Dietary Supplements in Complementary Medicine
RENATODALMACIO
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Aug 06, 2024
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About This Presentation
Dietary Supplements
Slide Content
Dietary SupplementsDietary Supplements
Foods or Drugs?Foods or Drugs?
Complementary & Alternative MedicineComplementary & Alternative Medicine
11
Foods or Drugs?Foods or Drugs?
Complementary & Alternative MedicineComplementary & Alternative Medicine
11
22
What is a Dietary Supplement?What is a Dietary Supplement?
Definition: Definition: (Sec 3.)(Sec 3.)
–A A productproduct (other than tobacco) (other than tobacco) intendedintended to to
supplementsupplement the diet that bears or contains the diet that bears or contains
one or more of the following dietary ingredientsone or more of the following dietary ingredients
VitaminsVitamins
MineralsMinerals
Herbs or other botanicalsHerbs or other botanicals
Amino acidsAmino acids
Concentrate, metabolite, constituent, extract or Concentrate, metabolite, constituent, extract or
combination of above listed ingredientscombination of above listed ingredients
What is a Dietary Supplement?What is a Dietary Supplement?
Definition: Definition: (Sec 3.)(Sec 3.)
–A A productproduct (other than tobacco) (other than tobacco) intendedintended to to
supplementsupplement the diet that bears or contains the diet that bears or contains
one or more of the following dietary ingredientsone or more of the following dietary ingredients
VitaminsVitamins
MineralsMinerals
Herbs or other botanicalsHerbs or other botanicals
Amino acidsAmino acids
Concentrate, metabolite, constituent, extract or Concentrate, metabolite, constituent, extract or
combination of above listed ingredientscombination of above listed ingredients
Dietary Supplement Health and Dietary Supplement Health and
Education Act of 1994 (DSHEA)Education Act of 1994 (DSHEA)
Reclassified botanicals as dietary supplements, Reclassified botanicals as dietary supplements,
distinct from food or drugsdistinct from food or drugs
Plant extracts, enzymes, vitamins, minerals, Plant extracts, enzymes, vitamins, minerals,
hormonal products available without prescription hormonal products available without prescription
may carry “structure-function” claimsmay carry “structure-function” claims
Cannot claim to prevent or cure specific Cannot claim to prevent or cure specific
conditionsconditions
Must display disclaimer, “This statement has not Must display disclaimer, “This statement has not
been evaluated by the Food and Drug been evaluated by the Food and Drug
Administration. This product is not intended to Administration. This product is not intended to
diagnose, treat, cure or prevent any disease.”diagnose, treat, cure or prevent any disease.”
Education Act of 1994 (DSHEA)Education Act of 1994 (DSHEA)
Reclassified botanicals as dietary supplements, Reclassified botanicals as dietary supplements,
distinct from food or drugsdistinct from food or drugs
Plant extracts, enzymes, vitamins, minerals, Plant extracts, enzymes, vitamins, minerals,
hormonal products available without prescription hormonal products available without prescription
may carry “structure-function” claimsmay carry “structure-function” claims
Cannot claim to prevent or cure specific Cannot claim to prevent or cure specific
conditionsconditions
Must display disclaimer, “This statement has not Must display disclaimer, “This statement has not
been evaluated by the Food and Drug been evaluated by the Food and Drug
Administration. This product is not intended to Administration. This product is not intended to
diagnose, treat, cure or prevent any disease.”diagnose, treat, cure or prevent any disease.”
