Defining Dietary Supplements

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Defining Dietary Supplements

• Provided Courtesy of Nutrition411.com

Review Date 3/14 G-0519
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Definition Dietary Supplement

• Products other than tobacco that are taken by
  mouth and contain dietary ingredients
• Categorized as foods, not drugs or food additives
  (intended for ingestion)
• Not always represented as a conventional food or
  meal
• Dietary supplement required

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Types of Dietary Supplements

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

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Forms of Dietary Supplements

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

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Regulating Agencies

• US Food and Drug Administration (FDA)
• http//www.fda.gov/Food/DietarySupplements/default
  .htm
• Adverse Events Reporting (AER)
• http//www.fda.gov/medwatch or (800) FDA-1088
• Federal Trade Commission (FTC)
• http//www.ftc.gov/bcp/index.shtml

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Safety Provisions

• DSHEA (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 good manufacturing practices
• Regulations for products demonstrating adverse
  reactions

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Labels Must Include the Following

• 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
• The FDA disclaimer if a structure-function
  statement is used

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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
• Example 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 conditions
• Structure-function claims
• Example supports health immune function

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Dietary Supplement Resources

• National Institutes of Health, Office of Dietary
  Supplements http//dietary-supplements.info.nih.g
  ov/
• PDR for Nonprescription Drugs, Dietary
  Supplements, and Herbs 2011. 32nd ed. Montvale,
  NJ PDR Network 2011.

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Questions?