Dietary Supplements, a Glance at Global Trends

Dr. Zargari, Aug 2021
Dietary Supplements
A G l a n c e a t t h e G l o b a l Tre n d s
F a r h a d Z a r g a r i , M D , P h D , D B A
A u g u s t 2 0 2 1

• 1…………………. Paradigm Shifts
• 2…………………. Definitions
• 3…………………. Market Overview
• 4…………………. Market Segmentation
• 5…………………. Personalized Nutrition
• 6…………………. Supplements in Clinical Care
• 7…………………. Adverse Effects
• 8…………………. Regulatory Considerations
2

Paradigm
Shifts
3

• The socio-economic developments which coupled with the
technological breakthroughs of 21st century has paved the
road for paradigm shifts in the overall philosophy of life and
profound changes in the lifestyle of the entire generation
spectrum in many societies.
• Along with the significant increase in the life expectancy,
almost in every culture people are willing to have a better
quality of life, this in turn has intensely changed the
healthcare environment and created new visions and
frontiers.
New Frontiers
4

• The convergence of health, wellness and beauty spheres,
is creating new service areas and thus fresh opportunities
for investors and retailers.
• Global awareness about weight loss, healthy living, protein
intake, fitness, and natural beauty is on the rise
particularly among the millennials and Gen Xers.
Paradigm Shifts
Health Wellness
Beauty
Quality of Life
Longevity
5

Illness Orientation (Disease Treatment) Wellness Orientation (Health Management)
Fragmented Care Integrated Spectrum Care
Process Vision Outcome Vision (Quality)
Reactive (Therapeutic) Proactive (Preventive)
One Fits All (Volume-Based Therapy) Personalized Care (Value-based Therapy)
Rigid Medical Protocols
Rise of informed Patient and
Therapy Co-development with Patient
Traditional Delivery Connected Health and Homecare
Sole Person Vision Whole Person Vision
Source: Healthcare Disruption, Zargari, et al. September 2020
Traditional Healthcare System Comprehensive Healthcare System
Paradigm Shifts in Healthcare

New Model of Sustainable Health
Source: US National Institute of Health, NCCIH Report, May 2021
• Now, we are expanding our
definition of integrative health
to include whole person health,
or empowering individuals,
families, communities, and
populations to improve their
health in multiple
interconnected domains
namely: biological, behavioral,
social, and environmental.
7

New Model of Sustainable Health
Source: US National Institute of Health, NCCIH Report, May 2021
Comprehensive Therapeutic Framework
Framework
8

• On the basis of paradigm shifts that happened, healthcare
and personal care markets have evolved in recent years,
extending the focus of their business to new areas and
addressing common consumer needs.
• The expansion of the business, together with the latest
industry trends, has developed transversal and innovative
market segments, focused on offering sustainable health and
wellness benefits.
New Frontiers
9

Definitions
10

• One of the principal areas in the new lifestyle paradigm is
dietary supplementation of various substances such as
vitamins, minerals, amino acids, food stuffs, herbs, roots, oils,
animal extracts, etc. to our daily intake. Dietary factors are
known to play an important role in health and diseases, and
there is convincing evidence that adopting a correct diet
containing the essential nutrients can be more effective than
drug treatment in the maintenance of health and prevention
of diseases, thus improving the quality of your natural life.
Dietary Supplements
11

• The usual unbalanced diet of today, full of refined
carbohydrates, sugars, saturated fatty acids and lacking in
essential vitamins, trace elements and antioxidants, can leave
us deficient in many key nutrients needed for normal
physiology to run all body systems efficiently and to prevent
chronic disease.
• Nutritional Supplementation can help us keep our wellbeing,
hence reduce our long term healthcare costs.
Dietary Supplements
12

• "The Dietary Supplement Health and Education Act of 1994
(DSHEA) defines the term “dietary supplement” (DS) to mean
a product (other than tobacco) intended to supplement the
diet that bears or contains one or more of the following
dietary ingredients: a vitamin, a mineral, an herb or other
botanical, an amino acid, a dietary substance for use by man
to supplement the diet by increasing the total dietary intake,
or a concentrate, metabolite, constituent, extract, or
combination of any of the aforementioned ingredients.
Dietary Supplements
Source: DSHEA Act, US Congress, 1994
13

• A food supplement is defined as any foodstuff the purpose of
which is to supplement the normal diet and which are
concentrated sources of nutrients or other substances with a
nutritional or physiological effect, alone or in combination,
marketed in dose form, namely forms such as capsules,
pastilles, tablets, pills and other similar forms, sachets of
powder, ampoules of liquids, drop dispensing bottles, and
other similar forms of liquids and powders designed to be
taken in measured small unit quantities.
Dietary Supplements
Source: The EU Food Supplements Directive 2002/46/EC
came into force on 1 August 2005
14

Dietary Supplements
• DS play an important role in
the overall hierarchy of
human health.
• The pyramid shows the
distinction between general
food and nutrition, specialist
nutrition or dietary
supplementation and
pharmaceuticals or prescribed
medical treatments.
Source: Scientific Evidence on Vitamins and Lipids for
Pharmaceutical Applications, DSM Report, 2017
15

• DS are substances you might use to fortify the ordinary diet
by adding nutrients to improve your health or lower your risk
of health problems.
• Supplement products are or contain vitamins, nutritionally
essential minerals, amino acids, essential fatty acids and non-
nutrient substances extracted from plants or animals or fungi
or bacteria, or in the instance of probiotics, are live bacteria.
• DS ingredients are natural products but they may also be
synthetic copies of naturally occurring substances (example:
melatonin).
Dietary Supplements
16

• Dietary supplements are neither drugs nor conventional foods; they are intended to supplements
food in providing added nutrients and improve general wellbeing.
• It should be noted they are not intended to replace complete meals which are necessary for a
healthful diet so, be sure you eat a variety of foods as well.
• DS cannot serve as a replacement to medicines to cure chronic diseases.
Dietary Supplements
17

• DS have vast physiological functions, for example
• Vitamin supplements, serve as antioxidants in the body, it is
believed that antioxidant supplements reduce the level of free
radicals in the body which improves general and cognitive
functions.
• Calcium and vitamin D supplements have a greater positive
impact on bone density and reduce bone demineralization at a
later age.
• Folic acid and omega 3 fatty acids prevent birth defects and
reduce the risk of developing heart related diseases,
respectively.
Dietary Supplements
18

Dietary supplements can help assure that
you get enough of the vital substances the
body needs to function, DS roles include:
• Compensation for Dietary Shortcomings
• Prevention of Diseases
• Improvement in General Health
• Improvement of Mental Health
• Enhancement of Athletic Performance
Dietary Supplements
19

• The increasing consumer awareness
regarding personal health and
wellbeing is expected to be a key factor
driving the market for DS. The working
population around the globe is
struggling to fulfill the daily nutrient
requirements owing to hectic work
schedules and changing lifestyles. This
is increasing their dependency on DS to
fulfill the nutrient requirements which,
in turn, is expected to drive the market.
Dietary Supplements
Do you ever take / have you ever taken food supplements such as vitamins?
Source: Food Supplements Consumer Research, Food Standard Agency, 2018
20

