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1. Dietary supplement
By:
Dr. Ahmed Zuhair Shkukani
Dr. Muhammad Adnan AL-Qazzaz
Supervised by
Dr. Jihad Hammad

2. What is a dietary supplement?
• in the Dietary Supplement Health and Education
Act (DSHEA) of 1994,
• A dietary supplement is a product taken by
mouth that contains a "dietary ingredient"
intended to supplement the diet.
• The "dietary ingredients" in these products may
include: vitamins, minerals, herbs or other
botanicals, amino acids, and substances such as
enzymes, organ tissues, glandulars, and
metabolites.

3. Cont…What is a dietary supplement?
• Dietary supplements can also be extracts or
concentrates, and may be found in many forms
such as tablets, capsules, softgels, gelcaps,
liquids, or powders.
• They can also be in other forms, such as a bar,
but if they are, information on their label must
not represent the product as a conventional food
or a sole item of a meal or diet.

4. • Whatever their form may be, DSHEA places
dietary supplements in a special category
under the general umbrella of "foods," not
drugs, and requires that every supplement be
labeled a dietary supplement.

5. "new dietary ingredient“
VS
“dietary supplement”
• The Dietary Supplement Health and Education Act (DSHEA) of 1994
defined both of the terms "dietary ingredient" and "new dietary
ingredient" as components of dietary supplements.
• In order for an ingredient of a dietary supplement to be a "dietary
ingredient," it must be one or any combination of the following
substances:
• 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 (e.g., enzymes or tissues from organs or glands), or
• a concentrate, metabolite, constituent or extract.
• A "new dietary ingredient" is one that meets the above definition for a
"dietary ingredient" and was not sold in the U.S. in a dietary supplement
before October 15, 1994.

6. Dietary Supplement Health and
Education Act 1994
• In October 1994, the Dietary Supplement
Health and Education Act (DSHEA) was signed
into law by President Clinton. Before this time,
dietary supplements were subject to the same
regulatory requirements as were other foods.
• This new law created a new regulatory
framework for the safety and labeling of
dietary supplements.

7. Cont…..
• firm is responsible for determining that the dietary
supplements it manufactures or distributes are safe,
• Manufacturers/distributors are not required to record,
investigate or forward to the FDA any reports of
injuries or illnesses that may be related to use of their
product.

8. Cont…..
• The product must be labeled as a dietary
supplement.
• Information on the product label must not
represent the product as a conventional food
or a sole item of a meal or diet.

9. Cont…..
• Allows for product labeling claims as long as it
does not diagnose, prevent, treat or cure a
specific disease.
• While the statements must be truthful and
not misleading, there is not a review/approval
process by the FDA.

10. When must a manufacturer or distributor notify FDA
about a dietary supplement it intends to market in the
U.S.?
• The Dietary Supplement Health and Education
Act (DSHEA) requires that a manufacturer or
distributor notify FDA if it intends to market a
dietary supplement in the U.S. that contains a
"new dietary ingredient.“
• The manufacturer (and distributor) must
demonstrate to FDA why the ingredient is
reasonably expected to be safe for use in a
dietary supplement.

11. Cont…………
• There is no authoritative list of dietary
ingredients that were marketed before
October 15, 1994. Therefore, manufacturers
and distributors are responsible for
determining if a dietary ingredient is "new",
• and if it is not,
• for documenting that the dietary supplements
its sells, containing the dietary ingredient,
were marketed before October 15, 1994.

12. What information must the manufacturer
disclose on the label of a dietary supplement?
• FDA regulations require that certain information appear on
dietary supplement labels. Information that must be on a
dietary supplement label includes:
1. a descriptive name of the product stating that it is a
"supplement;" ,the name and place of business of the
manufacturer, packer, or distributor;
2. a complete list of ingredients; and the net contents of the
product
3. each dietary supplement (except for some small volume
products or those produced by eligible small businesses)
must have nutrition labeling in the form of a "Supplement
Facts" panel. This label must identify each dietary
ingredient contained in the product.