44
Dietary SupplementsDietary Supplements
Traditionally defined as products made of Traditionally defined as products made of
one or more essential nutrients such as one or more essential nutrients such as
vitamins, minerals, and proteins, but…vitamins, minerals, and proteins, but…
DSHEA broadened definition to include DSHEA broadened definition to include
almost any product intended for almost any product intended for
ingestion as a supplement to the dietingestion as a supplement to the diet
Must be identified on label as a D/SMust be identified on label as a D/S
Dietary SupplementsDietary Supplements
Traditionally defined as products made of Traditionally defined as products made of
one or more essential nutrients such as one or more essential nutrients such as
vitamins, minerals, and proteins, but…vitamins, minerals, and proteins, but…
DSHEA broadened definition to include DSHEA broadened definition to include
almost any product intended for almost any product intended for
ingestion as a supplement to the dietingestion as a supplement to the diet
Must be identified on label as a D/SMust be identified on label as a D/S
55
Dietary SupplementsDietary Supplements
Distinguished from DrugsDistinguished from Drugs::
–Drug = Drug = article intended to diagnose, cure, article intended to diagnose, cure,
mitigate, treat, or prevent diseasemitigate, treat, or prevent disease
–Both intended to affect Both intended to affect structurestructure and and
functionfunction of body of body
–Drug must undergo FDA approval after clinical Drug must undergo FDA approval after clinical
studies to determine effectiveness and safetystudies to determine effectiveness and safety
–D/S = no pre-market testingD/S = no pre-market testing
Dietary SupplementsDietary Supplements
Distinguished from DrugsDistinguished from Drugs::
–Drug = Drug = article intended to diagnose, cure, article intended to diagnose, cure,
mitigate, treat, or prevent diseasemitigate, treat, or prevent disease
–Both intended to affect Both intended to affect structurestructure and and
functionfunction of body of body
–Drug must undergo FDA approval after clinical Drug must undergo FDA approval after clinical
studies to determine effectiveness and safetystudies to determine effectiveness and safety
–D/S = no pre-market testingD/S = no pre-market testing
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History of Dietary History of Dietary
SupplementsSupplements
1938 Act established standards of identity 1938 Act established standards of identity
for vitamins and mineralsfor vitamins and minerals
Proxmire AmendmentsProxmire Amendments extended FDA extended FDA
jurisdiction to advertising of Vits and minsjurisdiction to advertising of Vits and mins
–Prohibited FDA from setting max limits on Prohibited FDA from setting max limits on
potencypotency
–Forbade FDA from classifying supplements as Forbade FDA from classifying supplements as
drugsdrugs
History of Dietary History of Dietary
SupplementsSupplements
1938 Act established standards of identity 1938 Act established standards of identity
for vitamins and mineralsfor vitamins and minerals
Proxmire AmendmentsProxmire Amendments extended FDA extended FDA
jurisdiction to advertising of Vits and minsjurisdiction to advertising of Vits and mins
–Prohibited FDA from setting max limits on Prohibited FDA from setting max limits on
potencypotency
–Forbade FDA from classifying supplements as Forbade FDA from classifying supplements as
drugsdrugs
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History of Dietary History of Dietary
SupplementsSupplements
1990 Nutritional Labeling and Education 1990 Nutritional Labeling and Education
ActAct
–Permitted use of therapeutic claims made about Permitted use of therapeutic claims made about
vits/minsvits/mins
1994 President Clinton signed 1994 President Clinton signed Dietary Dietary
Supplement, Health and Education ActSupplement, Health and Education Act
(DSHEA) into law(DSHEA) into law
Defined D/SDefined D/S as as ““separate regulatory separate regulatory
category of food”category of food”
History of Dietary History of Dietary
SupplementsSupplements
1990 Nutritional Labeling and Education 1990 Nutritional Labeling and Education
ActAct
–Permitted use of therapeutic claims made about Permitted use of therapeutic claims made about
vits/minsvits/mins
1994 President Clinton signed 1994 President Clinton signed Dietary Dietary
Supplement, Health and Education ActSupplement, Health and Education Act
(DSHEA) into law(DSHEA) into law
Defined D/SDefined D/S as as ““separate regulatory separate regulatory
category of food”category of food”
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DSHEADSHEA
Created Created Office of Dietary SupplementsOffice of Dietary Supplements
within National Institute of Health (NIH)within National Institute of Health (NIH)
Permits statements of nutritional Permits statements of nutritional
support including support including structurestructure and and
functionfunction claims claims
After passage of DSHEA, sales After passage of DSHEA, sales
increased to 13 billion per yearincreased to 13 billion per year..
DSHEADSHEA
Created Created Office of Dietary SupplementsOffice of Dietary Supplements
within National Institute of Health (NIH)within National Institute of Health (NIH)
Permits statements of nutritional Permits statements of nutritional
support including support including structurestructure and and
functionfunction claims claims
After passage of DSHEA, sales After passage of DSHEA, sales
increased to 13 billion per yearincreased to 13 billion per year..
