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ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION 34 th Annual Conference 1 Nutrition and Dietary Supplements Motuma Adimasu (B. Pharm, M.Sc., MPH) Venue: African Union Conference Hall August 23 – 24, 2014 Addis Ababa EPA 34th Annual Conference

Nutrition and Dietary Supplements

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The Power point briefs about the introduction to Nutrition as a Science and Dietary Supplements, and how they are regulated in various countries.

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ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION ETHIOPIAN PHARMACEUTICAL ASSOCIATION

34th Annual Conference

1

Nutrition and Dietary Supplements

Motuma Adimasu (B. Pharm, M.Sc., MPH)

Venue: African Union Conference HallAugust 23 – 24, 2014Addis Ababa

EPA 34th Annual Conference

Outline of the presentation

• Introduction:

– Nutrition, DRI & Nutrition through life cycle

• Dietary Supplements• Dietary Supplements

– Benefits and Concerns

– Label Claims

– Regulatory Framework

• Summary

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Introduction

Nutrition:

– foods and the nutrients they contain,

– the action of these foods and nutrients in the body,

– the progress by which an individual:– the progress by which an individual:

• ingest, digest, absorb, transport, metabolize, and excrete food substances

• Nutrition:

– the action, interaction, and balances of nutrients in relation to

health and disease,

– How food influences our health.

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Why do we study Nutrition?

• Access to Food – is Human Right!!

• The cost of malnutrition is very big to accept!!

– Close to 1 billion global population go to bed without

dinner,dinner,

– Coexistence of Malnutrition as:

• Under-nutrition – characterize LDCs

• Over-nutrition – the new face of Global Health Problems

– Confounded by inappropriate nutritional behaviors

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> 1

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Lack of Access in the world of Plenty!!

Malnutrition:

• Lowers cognitive performance and physical productivity

• Accentuates Poverty Cycle & degrades Economic Development

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YET, Nutrition is a Major, Modifiable, and Powerful Factor in:

• promoting health,

• preventing and treating disease, and

• improving quality of life.

Comparing Nutrients in Foods & our Body

Macronutrients Micronutrients

Protein

Vitamins

Composition of Foods

1 2

Water

Carbohydrate

Fat

Vitamins

Minerals

7

Energy yielding Non-Energy yielding

3

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Composition of Human Body

FATS:

•13 to 21 % in Young Men

Proteins, Carbohydrates,

Vitamins, Minerals, and

others.

8

Water – 60 %

•13 to 21 % in Young Men

•23 to 31% in Young Women

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How much is Good? How much is Healthy?

•• DietaryDietary ReferenceReference Intakes(DRIs)Intakes(DRIs): set of standards that define:

– the amounts of energy, nutrients, other dietary components, and physical

activity, that best support health.

• Serves as:

• guide for good nutrition: Canada, US, UK tables for DRI• guide for good nutrition: Canada, US, UK tables for DRI

• bases for the development of food guidelines.

• DRIs include:

– Estimated Average Requirement(EAR)

–– RecommendedRecommended DietaryDietary Allowance(RDA)Allowance(RDA)

–– AdequateAdequate IntakeIntake (AI)(AI)

– Tolerable Upper Intake Level(UL)

9

Nutritional Goals

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I

N

T

Tolerable Upper Intake

A

K

E

RDA

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RDA or AI

Estimated Average Requirement

Nutrition in the Lifecycle

• All people need thethe samesame nutrientsnutrients.

• The amount to eat or DRI recommendations vary based on:

– Gender:

• Men & Women• Men & Women

– Age:

• Pregnant and Lactating Women; children, teens & adults; Elderly

– Level of Physical Activity:

• Sedentary, Low Active, Active & Very Active

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***Focus is on the

1000days when

impact is greatest!

Impact Window in the life cycle, ..

Children

aged 6- 23

months

Pregnant &

lactating

women

Infants

aged 0–6

months

*

**

***

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Women of child

bearing age

Adolescent girls

Children aged 5-

12 years

Children

aged 24-59

months

12

IMPACT

WINDOW

(the 1000 days)When is Critical?

• Early period of

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CRITICAL PERIOD

(1st 60 days)

Why Critical?

• Critical Growth

• Fetal Programming

Pregnancy

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The critical period for neural tube development – from 17 to 30 days gestation.

• Needs the vitamin folate.

• Folate deficiency – Neural Tube Defects

Spina bifida - split spineAnencephaly – no brain

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• Critical because:

– Impact is Irreversible!

– ≥ ½ of all pregnancies

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– ≥ ½ of all pregnancies

worldwide

• unplanned!