13. Must all ingredients be declared on the label of
a dietary supplement?
• Yes, ingredients not listed on the "Supplement Facts"
panel must be listed in the "other ingredient"
statement beneath the panel.
• The types of ingredients listed there could include:
1. the source of dietary ingredients, if not identified in
the "Supplement Facts" panel (e.g., rose hips as the
source of vitamin C),
2. other food ingredients (e.g., water and sugar),
3. technical additives or processing aids (e.g., gelatin,
starch, colors, stabilizers, preservatives, and flavors).

16. Are dietary supplement serving sizes standardized or
are there restrictions on the amount of a nutrient that
can be in one serving?
• Other than the manufacturer's responsibility
to ensure safety, there are no rules that limit a
serving size or the amount of a nutrient in any
form of dietary supplements.
• This decision is made by the manufacturer and
does not require FDA review or approval.

17. Where can I get information about a specific
dietary supplement?
• Manufacturers and distributors do not need FDA
approval to sell their dietary supplements.
• This means that FDA does not keep a list of
manufacturers, distributors or the dietary
supplement products they sell.
• If you want more detailed information than the
label tells you about a specific product, you may
contact the manufacturer of that brand directly.
The name and address of the manufacturer or
distributor can be found on the label of the
dietary supplement.

18. Do manufacturers or distributors of dietary supplements have to
tell FDA or consumers what evidence they have about their
product's safety or what evidence they have to back up the claims
they are making for them?
• No, except for rules described above that
govern "new dietary ingredients.
• It is up to each firm.

19. How can consumers inform themselves about safety
and other issues related to dietary supplements?
• manufacturer .
• FDA is providing the following sites:
• Tips For The Savvy Supplement User: Making
Informed Decisions And Evaluating
Information7
• Claims That Can Be Made for Conventional
Foods and Dietary Supplements8

20. Is it legal to market a dietary supplement product as a
treatment or cure for a specific disease or condition?
• No, a product sold as a dietary supplement and
promoted on its label or in labeling as a
treatment, prevention or cure for a specific
disease or condition would be considered an
unapproved--and thus illegal--drug.
• To maintain the product's status as a dietary
supplement, the label and labeling must be
consistent with the provisions in the Dietary
Supplement Health and Education Act (DSHEA) of
1994.

21. what kinds of claims can be made on dietary
supplement labels?
• By law, manufacturers may make three types of claims
for their dietary supplement products:
1. health claims,
2. structure/function claims,
3. and nutrient content claims.
• Some of these claims describe:
• the link between a food substance and disease or a
health-related condition;
• the intended benefits of using the product;
• or the amount of a nutrient or dietary substance in a
product.

22. Why do some supplements have wording (a
disclaimer) that says: "This statement has not
been evaluated by the FDA. This product is
not intended to diagnose, treat, cure, or
prevent any disease"?

23. • This statement is required by law (DSHEA) when a
manufacturer makes a structure/function claim on a
dietary supplement label. In general, these claims describe
the role of a nutrient or dietary ingredient intended to
affect the structure or function of the body. The
manufacturer is responsible for ensuring the accuracy and
truthfulness of these claims; they are not approved by FDA.
For this reason, the law says that if a dietary supplement
label includes such a claim, it must state in a "disclaimer"
that FDA has not evaluated this claim. The disclaimer must
also state that this product is not intended to "diagnose,
treat, cure or prevent any disease," because only a drug can
legally make such a claim.

24. General Concerns

25. • Without regulatory control there is a buyer beware
market
– Dietary supplement advertisements can be
misleading and deceptive
– Claims of effectiveness may not be credible
– The concentration and quality of active
ingredients can differ from product to product

26. Cont…………..
• Study of 12 brands
– 11/12 contained <90% or >110% of amount listed on label
– 5/12 contained at least one ingredient not listed on label
– 2/12 were missing at least one ingredient listed on label
• Study of 240 supplements
– 18.8% contained steroids or pro-hormones not listed on
label

27. • Dietary supplements may adversely interact
with each other as well as prescription
medications.
• Dietary supplements are often utilized as a
short cut to optimal nutritional practices.