99
Dietary Dietary
SupplementsSupplements
Distinguished from FoodsDistinguished from Foods::
–Foods not Foods not intendedintended to affect to affect structurestructure
and and functionfunction
–D/S intended only to D/S intended only to supplementsupplement diet diet
Not represented for use as conventional Not represented for use as conventional
foodfood
Not intended as Not intended as sole item of a mealsole item of a meal or or
the diet”the diet”
Dietary Dietary
SupplementsSupplements
Distinguished from FoodsDistinguished from Foods::
–Foods not Foods not intendedintended to affect to affect structurestructure
and and functionfunction
–D/S intended only to D/S intended only to supplementsupplement diet diet
Not represented for use as conventional Not represented for use as conventional
foodfood
Not intended as Not intended as sole item of a mealsole item of a meal or or
the diet”the diet”
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Dietary Dietary
SupplementsSupplements
No premarket approvalNo premarket approval
Manufacturer responsible for safety Manufacturer responsible for safety
evaluationevaluation
If D/S contains a If D/S contains a new ingredientnew ingredient::
–Manufacturer must submit information that Manufacturer must submit information that
ingredient “ingredient “can reasonably be expected can reasonably be expected
to be safe”to be safe” within 75 days of marketing within 75 days of marketing
–Safe = no significant risk of illnessSafe = no significant risk of illness
Dietary Dietary
SupplementsSupplements
No premarket approvalNo premarket approval
Manufacturer responsible for safety Manufacturer responsible for safety
evaluationevaluation
If D/S contains a If D/S contains a new ingredientnew ingredient::
–Manufacturer must submit information that Manufacturer must submit information that
ingredient “ingredient “can reasonably be expected can reasonably be expected
to be safe”to be safe” within 75 days of marketing within 75 days of marketing
–Safe = no significant risk of illnessSafe = no significant risk of illness
1111
Good Manufacturing Good Manufacturing
PracticesPractices
DSHEA authorized DSHEA authorized specific GMPsspecific GMPs for D/S for D/S
–LimitationsLimitations
Cannot impose standard if Cannot impose standard if no “available no “available
analytical methodology”analytical methodology”
–““that exist only in the minds of the inspector”that exist only in the minds of the inspector”
Cannot impose standard not promulgated Cannot impose standard not promulgated
under under Administrative Procedure ActAdministrative Procedure Act
–subjected to public commentsubjected to public comment
Good Manufacturing Good Manufacturing
PracticesPractices
DSHEA authorized DSHEA authorized specific GMPsspecific GMPs for D/S for D/S
–LimitationsLimitations
Cannot impose standard if Cannot impose standard if no “available no “available
analytical methodology”analytical methodology”
–““that exist only in the minds of the inspector”that exist only in the minds of the inspector”
Cannot impose standard not promulgated Cannot impose standard not promulgated
under under Administrative Procedure ActAdministrative Procedure Act
–subjected to public commentsubjected to public comment
Required Labeling of Dietary Required Labeling of Dietary
Supplements under DSHEASupplements under DSHEA
Name (echinacea, for example) Name (echinacea, for example)
Ingredient information Ingredient information
Disclaimer: "This statement has not been Disclaimer: "This statement has not been
evaluated by the Food and Drug evaluated by the Food and Drug
Administration. This product is not intended to Administration. This product is not intended to
diagnose, treat, cure or prevent any disease." diagnose, treat, cure or prevent any disease."
Supplement Facts panel, which includes Supplement Facts panel, which includes
serving size, amount and active ingredient. serving size, amount and active ingredient.
Name and address of manufacturer, packer Name and address of manufacturer, packer
or distributor. or distributor.
Supplements under DSHEASupplements under DSHEA
Name (echinacea, for example) Name (echinacea, for example)
Ingredient information Ingredient information
Disclaimer: "This statement has not been Disclaimer: "This statement has not been
evaluated by the Food and Drug evaluated by the Food and Drug
Administration. This product is not intended to Administration. This product is not intended to
diagnose, treat, cure or prevent any disease." diagnose, treat, cure or prevent any disease."
Supplement Facts panel, which includes Supplement Facts panel, which includes
serving size, amount and active ingredient. serving size, amount and active ingredient.
