dietary supplement health and education act of 1994 definition of dietary supplement is a product...

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).

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

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."

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

Chemistry, Functions, Toxicity

• Steroidal terpenes, cimigoside, acteina, isoflavone, formononetine

• Vascular and estrogen-like action, suppress LH,(?)

• Contraindicated during pregnancy (uterine contraction)

Herb –Drug Interaction

• Anesthetics, antihypertensive, sedatives: may increase hypotensive effect

• Estrogens, hormonal contraceptives: may increase effects.

• Possible interaction with tamoxifen (Nolvadex)

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)


• 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)


• Anticoagulants/antiplatelet• Don’t take with alcohol Disulfiram-like reactions• Don’t take it during breast-feeding

Chamomile

• Actions: Anti-inflammatory, antiseptic, sedative, antispasmodic.

• Medicinal Uses: Gastrointestinal disorders. Calming and sedative effect general relaxation. Children’s cold, eye wash, skin treatment.


• Dose: 1-3 teaspoon decoction

tincture 1-4 ml in a cup water

oil:1-2 drop (1:50 dilution)

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


Antiplatelet and anticoagulants (warfarin, aspirin, heparin, NSAIDs, clopidogrel, eptifibatide, tirofiban, ticlopidine, dipyridamole and COX-2 inhibitors

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.


• Dose: 125-500 mg std ext(eve)

tincture 1-2 teaspoon


• 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


• Enhance anticoagulant effect

• Increased risk of photosensitivity

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.


• Alkylamides, caffeic acid derivatives, polysaccharides, essential oils, polyacetylene flavonoids

• Stimulates phagocytosis, mobility of leucocytes, respiratory cellular activity

• Allergic reactions, angioedema, urticaria, anaphylaxis

Herb –Drug Interaction• Alkylating agents : anticancer therapy drugsazathioprine (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

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


• Doses:250-500 mg/ day

600mg arthritis, hypertension, cardiovascular disorders


• PUFA, gamma linoleic acid

• Anti-inflammatory, intestinal Ca absorption,

• Hypotensive, inhibit gastric mucosal damage

• Headache, mild nausea, arachidonic acid build up


• Avoid concomitant use with phenothiazines.

• Contraindicated in : epilepsy

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


• 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)


• None documented

• potential antithrombic effects

• Potential interaction with nonsteroidal anti-inflammatory drugs (NSAIDs)

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.

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


• Acetaminophen and other drugs metabolized by CYP2E1

• Anticoagulants, NSAIDs, prostacyclin

• Antidiabetics

• Herbs exert anticoagulation, antihyperglycemic effect

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

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.

Precautions and dosage:

Few, if any side effects have been documentedGastric 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 factorInsulin and oral hypoglycemic agents: elevated glucose because increased clearance of insulin and sulfunylureasThiazide diuretics: increased blood pressureTrazodone combination with ginkgo caused coma (in Alzheimer’s)

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


• Doses:0.5-1g of fresh or dried root

500 mg candy, 1-2ml tincture


• 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


• Large doses may increase bleeding time• Large doses cardiac arrhythmias, depression

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


• 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)


• Anticoagulants (warfarin)

• Antidiabetics, insulin; increases hypoglycemic effect

• Drugs metabolized by CYP3A4 (inhibits the enzyme system)

• MAO inhibitors, phenelzine, hypericin (tremor, headache, mania)

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)


• 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


• 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

Hawthorn

• Actions: Cardio tonic, cardioprotective, antioxidant, hypotensive antiarrhytmic

• Medicinal Uses: 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)


• 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


• Antiarrhytmics ; the herb action is similar to class III antiarrhytmics

• Antihypertensive nitrates; increased risk of hypotension

• Cardiac glycosides; increased risk of cardiac toxicity.

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.

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.

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.

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


• 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.


• 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.

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

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

St. John’s Wort

• Actions: Antiviral, nervine, antidepressant, antiseptic

• Medicinal Uses: treatment for mild to moderate depression, neuralgia , sciatica, muscular rheumatism, menopausal anxiety, bruises, shingles


• Doses: 300 mg std ext 0.3% hypericin 3xd 3-6 ml liquid ext

Herb-Drug Interaction• St. John's wort may interact with oral contraceptives• protease inhibitors (such as indinavir and ritonavir

, which are used to treat HIV infection• MAOIs and other antidepressants• immunosuppressant cyclosporine • Cardiac glycosides digoxin • iron supplements• the anticoagulant warfarin

Uva-ursi

• Actions: Astringent, antibacterial, mild diuretic, urinary antiseptic.

• Medicinal Uses: urinary tract infections including cystitis, nephritis, urethritis, yeast infection early stage of genital herpes

• Side effects:low-medium

• Doses: 1 tsp in 0.5 L water boiled for 15 min. 1-4 ml tincture in a glass of water.


