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Defining Dietary Supplements

Defining Dietary Supplements. Provided Courtesy of www.RD411.com. Review Date 11/07 G-0519. 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)

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Defining Dietary Supplements

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  1. Defining Dietary Supplements Provided Courtesy of www.RD411.com Review Date 11/07 G-0519

  2. 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.”

  3. TYPES • Vitamins • Minerals • Botanicals • Sports nutrition supplements • Weight management products • Specialty supplements

  4. FORMS: • Capsules • Softgels • Gelcaps • Tablets • Liquids/tinctures • Powders • Bars • Beverages

  5. 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

  6. 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

  7. 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

  8. 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.”

  9. ANATOMY OF A LABEL

  10. 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

  11. 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)

  12. QUESTIONS?

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