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DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994

DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994. DEFINITION OF DIETARY SUPPLEMENT

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DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994

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  1. DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 DEFINITION OF DIETARY SUPPLEMENT is a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: 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 daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients. is intended for ingestion in pill, capsule, tablet, or liquid form. is not represented for use as a conventional food or as the sole item of a meal or diet. is labeled as a "dietary supplement." includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

  2. SAFETY • Under DSHEA a dietary supplement is adulterated if it or one of its ingredients presents "a significant or unreasonable risk of illness or injury" when used as directed on the label, or under normal conditions of use (if there are no directions). • A dietary supplement that contains a new dietary ingredient (i.e., an ingredient not marketed for dietary supplement use in the U.S. prior to October 15, 1994) may be adulterated when there is inadequate information to provide reasonable assurance that the ingredient will not present a significant or unreasonable risk of illness or injury • The Secretary of HHS may also declare that a dietary supplement or dietary ingredient poses an imminent hazard to public health or safety

  3. NUTRITIONAL SUPPORT STATEMENTS • Claims may not be made about the use of a dietary supplement to diagnose, prevent, mitigate, treat, or cure a specific disease (For example, a product may not carry the claim "cures cancer" or "treats arthritis." ) • Appropriate health claims authorized by FDA--such as the claim linking folic acid and reduce risk of neural tube birth defects and the claim that calcium may reduce the risk of osteoporosis--may be made in supplement labeling if the product qualifies to bear the claim. • Manufacturers may describe the supplement's effects on "structure or function" of the body or the "well-being" achieved by consuming the dietary ingredient. To use these claims, manufacturers must have substantiation that the statements are truthful and not misleading and the product label must bear the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

  4. Black Cohosh • Action: Antispasmodic, regulates menses, astringent, diuretic, cough suppressant, and diaphoretic. Astringent and sedative. • Medicinal uses: Delayed painful menstruation and ovarian cramps. Menopausal symptoms Rheumatic pains, muscular and neurological pain. • Side effects: low • Dose:20-80mg std ext. (2xd) 250-550 mg freeze dried root

  5. Chemistry, Functions, Toxicity • Steroidal terpenes, cimigoside, acteina, isoflavone, formononetine • Vascular and estrogen-like action, suppress LH,(?) • Contraindicated during pregnancy (uterine contraction)

  6. Herb –Drug Interaction • Anesthetics, antihypertensive, sedatives: may increase hypotensive effect • Estrogens, hormonal contraceptives: may increase effects. • Possible interaction with tamoxifen (Nolvadex)

  7. Bilberry • Actions: vasoprotective, anti-edema, anti-inflammatory, astringent. • Medicinal uses:acute diarrhea and mild inflammation of the mucus membranes. Prevent capillary fragility (eye disorders, macular degeneration)Varicose veins, thrombosis and angina. • Side effects:none • Dose: 80-100mg std ext (2xd)

  8. Chemistry, Functions, Toxicity • Active components:Anthocyanoside, tannins, flavonoids • Reduction of vascular permeability and tissue edema, aid in micro vascular blood flow, retina, macular degeneration • Hepatic dysfunction (if tannin high)

  9. Herb –Drug Interaction • Anticoagulants/antiplatelet • Don’t take with alcohol Disulfiram-like reactions • Don’t take it during breast-feeding

  10. Chamomile • Actions: Anti-inflammatory, antiseptic, sedative, antispasmodic. • Medicinal Uses: Gastrointestinal disorders. Calming and sedative effect general relaxation. Children’s cold, eye wash, skin treatment. • Side effects: low • Dose: 1-3 teaspoon decoction tincture 1-4 ml in a cup water oil:1-2 drop (1:50 dilution)

  11. Chemistry, Functions, Toxicity • Volatile oils: α-bisabolol, chamazulene, (↓ inflammation, fever) flavonoids: apeginin, luteolin, quercetin (inflammation, sedative, antioxidant) • CNS action is through benzodiazepine receptors • Orally used to treat diarrhea, anxiety, restlessness, flatulence , teas mainly used for sedation or relaxation. • Topically reduce inflammation, induce healing of wounds and burns • Toxicity: contact dermatitis, allergic reactions GI; nausea, vomiting Anaphylaxis in case of extreme sensitivity

  12. Herb –Drug Interaction Antiplatelet and anticoagulants (warfarin, aspirin, heparin, NSAIDs, clopidogrel, eptifibatide, tirofiban, ticlopidine, dipyridamole and COX-2 inhibitors

