title: An innovative approach to the safety evaluation of natural products: cranberry (Vaccinium macrocarpon Aiton) leaf aqueous extract as a case study.
abstract: Assessment of safety for a food or dietary ingredient requires determination of a safe level of ingestion compared to the estimated daily intake from its proposed uses. The nature of the assessment may require the use of different approaches, determined on a case-by-case basis. Natural products are chemically complex and challenging to characterize for the purpose of carrying out a safety evaluation. For example, a botanical extract contains numerous compounds, many of which vary across batches due to changes in environmental conditions and handling. Key components integral to the safety evaluation must be identified and their variability established to assure that specifications are representative of a commercial product over time and protective of the consumer; one can then extrapolate the results of safety studies on a single batch of product to other batches that are produced under similar conditions. Safety of a well-characterized extract may be established based on the safety of its various components. When sufficient information is available from the public literature, additional toxicology testing is not necessary for a safety determination on the food or dietary ingredient. This approach is demonstrated in a case study of an aqueous extract of cranberry (Vaccinium macrocarpon Aiton) leaves.
authors.affiliation: Spherix Consulting, Incorporated, 6430 Rockledge Drive, Suite 503, Bethesda, MD 20817, USA.
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Booth
authors.forename: Claire L
authors.initials: CL
authors.lastname: Kruger
authors.forename: A
authors.initials: A
authors.lastname: Wallace Hayes
authors.forename: Roger
authors.initials: R
authors.lastname: Clemens
mesh_terms: D000818:Animals; D001688:Biological Products / Q000009:adverse effects*; D057230:Limit of Detection; D010936:Plant Extracts / Q000009:adverse effects*; D018515:Plant Leaves / Q000737:chemistry*; D029799:Vaccinium macrocarpon / Q000737:chemistry*
chemical_list: D001688:Biological Products; D010936:Plant Extracts