver Disease #4 Cause of Death Age 45-54
The American Liver Foundation/CDC, 2012
Liver Problems Underestimated for Long
Time Due to Screening Techniques
Prior to the 3rd NHANES Survey, 1988-1994 - 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 →
•
•
•
•
•
•
•
•
•
•
The American Liver Foundation/CDC, 2012
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
NAFLD Increases with Age, Men > Women,
Mexican Am. Men Highest Incidence
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%
CDC/NHS – NHANES 3, 2012
Race NAFLD
• Mexican Am. 24.1%
• Whiles 17.8%
• Blacks 13.5%
Top Causes of Death U.S.
Hispanics
•
•
•
•
•
•
•
•
Heart disease
Cancer
Accidents
Stroke
Diabetes
Suicide
Pulmonary Disease
Liver Disease
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
The American Liver Foundation/CDC, 2012; Am. Heart Assn. Statistics,
Millions (20+)
HBP
77.9
Pre-hyper
67.0
Cholest > 200
98.9
Cholest > 240
31.8
LDL>130 mg/dL 71.0
HDL<40
48.7
Triglycerides
27.2
Overweight
154.7
Obese
78.4
Diabetes (Diag) 19.7
Pre-diabetes
87.3
Met Syndrome 77.2
% Pop
34%
30%
46%
14%
33%
16%
12%
66%
34%
9%
26%
34%
Choline & Heart Health
Choline & Heart Health
•
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 8th 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.
•
83.6 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.
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 2012.
Just under half (45%) of supplement users took a supplement to keep their heart
healthy in 2013.
•
Heart is the health condition that has the greatest impact on food purchases, cited by
72% of food shoppers in 2014.
Top 10 U.S. Health Concerns
Incidence of Heart Related Health
Issues in U.S. Population
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
31% Say Heart Disease
“Runs in My Family”
Am. Heart Assn. Statistics, 2014; HealthFocus, U.S. Consumer
Health Survey, 2012; Mintel, Heart Disease - U.S., 2014
44% Have Both High
Cholesterol &
High Blood Pressure
New Focus heart Health
Heart Attack, Stroke, Circulation, Atherosclerosis
Medical/Nutrition
Consumer
300000
25000
TrendSense™:
250000
20000
200000
15000
150000
Commercialization – Mega Phase
10000
100000
Commercialization – Level 3
5000
Commercialization – Level 2
50000
Commercialization – Level 1
Medical Threshold
0
0
00
00
01
02
03
04
05
High Blood Pressure
Cholesterol
Improve/Increase Circulation
06
07
08
09
10
11
12
Stroke
Heart Attack
Atherosclerosis
Annual rate of first heart attack
14
Per 1,000 Persons
12
10
White Men
8
Black Men
6
White Women
Black Women
4
2
0
35-44
45-54
55-64
01
02
03
04
05
06
07
08
09
10
11
12
13
13
65-74
Ages
Sloan Trends, Inc. 2012; Am. Heart Assn, Heart & Stroke Statistics, 2013
High Blood Pressure
Stroke
Cholesterol
Heart Attack
Improve/Increase Circulation
Atherosclerosis
Annual rate 1st intra-cerebral hemorrhage
Stroke: Healthy Circulation, Blood
Plaque
•
An American has a stroke every 40 seconds; every 4 minutes someone dies due to stroke,
stroke 4th leading cause of death U.S.
•
Incidence of stroke increasing in those < age 65: incidence rate is down for those over age 65.
•
6.8 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.
2010
Ref. #2
“I have not had one but am concerned about having one” –
30% stroke, 32% heart attack - US
Am. Heart Assn. 2014; Packaged Facts , Healthy Americans 50+, 2011; Mintel, Heart - U.S. 2012
TrendSense™ Predictive Model:
Blood Plaque/Heart Mass Market Op Since 2005
Consumer
Medical/Nutrition
4000
3500
3000
2500
2000
1500
1000
500
0
1600
1400
1200
1000
800
600
400
200
0
Medical Threshold
00
01
02
03
04
05
06
07
08
Plaque & Heart
09
10
11
12
13
Proj.
Commercialization – Level 1
Popularization
00
01
02
03
04
05
06
07
08
09
10
11
12
13
Proj.
Plaque & Heart
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 Options
Very Important
Important
Atherosclerosis
13.9%
21.9%
Somewhat
Important
28.3%
55
Sloan Trends, Virginia Dare Boomer Health Survey, SPINS/Nielsen, 2010
Heart Health U.S. Supplement Sales
$2.2B, +6.6% in 2012 → $2.42 In 2013
$2,500
$2,294
$2,133
$2,000
$1,872
Heart Supplements
+5.7% in 2013
$2,000
$1,738
In Millions
$1,543
$1,500
$1,325
$1,000
$870
$713
$649 $680
$947
$1,016
$759
$500
$0
Heart Health
'99
'00
Nutrition Business Journal Data Sheets, 2013
'01
'02
'03
'04
'05
'06
'07
'08
'09
'10
'11
'12
Potential Heart Dietary Supplements High
Ref #1
1. SymphonyIRI, OTC Medication Report, 10/2010
Heart #1 Condition Influences Food/
Drink Selection, Cited by 72% in 2014
Food Marketing Institute, Shopping for Health 2014; Shopping for Health, 2012
Consumers Look to
Supplements & Foods
Help with Heart Health
8 in 10 Feel Supplements/Fx Foods
Effective Blood Pressure = to Heart
Health
2013 64% 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%
The 2012 Gallup Study of the U.S. Market For Vitamins & Other Dietary Supplements
Packaged Facts, Targeted Health and Wellness Foods and Beverages, 2012
59
Choline & Sports Performance
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.
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 2013. 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 2014.