  13. Dong Quai • Actions:adaptogenic, restores menstrual regularity, reduces PMS, prevents anemia, digestive bitter • Medicinal uses: Female hormonal balance, high iron content (anemia treatment), promotes circulation and bile secretion. • Side effects: low • Dose: 125-500 mg std ext(eve) tincture 1-2 teaspoon

  14. Chemistry, Functions, Toxicity • At least six coumarin derivatives (anticoagulant, vasodilating, antispasmodic activity) • N-buthylphtalide, nicotinic acid, safrole, • Vitamins; A, E, B12 • Weak estrogen-agonist activity, treats blood deficiency, chronic hepatitis and cirrhosis, irregular menstruation. • High dose cytotoxic, bleeding tendency ,first trimester abortive) don’t use in acute virus infection

  15. Herb –Drug Interaction • Enhance anticoagulant effect • Increased risk of photosensitivity

  16. Echinacea • Actions: immuno-stimulant, anti-inflammatory, vulnerary, lymphatic. • Medicinal Uses: preventive use in case of colds and flu at early stage of infections. Wound and burns. Infections of urinary tract. Inflammation of the mouth and pharynx. • Side effects: low • Doses: tincture15-30 drops 2-5 times the first day /2x the following days.

  17. Chemistry, Functions, Toxicity • Alkylamides, caffeic acid derivatives, polysaccharides, essential oils, polyacetylene flavonoids • Stimulates phagocytosis, mobility of leucocytes, respiratory cellular activity • Allergic reactions, angioedema, urticaria, anaphylaxis

  18. Herb –Drug Interaction • Alkylating agents : anticancer therapy drugs azathioprine (Imuran) CellCept cyclosporine (Neoral, Sandimmune) Prograf Rapamune Zenapak • Liver enzyme influence/clearance • Allergy drugs such as Allegra • Antifungal drugs such as ketoconazole (Nizoral) and Sporanox • Cancer drugs such as etoposide, paclitaxel, vinblastine, or vincristine • Drugs for high cholesterol such as lovastatin • midazolam (Versed) • Oral contraceptives

  19. Evening Primrose • Actions: Anti-inflammatory, anti-allergic, corrects omega-6 deficiency, hypotensive • Medicinal Uses: PMS, atopic dermatitis, rheumatoid arthritis, CFS, ulcerative colitis, IBS, hypertension, mastalgia • Side effects: low • Doses:250-500 mg/ day 600mg arthritis, hypertension, cardiovascular disorders

  20. Chemistry, Functions, Toxicity • PUFA, gamma linoleic acid • Anti-inflammatory, intestinal Ca absorption, • Hypotensive, inhibit gastric mucosal damage • Headache, mild nausea, arachidonic acid build up

  21. Herb –Drug Interaction • Avoid concomitant use with phenothiazines. • Contraindicated in : epilepsy

  22. Feverfew • Actions: Anti-inflammatory, vasodilator, anti-pyretic, antispasmodic, bitter • Medicinal Uses: Prophylaxis and treatment of migraine. Cough, colds, febrile diseases, nervous debility, worm infestation, dyspepsia. • Side effects: low-medium • Doses: 50-200 mg/day tincture 5-20 drops

  23. Chemistry, Functions, Toxicity • Sesquiterpene lactons: parthenolide, (and derivatives) canin, balchanin, volatile oils, flavonols. • Extracts inhibit the release of serotonin from platelets • Inhibits platelet aggregation • Inhibits arachidonic acid pathway, (prostaglandins and leukotrienes) • Inhibits release of granule contents from white blood cells • Contraindicated in pregnancy, inflammation of oral mucosa (ulceration)

  24. Herb –Drug Interaction • None documented • potential antithrombic effects • Potential interaction with nonsteroidal anti-inflammatory drugs (NSAIDs)

  25. Garlic • Action: Lipid lowering, Anti-hypertensive, anti-thrombic, anti-oxidant, anti-fungal, anti-bacterial anti-tumor • Medicinal Uses: lower serum cholesterol and triglyceride elevate HDL, treatments of infections, high blood pressure , Stroke and cancer of GI tract prevention. • Side effects: low-medium • Doses: up to 1 g of std ext 2-5mg allicin.

