Dietary Supplements

Foods or Drugs?
Complementary & Alternative Medicine

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What is a Dietary Supplement?
Definition: (Sec 3.)
– A product (other than tobacco) intended
to supplement the diet that bears or
contains one or more of the following
dietary ingredients
Vitamins
Minerals
Herbs or other botanicals
Amino acids
Concentrate, metabolite, constituent,
extract or combination of above listed
ingredients
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Dietary Supplement Health and
Education Act of 1994 (DSHEA)
Reclassified botanicals as dietary supplements,
distinct from food or drugs
Plant extracts, enzymes, vitamins, minerals,
hormonal products available without prescription
may carry “structure-function” claims
Cannot claim to prevent or cure specific
conditions
Must display disclaimer, “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.”
Dietary Supplements

Traditionally defined as products made

of one or more essential nutrients such
as vitamins, minerals, and proteins,
but…
DSHEA broadened definition to
include almost any product intended
for ingestion as a supplement to the
diet
Must be identified on label as a D/S
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Dietary Supplements
Distinguished from Drugs:
– Drug = article intended to diagnose,
cure, mitigate, treat, or prevent disease
– Both intended to affect structure and
function of body
– Drug must undergo FDA approval after
clinical studies to determine effectiveness
and safety
– D/S = no pre-market testing

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History of Dietary
Supplements
1938 Act established standards of identity
for vitamins and minerals
Proxmire Amendments extended FDA
jurisdiction to advertising of Vits and mins
– Prohibited FDA from setting max limits on
potency
– Forbade FDA from classifying supplements as
drugs

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History of Dietary
Supplements
1990 Nutritional Labeling and
Education Act
– Permitted use of therapeutic claims made
about vits/mins
1994 President Clinton signed Dietary
Supplement, Health and Education Act
(DSHEA) into law
Defined D/S as “separate regulatory
category of food”
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DSHEA
Created Office of Dietary Supplements
within National Institute of Health (NIH)
Permits statements of nutritional
support including structure and
function claims
After passage of DSHEA, sales
increased to 13 billion per year.

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Dietary
Supplements
Distinguished from Foods:
– Foods not intended to affect structure
and function
– D/S intended only to supplement diet
Not represented for use as conventional
food
Not intended as sole item of a meal or
the diet”

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Dietary
Supplements
No premarket approval
Manufacturer responsible for safety
evaluation
If D/S contains a new ingredient:
– Manufacturer must submit information that
ingredient “can reasonably be expected
to be safe” within 75 days of marketing
– Safe = no significant risk of illness

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Good Manufacturing
Practices
DSHEA authorized specific GMPs for
D/S
– Limitations
Cannot impose standard if no
“available analytical methodology”
– “that exist only in the minds of the inspector”
Cannot impose standard not
promulgated under Administrative
Procedure Act
– subjected to public comment 11
Required Labeling of Dietary
Supplements under DSHEA
Name (echinacea, for example)
Ingredient information
Disclaimer: "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."
Supplement Facts panel, which includes
serving size, amount and active ingredient.
Name and address of manufacturer, packer
or distributor.
Supplement Facts Panel
Dietary Supplement Claims

Health claim: describes the relationship

between a substance and a disease
condition; FDA does not approve, but must
be notified
Qualified health claim: based on emerging
scientific evidence; must be approved by
FDA
Structure-function claim: most common;
does not claim to prevent disease, but a
physiological effect is noted, e.g. “increases
blood flow to the heart.”
Health Claims
DSHEA authorized use of FDA approved
“Health claims” on label
Describe the connection between a
nutrient or food substance and a disease
or health-related condition
– (diet/disease relationship)
Statements may be included on the label that
give the manufacturers description of the role
of the D/S
– Not authorized by FDA
– Manufacturer resp. for accuracy and truth of statement

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 Labeling Under DSHEA
Allowed Not Allowed
This product helps to
increase blood flow to the
heart.
This product promotes
urinary tract health
This product improves
absent-mindedness.
This product reduces
stress and frustration
This product prevents
heart disease
This product prevents
urinary tract infections.
This product reduces risk
of Alzheimer’s Disease.
This product improves
depression.
FDA Approved Health
Claims
Folic acid and neural tube pregnancies
Calcium and osteoporosis
Sodium and hypertension
Fruits and vegetables and cancer
Dietary lipids and cancer
Saturated fat and cholesterol and
coronary artery disease