• The term “nutraceutical” combines the two words of
“nutrient,” which is a nourishing food component, and
“pharmaceutical,” which is a medical drug. It was coined for
the first time in 1989 by Stephen DeFelice.
• Nutraceuticals is a broad umbrella term that is used to
describe any product derived from food sources with extra
health benefits in addition to the basic nutritional value
found in foods. Nutraceutical products can be considered
non-specific biological therapies used to promote general
well-being, control symptoms, and prevent pathologic
processes.
Nutraceuticals
Source: Nutraceuticals: Nutritionally Functional Foods – an Overview,
Biomedical Journal of Scientific & Technical Research, February 2019
21

• “Nutraceutical” is a substance that may be considered a food
or part of a food which provides medical or health benefits,
encompassing prevention and treatment of disease. Products
as diverse as isolated nutrients, dietary supplements and
diets to genetically engineered “designer” foods, herbal
products, and processed foods (cereals, soups, beverages)
may be included under the umbrella of nutraceuticals.
Nutraceuticals
Source: Nutraceuticals, P. Dudeja, R.K. Gupta, in Food
Safety in the 21st Century, 2017
22

• Nutraceuticals refer to extracts of foods having a medicinal
effect on human health. They comprise of foods, dietary
supplements, and medical foods meant for prevention or
treatment of certain diseases.
• Nutraceuticals are foods that provide both health benefits to
reduce the risk of chronic diseases and basic nutrition.
• Modern nutraceuticals are available as forms of food, or
included in foods or as whole food itself such as probiotic
drinks and yogurt.
Nutraceuticals
Source: Strategic Design of Delivery Systems for Nutraceuticals,
S. Lee, in Nanotechnology Applications in Food, 2017
23

• Nutraceuticals (often referred to as phytochemicals or
functional food) are natural bioactive, chemical compounds
that have health-promoting, disease-preventing, or medicinal
properties.
• The philosophy behind nutraceuticals is to focus on
prevention, according to the saying by Hippocrates (the
father of medicine) who said “let food be your medicine”.
Their role in human nutrition is one of the most important
areas of investigation, with wide-ranging implications for
consumers, healthcare providers, regulators, food producers,
and distributors.
Nutraceuticals
Source: Innovative and fortified food: Probiotics,
prebiotics, GMOs, and superfood, T. Varzakas et al, 2018
24

• The term ‘functional food’ was coined in Japan in the early
1980s. Although there is no universal definition of functional
food, a typical and simple definition is “processed foods
having disease-preventing and/or health-promoting benefits
in addition to their nutritive value.” Functional foods overlap
with nutraceuticals, medical foods, probiotics, designer foods,
pharmafoods, and vitafoods.
• “Functional foods” is a relatively new term used to describe
food products which have been enriched with natural
substances/components with a specific physiological
preventive and/or health-promoting effect.
Functional Foods
Source: Tina Vukasović, Developing New Functional Food
and Nutraceutical Products, 2017
25

• Functional foods are foods that have a potentially positive
effect on health beyond basic nutrition. They may promote
optimal health and help reduce the risk of disease.
• A familiar example of a functional food is oatmeal because it
contains soluble fiber that can help lower cholesterol levels.
Some foods are modified to have health benefits. An example
is orange juice that's been fortified with calcium for bone
health.
• The Food and Drug Administration regulates the claims that
manufacturers can make about functional foods' nutrient
content and effects on disease, health or body function.
Functional Foods
Source: Mayo Clinic, June 2020
26

• Medical foods are foods that are specially formulated and
intended for the dietary management of a disease that has
distinctive nutritional needs that cannot be met by normal
diet alone. In the United States they were defined in the Food
and Drug Administration's 1988 Orphan Drug Act
Amendments and are subject to the general food and safety
labeling requirements of the Federal Food, Drug, and
Cosmetic Act.
• In Europe the European Food Safety Authority established
definitions for "foods for special medical purposes" (FSMPs)
in 2015.
Medical Foods
Source: Wikipedia, Medical Foods
27

• A medical food is defined as a food which is formulated to be
consumed or administered enterally under the supervision of
a physician and which is intended for the specific dietary
management of a disease or condition for which distinctive
nutritional requirements, based on recognized scientific
principles, are established by medical evaluation. This
particular category of food has gained traction recently and
many companies are looking to develop an innovative
medical food.
Medical Foods
Source: Regulatory constraints on new product
development and approval procedures in the United
States,Jennifer Shield et al, in Developing New Functional
Food and Nutraceutical Products, 2017
28

Source: PWC Vitamins & Dietary Supplements Market Trends Overview, 2020
The nutraceutical market includes functional foods, foods for medical purposes and food supplements.
The Articulate Spectrum
29

Market
Overview
30

• The global DS market is expanding constantly. Market size
was valued at USD 140.3 billion in 2020.
• FDA estimates that more than 75,000 different DS are now
available to consumers globally, and an average of 1,000 new
products are introduced annually.
• Close to 8,000 companies pump out about 75,000 products to
the consumer market.
Market Overview
Source: Grand View Research, Inc, 2020
Source: Dietary supplements, A Framework for Evaluating Safety,
Institute of Medicine and National Academy of Sciences
31

• With the increasing prevalence of lifestyle-related diseases
and the increasing geriatric population, the consumers are
more inclined towards food supplements, which is expected
to drive the global market.
• In 2025, DS will reach the market value of OTC, which is
historic and very important for the business model of pharma
companies expanding to DS.
Market Overview
Source: Euromonitor Consumer Health data, December 2020
32

• The DS market is expected to expand at a compound annual
growth rate (CAGR) of 8.6% from 2021 to 2028, with the U.S.,
China, and India accounting for the largest shares.
• It is estimated that the supplement market will reach USD
300 billion in the next 5 years. The market may become even
larger due to the COVID-19 pandemic.
• The top two reasons supplement users increased their
supplement routine were for “overall immune support” and
for “health/wellness benefits”.
Market Overview
Source: Nutrients, MDPI, November 2020
33

• Dietary supplements are a lucrative industry for many
reasons, including:
• The high demand for the products
• The relatively low cost to develop the products
• Furthermore, unlike drugs, consumers do not always expect to
have an immediate effect upon consuming the products
• Unlike pharmaceuticals DS are not over-regulated and are
relatively easier business.
• Due to the high use of dietary supplements and the potential
health benefits as well as adverse effects, there is an urgent
need for better regulation.
Market Overview
34

• Vitamins, minerals, and plant products are the most
commonly used dietary supplements in the USA market,
while vitamins and minerals derived products are most widely
used in the EU countries as they account for 50% of total
sales, energy drinks account for 7% market share, and other
forms of DS account for the remaining 43%.
Market Overview
35

Market Overview
Global DS Market Size
(2020)
USD 140.3 billion
Global DS Market
Growth at a
(CAGR) of 8.6% from
2021 to 2028
Market Size Estimation
In 2025 About:
USD 300 billion
Global DS Manufacturers:
About 8000 companies
producing 71K products
Global
DS
Market
36

Dietary Supplement Consumption by Region in 2020
Source: Mordor Intelligence, 2020
37

