Published: Monday, March 18, 2013
This document provides a practical guide for
companies implementing organoleptic characterization, with or without
macroscopic descriptors, for the identification of botanical materials.
When properly conducted by adequately trained personnel, organoleptic examination is a scientifically valid method for verifying the identity of many botanical ingredients. In practical terms this means that organoleptic analysis can in fact identify botanical ingredients in commerce.
Federal regulations require identity specifications to be established for each
component used in the manufacture of a dietary supplement and, unless an
exemption is obtained, to “(c)onduct at least one appropriate test or examination
to verify the identity of any component that is a dietary ingredient” before use. These regulations also identify the types of tests and analyses that may be used to verify
ingredient identity, including gross organoleptic analysis and macroscopic analysis. The specific objective of organoleptic analysis procedures
outlined in this guidance is to affirm a positive material identification of dietary
components, or to reject or question the identification of such components. These
procedures can also be applied to incorporating organoleptic analysis into a
quality control program.
Manufacturers have the responsibility to ensure that their identity examinations or
tests are appropriate, scientifically valid methods. Organoleptic and macroscopic
analyses are useful and valuable tools for determining the identity of fresh or dry
raw herbal materials and may also have applicability to the various forms that
these materials may present such as powdered extracts, tinctures, etc.
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