•
The nutritional and performance drink market grew by 48% in the 5-year span
between 2008 – 2013. 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 2006-2011 (Mintel, 2014).
•
Euromonitor projects sports nutrition is poised to outgrow all other major consumer
health categories through 2018. 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.
Consumers More Active
•
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.
Sports Nutrition Poised to Outgrow All Other
Major Consumer Health Categories → 2018
Consumer Health (Growth Index, Constant, Fixed 2013 Terms) 2008-2018
Sports Nutrition to Lift Industry Growth
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.
Euromonitor: Weight, Sports Nutrition & Dietary Supplements, 7/12/14; http://blog.euromonitor.com/2014/07/consolidation-pushes-ahead-in-sportsnutrition.html
$30.7B Sports Nutrition Market;
Mainstreams: Post, Hormel Enter Market
Top 3 Benefits Sought from SNP
KEY BENEFITS SOUGHT
Bars
Satisfy hunger (54%)
Energy boost (49%)
Weight management (42%)
Drinks
Energy 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%)
New Mainstream Sports Sector
Recreational Sports, Gym Workout
Weekend Warriors
Women: Fitness/Weight
Boomers Aging Well
Moms: Kids’ Nutrition Support
65
Nutrition Busn. J., 5, 2014; 2013 Gallup Study of Sports Nutrition
Sports Nutrition & Weight Loss
Category $30.6B in 2013
Nutrition Business Journal, March 2014
Sports Nutrition Supplements - Powders,
Pills & Hardcore Body Building Ready-toDrink Beverages $4.5B 2013
U.S. Sports Nutrition & Weight Loss Product & Channel Sales Matrix 2013
Nutrition Business Journal, March, 2014
$4.4B Sales of Sport Nutrition Weight
Supplements, +12% to $4.89B 2014
Sport Nutrition Supplements
6,000
4,886
5,000
4,432
3,999
4,000
Millions
3,579
3,218
2,947
3,000
2,793
2,595
2,392
2,129
2,250
1,991
2,000
1,726
1,833
1,590
1,344
1,450
1,189
1,000
'97 '98 '99 '00 '01 '02 '03 '04 '05 '06 '07 '08 '09 '10 '11 '12 '13 14
Nutrition Business Journal Data Charts, 2014
Consumers Giving More Attention to Being
Active, Exercising, Casual Sports, 6 in 10
Think A Lot about Being Active
IFIC Food & Health Survey, 2014
66% Adults Physically Active 2014 - Active 3-5
Days/Week, Duration Physical Activity, 45 Minutes
IFIC, Food & Health Survey, 2013
TrendSense™ Predictive Model: Muscle
Medical/Nutrition
Consumer
250000
140000
120000
200000
100000
150000
80000
60000
100000
40000
50000
20000
Medical Threshold
0
Commercialization – Mega Market
0
02
03
04
05
06
07
08
09
10
11
12
13
02
03
04
05
06
Strength
08
09
10
11
12
13
Year
Year
Muscle
07
Muscle
Strength
Copyright Sloan Trends, Inc. 2014 NOT TO BE COPIED, PUBLISHED, DIVULGED WITHOUT PRIOR WRITTEN PERMISSION FROM SLOAN TRENDS
2012: 1st Time Building Physical Strength
Shows Up as Having an Impact on
Food/Bev Purchase: Protein
72
Food Marketing Institute, Shopping for Health, 2012
Sports Participation
Women
in millions
Total Adults
in millions
Age 45-54
in thousands
Exercise Walking
95.8
Exercise Walking
58.7
Exercise Walking
18.1
Exercising with Equip.
55.3
Exercising with Equip.
29.4
Exercising with Equip.
9.4
Swimming
51.9
Swimming
27.3
Camping
7.3
Camping
44.7
Aerobic Exercising
26.9
Hiking
6.4
Bicycle Riding
39.8
Camping
29.6
Swimming
6.0
Bowling
39.0
Workout at Club
18.8
Aerobic Exercising
5.8
Aerobic Exercising
38.5
Hiking
18.5
Workout at Club
5.7
Hiking
37.7
Bowling
18.3
Bicycle Riding
4.9
Workout at Club
36.3
Bicycle Riding
17.7
Bowling
4.5
Running/Jogging
35.5
Running/Jogging
16.9
Running/Jogging
3.5
National Sporting Goods Assn., 2013
Performance/Energy Reasons Hispanic Try
Eat Healthy, 1 in 5 Men Sports Supplement
Energy #6 Hispanic Health Concern 51%
2:1
Gen. Pop.
1 in 5 Men Use Sports Nutrition Suppl.
% Hispanics Use Sports Nutrition Supplements
Total Hispanics
12
GENDER
Male
18
Female
6
18-24 years
18
25-34 years
14
35-49 years
14
50+ years
2
AGE
Active
The 2012 Gallup Study of Hispanic Nutrition & Supplement Use; HealthFocus, 2013
ACCULTURATION
SEGMENTATION
Most acculturated
12
Moderately acculturated
14
Least acculturated
10
Regulatory Status, Issues
Regulatory Status
Choline is Regarded as GRAS by FDA
• A choline-containing compound was reviewed by the Select Committee
on GRAS Review (SCOGS) that convened between 1972-1980 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
• Choline chloride
CFR 21 182.825
CFR 21 182.8252
76
Regulatory Status
Recognized Health Claims for Choline Products:
• The Balchem Corporation presented a dossier of the following structurefunction 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
77
Regulatory Status
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)."
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/FDAModernizationActFDAMAClaims/ucm073599.htm
78
Regulatory Enforcement Actions
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-810-152)
The following statements were observed on the company’s website:
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.
79
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).”
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-tomoderate 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)”
80
Overconsumption Levels
•
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.
81
IOM NAS