Total Global Forecast USD 297,650
Source: Future Market Insight, 2018
Forecast on Global DS Market Value by Regions in 2025
38

Over a fifth of consumers globally belong
to the older segment of the population,
increasing the need for products that
supplement the intake of vitamins,
calcium and other nutrients, in order to
delay the effects and disorders
related to aging.
Aging
New Lifestyle
39
Dietary
Supplements
Market
Vitamins and Minerals Herbal and Botanical Supplements
Sports Nutrition and
Weight Management
Specialty Supplements
are the largest submarket with 98% of all
supplement users using a vitamin or mineral
supplement.
Specialty Supplements – are designed to
support a specific structure of or function in the
body with a similar effect of a pharmaceutical
drug. The top five specialty supplements used
today include: Omega-3 Fatty Acids, Probiotics,
Fiber, Melatonin, Glucosamine/chondroitin
are derived from fruits, vegetables, barks, and
roots. Looking for fewer side effects, consumers
are purchasing organic supplement brands.
is the fastest growing supplement submarket
with frequent product launches targeted to
new consumers. Consumers are seeking to
reach their lifestyle and fitness goals and
supplement their normal diet.
Dietary Supplement Submarkets
The dietary supplements market is broken down into the following major submarkets:

Over a fifth of consumers globally belong
to the older segment of the population,
increasing the need for products that
supplement the intake of vitamins,
calcium and other nutrients, in order to
delay the effects and disorders
related to aging.
Aging
Consumers' awareness of the importance
of wellbeing and prevention is growing. In
general, consumers show increasing
attention to the health, with a proactive
approach to the treatment and prevention
of potential diseases with natural
products.
Attention to Health
With increased technology and wealth, we eat
more and exercise less resulting in obesity issues.
Obesity is associated with many diseases
including diabetes, cardiovascular disease, high
blood pressure, stroke, sleep apnea, liver and
kidney diseases, and osteoarthritis. Vitamins and
supplements are an easy way to help alleviate
some of the ill effects of obesity driven diseases.
New Lifestyle
An increase in self-directed care has
shaped the markets. Societies have
become increasingly interested in
personalized medicine and care with the
priority of natural cures.
Personalized Care
DS Market Drivers
40

Ease of access in health services through
channel proliferation has improved
significantly. With the rise of internet and
digital solutions more people seek help
online and become healthcare consumer.
Ease of Access
The growing popularity of fitness,
bodybuilding and specialized sports
(“from health to fit”) in the age group
between 20 and 40 years is increasing the
demand for food supplements useful for
achieving aesthetic goals or increasing
performance.
Sport Nutrition
The increase in the cost of healthcare is
inducing more attention to prevention
through applying preventive measures
including food supplements, in order to
reduce long-term costs.
Healthcare Cost
Technological advancements and increased
investment in R & D of nutraceuticals and DS
products are expected to further boost the
market growth in the upcoming years.
Increasing innovation by key market players
operating in the DS industry is further
augmenting the growth of the market at the
global level.
R & D
DS Market Drivers
41

• The market demand for Vitamins and Dietary Supplements is
driven by:
• Increasing attention to health and prevention by the consumers
• Greater customization of needs for different segments of the
population
• Increased health care costs and search for alternatives to cure
specific problems
• The growth in demand for DS is mainly driven by probiotic
supplements, fatty acids (i.e. fish oils) and protein supplements
• Herbal/Botanical supplements usage has emerged as a popular
complementary and alternative medicine or supplement to
modern medicine
• Rising consumer awareness regarding the severity of digestive
disorders, stimulate the growth of the enzymes segment
DS Market Drivers
42

Anti-Cancer
Anti-Parkinson
Anti-Depressants
Anxietolytic
Sleep Gummies
Irish Moss
Turmeric Coffee
Mushroom Coffee
Collagen
CBD Gummies
ACV* Gummies
*ACV: Apple Cider Vinegar
**DTC: Direct to Customer, Mostly By Online Shopping
Source: Exploding Topics, 6 Key Supplement Trends, May 2021
1
2
3
4
5
6
7
8
9
Sport Nutrition
Immunity Health
Weight Management
Memory and Cognition Enhancement
New Supplement Categories
Growing Number of Vegan Supplements
More DTC** Supplement Brands
Pet Supplements Take off
Beauty Support
DS Market Opportunities & Megatrends
Demand for
protein powders,
protein bars,
energy gels and
other so-called
active nutrition
products have
surged globally.
43
• The DS global market trends
indicate that in response to the
novel customer requirements,
new categories of specialized
supplements are being
developed and there will be a
growing demand for such
dietary supplements
worldwide. This in turn guides
the investors to find the fitting
investment opportunities.

• Here are our 5 bold DS industry predictions for 2021 and 2022:
• 1-Demand for DS will rise in emerging economies, where
preventative healthcare is seen as a springboard to work towards a
better health index.
• 2-Asia-Pacific will emerge as a huge market for DS and personal
care products. Growing incomes, changing lifestyles and more
purchasing power will create a surge in the demand for
convenience and health products. However, the United States will
remain a mature market for these products and the DS industry
will see more innovation here.
• 3-Probiotics will rule the nutraceutical roost, with a wider
collaborative research effort to support the growing demand for
products around immunity and gut health.
DS Market Prediction 2021-2022
Source: Nutra Science Labs Report, March 2021
44

• Here are our 5 bold DS industry predictions for 2021 and 2022:
• 4-Brand owners will face greater market and regulatory challenges
than ever before. Those brands that refuse to cut corners in terms
of quality and are able to adjust their strategies to compensate for
longer lead times and ingredient shortages will thrive.
• 5-Consumer demand for high-quality immune support
supplements will surge over the next 24 months - and beyond.
DS Market Prediction 2021-2022
Source: Nutra Science Labs Report, March 2021
45

• The increasing price of regular dietary supplements and the high
price of premiumized supplements are expected to restrain
market growth.
• The rising consumer inclination towards organic products and
the limited availability of organic supplements can further
hamper product growth. However, their manufacturers are
embarking on technological advancement to minimize the
production costs.
• DS manufacturers will face higher regulatory pressure.
DS Restraining Factors
Source: Fortune Business Insights, August 2020
46

• As the coronavirus pandemic worsened, sales of herbal supplements, vitamins and minerals
experienced astoundingly high levels of growth.
• Although there is no proven scientific evidence, consumers increased the consumption of vitamins and
supplements such as vitamin D and zinc. Due to this surge in demand, there is a shortage of DS. On Amazon,
many popular types of zinc are sold out. One box of 18 lozenges is selling for up to $120 but they wouldn’t
be delivered until next month.
• This scenario could positively affect the demand of other supplements as well.
Covid-19
Covid-19 Effect
47

• During the COVID-19 pandemic in the US, the FDA and
Federal Trade Commission (FTC) warned consumers about
marketing scams of fraudulent supplement products,
including homeopathic remedies, herbals, teas, essential oils,
tinctures and colloidal silver, among others.
• By August 2020, the FDA and FTC had issued warning letters
to dozens of companies advertising scam products, which
were purported "to be drugs, medical devices or vaccines.
Fraudulent Products During the COVID-19 Outbreak
48

Source: An Introduction to Royal DSM, 2021
• Selected from the annual report of DSM company.
49

