Defining Dietary Supplements

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Defining Dietary Supplements

• Provided Courtesy of www.RD411.com

Review Date 11/07 G-0519
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WHAT ARE DIETARY SUPPLEMENTS?

• Products other than tobacco that are taken by
  mouth and contain dietary ingredients.
• Categorized as foods not drugs or food
  additives. (Intended to be ingested)
• 3. May not be represented as a conventional food
  or meal.
• 4. Must be labeled as a Dietary Supplement.

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TYPES

• Vitamins
• Minerals
• Botanicals
• Sports nutrition supplements
• Weight management products
• Specialty supplements

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FORMS

• Capsules
• Softgels
• Gelcaps
• Tablets
• Liquids/tinctures
• Powders
• Bars
• Beverages

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REGULATING AGENCIES

• Food and Drug Administration (FDA)
• www.fda.gov
• Adverse Events Reporting (AER)
• www.fda.gov/medwatch/
• or (800) FDA-1088
• Federal Trade Commission (FTC)
• www.ftc.gov

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SAFETY PROVISIONS

• DSHEA (The Dietary Supplement Health and
  Education Act of 1994) provides a framework for
  FDA regulation of dietary supplements
• Labeling requirements
• Health claims
• Registration of new ingredients
• Establishment of GMPs
  (Good Manufacturing Practices)
• Issuing of regulation for products demonstrating
  adverse reactions

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LABELS MUST INCLUDE

• Statement of Identity
• Net quantity of contents
• Directions for use
• Other Ingredients in descending order of
  predominance
• Storage conditions, warning label and expiration
  date
• Name and address of manufacturer or distributor
• If a structure-function statement is used, the
  FDA disclaimer must appear

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FDA DISCLAIMER

• These statements have not been evaluated by the
  Food and Drug Administration. This product is
  not intended to diagnose, treat, cure, or prevent
  any disease.

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ANATOMY OF A LABEL
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PRODUCT LABEL CLAIMS

• Health Claims
• ex calcium linked to reduced risk of
  osteoporosis
• Structure/Function Statements also known as
  Nutrition Support Statements
• Nutrient content
• Classical nutrient deficiency diseases or
  health-related condition
• Structure-function claims
• ex Supports healthy immune function

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DIETARY SUPPLEMENT RESOURCES

• National Institutes of Health Office of Dietary
  Supplements
• http//dietary-supplements.info.nih.gov/
• PDR for Nonprescription Drugs, Dietary
  Supplements, and Herbs, 2008
• Thomson Healthcare 29th edition
• (September 1, 2007)

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QUESTIONS?