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Structure and Function
Claims
Manufacturers may use S/F claims
– Not authorized by FDA
Must be true and not misleading
Must be accompanied by disclaimer
– “This statement has not been evaluated
by the FDA. This product is not
intended to diagnose, treat, cure or
prevent any disease”
Examples:
– “Calcium builds strong bones”
– “Antioxidants maintain cell integrity”

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Other
Claims:
Health-maintenance claims:
– “Maintains healthy circular system”
Non-disease claims:
– “helps you relax”
– “for muscle enhancement”
Cannot make maintenance claims about
osteoporosis and other “serious diseases”
Can make health claim about relationship
between a product or substance and the
disease if approved

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Nutraceuticals / Functional Foods

Nutraceuticals / Designer foods /

Phytochemicals / Functional Foods
“any food or food ingredient
considered to provide medical or
health benefits, including prevention
and treatment of disease
No legal status in US!!

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Nutraceuticals as per Chemical
Groupings

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Uses of Nutraceuticals

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Terminology
Nutraceuticals
– Nutrient rich products with limited health
claims
Functional Foods
– Any modified food or ingredient that may
provide a benefit beyond the traditional
nutrients it contains
Phytochemicals
– Such foods that are derived from naturally
occurring ingredients
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 Commonly Used
Dietary Supplements
(Botanicals)
Echinacea Hawthorn
Garlic Milk thistle
Ginger Saw palmetto
Gingko biloba St. John’s wort
Ginseng Valerian
 Echinacea

Source: Purple cornflower

Indication: Stop or moderate colds
or flu
Action: Macrophages and their
secretions
Cautions: Avoid if immune system is
hampered and do not use
continually
 Garlic
Source: Garlic plant
Indication: Lower serum cholesterol and
triglycerides
Action: Chewing or crushing
activates several sulfur-
containing compounds
Cautions: Allergies, GI symptoms,
interaction with anticoagulant
drugs
 Ginger
Source: Root of ginger plant
Indication: For nausea and vomiting of
pregnancy and motion
sickness; anti-inflammatory
Action: Volatile oils in the rhizome,
called gingerols; may act on
serotonin receptors in the
ileum
Cautions: Interaction with anti-
coagulant, antihypertensive,
glucose-lowering drugs
 Gingko Biloba
Source: Gingko tree
Indication: Improved blood circulation;
used to treat age-related
mental function decline r/t
cerebrovascular insufficiency
Action: Flavone glycosides have
antioxidant effect, inhibit
platelet aggregation
Cautions: Class 2d botanical; may
potentiate MAO inhibitors; GI
complaints, headache, allergy
 Ginseng
Source: Ginseng plant (radish-like
herb) root
Indication: General improvement from
the steroidlike components
Action: Ginsenosides, enhanced
immune function; studies
mixed
Cautions: Class 2d botanicals;
contraindicated in persons
with hypertension;
overstimulation, GI distress
 Hawthorn

Source: Native European tree;

leaves, blossoms, fruit
Indication: Improve blood flow in
circulatory disorders
Action: Dilates coronary vessels;
strengthens heart
contractions and rate
Cautions: Class 1 botanical
 Saw Palmetto
Source: Palm tree
Indication: Reduce incidence of BPH
Action: Action unclear; research
results mixed
Cautions: Contains phytoestrogens,
could interfere with estrogen
therapy, oral contraceptives,
other phytohormone-
containing herbs
 St. John’s Wort
Source: Perennial herb
Indication: Mild to moderate depression
Action: Hypericin and hyperforin in
flowering tops; reuptake of
neurotransmitters
Cautions: Rated as 2d botanical; may
potentiate pharmaceutical
MAOIs; interact with other
antidepressives;
photosensitivity
 Valerian
Source: Perennial herb; active
element in roots and rhizomes
Indication: Minor tranquilizer and sleep
aid; fewer side effects than
medications
Action: Volatile oils (bornyl acetate
and valerenic acid) mode of
action GABA binding
Cautions: Class 1 botanical; abrupt
withdrawal may precipitate
symptoms
 Milk Thistle
Source: Herb in daisy family; seeds
are highest in silymarin
Indication: Hepatoprotective; used to
treat liver damage in cirrhosis,
hepatitis, fatty infiltration
Action: Silymarin stimulates protein
synthesis, antioxidant; shown
to be moderately effective
Cautions: Class 1 botanical; mild
laxative effect; allergies