Some of the Major Global Players of the DS Market
50

Market
Segmentation
51

Source: Future Market Insights, 2021
DS Market Segmentation
By
Ingredients
By
Form
By
Application
By
Consumer
By
Distribution
Channel
By
Region
• Vitamins
• Minerals
• Amino Acids
• Botanical
• Animal Extracts
• Others:
Concentrate
Metabolite
Constituent
Extract
• Pharmaceutical P
- Pills
- Chewable pills
- Powder
- Liquid
- Soft Gel
• Confectionery P
- Chews
- Gummies
- Lollipops
- Hard boiled candies
• General Well-being
• Sports Nutrition
• Weight Loss
• Immunity
• Digestive Health
• Bone & Joint
• Heart Health
• Anti-allergies
• Beauty
• Eye-health
• Memory & Cognition
• Sexual Enhancement
• Anti-cancer
• Analgesics
• Men
• Women
• Senior
citizens
• Kids
• Special
Groups
• Store Based Retailing
- Supermarkets
- Hypermarkets
- Convenience Stores
- Pharmacies
- Wellness Stores
- Leisure Centers
- Beauty Salons
- Other Retailers
• Online Retailing
• Direct Selling
• N. America
• Asia& Pacific
• Europe
• Middle East
• Africa
• L. America
52

53
By
Ingredients

Amino Acids
Animal Extracts
Botanicals
Carbohydrates
Dietary Fiber or Prebiotics
Enzymes
Fat or Fatty Acids
Food or Food Products
Hormones
Low-calorie Sweeteners
Minerals
Phytochemicals
Plant Proteins
Probiotics
Protein or peptides
Resistant Starch
Spices or herbs
Vitamins
Whole Grains
Market Insight by Ingredients
54

• Among various types of DS, vitamins are the widely
consumed items across the globe, followed by minerals, and
proteins.
• In many developed and developing economies, the deficiency
of vital vitamins such as A, B, C, and E among the population
is becoming very common, and hence to fulfill the required
daily dose of vitamin, consumers are highly inclined towards
vitamin supplements.
• In pregnant women, the elderly, and in some adults, lack of
certain minerals can lead to serious diseases due to which the
demand for DS is increasing rapidly among these groups.
Market Insight by Ingredients-Vitamins & Minerals
55

• Studies show vitamins dominated the market and accounted
for 31.4% share in 2020 owing to high demand from working
professionals and sports athletes for energy and weight
management. The vitamin market growth alone is estimated
to see a CAGR rate of 5.5% for the period of 2019-2026.
Market Insight by Ingredients-Vitamins & Minerals
56

• The global botanicals market is anticipated to witness
continuous growth over the next 5 years. From ages, natural
products, extracts & nature-based products have been used
as a form of treatment for various acute & chronic ailments.
With time, various improvements have been made to the
natural products that resulted in proper dosage & properties
from crude forms and now are categorized under the name
botanicals/herbal supplements/natural supplements.
• Botanicals in the market are available in various forms that
include oils, tablets, herbs, powders, even in this advanced
age, botanicals are being used widely by almost all the
population pools ranging from infants, youth & adults.
Market Insight by Ingredients-Botanicals
57

• Botanicals held the second-largest share in 2020 and are
expected to witness significant growth over the next few
years. The increasing adoption of the vegan diet around the
globe owing to growing environmental concerns is expected
to boost the demand for botanicals.
• The 2017 supplement market value of herbal and botanical
supplements was 56.1 Billion USD with an expected CAGR of
10.8% from 2019-2026. The total market value of herbal and
botanical supplements is expected to reach over 137.3 Billion
in USD in 2026. Studies show 41% of all supplement users
take an herbal or botanical supplement.
Market Insight by Ingredients-Botanicals
58

• Consumer expenditure on various protein and related
supplements including ready to drink protein-based pediatric
milk formulations has been increasing in the past few years.
• The demand for protein supplements from the young
population is increasing mainly in athletes as they provide
various benefits such as lowering cholesterol, building of
muscles, increasing strength, fighting cancer, improving
immunity, and lowering blood pressure.
Market Insight by Ingredients-Protein Products
Source: Allied Market Research, 2019
59

• The global protein supplement market was valued at $4,908.9 million in 2017 and is projected to reach
$8,717.1 million by 2025. Proteins and amino acids are expected to exhibit the highest CAGR of 13.3% over
the next 5 years.
Source: Allied Market Research, 2019
60

Source: Insights on CBD, KPMG, 2020
• CBD is already at the forefront of health and wellness trends
with CBD-based products found in premium grocery chains,
luxury beauty brands, and health expos. Conservative
estimates pegged the global CBD market at US$8.2 billion in
2019; by 2027, it’s forecast to grow to US$43 billion at a CAGR
of 28.4%.
Market Insight by Ingredients-CBD
61

• The global krill oil market size is projected to be valued at
USD 664.6 million by 2027, expanding at a CAGR of 11.6%,
according to a new report by Grand View Research, Inc.
Growing consumer health awareness, coupled with rising
investment in clinical research and development is expected
to promote market growth over the forecast.
• Health benefits offered by consumption of krill oil to reduce
cholesterol level, blood pressure, and coronary heart diseases
such as heart attacks and strokes are expected to drive
demand in the forecast period.
Market Insight by Ingredients-Oils
62

Market Insight by Ingredients
Most Popular DS Among UK Adults
Source: Food Supplements Consumer Research,
Food Standard Agency, 2018
• The chart shows the most
popular supplements
overall in the UK. The
chart consists of the
answers to the following
question:
• Which of the following
supplements do you
currently / have you ever
taken?
63

64
By
Application

Aesthetics
Allergies and Immunity
Anti-aging and Longevity
Antioxidant and Anti-inflammatory
Bone and joint health
Cardiovascular
Cognitive Function and Brain Health
Energy and Stimulation
Eye Health
Weight Management and Fat Loss
General Health
Gut Health
Insulin Sensitivity
Libido and Sexual Health
Liver Health and Detoxification
Men's Health
Sport and Muscle Gain
Sleep
Testosterone Boosting
Women's Health
Market Insight by Application
65

Market Insight by Application
• The vast majority of consumers
fell into the ‘day-to-day health’
category, taking ‘mainstream’ DS
such as different vitamins or oils,
from mainstream retailers.
‘Herbal remedies’ have been
pulled out as a separate category
as the consumers we spoke to did
not tend to differentiate between
herbal medicines such as St
John’s Wort and herbal
supplements such as ginseng.
66

• By the global estimation of the WHO, the number of
overweight adults will rise from 1.9 billion in 2017 to 2.7
billion in 2025, with roughly 1 in 3 individuals having obesity
or overweight issues.
• Weight management is one of the fastest growing DS
submarkets with frequent product launches targeted to new
consumers. Consumers are seeking to reach their lifestyle and
fitness goals and supplement their normal diet.
• Studies indicate 20% of all supplement users use a weight
loss supplement. This segment led the market and accounted
for a revenue share of 29.5% in 2020.
Market Insight by Application-Weight Management
67