Name and address of manufacturer, packer Name and address of manufacturer, packer
or distributor. or distributor.
Supplement Facts PanelSupplement Facts Panel
Dietary Supplement ClaimsDietary Supplement Claims
Health claim: describes the relationship Health claim: describes the relationship
between a substance and a disease between a substance and a disease
condition; FDA does not approve, but must condition; FDA does not approve, but must
be notifiedbe notified
Qualified health claim: based on emerging Qualified health claim: based on emerging
scientific evidence; must be approved by scientific evidence; must be approved by
FDAFDA
Structure-function claim: most common; does Structure-function claim: most common; does
not claim to prevent disease, but a not claim to prevent disease, but a
physiological effect is noted, e.g. “increases physiological effect is noted, e.g. “increases
blood flow to the heart.”blood flow to the heart.”
Health claim: describes the relationship Health claim: describes the relationship
between a substance and a disease between a substance and a disease
condition; FDA does not approve, but must condition; FDA does not approve, but must
be notifiedbe notified
Qualified health claim: based on emerging Qualified health claim: based on emerging
scientific evidence; must be approved by scientific evidence; must be approved by
FDAFDA
Structure-function claim: most common; does Structure-function claim: most common; does
not claim to prevent disease, but a not claim to prevent disease, but a
physiological effect is noted, e.g. “increases physiological effect is noted, e.g. “increases
blood flow to the heart.”blood flow to the heart.”
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Health ClaimsHealth Claims
DSHEA authorized use of DSHEA authorized use of FDA approvedFDA approved
“Health claims” on label“Health claims” on label
Describe the connection between a Describe the connection between a
nutrient or food substance and a disease nutrient or food substance and a disease
or health-related conditionor health-related condition
–((diet/disease relationship)diet/disease relationship)
Statements may be included on the label that Statements may be included on the label that
give the manufacturers description of the role give the manufacturers description of the role
of the D/Sof the D/S
–Not authorized by FDANot authorized by FDA
–Manufacturer resp. for accuracy and truth of statementManufacturer resp. for accuracy and truth of statement
Health ClaimsHealth Claims
DSHEA authorized use of DSHEA authorized use of FDA approvedFDA approved
“Health claims” on label“Health claims” on label
Describe the connection between a Describe the connection between a
nutrient or food substance and a disease nutrient or food substance and a disease
or health-related conditionor health-related condition
–((diet/disease relationship)diet/disease relationship)
Statements may be included on the label that Statements may be included on the label that
give the manufacturers description of the role give the manufacturers description of the role
of the D/Sof the D/S
–Not authorized by FDANot authorized by FDA
–Manufacturer resp. for accuracy and truth of statementManufacturer resp. for accuracy and truth of statement
Labeling Under DSHEALabeling Under DSHEA
AllowedAllowed
This product helps to This product helps to
increase blood flow to the increase blood flow to the
heart.heart.
This product promotes This product promotes
urinary tract healthurinary tract health
This product improves This product improves
absent-mindedness. absent-mindedness.
This product reduces This product reduces
stress and frustration stress and frustration
Not AllowedNot Allowed
This product prevents This product prevents
heart diseaseheart disease
This product prevents This product prevents
urinary tract infections.urinary tract infections.
This product reduces risk This product reduces risk
of Alzheimer’s Disease.of Alzheimer’s Disease.
This product improves This product improves
depression.depression.
AllowedAllowed
This product helps to This product helps to
increase blood flow to the increase blood flow to the
heart.heart.
This product promotes This product promotes
urinary tract healthurinary tract health
This product improves This product improves
absent-mindedness. absent-mindedness.
This product reduces This product reduces
stress and frustration stress and frustration
Not AllowedNot Allowed
This product prevents This product prevents
heart diseaseheart disease
This product prevents This product prevents
urinary tract infections.urinary tract infections.
This product reduces risk This product reduces risk
of Alzheimer’s Disease.of Alzheimer’s Disease.
This product improves This product improves
depression.depression.