16

1

2

3

Fig: Critical Periods in Fetal Development

•• AttemptsAttempts toto avoidavoid deficiencydeficiency ofof CriticalCritical NutrientsNutrients::

-- Diet/FoodDiet/Food ApproachApproach –– balancedbalanced dietdiet forfor everyevery oneone

-- SupplementationSupplementation ApproachApproach -- targetedtargeted

-- ClinicalClinical ApproachApproach -- targetedtargeted

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Nutrition Intervention Priorities

Special Emphasis to the

Critical Period!

Target the

Impact Window!

Life cycle Nutrition!

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Dietary Supplements

• Also known as: Food Supplements or Nutritional Supplements,

• Dietary Supplement is a product that:

– Is intended to SupplementSupplement thethe Diet,Diet,

– Contains one or more dietary ingredients– Contains one or more dietary ingredients

• vitamins, minerals, herbs ,amino acids or other botanicals, etc.

– Is intended to be taken by mouth, as:

• tablet, capsule, powder, softgel, gelcap, or liquid

– Is labeled as being a DietaryDietary SupplementSupplement.

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Dietary Supplements Situation:

• The Dietary Supplement industry and market is booming.

– Global Sales in 2004: $70–250 billion.

– Demand increased at annual rate of 8% from 1994 to 2001.

– Only 4000 Dietary Supplement in 1994.

– An estimated 75,000 Dietary Supplements in 2008.

• 1,000 new products each year.

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• Why do most people take Dietary Supplements?

–– DietaryDietary InsuranceInsurance::

• in case they are not meeting their nutrient needs from

foods alone.

–– HealthHealth InsuranceInsurance::

• to protect themselves against certain diseases.

JUSTJUST ININ CASECASE APPROACH!!APPROACH!!

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Megadosing: “if a little is a good, more has to be better.”

“Natural is safe” and “Natural is better!”

“It’s been used for thousands of years, so it must work!”

COMMON

MYTHS,

Regarding

“It can’t hurt to take supplements along with my regular medicines!”

“FDA wouldn’t let them make that claim if it wasn’t true!”

“If it could hurt you, they wouldn’t be allowed to sell it!”

Regarding

Dietary Supplements!!

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Dietary Supplement use

• Correct Overt Deficiencies – e.g., Zinc deficiency, Vit A deficiency, etc

• Support Increased Nutrient Needs, e.g. pregnancy & lactationpregnancy & lactation

• Improve Nutrition Status

• Improve the Body’s Defenses

• Reduce Disease Risks – associated with deficiencies!• Reduce Disease Risks – associated with deficiencies!

• Quality and Safety concerns

• Nutrient imbalances and/or toxicities – unlike foods

• Life-Threatening Misinformation – e.g., Megadosing of Vitamin cures disease

• Unknown Needs

• False Sense of Security – e.g., my supplement will cover my needs

• Bioavailability and Antagonistic Actions

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Supplement use, ctd …

• Nutrients in Foods Vs Supplements:

InIn FoodsFoods::

– nutrients are diluted and dispersed among other substances.

• Best absorbed by the body as such.

DietaryDietary SupplementsSupplements::

– Nutrients as Pure & Concentrated form – likely to interfere with:

• Each other’s absorption or

• with the absorption of nutrients in foods eaten at the same time.

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Betacarotene

(Vit A precursor)

Vitamin E

Long term use as

a supplement

Antagonism among Minerals and Vitamins

Interferes

metabolismA

nta

go

nize

s

Vitamin E

Vitamin K

MINERALS VITAMINS25EPA 34th Annual Conference

Who Needs Supplements?

• Most adults can normally get all the nutrients they need by eating a varied

diet of nutrient-dense foods.

• Thus, Dietary Supplements usage should be limited to people with:

– Specific nutrient deficiencies,

– Low energy intakes ( ≤1600 kcal per day),

– Vegetarians (vegans),

– Lactose Intolerance or Milk allergies

– Special stages of the life cycle - increased nutrient requirements.

– Inadequate milk intakes, limited sun exposure, or heavily pigmented skin –

Vitamin D.

– have diseases, infections, or injuries, etc – as result need more doses

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Dietary Supplements Labels

• Regulation requires

claims to be:

• Facts about most of the claims:

– Based on anecdotal evidence:

– True,

– Not misleading, &

– Clear to the consumer.

• personal experiences or opinions

• Not based on objective &

controlled research studies.

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Label Claims, ctd …

• Three different types of claims are available:

– Nutritional Claims

– Qualified Health Claims or Structure-Function Claims

– Health Claims

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Label Claims, ctd …

• Nutritional claims:

– Statements about:

‘the effect Dietary Supplements have on diseases known to be

caused by nutrient deficiency.’caused by nutrient deficiency.’

– For example, “vitamin C prevents scurvy.”

– Regulation?

• Do not need approval.

• But, the claim must also state prevalence of the disease.