• Energy and weight management product manufacturers are
recently focusing more on incorporating nutraceutical
ingredients to enhance the nutritional value of the products.
It has increased the demand for fibers and specialty
carbohydrates that are indigestible by humans but help in
weight management, reducing cholesterol levels, and
controlling blood sugar levels.
• For instance, in March 2018, The GHT companies announced
the launch of new product line of 100% vegan supplements.
The new products are manufactured to meet the increasing
demand for animal-free plant-based products that aid in
weight management.
Market Insight by Application-Weight Management
68

• The sports nutrition submarket value almost doubled from
2004-2018 with a total revenue of 36 Billion USD in 2019.
Studies show 32% of all supplement consumers use sports
nutritional supplements making the sport subunit one of the
fastest growing segments.
Market Insight by Application-Sports Nutrition
69

• Within consumer health, only DS
saw y-o-y growth in 2020 (purple
line), showing there is substantial
variability between categories.
Great Leap
70

• Increasing awareness regarding gut health owing to the
increasing prevalence of irritable bowel syndrome,
constipation, acid reflux, and indigestion around the globe is
expected to drive the demand for fibers and specialty
carbohydrates from the gastrointestinal health application
segment.
Market Insight by Application-Gut Health
71

• Apart from the general interest in immunity enhancers since
a decade ago, immunity optimizers surged due to Covid-19,
the immunity application segment is anticipated to expand at
a CAGR of 8.5% over the next five years.
• Immunity products growth has “carried” the dietary
supplements segment in 2020 by itself. Some markets were
extreme cases like Latin America that saw 53% growth for
such products versus just 9% growth for DS with other
positionings.
• Immunity segment represented 15% of the global DS
marketplace in 2020.
Market Insight by Application-Immunity
72

• Creating science-based nutritional solutions for high quality
animal food by supplementing various nutrients is an essential
part of the DS industry across the globe, by which healthy food is
provided for people.
• Feed segment is a huge business encompassing numerous
industries involving vitamins, minerals, enzymes, carotenoids,
eubiotics, etc.
Source: Animal Nutrition and Health, DSM Report, 2019
Market Insight by Application-Supplemented Animal Feed
73

Source: Animal Nutrition and Health, DSM Report, 2019
Market Insight by Application-Supplemented Animal Feed
Global Nutritional Ingredients Market (Animal Feed)
74

• The global pet supplements market size was valued at USD 637.6
million in 2019 and is expected to grow at a compound annual
growth rate (CAGR) of 6.4% to reach around USD 1 billion by
2027.
• Top Companies in pet supplement market include:
• Nutramax Laboratories
• NOW Foods
• FOODSCIENCE CORPORATION
• Only Natural Pet
• Beaphar
• Nutramax Laboratories Inc
• Major Applications are:
• Dog Dietary Supplements
• Cat Dietary Supplements
Source: Read Market Research, 2020
Pet
Supplements
Market Insight by Application-Pet Supplements
75

76
By
Distribution
Channel

• In the last few years the variety of outlets that sell dietary
supplements has increased, with supplements now sold in
drugstores, hospitals, hypermarkets, gyms, leisure centers,
beauty salons, small retail shops and sports shops.
Market Insight by Distribution Channels
77

• OTC channel accounted for the largest revenue share of
supplements around 73.2% in 2020 and is expected to
maintain its lead over the next five years.
• Supermarkets/hypermarkets contribute significantly to the
sales of DS in Europe and North America owing to higher
prevalence. The availability of a wide range of products and
higher discounts are responsible for the growth of sales
through supermarkets/hypermarkets. Furthermore, an
increasing number of supermarkets in developing countries is
expected to augment the sales of DS in these channels.
78

• Other OTC distribution channels of DS include nutrition and
specialty stores. A specialty store carries more products in a
single category, which helps consumers to find unique
products that they cannot find in other retail stores. With an
explosive growth of specialty stores, supermarkets and
hypermarkets are losing their market shares because of their
wide product offerings in a single category, flexible store
formats, unique designs, and product displays.
79

• An increasing number of prescriptions for DS for individuals
with nutritional deficiencies for the precise delivery of
nutrients is expected to drive the sales through the
prescribed channel.
80

• Online sales of DS has extensively improved accessibility to
various types of supplements. The Analyst’s study shows
online supplement sales doubled between 2019 and 2022.
• While the coronavirus pandemic has surely created many
lasting shifts in consumer behavior, one of the most impactful
in the supplement industry is the significant growth of
e-commerce sales.
• As a result, online sales are projected to grow from $5 billion
in 2019 to over $10 billion in 2022 and are expected to
represent 19.6% of all supplement sales by 2023.
Source: Informa New Hope Network, November 2020
81

As a retail channel, Amazon
has become a leader in both
VMS and sports nutrition. It’s
the preferred channel across
all consumer segments
overall, driven by both
millennials and Gen Xers.
Source: L.E.K. Health and Wellness Consumer Survey, 2018
82

83
By
Consumer

Market Insight by Consumer
• A recent survey conducted by the Council for Responsible
Nutrition (CRN), states that the intake of DS is prevalent
amongst the following demographic groups:
• 79% of female adults
• 74% of male adults
• 70% of adults 18 – 34
• 81% of adults 35 – 54
• 79% of adults 55+
• 81% of adults employed full-time
• 77% of adults employed part-time
• 68% of adults without employment
• 76% of retired adults
• 81% of adults who are married
Source: The Council for Responsible Nutrition (CRN), 2019
84

• The growing geriatric population in regions, like North
America, Europe, and the Asia Pacific, is expected to augment
the market growth over the next 5 years. As the geriatric
population is susceptible to cognitive deterioration and also
infections, the demand for memory as well as immunity
boosters is expected to grow at a higher rate.
85

Cycle of Malnutrition in the Elderly
Factors predisposing malnutrition and
deficiency in vitamins and minerals can
include poor nutrient intake, caused by
issues including having difficulty
eating, medication, depression and
dementia, as well as suboptimal
nutrient utilization, such as
malabsorption or nutrient loss. In the
elderly particularly, malnutrition is a
prevalent issue which can form a cycle
that is difficult to break if left
untreated.
Higher
Demands of
the Elderly
Population
for Dietary
Supplements
86

Source: Innova Market Insights, 2020
The Position of Aging Related Supplement Products, (Global, 2018-2020)
87

• Adults dominated the market and accounted for 47.2% share
of the overall revenue in 2020. Changing lifestyles and hectic
work schedules among working adults are leading to
nutritional deficiencies, which are expected to lead to the
increased consumption of supplements by adults.
• The increasing prevalence of obesity, cardiovascular diseases,
diabetes, and other related conditions among adults around
the globe is expected to be the key factor driving the market.
• The growing awareness regarding the nutritional
requirements for children and infants is expected to augment
the demand for DS in younger age groups.
88

• The global women health and beauty supplements market
size was valued at USD 49.8 billion in 2019 and is projected to
expand at a compound annual growth rate (CAGR) of 4.75%
from 2020 to 2026.
• Rising incidences of hormonal imbalances as a consequence
of poor dietary habits, the presence of a large women
population suffering from menstrual disorders, increasing
stress levels, obesity, rising geriatric population, mental
health issues, and alcohol consumption are among the driving
factors for market growth.
Source: Grand View Research, Inc, May 2020
89