28. • There is a lack of quality peer reviewed research
on human subjects.
• The high dosages, utilized by athletes, have not
been well studied.
• The long term side effects are not well studied, if
at all.
• Research has not been equally completed on
men, women and adolescents.

29. It's important to remember that
dietary supplements are designed to
supplement your diet, not to replace
nutritious foods.

30. some people may require supplements because the
vitamins and/or minerals they need are hard to get in
adequate amounts in the diet. These groups include:
1 Pregnant women.
2 Nursing mothers.
3 Strict vegetarians.
4 People with food allergies or intolerances.
6 Those with diseases such as cancer, or kidney,
cardiovascular, or bone disease.

31. Whether they really need them or not, sales figures show
that plenty of people are purchasing supplements. Here
are some of the most popular supplement categories:
Calcium
B vitamins
Vitamin C
Vitamin D
Iron
Omega-3 fatty acids

32. Calcium
Calcium is needed for strong bones.
Heart muscles and nerves .
blood to clot normally.
An inadequate calcium intake is thought to play a significant role in
contributing to the development of osteoporosis.
Each day we lose some calcium in the urine and feces and to a lesser
extent through perspiration. These losses must be balanced by
consuming adequate amounts of calcium.

33. Many foods contain calcium, but dairy products are the most
significant source. Milk ,yogurt, cheeses.
Green leafy vegetables such as broccoli, collards, kale, mustard
greens, turnip greens.
Other sources of calcium are salmon and sardines canned with
their soft bones
Source of calcium

34. Calcium needs vary throughout life
The recommended dietary intake of calcium is different for people of different ages and life
stages:
Babies – from 7–12 months, 270mg per day if breastfed .
350mg per day if bottle fed.
For children aged 1–3 years, 500mg per day.
Young children –4–8 years need around 700mg per day.
1,000mg per day for those aged 9–11 years.
Pre-teens and teenagers –1,300mg per day for both boys and girls
between the ages of 12 and 18 years.
Peak bone mass years – 1,000mg per day.

35. Pregnant women –1,300mg per day of calcium to meet the
requirements of both her own growth and the foetus.
Breastfeeding women – there is no increased requirement for calcium
during breastfeeding, except for the breastfeeding adolescent, who
needs an additional 1,300mg per day.
Elderly people – 1,300mg per day for women over the age of 50 years
and men over the age of 70 years.

36. Calcium Citrate
Calcium is best absorbed in an acidic
environment, hence calcium citrate is the
best absorbed supplemental form of
calcium. It does not require extra stomach
acid for absorption, hence we may take it
anytime in a day, even on an empty
stomach.
If you suffer from acid stomach, it is best to
avoid Calcium Citrate.

37. Absorption: Calcium Carbonate is alkaline based, it
requires extra stomach acid for better absorption,
hence it is best taken right after meals or with a glass
of acidic juice such as orange juice.
Calcium Content: Calcium Carbonate is the most
prevalent calcium supplements in the market . It
provides more elemental calcium than Calcium
Citrate hence you may not need take as many pills.
Calcium Carbonate

38. nausea or vomiting
decreased appetite
constipation
dry mouth or increased thirst
increased urination
Side effects :

39. calcium inhibits the absorption of iron
Administration of a tetracycline with aluminum, calcium, or
magnesium salts significantly decreases tetracycline serum
concentrations. The proposed mechanism is chelation of tetracycline
by the cation, forming an insoluble complex that is poorly absorbed
from the gastrointestinal tract.
Increase the risk for kidney stones. when urine becomes highly
concentrated and the calcium oxalate it contains crystallizes (both
the calcium and the oxalate come from the diet)
Side effects con.