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FDA Approved Health FDA Approved Health
ClaimsClaims
Folic acidFolic acid and neural tube pregnancies and neural tube pregnancies
CalciumCalcium and osteoporosis and osteoporosis
SodiumSodium and hypertension and hypertension
Fruits and vegetablesFruits and vegetables and cancer and cancer
Dietary lipidsDietary lipids and cancer and cancer
Saturated fatSaturated fat and and cholesterolcholesterol and and
coronary artery diseasecoronary artery disease
FDA Approved Health FDA Approved Health
ClaimsClaims
Folic acidFolic acid and neural tube pregnancies and neural tube pregnancies
CalciumCalcium and osteoporosis and osteoporosis
SodiumSodium and hypertension and hypertension
Fruits and vegetablesFruits and vegetables and cancer and cancer
Dietary lipidsDietary lipids and cancer and cancer
Saturated fatSaturated fat and and cholesterolcholesterol and and
coronary artery diseasecoronary artery disease
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Structure and Function Structure and Function
ClaimsClaims
Manufacturers may use S/F claimsManufacturers may use S/F claims
–Not authorized by FDANot authorized by FDA
Must be true and not misleadingMust be true and not misleading
Must be accompanied by disclaimerMust be accompanied by disclaimer
–““This statement has not been evaluated by This statement has not been evaluated by
the FDA. This product is not intended to the FDA. This product is not intended to
diagnose, treat, cure or prevent any diagnose, treat, cure or prevent any
disease”disease”
Examples:Examples:
–““Calcium builds strong bones”Calcium builds strong bones”
–““Antioxidants maintain cell integrityAntioxidants maintain cell integrity””
Structure and Function Structure and Function
ClaimsClaims
Manufacturers may use S/F claimsManufacturers may use S/F claims
–Not authorized by FDANot authorized by FDA
Must be true and not misleadingMust be true and not misleading
Must be accompanied by disclaimerMust be accompanied by disclaimer
–““This statement has not been evaluated by This statement has not been evaluated by
the FDA. This product is not intended to the FDA. This product is not intended to
diagnose, treat, cure or prevent any diagnose, treat, cure or prevent any
disease”disease”
Examples:Examples:
–““Calcium builds strong bones”Calcium builds strong bones”
–““Antioxidants maintain cell integrityAntioxidants maintain cell integrity””
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Other Other
Claims:Claims:
Health-maintenance claims:Health-maintenance claims:
–““Maintains healthy circular system”Maintains healthy circular system”
Non-disease claims:Non-disease claims:
–““helps you relax”helps you relax”
–““for muscle enhancement”for muscle enhancement”
CannotCannot make maintenance claims about make maintenance claims about
osteoporosis and other osteoporosis and other “serious diseases”“serious diseases”
CanCan make health claim about relationship make health claim about relationship
between a product or substance and the between a product or substance and the
disease if disease if approvedapproved
Other Other
Claims:Claims:
Health-maintenance claims:Health-maintenance claims:
–““Maintains healthy circular system”Maintains healthy circular system”
Non-disease claims:Non-disease claims:
–““helps you relax”helps you relax”
–““for muscle enhancement”for muscle enhancement”
CannotCannot make maintenance claims about make maintenance claims about
osteoporosis and other osteoporosis and other “serious diseases”“serious diseases”
CanCan make health claim about relationship make health claim about relationship
between a product or substance and the between a product or substance and the
disease if disease if approvedapproved
2020
Nutraceuticals / Functional FoodsNutraceuticals / Functional Foods
Nutraceuticals / Designer foods / Nutraceuticals / Designer foods /
Phytochemicals / Functional FoodsPhytochemicals / Functional Foods
““any food or food ingredient any food or food ingredient
considered to provide medical or considered to provide medical or
health benefits, including prevention health benefits, including prevention
and treatment of diseaseand treatment of disease
No legal status in US!!No legal status in US!!
Nutraceuticals / Functional FoodsNutraceuticals / Functional Foods
Nutraceuticals / Designer foods / Nutraceuticals / Designer foods /
Phytochemicals / Functional FoodsPhytochemicals / Functional Foods
““any food or food ingredient any food or food ingredient
considered to provide medical or considered to provide medical or
health benefits, including prevention health benefits, including prevention
and treatment of diseaseand treatment of disease
No legal status in US!!No legal status in US!!