• Post-menopause female population is more susceptible to
diseases such as anemia, osteoporosis, osteoarthritis (OA),
fibromyalgia, obesity, and depression.
• According to the WHO, 18.0% of women above 60 years have
osteoarthritis globally out of which 80% have movement
limitations and 25% are not able to perform major activities
of daily life. The report adds in 2016, 15% of women were
obese owing to a higher intake of fat-constituted products,
rising physical inactivity.
• High prevalence of such conditions is a key factors driving DS
adoption in women.
Source: Grand View Research, Inc, May 2020
90

• Market research show the higher the educational level
achieved, the more likely it is that a person decide to take DS
(63% of those with a higher university degree, compared to
45% of those with up to secondary education).
• Those currently working are more likely to take DS than those
who are not (51% vs 43%).
• The average consumer had taken 5.36 different supplements.
Women had taken more on average than men (5.64
compared to 5.05).
Source: Food Supplements Consumer Research, Food
Standard Agency, 2018
91

Popular DS Mapped by Age and Gender
• Multivitamins, Vitamin D and Iron
supplements are more popular amongst
women (17% of those who regularly take
DS take iron currently compared to 8% of
men).
• Older women tend to be taking Vitamin B,
calcium and magnesium, and younger
women take more folic acid.
• Amongst men, protein, caffeine and
Amino Acids tend to be most popular
amongst younger men, while garlic is
most popular amongst older men. As well
as fish oils, glucosamine is most popular
amongst older consumers.
92

93
By
Region

Market Insight by Region
• North America emerged as a leading regional market with a
revenue share of 35.7% in 2020 on account of the growing
use of products with high nutritional value.
• The DS products in North America are witnessing a surge in
demand on account of the rising prevalence of lifestyle
related diseases such as obesity, diabetes, etc. The increasing
aging population, hectic lifestyle, and positive attitude
towards preventive healthcare measures are some of the
factors that are fueling the market across the region.
94

• In the United States, the adoption of food supplements is
incredibly high due to higher emphasis on wellness and the
significant presence of fitness enthusiasts who are willing to
purchase health benefits products.
• However, to ensure high quality and safe DS in the U.S.
marketplace, regulatory attention to the commercialization of
DS products has been enhanced in recent years and may slow
the absolute growth of the market.
95

• Asia Pacific is expected to witness significant growth over the
next years. The market will register the fastest compound
annual growth rate of 10.3% during 2020-2027. It is expected
to be the largest regional market by 2027 owing to the
increasing health-consciousness among consumers, which is
motivating them to adopt health-enhancing supplement
products in their daily life. The demand for nutritional
supplements is increasing at a rapid pace in highly populated
countries of the region, such as China and India. The rising
awareness about the concept of personalized nutrition is
predicted to enhance the consumer-base for food
supplements within the region. Source: Fortune Business Insights, August 2020
96

• The European region accounted for a significant revenue
share in 2020 and is expected to expand at a CAGR of 6.8%
over the next five years. Higher consumer awareness and
higher per capita disposable income in the developed
countries, like France, Germany, and the U.K., are expected to
drive the regional market.
• France is the fastest growing dietary supplement market in
Europe.
97

• Asia Pacific and North America represent the bulk of the global
market size and absolute growth.
• North America’s absolute growth is slowing down in 2020 - 2025,
the rest are enduring (WE) or increasing (APAC, LATAM, MENA).
Evolution of Regional Markets 2015-2025
98

Market by Selected Countries
• Countries will have seen various growth rates as different as 24,9% (Egypt) and -9,6% (Thailand) by 2025.
99

100
By
Form

Market Insight by Form
• Globally, the tablet form is the leading form in the global DS
market, followed by capsules. High affordability, convenient
packaging, and higher shelf-life of tablet and capsule
supplements are some of the crucial reasons behind their
high demand in the global market. The dosage is well-defined
in capsules and tablets forms, and hence they are preferred
over liquid and other available forms.
• The surging demand for protein supplements is predicted to
create a massive scope of growth for powder supplements, as
most of the protein supplements available in the market are
present in the powder form.
101

• The powder segment dominated the nutritional supplements
market and accounted for a revenue share of 39.4% in 2020.
• The surging demand for protein supplements is predicted to
create a massive scope of growth for powder supplements, as
most of the protein supplements available in the market are
present in the powder form.
102

• Oral nutritional supplements are semi-solids or powders,
sterile liquids, that offer micro and macro nutrients. Oral
clinical nutrition supplements are useful for the patients who
are suffering from prolonged infection or half-starved
patients for improving their dietary situation. These
supplements consist of fortified/functional food & beverages,
dietary supplements, food intolerance products, and derma-
cosmetic skin essentials.
Source: MarketResearch.biz., 2020
103

Personalized
Nutrition
104

• In recent decades, it has become clear to those in the science
community and to those in the general population that a one-
size-fits-all approach to health and nutrition may not be that
effective. “The American $66 billion diet industry, which churns
out new diet books every day, is proof that many people haven’t
found success with one-size-fits-all approaches,” says Neil
Grimmer, founder and CEO of Habit, a personalized nutrition
company.
Personalized Nutrition
Source: FOOD TECHNOLOGY MAGAZINE, October 2018
105

• Imagine a runner mixing a morning smoothie with supplements
customized to his/her specific metabolism that help him/her hit
peak performance during a race. Or someone with a chronic
illness preparing a meal with the exact nutrients necessary to
keep the condition from getting worse.
• The ability to produce such highly customized nutritional
compounds may sound futuristic, but it is becoming more
commonplace today.
Source: Personalized Nutrition, BCG Insights, 2020
106

• Generalized dietary recommendations may have a limited
impact and often lead to modest improvements; and in many
special conditions may not be effective enough in supplying the
body with its nutritional requirements.
• Personalization of dietary recommendations, by taking into
account specific characteristics of the recipients, may thus
increase effectiveness. In order for these changes to be
efficacious, personalization can be based on biological evidence
and/or personal behaviors, preferences, and objectives.
Source: Trends in Personalized Nutrition, by
Charis M. Galanakis, 2019
107

• Personalized nutrition takes general supplements a step further,
with companies selling DS and related substances that are
tailored to the circumstances or needs of much smaller groups,
and even to specific individuals.
• The industry uses the term “personalized nutrition” to mean
anything from semi-customized products for specific groups,
such as long-distance runners or people with a specific chronic
disease, to fully customized supplements for a single person.
108

• Clearly, age, sex, body size,
level of physical activity, and
genetics cause variations in
nutrition needs, which is why
personalized nutrition is
emerging as a way to monitor
and improve health and
wellness.
Personal
Preferences
Genetics
Physical Traits
& Lifestyle
Dietary Needs
Microbiom
Biomarkers
109

• Genotype-based dietary advice, commonly known as
nutrigenetics, uses individual genetic information to contribute
to personalized nutrition. As a result, there are personalized
nutrition assessments based on genetic information (DNA), some
based on the gut microbiome, and some based on blood
chemistry.
• Currently, like most applied genetic approaches, we are at the
beginning of this interdisciplinary science and nutrigenetics and
nutrigenomics are frontiers yet to be explored and regulated.
Source: Trends in Personalized Nutrition, by
Charis M. Galanakis, 2019
110

