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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
2EPA 34th Annual Conference
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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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
EPA 34th Annual Conference
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
EPA 34th Annual Conference
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
EPA 34th Annual Conference
I
N
T
Tolerable Upper Intake
A
K
E
RDA
10EPA 34th Annual Conference
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
*
**
***
EPA 34th Annual Conference
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
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
EPA 34th Annual Conference
– ≥ 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.
EPA 34th Annual Conference
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.
37EPA 34th Annual Conference
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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