Dietary Supplements Foods or Drugs?

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Dietary SupplementsFoods 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