Title: DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994
1DIETARY 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).
2SAFETY
- 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
3NUTRITIONAL 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."
4Black 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
- Dose20-80mg std ext. (2xd)
- 250-550 mg freeze dried root
5Chemistry, Functions, Toxicity
- Steroidal terpenes, cimigoside, acteina,
isoflavone, formononetine - Vascular and estrogen-like action, suppress
LH,(?) - Contraindicated during pregnancy (uterine
contraction)
6Herb Drug Interaction
- Anesthetics, antihypertensive, sedatives may
increase hypotensive effect - Estrogens, hormonal contraceptives may increase
effects. - Possible interaction with tamoxifen (Nolvadex)
7Bilberry
- Actions vasoprotective, anti-edema,
anti-inflammatory, astringent. - Medicinal usesacute diarrhea and mild
inflammation of the mucus membranes. Prevent
capillary fragility (eye disorders, macular
degeneration)Varicose veins, thrombosis and
angina. - Side effectsnone
- Dose 80-100mg std ext (2xd)
8Chemistry, Functions, Toxicity
- Active componentsAnthocyanoside, tannins,
flavonoids - Reduction of vascular permeability and tissue
edema, aid in micro vascular blood flow, retina,
macular degeneration - Hepatic dysfunction (if tannin high)
9Herb Drug Interaction
- Anticoagulants/antiplatelet
- Dont take with alcohol Disulfiram-like reactions
- Dont take it during breast-feeding
10Chamomile
- Actions Anti-inflammatory, antiseptic, sedative,
antispasmodic. - Medicinal Uses Gastrointestinal disorders.
Calming and sedative effect general relaxation.
Childrens cold, eye wash, skin treatment. - Side effects low
- Dose 1-3 teaspoon decoction
- tincture 1-4 ml in a cup water
- oil1-2 drop (150 dilution)
11Chemistry, Functions, Toxicity
- Volatile oils a-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
12Herb Drug Interaction
- Antiplatelet and anticoagulants (warfarin,
aspirin, heparin, NSAIDs, clopidogrel,
eptifibatide, tirofiban, ticlopidine,
dipyridamole and COX-2 inhibitors
13Dong Quai
- Actionsadaptogenic, 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
14Chemistry, 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) dont use in acute virus
infection
15Herb Drug Interaction
- Enhance anticoagulant effect
- Increased risk of photosensitivity
16Echinacea
- 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.
17Chemistry, Functions, Toxicity
- Alkylamides, caffeic acid derivatives,
polysaccharides, essential oils, polyacetylene
flavonoids - Stimulates phagocytosis, mobility of leucocytes,
respiratory cellular activity - Allergic reactions, angioedema, urticaria,
anaphylaxis
18Herb 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
19Evening 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
- Doses250-500 mg/ day
- 600mg arthritis, hypertension, cardiovascular
disorders
20Chemistry, Functions, Toxicity
- PUFA, gamma linoleic acid
- Anti-inflammatory, intestinal Ca absorption,
- Hypotensive, inhibit gastric mucosal damage
- Headache, mild nausea, arachidonic acid build up
21Herb Drug Interaction
- Avoid concomitant use with phenothiazines.
- Contraindicated in epilepsy
22Feverfew
- 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
23Chemistry, 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)
24Herb Drug Interaction
- None documented
- potential antithrombic effects
- Potential interaction with nonsteroidal
anti-inflammatory drugs (NSAIDs)
25Garlic
- 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.
26Chemistry, 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
27Herb Drug Interaction
- Acetaminophen and other drugs metabolized by
CYP2E1 - Anticoagulants, NSAIDs, prostacyclin
- Antidiabetics
- Herbs exert anticoagulation, antihyperglycemic
effect
28Gingko
- 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
29Indications 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.
30Precautions 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 (501) 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
Alzheimers)
31Ginger
- 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
- Doses0.5-1g of fresh or dried root
- 500 mg candy, 1-2ml tincture
32Chemistry, 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) dont use it
for morning sickness
33Herb Drug Interaction
- Large doses may increase bleeding time
- Large doses cardiac arrhythmias, depression
34Ginseng (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
- Doses05-2g dried root
- 1-5ml tincture
35Chemistry, 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)
36Herb Drug Interaction
- Anticoagulants (warfarin)
- Antidiabetics, insulin increases hypoglycemic
effect - Drugs metabolized by CYP3A4 (inhibits the enzyme
system) - MAO inhibitors, phenelzine, hypericin (tremor,
headache, mania)
37Goldenseal
- Actions antispasmodic, weak antibiotic,
expectorant, laxative, bitter hepatic. - Medicinal Uses stimulate bile secretion,
inflammatory conditions of the mucous membranes
(respiratory, GI,) external applications - Side effectslow-medium
- Doses 250-300 mg fd ext. 05-1g dried root
(capsule)
38Chemistry, 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
39Herb 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
40Hawthorn
- 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)
41Chemistry, 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
42Herb 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.
43Kava-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.
44Precautions 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 dermopathya
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.
45Possible 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.
46Milk thistle
- Actions hepatoprotective, antioxidant,
cholerectic - Medicinal Uses regeneration of hepatocytes,
cirrhosis, poisonous, alcoholic liver damage,
fatty liver, expelling gallstone. - Side effectsnone low
- Doses 140 mg (2xd std for sylimarine) 1-5ml
tincture
47Chemistry, 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.
48Herb 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.
49Saw 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
- Doses160 mg (2xd std lipophylic ext) or 2-4 ml
tincture
50Chemistry, 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
51St. Johns 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
52Herb-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
53Uva-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 effectslow-medium
- Doses 1 tsp in 0.5 L water boiled for 15 min.
1-4 ml tincture in a glass of water.
54Chemistry, 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.
55Herb 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
56Valerian
- Actions Anxiolytic, mild sedative, hypnotic,
spasmolytic - Medicinal Uses insomnia, nervous unrest, stress
and neuralgia, depression and anxiety - Side effectslow
- Doses 400-500 mg liquid ext capsules of 100,
250, 380, 400, 445, 475, 500, 1000 mg - tablets 160 mg 550 mg
57Chemistry, 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
58Drug-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.
59Vitex
- 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)
60Chemistry, 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
61Drug-herb Interaction
- Antihypertensive (antagonistic effect)
- Beta-blockers possible risk of hypertensive
crisis
62Stress
- 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)
63Herbal 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)
64Herbs used in depression Mugwort (Artemissa
vulgaris) California Poppy (Eschscholtzia
californica) St. Johns Wort (Hypericum
perforatum) Lemon Balm (Melissa
officinalis) Basil (Ocimum basilicum) Passion
Flower (Passiflora incarnata) Marijuana (Cannabis
sativa) Kava-kava (Piper methysticum)
65Herbs 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. Johns wort meadosweet
- Valerian saffron
- rosemary
- wild ginger
- yerba mate
- willow
66Herbs used in Common Cold
- Anise Bayberry Burdock Catnip
- Cinnamon Coltsfoot Echinacea Ephedra
- Garlic Hyssop Linden Licorice
- Onion Pau darco Pennyroyal Peppermint
- Rose hip Saw palmetto Sweet violet Vervain
- Willow Yarrow Yerba santa Meadowsweet
67Herbs used in kidney and bladder disorders
- Asparagus Blackthorn Borage
- Buchu Capsicum Celery
- Coriander Corn silk Devils claw
- Horsetail Juniper Marshmallow
- Parsley Pau darco Sarsaparilla
- Schisandra Soapwort Stone root
- Uva ursi