Dietary supplement By: Dr. Ahmed Zuhair Shkukani Dr. Muhammad Adnan AL-Qazzaz Supervised 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 FDAabout 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 product3. 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 orare there restrictions on the amount of a nutrient that can be in one serving?• Other than the manufacturers 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 theirproducts 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 products 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 (adisclaimer) 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.
• 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.
Its important to remember thatdietary supplements are designed tosupplement your diet, not to replace nutritious foods
some people may require supplements because thevitamins and/or minerals they need are hard to get inadequate amounts in the diet. These groups include1 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 showthat plenty of people are purchasing supplements. Hereare some of the most popular supplement categories Calcium B vitamins Vitamin C Vitamin D Omega-3 fatty acids Iron
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 incontributing to the development of osteoporosis.Each day we lose some calcium in the urine and feces and to a lesserextent through perspiration. These losses must be balanced byconsuming adequate amounts of calcium.
Source of calciumMany foods contain calcium, but dairy products are the mostsignificant source. Milk ,yogurt, cheeses.Green leafy vegetables such as broccoli, collards, kale, mustardgreens, turnip greens.Other sources of calcium are salmon and sardines canned withtheir soft bones
Calcium needs vary throughout lifeThe recommended dietary intake of calcium is different for people of different ages and lifestages: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 girlsbetween 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 therequirements of both her own growth and the foetus.Breastfeeding women – there is no increased requirement for calciumduring breastfeeding, except for the breastfeeding adolescent, whoneeds an additional 1,300mg per day.Elderly people – 1,300mg per day for women over the age of 50 yearsand men over the age of 70 years.
Calcium CitrateCalcium is best absorbed in an acidicenvironment, hence calcium citrate is thebest absorbed supplemental form ofcalcium. It does not require extra stomachacid for absorption, hence we may take itanytime in a day, even on an emptystomach.If you suffer from acid stomach, it is best toavoid Calcium Citrate.
Calcium CarbonateAbsorption: Calcium Carbonate is alkaline based, itrequires extra stomach acid for better absorption,hence it is best taken right after meals or with a glassof acidic juice such as orange juice.Calcium Content: Calcium Carbonate is the mostprevalent calcium supplements in the market . Itprovides more elemental calcium than CalciumCitrate hence you may not need take as many pills.
Side effects :nausea or vomitingdecreased appetiteconstipationdry mouth or increased thirstincreased urination
Side effects con.calcium inhibits the absorption of ironAdministration of a tetracycline with aluminum, calcium, ormagnesium salts significantly decreases tetracycline serumconcentrations. The proposed mechanism is chelation of tetracyclineby the cation, forming an insoluble complex that is poorly absorbedfrom the gastrointestinal tract.Increase the risk for kidney stones. when urine becomes highlyconcentrated and the calcium oxalate it contains crystallizes (boththe calcium and the oxalate come from the diet)
B vitaminsThe B vitamins are eight water-soluble vitamins that play important roles in cellmetabolism. 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 BVitamin B1 (thiamine) - helps the body convert carbohydrates into energy and helps in themetabolism 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 ofcarbohydrates.Vitamin B5 (pantothenic acid) - promotes a large number of metabolic reactions essentialfor the growthVitamin B6 (pyridoxine, pyridoxal, and pyridoxamine) - is a coenzyme for several enzymesystems involved in the metabolism of proteins, carbohydrates, and fats.
Vitamin B7 (biotin), also known as vitamin H - plays a role in metabolicprocesses 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 nucleicacids and the formation of red blood cells.Vitamin B12 (various cobalamins; commonly cyanocobalamin in vitaminsupplements) - is a complex crystalline compound that functions in all cells, butespecially in those of the gastrointestinal tract, the nervous system, and thebone marrow. It is known to aid in the development of red blood cells in higheranimals.
