1. Defining Dietary Supplements Provided Courtesy of RD411.com Where dietitians go for information Review Date 11/11 G-0519

2. 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

3. Types of Dietary Supplements Vitamins Minerals Botanicals Sports nutrition supplements Weight management products Specialty supplements

4. Forms of Dietary Supplements Capsules Softgels Gelcaps Tablets Liquids/tinctures Powders Bars Beverages

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

6. 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 (GMP) Regulations for products demonstrating adverse reactions

7. 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

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 – 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 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 2011. 32nd ed. Montvale, NJ: PDR Network; 2011.

12. Questions?