Dietary

Supplements
Foods or Drugs?

Dietary
Supplements
Alternative therapies and
natural remedies
(Wholistic Medicine

Dietary supplements = 6.5

billion / Prescription Drug
sales = 85 billion
Increased consumer
dissatisfaction with
conventional health care
of US population use
Dietary Supplements
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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.
CFSAN oversees regulation of D/S
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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

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

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

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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Adulteration under DSHEA

D/S is adulterated if it or an ingredient
presents significant or unreasonable
risk of illness or injury when used as
directed
If contains a new ingredient standard is
insufficient information to provide
assurance that ingredient does not
present.
FDA has burden of proving D/S is unsafe
once product is marketed
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Adulteration under DSHEA

Prior to DSHEA, FDA tactic was to
declare dubious supplements as
unapproved food additives
DSHEA prohibits FDA from doing this
Since DSHEA, no FDA enforcement
jurisdiction unless can prove
supplement is unsafe
(significant or unreasonable risk of injury)
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FDA Enforcement Authority:

FDA bears Burden of Proof
Must prove that product is unsafe

DSHEA requires de novo (fresh look)

determination for each case
No longer presumes FDA is correct on science

FDA must provide 10 days notice before

initiating civil proceeding
Only required in criminal case before DSHEA
Whose idea was this!!!!!!!!!!!

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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

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Labeling of Dietary Supplements

DSHEA authorized to provide accurate
information to consumers
Label must include:
Name of each ingredient
Quantity of each ingredient
Total weight of all ingredient if a blend
Identity of part of plant derived from
Term Dietary Supplement
Must contain nutritional labeling information also
Calories, fat, sodium
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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 healthrelated 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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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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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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Some Examples:
Benecol
Plant stanol esters

Glucosamine
New Approved Health Claims
Flavonoids (Teas) and heart
disease

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Summary
Not food, not drug, broadly definition
under DSHEA (1994)
Regulated by FDA/CFSAN since DSHEA
No premarket approval even if contains
new ingredient
Must be labeled as Dietary
Supplements
Nutraceuticals not regulated by FDA
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