Deficiency of certain B vitamins can causeAnemiaTirednessloss of appetite, abdominal painDepressionnumbness and tingling in the arms and legsmuscle crampsrespiratory infections, hair losseczema,poor growth in children and birth defects.weaken the immune systemmake the body vulnerable to cancer
NeurotonComposition: Tablet: Each coated tabletcontains:- Thiamine HCl (Vitamin B1) 250mg- Riboflavine phosphate (Vitamin B2) 15mg- Pyridoxine HCl (Vitamin B6) 200mg- Cyanocobalamin (Vitamin B12) 250mcg- Folic acid 500mcgIndications: - 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
Vitamin CFunctionVitamin C is required for the growth and repair oftissues in all parts of your body. It is necessary toform collagen, an important protein used to makeskin, scar tissue, tendons, ligaments, and bloodvessels maintenance of cartilage, bones, and teeth.
Food SourcesAll fruits and vegetables contain some amount of vitamin C.Foods that tend to be the highest sources of vitamin C includegreen peppers, citrus fruits and juices, strawberries, tomatoes,broccoli, turnip greens and other leafy greens, sweet and whitepotatoes, and cantaloupe.
Side Effects :Vitamin C toxicity is very rare, because the body cannotstore the vitamin. However, amounts greater than 2,000mg/day are not recommended because such high doses canlead to stomach upset and diarrhea
Too little vitamin C can lead to signs andsymptoms 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 arestored in the bodys fatty tissue.FunctionIn addition to helping the body absorb calcium, vitamin D also helps the body keep theright amount of calcium and phosphorus in the blood.Food SourcesVitamin D is found in the following foods:Dairy products Cheese Butter CreamFishOystersFortified 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 causehigh levels of calcium in the blood. High blood calcium can lead to calcium deposits insoft 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 muchvitamin D.
Omega-3 fatty acidsare considered essential fatty acids: They are necessary forhuman health but the body can t make them -- you have to getthem through food. Omega-3 fatty acids can be found infish, such as salmon, tuna, and halibut, other seafood includingalgae and, some plants, and nut oils. Also known aspolyunsaturated fatty acids (PUFAs),They have also become popular because they may reduce therisk of heart disease. The American Heart Association recommends eating fish(particularly fatty fish such as mackerel, laketrout, herring, sardines, albacore tuna, and salmon) at least 2times a week.
High cholesterolPeople who follow a Mediterranean-style diet tend to have higher HDL or “good”cholesterol levels, which help promote heart health.Macular DegenerationDiabetesPeople with diabetes often have high triglyceride and low HDL levels. Omega-3fatty acids from fish oil can help lower triglycerides and Apo proteins (markers ofdiabetes), and raise HDL, so eating foods or taking fish oil supplements may helppeople with diabetesRheumatoid arthritisDepressionStudies have found mixed results as to whether taking omega-3 fatty acids canhelp depression symptoms.
AsthmaMenstrual painColon cancerBreast cancerProstate cancerHigh blood pressureSeveral clinical studies suggest that diets or fish oil supplementsrich in omega-3 fatty acids lower blood pressure in people withhypertension.
Do not take more than 3 grams daily of omega-3 fatty acids fromcapsules without the supervision of a health care provider, due to anincreased risk of bleeding.For healthy adults with no history of heart disease: The AmericanHeart Association recommends eating fish at least 2 times per week.For adults with coronary heart disease: The American HeartAssociation recommends an omega-3 fatty acid supplement (as fishoils), 1 gram daily.For adults with high cholesterol levels: The American HeartAssociation recommends an omega-3 fatty acid supplement (as fishoils), 2 - 4 grams.
Side effect :Very high doses may cause some not so desirable fishoil omega 3 side effects such as a fishy body odorand/or "fish breath," including burping a "fishy" smell.In some people, fish oil supplementation has been reported toincrease cholesterol LDL levels. However, others have reportedthat taking garlic supplements can counteract this effect.If you have diabetes, it is recommended that you dont take fish oilsupplements unless your physician recommends it. Some studiesindicate that taking large amounts of fish oil may make it moredifficult to control blood sugar levels.
Fruits suchOf the liver and red meat, chicken, fish as apples, pears and dates and grapes and raisiand eggs and milk. 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 : Decrease the absorption:Fruits such as guava, citrus Drinking tea or coffee or cola after eating direcfruits (oranges, lemons, grapefruit). tlyVegetables suchas tomatoes and eggplant and carrotsandgreen pepper.