Download Dietary Supplements

Dietary
Supplements
Foods or Drugs?
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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
½ 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
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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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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 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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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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