• From the perspective of personalized nutrition, everything about
what a person should be eating and why they should be eating it
is embedded in genes.
• Nutritional genomics is the science that investigates the
relationship between our genome and the food that we
consume. One of its goals is to understand how the food
components regulate the expression of our genes and their
effects on the balance between health and disease.
• The other side of the coin of nutritional genomics is to
investigate the genetic basis of the interindividual differences in
response to foods. The study of the genetic basis of these
differences in dietary response is part of nutrigenomics.”
111

• Thus, nutrigenomics emphasizes the effects of nutrients on the
genome and how those interactions influence gene expression
and health outcomes while nutrigenetics emphasizes how
genetic variations determine a person’s response to diet and
nutrition. The personalized nutrition tests that DNAFit, Habit, and
Nutrigenomix provide are based on nutrigenetics. With just a
saliva sample or a cheek swab, these companies say they can
provide individualized nutrient requirements and dietary
recommendations by sequencing and analyzing a person’s
genotype.
112

Source: Genomics in Personalized Nutrition: Can You “Eat for Your
Genes”? Veronica A. Mullins and et al., Nutrients Review, 2020
No one body is the
same!
• Even amongst people of the same
gender, age, and activity level,
there are differences in how we
tolerate, metabolize, and utilize
nutrients, creating the need for
personalized nutrition. In other
words, any healthy person needs
a holistic set of solutions based
on his/her genetic make up.
113

• DNAFit offers four tests: Meal Planner, Fat Burner, Muscle Builder, and Fitness Diet Pro. Meal Planner
(priced at $159) and Fitness Diet Pro (priced at $259) are the two DNAFit tests that pertain directly to
food and nutrition. According to the company’s website, both tests require a saliva sample and
promise to help clients “discover their nutrigenetic profile with an in-depth selection of personalized
insights.”
11
4

• Presently, there is much hype about personalized nutrition,
both in nutritional research and in the food and nutrients
industry. In the former, it comes with a promise to change
how nutrition-related health problems may be addressed,
possibly prevented, or even solved through targeted
nutritional interventions. In the latter, it comes with a
promise of big business perspectives.
• A personalized nutritional program usually consists of, an
exercise plan, home delivery of a selection of personalized
nutritional supplements and an online health tracker topped
the list.
115

• The global personalized nutrition market size is projected to
grow from USD 8.2 billion in 2020 to USD 16.4 billion by 2025,
recording a compound annual growth rate (CAGR) of 15.0%
during the forecast period.
• The increasing demand for personalized solutions is due to:
• The rising health awareness
• Growing trend of digital solutions for healthcare
• Aging population across regions
• The shifting consumer trends, such as an increase in the preference
for high-quality nutritional food, according to their nutrient profile
Source: MarketsandMarkets Research, 2020
116

• When it comes to getting tailored
nutrition solutions just for a
target group, studies show 59%
of millennials and 55% of Gen
Xers express interest— and 37%
of our survey respondents say
they’d be willing to pay for such a
program as long as the price was
“reasonable.” With millennials in
particular, this is win-win, as the
younger they are, the longer the
time horizon is for having them as
a customer.
117

Supplements
in Clinical Care
118

• Emerging scientific findings show the benefits of the intake of
dietary supplements beyond currently recognized health
effects for risk groups like the elderly or people with certain
conditions. The studies highlight how vitamins, minerals,
lipids (EPA and DHA), etc. can play a part in supporting human
health during illness.
Supplements in Clinical Care
119

• Dietary supplements are available without prescription,
however they are increasingly prescribed by medical doctors
to accompany other clinical interventions in treating many
diseases.
• Medical prescription of dietary supplements continues to
increase in the European Union– up to 28% in the last 2
years. Growing awareness of the benefits of consuming
products derived from natural ingredients is the major driver
of this growth.
Medical Prescription of DS
Source: PWC Vitamins & Dietary Supplements
Market Trends Overview, 2020
120

Source: PWC Vitamins & Dietary Supplements
Market Trends Overview, 2020
The Role of DS in both Management of Diseases & Personal Care
121

• So far, it is clear from available scientific research that DS can
go beyond currently recognized health effects, with a number
of emerging therapeutic benefits for over-the-counter
products and prescription medications. Clinical data is clearly
critical to defining how vitamins and lipids should be used
within the pharmaceutical industry.
122

• It is also important to note that in many cases the dietary
malnutrition is a contributing factor for lifestyle-related
diseases that result in hospitalization, many patients enter
the hospital with an existing nutrient deficiency. It has been
estimated that malnutrition may be found in about one third
of hospitalized patients, with an even higher prevalence
(>90%) in elderly populations.
Source: Pharmaceutical Vitamins in Patient Care, DSM
Report, 2019
123

• Thiamine (vitamin B1) for diabetic nephropathy & neuropathy
• Riboflavin (vitamin B2) for hypertension
• Biotin (vitamin B7) for slowing the progress of MS
• Vitamin C and for cancer prevention and reduced risk of
mortality in diagnosed patients
• Vitamin E for non-alcoholic fatty liver, Alzheimer’s disease,
and normalization of the risk for cardiovascular events in
diabetics
• EPA and DHA consumption for Coronary Heart disease,
optimizing the survival of cancer patients, and reducing the
cytotxic effects of chemotherapy
Some examples of the Clinical Uses of DS
124

Dietary Supplements-Factors influencing hospital malnutrition and implications for patient care.
• Malnutrition has numerous
causes and serious
implications for hospitalized
patients which gives even a
more crucial role to tailored
nutritional support in
treating the patients.
Report, 2019
125

Dietary Supplements-Patients at Risk for Vitamin Deficiencies due to Disease States
Report, 2019
• Harm can arise if a
vitamin deficiency risk is
not proactively identified
and managed.
126

Dietary Supplements-Elderly Persons at Risk for Malnutrition
• Nutrition inadequacies and
malnutrition are even more
prevalent under clinical
conditions. There is a particularly
high prevalence of malnutrition
and low intake of vitamins and
lipids in vulnerable populations,
such as ill and/or elderly patients,
as well as patients recovering in
hospitals and other care facilities.
127

• The knowledge that DS can play an important role in disease
management beyond their traditional part in essentiality, can
open up new opportunities to market therapeutic
applications in the pharmaceutical industry.
• More investigation into the effects of dietary supplements
when used in combination with pharmaceuticals is needed,
as well as a clear understanding of their interactions, to
ensure optimal and safe patient treatment.
New Opportunities
128

Adverse
Effects
129

• Both over-the-counter (OTC) and prescription medications
are used every day for health promotion and management of
many health problems. It is estimated that 70% of Americans
take at least one prescription drug, and more than 50% take
two, on a regular basis.
• The patients might be at risk of an adverse drug interaction.
Typically, drug-drug interactions come to mind however,
interactions can also exist between drugs and nutrients. A
drug-nutrient interaction (DNI) is defined as a physical,
chemical, physiological or pathophysiological relationship
between a drug and a nutrient present in a food or a
supplement.
Adverse Effects
Source: Understanding drug-nutrient interactions and
their clinical relevance, DSM Report, 2020
130

