1. Dietary Supplements

2. Definition by DSHEA Product that is to supplement a healthy diet. Includes ingredients such as vitamins, minerals, herbs, botanicals, amino acids or their constituents. Taken by mouth in the form of a pill, capsule, tablet, liquid. Labeled as a dietary supplement.

3. New Dietary Ingredients Ingredients added to dietary supplements after October 15, 1994. Specific safety information required by the FDA from manufacturer before being released on the market.

4. Differences from foods and Drugs Supplements regulated as food by FDA. Regulated differently from foods and drugs. ◦ Classifications  Dietary Supplements  Conventional food  Drug Classifications of dietary supplements are based on information on the label.

5. Label Classifications Manufacturer Claims ◦ Health claim – relationship between food, supplement and reduction of health risk. ◦ Nutrient content – describes amount of nutrients in product. ◦ Structure/function-statement of how product may affect the organ system or other systems of the body. Cannot mention any specific disease. Labels must read, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

6. FDA Regulations on Supplements New dietary ingredients by a manufacturer must be presented to FDA of their marketing intent and evidence of safety for human consumption. FDA does not have to approve a supplement before marketing.

7. Information required on Dietary Supplement Labels General Information ◦ Name of product (with indications as a supplement) ◦ Quantity of Content ◦ Name and location of manufacturer packer or distributor. ◦ Directions of usage.

8. Supplements Facts Panel Serving size Ingredients Amount per serving Percent of Daily Value if possible Botanical – Scientific or common name and part of plant used. Proprietary Blend – total weight of blend and components from greatest to least.

9. Other ingredients Non-dietary ingredients listed by weight from greatest to least.

10. Quality of dietary Supplements Manufacturers must follow Good Manufacturing Practices put into place by the FDA in 2007. Manufacturers are to guarantee ◦ Identity ◦ Purity ◦ Strength ◦ Composition

11. Standardization Process manufacturers use to ensure the quality and consistency of their products. Not required in the United States.

12. Methods of Evaluation of Health and Safety History of use. Laboratory studies. Case reports. Observations. Clinical trials.

13. References http://ods.nih.gov/factsheets/DietarySuppl ements-HealthProfessional/