Nutraceuticals as per Chemical Nutraceuticals as per Chemical
GroupingsGroupings
2121
GroupingsGroupings
2121
Uses of NutraceuticalsUses of Nutraceuticals
2222
2222
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TerminologyTerminology
NutraceuticalsNutraceuticals
–Nutrient rich productsNutrient rich products with limited health claimswith limited health claims
Functional FoodsFunctional Foods
–Any modified food or ingredient that may Any modified food or ingredient that may
provide a provide a benefit beyond the traditional benefit beyond the traditional
nutrientsnutrients it contains it contains
PhytochemicalsPhytochemicals
–Such foods that are derived from Such foods that are derived from naturally naturally
occurring ingredientsoccurring ingredients
TerminologyTerminology
NutraceuticalsNutraceuticals
–Nutrient rich productsNutrient rich products with limited health claimswith limited health claims
Functional FoodsFunctional Foods
–Any modified food or ingredient that may Any modified food or ingredient that may
provide a provide a benefit beyond the traditional benefit beyond the traditional
nutrientsnutrients it contains it contains
PhytochemicalsPhytochemicals
–Such foods that are derived from Such foods that are derived from naturally naturally
occurring ingredientsoccurring ingredients
Commonly Used Commonly Used
Dietary Supplements Dietary Supplements
(Botanicals)(Botanicals)
EchinaceaEchinacea
GarlicGarlic
GingerGinger
Gingko bilobaGingko biloba
GinsengGinseng
HawthornHawthorn
Milk thistleMilk thistle
Saw palmettoSaw palmetto
St. John’s wortSt. John’s wort
ValerianValerian
Dietary Supplements Dietary Supplements
(Botanicals)(Botanicals)
EchinaceaEchinacea
GarlicGarlic
GingerGinger
Gingko bilobaGingko biloba
GinsengGinseng
HawthornHawthorn
Milk thistleMilk thistle
Saw palmettoSaw palmetto
St. John’s wortSt. John’s wort
ValerianValerian
EchinaceaEchinacea
Source: Source: Purple cornflowerPurple cornflower
Indication: Indication: Stop or moderate colds Stop or moderate colds
or fluor flu
Action: Action: Macrophages and their Macrophages and their
secretionssecretions
Cautions: Cautions: Avoid if immune system Avoid if immune system
is is hampered and do not hampered and do not
use use continuallycontinually
Source: Source: Purple cornflowerPurple cornflower
Indication: Indication: Stop or moderate colds Stop or moderate colds
or fluor flu
Action: Action: Macrophages and their Macrophages and their
secretionssecretions
Cautions: Cautions: Avoid if immune system Avoid if immune system
is is hampered and do not hampered and do not
use use continuallycontinually
GarlicGarlic
Source: Source: Garlic plantGarlic plant
Indication: Indication: Lower serum cholesterol Lower serum cholesterol
and and triglyceridestriglycerides
Action: Action: Chewing or crushing Chewing or crushing
activates several sulfur-activates several sulfur-containing containing
compoundscompounds
Cautions: Cautions: Allergies, GI symptoms, Allergies, GI symptoms,
interaction with interaction with
anticoagulant anticoagulant drugsdrugs
Source: Source: Garlic plantGarlic plant
Indication: Indication: Lower serum cholesterol Lower serum cholesterol
and and triglyceridestriglycerides
Action: Action: Chewing or crushing Chewing or crushing
activates several sulfur-activates several sulfur-containing containing
compoundscompounds
Cautions: Cautions: Allergies, GI symptoms, Allergies, GI symptoms,
interaction with interaction with
anticoagulant anticoagulant drugsdrugs
GingerGinger
Source: Source: Root of ginger plantRoot of ginger plant
Indication: Indication: For nausea and vomiting of For nausea and vomiting of
pregnancy and motion pregnancy and motion
sickness; anti-inflammatorysickness; anti-inflammatory
Action: Action: Volatile oils in the rhizome, Volatile oils in the rhizome,
called gingerols; may act on called gingerols; may act on serotonin serotonin
receptors in the receptors in the ileumileum
Cautions: Cautions: Interaction with anti-Interaction with anti-
coagulant, antihypertensive, coagulant, antihypertensive, glucose-glucose-
loweringlowering drugsdrugs
Source: Source: Root of ginger plantRoot of ginger plant
