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Provided Courtesy of Nutrition411.com
Defining Dietary
Supplements
Review Date 3/14
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/def
ault.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
• Regulations for products demonstrating adverse
reactions
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
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 health immune function
Dietary Supplement
Resources
• National Institutes of Health, Office of Dietary
Supplements: http://dietarysupplements.info.nih.gov/
• PDR for Nonprescription Drugs, Dietary
Supplements, and Herbs 2011. 32nd ed.
Montvale, NJ: PDR Network; 2011.
Questions?