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Label Claims, ctd …

• Qualified Health Claims or Structure-Function claims:

– Released in 2003, these are the most confusing claims made.

– Statements about:

‘the effect of the dietary supplement on the structure or function of

the body.’the body.’

– E.g., Builds strong bones, Boosts the immune system

– Regulation?

• Must be followed by a disclaimer:

“This“This statementstatement hashas NOTNOT BEENBEEN EVALUATEDEVALUATED byby thethe FDAFDA.. ThisThis productproduct isis notnot

intendedintended toto diagnose,diagnose, treat,treat, cure,cure, oror preventprevent anyany diseasedisease..””

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Label Claims, ctd …

•• HealthHealth ClaimsClaims::

– Are statements describing:

‘a positive relationship between a supplement and a health-related

condition (or disease)’.

• They are not therapeutic or disease-related claims.

– No statement as: mitigate, cure, treat, or diagnosis can be used!!

– Regulation?

• Subject to rigorousrigorous assessment!assessment!

•• OnlyOnly 1414 claimsclaims havehave beenbeen authorizedauthorized toto datedate..

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Regulation of Dietary Supplements

US - Dietary Supplement Health and Education Act (DSHEA), 1994

•• FDAFDA::

– No provisions in the law for astringent regulation of Dietary Supplements

• No evaluation of safety,safety, efficacyefficacy or qualityquality of ingredients or products.

– Once marketed, the FDA has the responsibility to show that a Dietary

Supplement is ‘unsafe’

•• ManufacturerManufacturer and/orand/or DistributorsDistributors areare::

– Responsible for ensuring supplements are safe before marketing.

– Not required by law to record,record, investigateinvestigate, or forwardforward any reports they

receive of adverse reactions: injuries or illnesses

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Regulation, ctd …

EU – Food Supplement Directive 2002/46/EC

• The Directive provides a list of vitamins and minerals

that are safe to use in food supplements,

– There are 112 vitamins and minerals on the “positive list”– There are 112 vitamins and minerals on the “positive list”

• Pre-approved list.

• If not on the list, it must receive premarket approval.

– takes 2 – 3 yrs,

– costs as much as: $119,000 – $372,000.

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Regulation, ctd …

Ethiopia: FMHACA – Food Supplement Directive:

•• ToTo acquireacquire MarketMarket AuthorizationAuthorization::

– Certificate of GMP and free sale certificates.

– Health Certificate (or certificate of otherwise from Embassy).

•• ForFor Import,Import, Export,Export, WholesaleWholesale oror DistributionDistribution::

– Certificate of competence – issued upon:

• fulfillment of requirements for location, building materials &

work force.

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Regulation, ctd …

– Technical Personnel must have B. Sc. in:

» Pharmacy,

» Food Science and Nutrition,

» Food Science and Technology, or Food Engineering.» Food Science and Technology, or Food Engineering.

•• SupplySupply ChainChain requirementsrequirements::

– An importer only sells to a wholesaler.

– A wholesaler only sales to Pharmacy, Drug Store & Special

Shops.

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Regulation of Drugs Vs Dietary Supplements, summary!!

• Drugs are considered

unsafe until proven safe!

– For Safety, Efficacy and

Effectiveness tests:

• Pre-clinical, Clinical

• Dietary supplements are considered safe

until proven unsafe!

– Manufacturers are responsible for:

• Ensuring safety, and

• Label information – is truthful and not

misleading.

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trials, & PMS,

• The responsibility of

Manufacturer.

misleading.

– Manufacturers must follow “cGMPs”

• Minimum set of standards (Consistency,

contamination, etc.).

• They are voluntary not mandatory

– Once on the market, FDA must prove that

the supplements are unsafe.

• Intended to Supplement the diet!!

Intended to Diagnose, prevent,

treat, or Cure a disease!! 36

Summary

• Taking Supplements:

– Mostly, harmless practice but costly;

– Sometimes, however, both costly and harmful to health.

• For the most part,• For the most part,

– People self-prescribe supplements, or

– Take under the recommendation of Healthcare Professionals.

– Usually without valid nutrition assessment.

• Even in this case, the preferred course of action is:

–– toto improveimprove foodfood choiceschoices andand eatingeating habitshabits.

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Summary, ctd …

• When choosing Dietary Supplements:

– Form, Content & Cost – is very important

• No matter what they claim, Dietary Supplements are not intended to:

– treat, diagnose, cure, or relieve the effects of diseases.

Products that are proven to have a significant effect on any disease are– Products that are proven to have a significant effect on any disease are

considered drugs and strictly regulated.

• Dietary supplements are considered safe until proven unsafe!

– Manufacturers are regulated under:

‘No‘No convictionconviction untiluntil provenproven guilty’guilty’ notion!notion!

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