Indication: Indication: For nausea and vomiting of For nausea and vomiting of
pregnancy and motion pregnancy and motion
sickness; anti-inflammatorysickness; anti-inflammatory
Action: Action: Volatile oils in the rhizome, Volatile oils in the rhizome,
called gingerols; may act on called gingerols; may act on serotonin serotonin
receptors in the receptors in the ileumileum
Cautions: Cautions: Interaction with anti-Interaction with anti-
coagulant, antihypertensive, coagulant, antihypertensive, glucose-glucose-
loweringlowering drugsdrugs
Gingko BilobaGingko Biloba
Source: Source: Gingko treeGingko tree
Indication: Indication: Improved blood circulation; Improved blood circulation;
used to treat age-related used to treat age-related mental function mental function
decline r/t decline r/t cerebrovascular insufficiency cerebrovascular insufficiency
Action: Action: Flavone glycosides have Flavone glycosides have
antioxidant effect, inhibit antioxidant effect, inhibit platelet platelet
aggregationaggregation
Cautions: Cautions: Class 2d botanical; may Class 2d botanical; may
potentiate MAO inhibitors; GI potentiate MAO inhibitors; GI complaints, complaints,
headache, allergyheadache, allergy
Source: Source: Gingko treeGingko tree
Indication: Indication: Improved blood circulation; Improved blood circulation;
used to treat age-related used to treat age-related mental function mental function
decline r/t decline r/t cerebrovascular insufficiency cerebrovascular insufficiency
Action: Action: Flavone glycosides have Flavone glycosides have
antioxidant effect, inhibit antioxidant effect, inhibit platelet platelet
aggregationaggregation
Cautions: Cautions: Class 2d botanical; may Class 2d botanical; may
potentiate MAO inhibitors; GI potentiate MAO inhibitors; GI complaints, complaints,
headache, allergyheadache, allergy
GinsengGinseng
Source: Source: Ginseng plant (radish-like Ginseng plant (radish-like
herb) rootherb) root
Indication: Indication: General improvement from General improvement from
the steroidlike componentsthe steroidlike components
Action: Action: Ginsenosides, enhanced Ginsenosides, enhanced
immune function; studies immune function; studies mixedmixed
Cautions: Cautions: Class 2d botanicals; Class 2d botanicals;
contraindicated in persons contraindicated in persons with with
hypertension; hypertension; overstimulation, GI distressoverstimulation, GI distress
Source: Source: Ginseng plant (radish-like Ginseng plant (radish-like
herb) rootherb) root
Indication: Indication: General improvement from General improvement from
the steroidlike componentsthe steroidlike components
Action: Action: Ginsenosides, enhanced Ginsenosides, enhanced
immune function; studies immune function; studies mixedmixed
Cautions: Cautions: Class 2d botanicals; Class 2d botanicals;
contraindicated in persons contraindicated in persons with with
hypertension; hypertension; overstimulation, GI distressoverstimulation, GI distress
HawthornHawthorn
Source: Source: Native European tree; Native European tree;
leaves, blossoms, fruitleaves, blossoms, fruit
Indication: Indication: Improve blood flow in Improve blood flow in
circulatory disorderscirculatory disorders
Action: Action: Dilates coronary vessels; Dilates coronary vessels;
strengthens heart strengthens heart
contractions and ratecontractions and rate
Cautions: Cautions: Class 1 botanicalClass 1 botanical
Source: Source: Native European tree; Native European tree;
leaves, blossoms, fruitleaves, blossoms, fruit
Indication: Indication: Improve blood flow in Improve blood flow in
circulatory disorderscirculatory disorders
Action: Action: Dilates coronary vessels; Dilates coronary vessels;
strengthens heart strengthens heart
contractions and ratecontractions and rate
Cautions: Cautions: Class 1 botanicalClass 1 botanical
Saw PalmettoSaw Palmetto
Source: Source: Palm tree Palm tree
Indication: Indication: Reduce incidence of BPHReduce incidence of BPH
Action: Action: Action unclear; research Action unclear; research
results mixedresults mixed
Cautions: Cautions: Contains phytoestrogens, Contains phytoestrogens,
could interfere with estrogen could interfere with estrogen therapy, therapy,
