Defining Dietary Supplements

Provided Courtesy of RD411.comWhere dietitians go for information

Review Date 11/11 G-0519

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

Types of Dietary Supplements

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

Forms of Dietary Supplements

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

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

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

Labels Must Includethe 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

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.”

Anatomy of a Label

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

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.

Questions?