AOAC International Announces Approval of Method for Beta-Carotene as an AOAC(R) Official Method(SM)

AOAC INTERNATIONAL is pleased to announce the approval as an AOAC Official First Action a method for the analysis of dietary supplements for beta-carotene. The method was developed under an AOAC/NIH, Office of Dietary Supplement Program/FDA contract.

An Expert Review Panel (ERP) selected the method, which was originally developed by J.Schierle, J.Klipfel and B.Pietsch at DSM. The ERP is carefully selected by AOAC to act as an independent 3rd party review panel and to choose the best methods for a particular dietary supplement ingredient. The ERP for beta-carotene was chaired by Ed Waysek of Caravan Products, Inc. and composed of five xperts from government (FDA), industry, and academia. Subsequently, J. Schierle and his group submitted the method for Single Laboratory Validation (SLV), and the results of the study were found, under peer review, to be acceptable and to justify proceeding to a full collaborative study. The SLV study was published in the Journal of AOAC INTERNATIONAL (J.AOAC Int. 87 (5), 1070-82 (2004).

An international collaborative study, led by J.Szpylka and J.DeVries of Medallion Laboratories, General Mills was conducted. The study included 12 laboratories in 4 countries; 11 of the laboratories successfully completed the study. The method involves an enzyme digestion followed by extraction with ethanol:dichloromethane, and determination by reversed phase HPLC with a visible light absorbance detector. The method is applicable to a wide range of supplement types (13 were included in the study), including vitamin tablets, softgels and capsules, and measures trans-beta-carotene as well as total beta-carotenes. The results of the study will be published in the Sept.-Oct. issue of the J. AOAC Int.

The method performance on a beadletted raw ingredient was found to be unsatisfactory, because of the inhomogeneity of the beadlets themselves. Because other carotenoids are also protected from oxidation through the beadletting process, AOAC has initiated a study, led by J. DeVries of General Mills, to examine this problem and develop techniques for handling dietary supplements containing such beadlets.

AOAC INTERNATIONAL is an independent, not-for-profit scientific association dedicated to the development and validation of analytical standards. Currently, AOAC is working under contract with the National Institutes of Health/FDA and with the dietary supplement industry to get inferior products off the market through sound, validated testing methodology. AOAC has developed standardized testing methods, validated through collaborative study, for ephedra, glucosamine, and is nearing completion of standardized tests for ginkgo, saw palmetto, omega-3 and 6 fatty acids, chondroitin, SAMe, CoQ10 and others, with the goal of validating 20 analytical methods over a five-year period.

Considering that there are more than 3,000 dietary supplement ingredients and more than 40,000 products in which they appear, AOAC is looking to industry to play a significant role in speeding up this process through engagement and infrastructure support.

To participate in a collaborative study or to find out more about AOAC dietary supplement program, contact Anita Mishra, Principal Scientific Liaison, Government and Industry, AOAC INTERNATIONAL, [email protected], telephone: 301 924-7077, ext. 131.

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