Transcript dietary supplement health and education act of 1994

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, antiedema, 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)
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)
Herb –Drug Interaction
• 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.
• Side effects: low
• 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
Herb –Drug Interaction
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.
• Side effects: low
• Dose: 125-500 mg std ext(eve)
tincture 1-2 teaspoon
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
Herb –Drug Interaction
• 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.
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
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
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
Chemistry, Functions, Toxicity
• PUFA, gamma linoleic acid
• Anti-inflammatory, intestinal Ca absorption,
• Hypotensive, inhibit gastric mucosal
damage
• Headache, mild nausea, arachidonic acid
build up
Herb –Drug Interaction
• 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
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)
Herb –Drug Interaction
• None documented
• potential antithrombic effects
• Potential interaction with nonsteroidal antiinflammatory drugs (NSAIDs)
Garlic
• Action: Lipid lowering, Antihypertensive, anti-thrombic,
anti-oxidant, anti-fungal, antibacterial 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 25mg 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
Herb –Drug Interaction
• Acetaminophen and other drugs
metabolized by CYP2E1
• Anticoagulants, NSAIDs, prostacyclin
• Antidiabetics
• Herbs exert anticoagulation,
antihyperglycemic effect
Gingko
• Actions: Anti-PAF, antioxidant, 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 & antitubercular 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 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)
Ginger
• Actions: Antiemetic, antiinflammatory, 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
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, noninsulin dependent diabetes,
preventive in certain types of
cancer.
• Side effects: low
• Doses:05-2g dried root
• 1-5ml tincture
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)
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)
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. 051g dried root (capsule)
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
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
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)
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
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
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
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.
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 5areductase 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
• Side effects: low
• 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.
Chemistry, Functions, Toxicity
• 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.
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.
• 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)
Chemistry, Functions, Toxicity
• 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
Stress
Every 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 mild
Lemon balm (Melissa officinalis)
Tilia europea
Skullcap (Scutellaria sp)
Chamomile (Matricaria recutita)
Mugwort (Artemissa vulgaris)
Oat (Avena sativa)
Lavender (Lavendula officinalis)
Short term extreme
Passionflower (passiflora incarnata)
Valerian (Valeriana officinalis)
Skulcap (Scutellaria sp)
Wild lettuce (Lactuca virosa)
Long standing
Ginseng (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)
Anxiety
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Black Cohos
Hops
Jamaican dogwood
Kava-kava
Lemon balm
Mugwort
St. John’s wort
Valerian
Herbs used in anxiety
and headache
Headache
Catnip
black pepper
green tea
damiana
feverfew
gingko
meadosweet
saffron
rosemary
wild ginger
yerba mate
willow
Herbs used in Common Cold
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Anise
Cinnamon
Garlic
Onion
Rose hip
Willow
Bayberry
Burdock
Coltsfoot
Echinacea
Hyssop
Linden
Pau d’arco
Pennyroyal
Saw palmetto Sweet violet
YarrowYerba santa
Catnip
Ephedra
Licorice
Peppermint
Vervain
Meadowsweet
Herbs used in kidney and bladder disorders
•Asparagus
•Buchu
•Coriander
•Horsetail
•Parsley
•Schisandra
•Uva ursi
Blackthorn
Capsicum
Corn silk
Juniper
Pau d’arco
Soapwort
Borage
Celery
Devil’s claw
Marshmallow
Sarsaparilla
Stone root