Janet McDonald, Ph'D', R'D'

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Regulation of Food Dietary Supplements
Janet McDonald, Ph.D., R.D.
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Todays Topics

• Introduction to the legal authority
• General requirements for food and dietary
  supplements
• Structure/function claims
• Boundaries

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FDAs Legal Authority

• Federal Food, Drug, and Cosmetic Act
• Fair Packaging and Labeling Act

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Dietary Supplements

• Nutrition Labeling and Education Act (NLEA)
• Dietary Supplement Health and Education Act
  (DSHEA)

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Interpretation of the Statute

• Code of Federal Regulations
• Guidance documents
• Case law
• Informal guidance

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What is Food ?

• ...articles used for food or drink for
  manchewing gumand articles used for components
  of... food or drink or chewing gum

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What is a food additive?

• Broad sense Any substance added to food.
• Legally Any substance the intended use of which
  results or may reasonably be expected to result-
  directly or indirectly - in its becoming a
  component or otherwise affecting the
  characteristics of any food.
• Direct additives
• Indirect additives

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What is GRAS?

• Substances whose use is generally recognized as
  safe, based on their extensive history of use in
  food before 1958, or based on published
  scientific evidence.
• Not set in concrete!

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What is a Drug ?

• article intended for use in the diagnosis,
  cure, mitigation, treatment, or prevention of
  disease

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What is a dietary supplement ?

• a product (other than tobacco) intended to
  supplement the diet that bears or contains one or
  more designated ingredients

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What is a dietary supplement ?

• Vitamin, mineral, amino acid
• Herb or other botanical
• Dietary substance for use by man to supplement
  the diet by increasing the total dietary intake

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What is a dietary supplement ?

• Concentrate, metabolite, constituent, or
  combination of the ingredients above

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What is a dietary supplement ?

• Intended for ingestion
• Pill, capsule, liquid, powder, other
• Not represented for use as conventional food
• Not sole item of meal or diet
• Labeled as a dietary supplement

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Messages..

• Definitions and Regulatory Boxes
• .And that they matter
• What to think about at this evolving point

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Dietary Supplement ComplianceBoundariesBounda
riesFood Dietary SupplementDrug
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Which Regulatory Box Is Important Because..

• Different legal requirements
• Different safety considerations
• Different substantiation for claims

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• Dietary Supplement or Food ?

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• Dietary Supplement or Food ?

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• Food Dietary Supplement
• Represented for use as conventional food
• Safe ingredients
• Claims
• Labeling

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• What is Functional Food?
• It is undefined but regulated as food

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• Functional Food?

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• Functional Food?

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• Functional Food Claims
• Structure/function claims
• Truthful
• Non-misleading
• Based on nutritive value
• No drug claims

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• Functional Food Claims
• Disease claims - Drug
• Dietary support during the cold and flu season
• Prevents the onset of disease complications

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• Dietary Supplement Drug
• Structure/function claims
• 30-day post-market notification for structure/
  function claim
• Use of disclaimer
• Manufacturer is responsible for substantiation

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• 30-Day Notification
• Disease claims - Drug
• Reduces cholesterol
• Reduces fever
• Helps promote normal body function after
  taking too much drink

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• 30-Day Notification
• Structure/function claim
• Gingko biloba promotes healthy brain
  function
• Guar gum promotes healthy intestinal function
• Helps maintain cholesterol levels in normal
  range

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The Key to Almost Everything Is.

• Intended Use
• (claims)

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Intended Use Gets You into Two Possible Boxes.
initially

• Functional Food

?
Foods Conv Foods
Dietary Supplements
Drugs Prescription OTC
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More on This Perspective

• Functional Foods
• -------gt Assumption probably about foods
• Dietary supplements are intended to supplement
  the diet

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Whats the Difference?

• Conv Foods versus Dietary Supplements
• Safety Standard
• Conv Food GRAS/Food Additive
• Dietary Supplm Signif-Unreasonable Risk
• Claim topic / substantiation
• Disease endpoint / Same Rigorous--Pre-review
• Non-disease endpoint / Essentially Same
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  Truthful/Not Misleading

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Whats the Difference?

• Nutritive Value / Food-Like Effect
• Characterizes oversight of conv food claims
• Not well defined or articulated
• DSHEA specifies that dietary supplements do not
  have to have nutritive effect
• Point of resolution
• NV Needed? Drug versus Food?
• What does it mean scientifically today?

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More on This Perspective

• Do Functional Foods need their own regulatory
  box?
• Probably not
• Do they need some special considerations?
• Probably yes

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• Food - Dietary Supplement - Drug
• Chewing Gum
• Breakfast cereal type products
• Product in bar form
• Bottled water

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FOR MORE INFORMATION

• Check out FDAs web site
• www.fda.gov
• Foods
• Food labeling
• Dietary supplements