  26. Chemistry, Functions, Toxicity • alliin, converted by the enzyme alliinase to allicin. • Functions: Antibacterial/Antifungal- Antimycotic/Antiviral- Hypoglycemic - Anticoagulant (antiplatelet aggregating) - Fibrinolytic activity enhancement - Lipid lowering- Antioxidant/Anticancer - Hypotensive - Hepatoprotective- Immunomodulatory • Large oral intakes can lead to gastrointestinal symptoms, changes to intestinal flora and allergic reactions. • Garlic is contraindicated before surgery

  27. Herb –Drug Interaction • Acetaminophen and other drugs metabolized by CYP2E1 • Anticoagulants, NSAIDs, prostacyclin • Antidiabetics • Herbs exert anticoagulation, antihyperglycemic effect

  28. Gingko • Actions: Anti-PAF, anti-oxidant, circulatory stimulant, vasodilation. • Medicinal Uses: effective in the management of cerebral insufficiency, dementia and circulatory disorders. Altitude sickness, tinnitus, PMS, headache, migraine, eye problems, allergies • Side effects: very low • Doses: 120-160mg/day std ext

  29. Indications: Traditionally known as an anti-microbial & anti-tubercular agent, new research has shown a profound activity on brain function and cerebral circulation. Clinically it is proving effective in a range of vascular disorders.

  30. Precautions and dosage: Few, if any side effects have been documented Gastric disturbance , headache and allergic skin reaction observed after prolonged administration. Dosage: Typical daily dose is 120-160mg. Available in capsules 40,60 or 120 mg of a concentrated (50:1) leaf extract. Tincture: 1-2 ml. Interaction: anticoagulants, antiplatelet (affects) platelet activating factor Insulin and oral hypoglycemic agents: elevated glucose because increased clearance of insulin and sulfunylureas Thiazide diuretics: increased blood pressure Trazodone combination with ginkgo caused coma (in Alzheimer’s)

  31. Ginger • Actions: Antiemetic, anti-inflammatory, digestive stimulant, antiplatelet, spasmolytic, carminative. • Medicinal uses: relieving motion sickness, used in variety of GI disorder, prevent lipid peroxidation, treat parasitic infections, circulatory stimulant (positive inotropic), arthritis • Side effects: low • Doses:0.5-1g of fresh or dried root 500 mg candy, 1-2ml tincture

  32. Chemistry, Functions, Toxicity • volatile oils and nonvolatile pungent compounds (zingeberene, curcumene, farnesene, and gingerol, shogaol) • The following functions have been tested experimentally: • Anti-emetic activity, Antiserotoninergic activity and gastrointestinal motility effect, • Muscular contractility in the gastrointestinal tract. • Ability to neutralize toxins and anti-tumor effect. • Anti-inflammatory effect. • Immune system potentiation • Platelet aggregation ,Fibrinolysis • No toxicity (at pharmacologic dose) don’t use it for morning sickness

  33. Herb –Drug Interaction • Large doses may increase bleeding time • Large doses cardiac arrhythmias, depression

  34. Ginseng (Panax) • Actions: Adaptogenic, tonic, immunomodulator, cancer preventive. • Medicinal Uses: general performance under stress, congestive heart failure, elevates HDL, impotency, non-insulin dependent diabetes, preventive in certain types of cancer. • Side effects: low • Doses:05-2g dried root • 1-5ml tincture

  35. Chemistry, Functions, Toxicity • Ginsenosides, biotin, B1,B2, B12, panthotenic acid, nicotinic acid, • Increase T-cell activity, stimulates interferon , HDL production, accelerate nuclear RNA production • Ginseng abuse syndrome (increased motor activity, diarrhea, nervousness, insomnia, hypertension, edema)

  36. Herb –Drug Interaction • Anticoagulants (warfarin) • Antidiabetics, insulin; increases hypoglycemic effect • Drugs metabolized by CYP3A4 (inhibits the enzyme system) • MAO inhibitors, phenelzine, hypericin (tremor, headache, mania)

  37. Goldenseal • Actions: antispasmodic, weak antibiotic, expectorant, laxative, bitter hepatic. • Medicinal Uses: stimulate bile secretion, inflammatory conditions of the mucous membranes (respiratory, GI,) external applications • Side effects:low-medium • Doses: 250-300 mg fd ext. 05-1g dried root (capsule)

  38. Chemistry, Functions, Toxicity • Alkaloids, berberine, hydrastine, volatile oils, chlorogenic acid • Anti-inflammatory, antihemorrhagic, immunomodulatory, muscle relaxant, hydrastin causes peripheral vasoconstriction, berberine antibacterial • CNS depression, paralysis, seizures • Asystole, bradycardia, respiratory depression • Abdominal cramp nausea, diarrhea • Anemia, leukoppenia • Contact dermatitis