• Leaves contain: hydroquinone derivatives; arbutin, methylarbutin, ericolin, ursone, gallic acid ellagic acid, tannin (5-7%)

• Arbutin is hydrolyzed to hydroquinone which acts as a mild astringent and antimicrobial in alkaline urine.

• Ursolic acid is contributing to the diuretic effect.

• Adverse reactions: seizures, tinnitus, nausea, irritation of the bladder and UT mucous membrane, hepatotoxicity.


• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and

Corticosteroids: Arbutin increases the inhibitory action of prednisolone and dexamethazone on contact dermatitis, allergic-type hypersensitivity and arthritis.

• Diuretics: enhanced effects

Valerian

• Actions: Anxiolytic, mild sedative, hypnotic, spasmolytic

• Medicinal Uses: insomnia, nervous unrest, stress and neuralgia, depression and anxiety

• Side effects:low

• Doses: 400-500 mg liquid ext capsules of 100, 250, 380, 400, 445, 475, 500, 1000 mg

tablets 160 mg 550 mg

Chemistry, Functions, Toxicity• Sesquiterpenes (volatile oils) and valepotriates (iridoid

triesters). • Acts via a central adenosine mechanism (partial agonist)

• Inhibits cAMP accumulations

• No clearly identified toxicities in humans • Possible adverse reactions:

CNS: headache, morning drowsiness, restlessness.

CV: cardiac disturbances

GI: GI complaints

Withdrawal symptoms

Drug-herb Interaction• No drug interactions have been reported in humans • Potential reaction with barbiturates and benzodiazepines• Contraindicated while undergoing treatment with

barbiturates• May be helpful in easing withdrawal from

benzodiazepines.

Vitex

• Actions: prolactin inhibitor, dopamine agonist , exert progesteronic effect in women and anti-androgenic in men

• Medicinal Uses: PMS, menstrual irregularities, menopausal symptoms and fibroids, increase lactation, impotence, BPH

• Side effects: none-low

• Doses: 150-330 std ext

(0.5% agnuside) (2xd)


• Iridoid glucosides: agnuside, aucubin luteolin like flavonoids, triterpenoids, alkaloid vitricine.

• Antiandrogenic, anti-inflammatory, progesteronic effect

• Female endocrine, reproductive disorders and hormonal imbalance, ovarian insufficiency inadequate lactation, PMS

• Headache, increased menstrual flow

Drug-herb Interaction

• Antihypertensive (antagonistic effect)

• Beta-blockers: possible risk of hypertensive crisis

StressEvery living organism is maintaining a complex dynamic equilibrium or homeostasis.

Stress is a mutual actions of forces that take place across any section of the body and it is a state of threatened homeostasis.

The human body reacts to stress by activating complex behavioral and physiologic responses.

(Hans Selye)

Herbal Stress Management

Daily mildLemon balm (Melissa officinalis)Tilia europeaSkullcap (Scutellaria sp)Chamomile (Matricaria recutita)Mugwort (Artemissa vulgaris)Oat (Avena sativa)Lavender (Lavendula officinalis)

Short term extremePassionflower (passiflora incarnata)Valerian (Valeriana officinalis)Skulcap (Scutellaria sp)Wild lettuce (Lactuca virosa)

Long standingGinseng (Panax , Quintifolum, Eleutherococcus)

Herbs used in depression:

Mugwort (Artemissa vulgaris)California Poppy (Eschscholtzia californica)St. John’s Wort (Hypericum perforatum)Lemon Balm (Melissa officinalis)Basil (Ocimum basilicum)Passion Flower (Passiflora incarnata)Marijuana (Cannabis sativa)Kava-kava (Piper methysticum)

Herbs used in anxiety and headache

Anxiety Headache• Black Cohos Catnip• Hops black pepper• Jamaican dogwood green tea• Kava-kava damiana• Lemon balm feverfew• Mugwort gingko• St. John’s wort meadosweet• Valerian saffron

rosemarywild gingeryerba matewillow

Herbs used in Common Cold

• Anise Bayberry Burdock Catnip

• Cinnamon Coltsfoot Echinacea Ephedra

• Garlic Hyssop Linden Licorice

• Onion Pau d’arco Pennyroyal Peppermint

• Rose hip Saw palmetto Sweet violet Vervain

• Willow Yarrow Yerba santa Meadowsweet

Herbs used in kidney and bladder disorders

•Asparagus Blackthorn Borage

•Buchu Capsicum Celery

•Coriander Corn silk Devil’s claw

•Horsetail Juniper Marshmallow

•Parsley Pau d’arco Sarsaparilla

•Schisandra Soapwort Stone root

•Uva ursi

dietary supplement health and education act of 1994 definition of dietary supplement is a product...

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