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Dietary Supplements Foods or Drugs?

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Title: Dietary Supplements Foods or Drugs?


1
Dietary SupplementsFoods or Drugs?
2
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

3
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

4
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

5
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

6
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

7
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

8
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

9
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

10
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

11
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

12
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)

13
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!!!!!!!!!!!

14
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

15
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

16
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

17
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

18
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

19
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

20
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!!

21
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

22
Some Examples
  • Benecol
  • Plant stanol esters
  • Glucosamine
  • New Approved Health Claims
  • Flavonoids (Teas) and heart disease

23
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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