40. The B vitamins are eight water-soluble vitamins that play important roles in cell
metabolism.
B vitamins
List of B vitamins are as follows:
Vitamin B1 (thiamine)
Vitamin B2 (riboflavin)
Vitamin B3 (niacin, includes nicotinic acid and nicotinamide)
Vitamin B5 (pantothenic acid)
Vitamin B6 (pyridoxine, pyridoxal, and pyridoxamine)
Vitamin B7 (biotin), also known as vitamin H
Vitamin B9 (folic acid), also, vitamin M
Vitamin B12 (various cobalamins; commonly cyanocobalamin in vitamin supplements)

41. Key Functions of Vitamin B
Vitamin B1 (thiamine) - helps the body convert carbohydrates into energy and helps in the
metabolism of proteins and fats.
Vitamin B2 (riboflavin) - is required to complete several reactions in the energy cycle.
Vitamin B3 (niacin, includes nicotinic acid and nicotinamide) - helps the metabolism of
carbohydrates.
Vitamin B5 (pantothenic acid) - promotes a large number of metabolic reactions essential
for the growth
Vitamin B6 (pyridoxine, pyridoxal, and pyridoxamine) - is a coenzyme for several enzyme
systems involved in the metabolism of proteins, carbohydrates, and fats.

42. Vitamin B7 (biotin), also known as vitamin H - plays a role in metabolic
processes that lead to the formation of fats and the utilization of carbon dioxide.
Vitamin B9 (folic acid), also, vitamin M - is necessary for the synthesis of nucleic
acids and the formation of red blood cells.
Vitamin B12 (various cobalamins; commonly cyanocobalamin in vitamin
supplements) - is a complex crystalline compound that functions in all cells, but
especially in those of the gastrointestinal tract, the nervous system, and the
bone marrow. It is known to aid in the development of red blood cells in higher
animals.

43. Deficiency of certain B vitamins can cause
Anemia
Tiredness
loss of appetite, abdominal pain
Depression
numbness and tingling in the arms and legs
muscle cramps
respiratory infections, hair loss
eczema,
poor growth in children and birth defects.
weaken the immune system
make the body vulnerable to cancer

44. Neuroton
Composition: Tablet: Each coated tablet
contains:
- Thiamine HCl (Vitamin B1) 250mg
- Riboflavine phosphate (Vitamin B2) 15mg
- Pyridoxine HCl (Vitamin B6) 200mg
- Cyanocobalamin (Vitamin B12) 250mcg
- Folic acid 500mcg
Indications: -
Acute or chronic neuritis
Diabetic neuritis
Painful neuropathies including; polyneuritis and rheumatic pain
Toxic damage of the nerve tissue due to drugs, chemicals, or alcohol
Megaloblastic and pernicious anemia
Cheilosis, glossitis, scaly dermatitis and angular stomatitis
Metabolic disorders

45. Function
Vitamin C is required for the growth and repair of
tissues in all parts of your body. It is necessary to
form collagen, an important protein used to make
skin, scar tissue, tendons, ligaments, and blood
vessels maintenance of cartilage, bones, and teeth.
Vitamin C

46. Food Sources
All fruits and vegetables contain some amount of vitamin C.
Foods that tend to be the highest sources of vitamin C include
green peppers, citrus fruits and juices, strawberries, tomatoes,
broccoli, turnip greens and other leafy greens, sweet and white
potatoes, and cantaloupe.

47. Side Effects :
Vitamin C toxicity is very rare, because the body cannot
store the vitamin. However, amounts greater than 2,000
mg/day are not recommended because such high doses can
lead to stomach upset and diarrhea

48. Too little vitamin C can lead to signs and
symptoms of deficiency :
Dry and splitting hair
Gingivitis (inflammation of the gums)
Bleeding gums
Rough, dry, scaly skin
Decreased wound-healing rate
Easy bruising
Nosebleeds
Weakened tooth enamel
Swollen and painful joints
Anemia
Decreased ability to fight infection
Possible weight gain because of slowed metabolism
A severe form of vitamin C deficiency is known as scurvy,
which mainly affects older, malnourished adults.

