Dietary supplement

By: Dr. Ahmed Zuhair Shkukani

Dr. Muhammad Adnan AL-QazzazSupervised by

Dr. Jihad Hammad

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.

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.

• 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.

"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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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

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.

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.

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"?

• 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.

General Concerns

• 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

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

• 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.

• 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.

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

nutritious foods.

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.

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

IronOmega-3 fatty acids

CalciumCalcium 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.

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

Calcium needs vary throughout lifeThe 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.

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.

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.

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

nausea or vomiting

decreased appetite

constipation

dry mouth or increased thirst

increased urination

Side effects :

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.

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)

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.

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.

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

NeurotonComposition: 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

FunctionVitamin 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

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.

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

Too little vitamin C can lead to signs and symptoms of deficiency :

Dry and splitting hairGingivitis (inflammation of the gums)Bleeding gumsRough, dry, scaly skinDecreased wound-healing rateEasy bruisingNosebleedsWeakened tooth enamelSwollen and painful jointsAnemiaDecreased ability to fight infectionPossible weight gain because of slowed metabolismA severe form of vitamin C deficiency is known as scurvy, which mainly affects older, malnourished adults.

Vitamin D is a fat-soluble vitamin that helps the body absorb calcium. Fat-soluble vitamins are stored in the body's fatty tissue.FunctionIn 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 SourcesVitamin D is found in the following foods:Dairy products

CheeseButterCream

FishOystersFortified cerealsMargarineSide Effects of Vitamin DVitamin 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.

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.

High cholesterolPeople who follow a Mediterranean-style diet tend to have higher HDL or “good” cholesterol levels, which help promote heart health.

DiabetesPeople 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

DepressionStudies have found mixed results as to whether taking omega-3 fatty acids can help depression symptoms.

Macular Degeneration

Asthma

Menstrual pain

Colon cancer

Breast cancer

Prostate cancer

High blood pressureSeveral clinical studies suggest that diets or fish oil supplements rich in omega-3 fatty acids lower blood pressure in people with hypertension.

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.

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 :

Iron :

Hemorrhage

Pregnancy

Anima

Of the liver and red meat, chicken, fish and eggs and milk.

Fruits such as apples, pears and dates and grapes and raisins 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 directly

Alternatives to Supplementation

• Appropriate diet and nutritional practices.

• Appropriate weight training and conditioning.

• Appropriate rest and recovery.

• Appropriate goal setting.