• While mostly preventable or curable, failure to identify and
properly manage DNIs can lead to severe, or even life
threatening, consequences and a negative impact on patient
outcomes. One study that examined 458 US patients taking
prescription medicines found that 43% were taking
supplements simultaneously. 45% of this population was at
risk of one or more interactions, of which 6% were potentially
serious.
• Given the increase in the number of drugs on the market,
aging populations and widespread supplement use,
understanding these reactions is crucial.
Adverse Effects
131

Patient, Nutrition, and Drug-related Determinants of DNI
• Groups that are at increased risk of
DNIs:
• Elderly populations
• Patients with chronic conditions
• Patients with allergies or intolerances
• People who are malnourished
• Pregnant women
• Fetuses / infant
132

Adverse Effects
• Among general reasons for the possible harmful effects of DS
and the risk of developing a clinically significant DNI, there
are several factors including:
• Absorption in a short time
• Manufacturing quality and contamination
• Enhancing both positive and negative effects at the same time
• Polypharmacy i.e. concurrent use of multiple medications to
manage different disease states
• Special diets
• Tube feeding
• Alcohol intake or drug abuse
Source: US Federal Trade Commission, 2011
133

Adverse Effects
• In the United States, manufacturers of DS are required to
demonstrate safety of their products before approval is
granted for commerce. Despite this caution, numerous
adverse effects have been reported, including muscle cramps,
hair loss, joint pain, liver disease, and allergic reactions, with
29% of the adverse effects resulting in hospitalization, and
20% in serious injuries or illnesses.
• By more than five-fold, the highest incidence of health
problems derived from "combination products", whereas
supplements for vitamins and minerals, lipid products, and
herbal products were less likely to cause adverse effects.
134

• The study elucidated drugs that frequently interact with DS
such as; warfarin, cyclophosphamide, paclitaxel, NSAIDS, and
vinorelbine, among others.
• Garlic, Green tea, Mistletoe, Iron, St John’s wort, Ginger,
potassium, and Magnesium, are among the most frequently
used supplements that interact with drugs.
• Some of the major DNIs include:
• Contraceptives & Folate
• Metformin & Vitamin B12
• Proton pump inhibitors & vitamins C and B12
• EPA AND DHA as an Adjunct to Cancer Treatment
• Statins & EPA AND DHA
Adverse Effects
135

Adverse Effects
• The incidence of liver injury from herbal and dietary
supplements is about 16–20% of all supplement products
causing injury, with the occurrence growing globally over the
early 21st century. The most common liver injuries from
weight loss and bodybuilding supplements involve
hepatocellular damage with resulting jaundice, and the most
common supplement ingredients attributed to these injuries
are green tea catechins, anabolic steroids, and the herbal
extract, aegeline. Weight loss supplements have also had
adverse psychiatric effects.
136

Adverse Effects
• As discussed, even “natural” supplements can be risky for
people on certain medicines or with certain medical
conditions, and some supplements have been found to be
contaminated with drugs or other chemicals.
• Some of the substances for which safety concerns have been
raised include: comfrey, chaparral, lobelia, germander,
aristolochia, ephedra (ma huang), L-tryptophan, germanium,
magnolia-stephania, and stimulant laxative ingredients, like
those found in dieter’s teas.
137

Adverse Effects
• To decrease the adverse effects a multidimensional approach
is needed:
More in depth
supervision from the
regulatory bodies
Higher quality and
safety standards to be
implemented by
manufacturers
Improved patient
education and
awareness
138

Regulatory
Considerations
139

Regulatory Considerations
• Medicines must be approved by the FDA before they can be
sold or marketed. Supplements do not require this approval.
DS companies are responsible for having evidence that their
products are safe, and the label claims are truthful and not
misleading.
• FDA is not authorized to review DS products for safety and
effectiveness before they are marketed.
140

• Under the Dietary Supplement Health and Education Act
(DSHEA) of 1994, dietary supplement ingredients may be sold
without undergoing a formal FDA approval process.
• The manufacturers and distributors of DS are responsible for
making sure their products are safe before they go to market.
141

• If the DS contains a NEW ingredient, manufacturers must
notify FDA about that ingredient prior to marketing. However,
the notification will only be reviewed by FDA (not approved)
and only for safety, not effectiveness. As long as the product
does not contain a “new dietary ingredient” the company
does not have to provide this safety evidence to the FDA
before the product is marketed.
142

• Manufacturers are required to produce DS in a quality
manner and ensure that they do not contain contaminants or
impurities, and are accurately labeled according to current
Good Manufacturing Practice (cGMP) and labeling
regulations. If a serious problem associated with a DS occurs,
manufacturers must report it to FDA as an adverse event. FDA
can take DS off the market if they are found to be unsafe or if
the claims on the products are false and misleading.
143

• DS are classified as food products, but DSHEA stipulates that such products must be labeled as
“dietary supplements” and be sold in the form of oral products and not be represented for use as
conventional foods.
• The DS label must list all dietary ingredients and the Daily Values (DV) of the amounts contained in a
serving. If no DV has been established for a dietary ingredient, this must be indicated.
• Every manufacturer or distributer of DS has to be in compliance with cGMP requirements.
Source: FDA Administration Office, 2017
144

• The European Union's (EU) Food Supplements Directive of
2002 requires that supplements be demonstrated to be safe,
both in dosages and in purity. Only those supplements that
have been proven to be safe may be sold in the EU without
prescription. As a category of food, food supplements cannot
be labeled with drug claims but can bear health claims and
nutrition claims.
Source: The EU Food Supplements Directive 2002/46/EC
came into force on 1 August 2005
145

• Medical experts and regulatory authorities are concerned
that certified nutraceuticals are still rare in the market.
• Most raw materials used for the manufacture of
nutraceuticals are imported and therefore offer no quality
control.
• Not much data available on how the herbal and botanical
ingredients-that go into the manufacture of nutraceuticals-
are produced.
• Nutraceuticals clearly affect physiology but they are not
submitted to testing process as rigorously as pharmaceutical
drug.
146

• While the majority of DS are not likely to pose a safety concern,
the growth of online sales has fueled an increase in products of
significant risk to public health, for instance:
• DNP is a chemical unfit for human consumption and has been
marketed, sold and consumed as a fat burner. DNP is often
sought by vulnerable consumers, those who are looking to lose
weight or improve muscle definition. Consumption of DNP has
resulted in eight deaths in the UK since 2015.
• MMS is advertised as a cure for a range of conditions including
autism and Ebola, but is essentially a sodium chlorite solution
(bleach). MMS is administered orally, topically and as an enema.
The harm from consuming the substance includes severe damage
to internal organs and difficulties breathing. Source: Food Supplements Consumer Research, Food
Standard Agency, 2018
147

• FDA in 2019 unveiled an advisory
ingredient list as part of the agency’s
efforts announced earlier that same
year to modernize its regulatory
framework over dietary supplements
to meet the demands of a fast-
growing industry.
Source: FDA Administration Office, July, 2021
148

Dietary
Supplements
for a
Healthy Life
149

Dietary Supplements, a Glance at Global Trends

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