oral contraceptives, oral contraceptives, other phytohormone-other phytohormone-
containing herbscontaining herbs
Source: Source: Palm tree Palm tree
Indication: Indication: Reduce incidence of BPHReduce incidence of BPH
Action: Action: Action unclear; research Action unclear; research
results mixedresults mixed
Cautions: Cautions: Contains phytoestrogens, Contains phytoestrogens,
could interfere with estrogen could interfere with estrogen therapy, therapy,
oral contraceptives, oral contraceptives, other phytohormone-other phytohormone-
containing herbscontaining herbs
St. John’s WortSt. John’s Wort
Source: Source: Perennial herbPerennial herb
Indication: Indication: Mild to moderate depressionMild to moderate depression
Action: Action: Hypericin and hyperforin in Hypericin and hyperforin in
flowering tops; reuptake of flowering tops; reuptake of neurotransmittersneurotransmitters
Cautions: Cautions: Rated as 2d botanical; may Rated as 2d botanical; may
potentiate pharmaceutical potentiate pharmaceutical MAOIs; interact MAOIs; interact
with other with other antidepressives; antidepressives;
photosensitivityphotosensitivity
Source: Source: Perennial herbPerennial herb
Indication: Indication: Mild to moderate depressionMild to moderate depression
Action: Action: Hypericin and hyperforin in Hypericin and hyperforin in
flowering tops; reuptake of flowering tops; reuptake of neurotransmittersneurotransmitters
Cautions: Cautions: Rated as 2d botanical; may Rated as 2d botanical; may
potentiate pharmaceutical potentiate pharmaceutical MAOIs; interact MAOIs; interact
with other with other antidepressives; antidepressives;
photosensitivityphotosensitivity
ValerianValerian
Source: Source: Perennial herb; active Perennial herb; active
element element in roots and rhizomesin roots and rhizomes
Indication: Indication: Minor tranquilizer and sleep Minor tranquilizer and sleep
aid; fewer side effects than aid; fewer side effects than
medicationsmedications
Action: Action: Volatile oils (bornyl acetate Volatile oils (bornyl acetate
and valerenic acid) mode of and valerenic acid) mode of action action
GABA bindingGABA binding
Cautions: Cautions: Class 1 botanical; abrupt Class 1 botanical; abrupt
withdrawal may precipitate withdrawal may precipitate symptomssymptoms
Source: Source: Perennial herb; active Perennial herb; active
element element in roots and rhizomesin roots and rhizomes
Indication: Indication: Minor tranquilizer and sleep Minor tranquilizer and sleep
aid; fewer side effects than aid; fewer side effects than
medicationsmedications
Action: Action: Volatile oils (bornyl acetate Volatile oils (bornyl acetate
and valerenic acid) mode of and valerenic acid) mode of action action
GABA bindingGABA binding
Cautions: Cautions: Class 1 botanical; abrupt Class 1 botanical; abrupt
withdrawal may precipitate withdrawal may precipitate symptomssymptoms
Milk ThistleMilk Thistle
Source: Source: Herb in daisy family; seeds Herb in daisy family; seeds are are
highest in silymarinhighest in silymarin
Indication: Indication: Hepatoprotective; used to Hepatoprotective; used to treat treat
liver damage in cirrhosis, liver damage in cirrhosis, hepatitis, fatty hepatitis, fatty
infiltrationinfiltration
Action: Action: Silymarin stimulates protein Silymarin stimulates protein
synthesis, antioxidant; shown synthesis, antioxidant; shown
to be moderately effectiveto be moderately effective
Cautions: Cautions: Class 1 botanical; mild Class 1 botanical; mild
laxative effect; allergieslaxative effect; allergies
Source: Source: Herb in daisy family; seeds Herb in daisy family; seeds are are
highest in silymarinhighest in silymarin
Indication: Indication: Hepatoprotective; used to Hepatoprotective; used to treat treat
liver damage in cirrhosis, liver damage in cirrhosis, hepatitis, fatty hepatitis, fatty
infiltrationinfiltration
Action: Action: Silymarin stimulates protein Silymarin stimulates protein
synthesis, antioxidant; shown synthesis, antioxidant; shown
to be moderately effectiveto be moderately effective
Cautions: Cautions: Class 1 botanical; mild Class 1 botanical; mild
laxative effect; allergieslaxative effect; allergies
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