Dietary SupplementsDietary Supplements

Definition by DSHEADefinition by DSHEAProduct 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.

New Dietary IngredientsNew Dietary IngredientsIngredients added to dietary

supplements after October 15, 1994.

Specific safety information required by the FDA from manufacturer before being released on the market.

Differences from foods and Differences from foods and DrugsDrugs

Supplements regulated as food by FDA.

Regulated differently from foods and drugs.◦Classifications

Dietary Supplements Conventional food DrugClassifications of dietary supplements are

based on information on the label.

Label ClassificationsLabel ClassificationsManufacturer 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.

FDA Regulations on FDA Regulations on SupplementsSupplements

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.

Information required on Information required on Dietary Supplement LabelsDietary 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.

Supplements Facts PanelSupplements Facts PanelServing sizeIngredientsAmount per servingPercent of Daily Value if possibleBotanical – Scientific or common

name and part of plant used.Proprietary Blend – total weight

of blend and components from greatest to least.

Other ingredientsOther ingredients

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

Quality of dietary Quality of dietary SupplementsSupplements

Manufacturers must follow Good Manufacturing Practices put into place by the FDA in 2007.

Manufacturers are to guarantee◦Identity◦Purity◦Strength◦Composition

StandardizationStandardization

Process manufacturers use to ensure the quality and consistency of their products.

Not required in the United States.

Methods of Evaluation of Methods of Evaluation of Health and SafetyHealth and Safety

History of use.Laboratory studies.Case reports.Observations.Clinical trials.

ReferencesReferences

http://ods.nih.gov/factsheets/DietarySupplements-HealthProfessional/