  39. Herb –Drug Interaction • Anticoagulants , sedatives, proton pump inhibitors (H2 antagonists), allergic drugs, antidepressants • Unpredictable: ACE inhibitors such as captopril, enalapril, lisinopril, and Monopril • Beta blockers such as atenolol, metoprolol, and propranolol • Calcium channel blockers such as nifedipine, Norvasc, and verapamil • Diuretics such as Dyazide, furosemide, and hydrochlorothiazide

  40. Hawthorn • Actions: Cardio tonic, cardioprotective, antioxidant, hypotensive antiarrhytmic • MedicinalUses: traditional drug to treat heart problems, hypertension, diuretic for kidney problems • Side effects: none • Doses: 1-3g flower leaves or berry, by infusion fluid extract 3-6 ml, tincture: 1-2 ml (3xd)

  41. Chemistry, Functions, Toxicity • Flavonoids and procyanidins primarily responsible for action • cAMP phosphodiesterase inhibition, slowly developing actions. • The combined pharmacological effects are positively inotropic, chronotropic and dromotropic. Its negative bathmotropic effect makes this herb unique among anti-arrhythmic drugs, plus antilipidemic. • No toxicity has been noted

  42. Herb –Drug Interaction • Antiarrhytmics ; the herb action is similar to class III antiarrhytmics • Antihypertensive nitrates; increased risk of hypotension • Cardiac glycosides; increased risk of cardiac toxicity.

  43. Kava-kava (Piper methysticum) Parts used : roots, rhizomes Properties: bitter, pungent, warming herb, diuretic, relieves pain, relaxes spasm, stimulant effect on circulatory and nervous system Constituents: kava lactones / pyrones, kavain, dihydro-kavain methysticin, yangonine, Medicinal use: nervous anxiety, stress, restlessness, insomnia The sedative effect of kava-pyrones might be mediated via the GABA-A receptor.

  44. Precautions and dosage: Patients should not use kava without first obtaining medical advice, and doses should not exceed 300 mg/day. In one clinical trial using WS 1490, the occurrence of adverse effects was rare. Only two reports (stomach upset in both cases) were rated as “possibly related.” The most commonly reported adverse effect of kava usage is kava dermopathy—a yellow, scaly, leprosy-like eruption of the skin and inflammation of the eyes. The drug contraindicated during pregnancy or nursing. It is also contraindicated in patients with endogenous depression because it increases the danger of suicide. Daily dose: equivalent of 60 to 120 mg kava lactones.

  45. Possible interaction between kava-lactones and pharmaceutical drugs. The drug may enhances the effectiveness of barbiturates and other psychopharmacological agents. Kava lactons inhibit Cytochrome P-450 Drug clearance is slowing down, extended effect or toxicity Deficiency of CYP2D6 (7-9% of Caucasian population) People should avoid kava predisposed to liver problem or already taking drugs that have adverse effect on the liver.

  46. Milk thistle • Actions: hepatoprotective, antioxidant, cholerectic • Medicinal Uses: regeneration of hepatocytes, cirrhosis, poisonous, alcoholic liver damage, fatty liver, expelling gallstone. • Side effects:none –low • Doses: 140 mg (2xd std for sylimarine) 1-5ml tincture

  47. Chemistry, Functions, Toxicity • Silymarin may stimulate the action of nucleolar polymerase A, resulting in an increase in ribosomal protein synthesis, thereby stimulating the regenerative ability of the liver and the formation of new hepatocytes. • Silybin, the active constituent of silymarin has been reported to work as an antioxidant, scavenging free radicals.

  48. Herb –Drug Interaction • Aspirin: improve clearance in patients with cirrhosis • Cisplatin: prevent kidney damage • Disulfiram: drugs containing alcohol may cause disulfiram like reactions • Tacrine: reduces adverse cholinergic effects • Hepatotoxic drugs: prevent liver damage caused by butyrophenones, phenothiazines, phenytoin, acetaminophen, and halothane.

  49. Saw Palmetto • Actions: Diuretic, urinary antiseptic, anti-inflammatory, spasmolytic, endocrine agent • Medicinal Uses: treat mild to moderate BPH, inflammation of respiratory and genitourinary tract • Side effects: none-low • Doses:160 mg (2xd std lipophylic ext) or 2-4 ml tincture

  50. Chemistry, Functions, Toxicity • It contains sterols, flavonoids, water-soluble polysacharides and fatty oil. • Antiandrogenic, antiestrogenic and anti-inflammatory actions • The oily fraction inhibits in vitro testosterone 5a-reductase activity, an enzyme in male hormone metabolism. 5 a-reductase converts testosterone to dihydrotestosterone. The overproduction of dihydrotestosterone is responsible for prostate enlargement. • No toxic or health hazard, occasional stomach complaints

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