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
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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.
• 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
• 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)
• 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
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
Herb –Drug Interaction
• 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
• 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
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.
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
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.
• Doses: 140 mg (2xd std for sylimarine) 1-5ml tincture
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.
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.
• 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
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
• 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.
Herb –Drug Interaction
• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and
Corticosteroids: Arbutin increases the inhibitory action of prednisolone and dexamethazone on contact dermatitis, allergic-type hypersensitivity and arthritis.
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