This Standard contains requirements for dietary supplements that contain one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by humans to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.

Products and ingredients deemed a hazard to public health or safety by a regulatory agency having jurisdiction shall be excluded from the scope of this document. Conventional foods are excluded from the scope of this Standard.

Manufacturers shall exercise due diligence to ensure compliance with all applicable regulatory requirements, but compliance with this Standard in itself does not imply that all regulatory requirements have been met.

Purpose

This Standard provides test methods and evaluation criteria for dietary supplement products to allow for the determination that the ingredients in the product are accurately identified, that the product contains the quantity of dietary ingredients and marker constituents declared on the product label, and that the product does not contain unacceptable quantities of contaminants.

This Standard provides criteria for determining that Good Manufacturing Practices were followed in the production of dietary supplements.

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