49. Vitamin D
is a fat-soluble vitamin that helps the body absorb calcium. Fat-soluble vitamins are
stored in the body's fatty tissue.
Function
In addition to helping the body absorb calcium, vitamin D also helps the body keep the
right amount of calcium and phosphorus in the blood.
Food Sources
Vitamin D is found in the following foods:
Dairy products
Cheese
Butter
Cream
Fish
Oysters
Fortified cereals
Margarine
Side Effects of Vitamin D
Vitamin D deficiency can lead to osteoporosis in adults or rickets in children.
Too much vitamin D can make the intestines absorb too much calcium. This may cause
high levels of calcium in the blood. High blood calcium can lead to calcium deposits in
soft tissues such as the heart and lungs. This can reduce their ability to function.
Kidney stones, vomiting, and muscle weakness may also occur if you have too much
vitamin D.

50. Omega-3 fatty acids
are considered essential fatty acids: They are necessary for
human health but the body can' t make them -- you have to get
them through food. Omega-3 fatty acids can be found in fish,
such as salmon, tuna, and halibut, other seafood including
algae and, some plants, and nut oils. Also known as
polyunsaturated fatty acids (PUFAs),
They have also become popular because they may reduce the
risk of heart disease.
The American Heart Association recommends eating fish
(particularly fatty fish such as mackerel, lake trout, herring,
sardines, albacore tuna, and salmon) at least 2 times a week.

51. High cholesterol
People who follow a Mediterranean-style diet tend to have higher HDL or “good”
cholesterol levels, which help promote heart health.
Diabetes
People with diabetes often have high triglyceride and low HDL levels. Omega-3
fatty acids from fish oil can help lower triglycerides and Apo proteins (markers of
diabetes), and raise HDL, so eating foods or taking fish oil supplements may help
people with diabetes
Rheumatoid arthritis
Depression
Studies have found mixed results as to whether taking omega-3 fatty acids can
help depression symptoms.
Macular Degeneration

52. Asthma
Menstrual pain
Colon cancer
Breast cancer
Prostate cancer
High blood pressure
Several clinical studies suggest that diets or fish oil supplements
rich in omega-3 fatty acids lower blood pressure in people with
hypertension.

53. Do not take more than 3 grams daily of omega-3 fatty acids from
capsules without the supervision of a health care provider, due to an
increased risk of bleeding.
For healthy adults with no history of heart disease: The American
Heart Association recommends eating fish at least 2 times per week.
For adults with coronary heart disease: The American Heart
Association recommends an omega-3 fatty acid supplement (as fish
oils), 1 gram daily.
For adults with high cholesterol levels: The American Heart
Association recommends an omega-3 fatty acid supplement (as fish
oils), 2 - 4 grams.

54. Very high doses may cause some not so desirable fish
oil omega 3 side effects such as a fishy body odor
and/or "fish breath," including burping a "fishy" smell.
In some people, fish oil supplementation has been reported to
increase cholesterol LDL levels. However, others have reported
that taking garlic supplements can counteract this effect.
If you have diabetes, it is recommended that you don't take fish oil
supplements unless your physician recommends it. Some studies
indicate that taking large amounts of fish oil may make it more
difficult to control blood sugar levels.
Side effect :

55. Iron :
Hemorrhage
Pregnancy
Anima

56. Of the liver and red meat, chicken, fish
and eggs and milk.
Fruits such
as apples, pears and dates and grapes and raisi
ns and mangoes.
Mallow and vegetables such
as spinach and cabbage and watercress.
Legumes such
as lentils, beans, peas and chickpeas.
Grains such as wheat, oats, corn, and others.
Increase the absorption :
Fruits such as guava, citrus
fruits (oranges, lemons, grapefruit).
Vegetables such
as tomatoes and eggplant and carrots
and
green pepper.
Decrease the absorption:
Drinking tea or coffee or cola after eating direc
tly

57. Alternatives to Supplementation

58. • Appropriate diet and nutritional practices.
• Appropriate weight training and conditioning.
• Appropriate rest and recovery.
• Appropriate goal setting.