AOAC INTERNATIONAL, a worldwide provider and facilitator in the development of analytical standards, has been under contract with the National Institutes of Health, Office of Dietary Supplements since September 2001/2002 to develop and validate methods for the top dietary supplement ingredients over a period of five years.  Through the leadership of the AOAC Task Force on Dietary Supplements, AOAC has developed several working groups representing key stakeholders interested in specific dietary supplement ingredients.  The purpose of these working groups is to drive and ensure the development of standardized analytical methods for the analysis of dietary supplements for ingredients of interest.

A number of working groups will be meeting November 9 and 10 in conjunction with the Supply Side West meeting in Las Vegas, NV.  If you are interested in attending one of the meetings, please RVSP Anita Mishra amishra@aoac.org as room space is limited. 

CoQ10 is chaired by Barry Titlow, President and CEO, Compound Solutions. This working group represents close to 15 key companies having interest in the standardization of methods for this ingredient. This working group includes the three largest bulk manufacturers of CoQ10, including Kaneka, Nisshin Pharma, and Mitsubishi Gas Chemicals. In addition, we have several manufacturers of CoQ10 containing dietary supplements, including Pharmavite, and Soft Gel.
 
A Single Laboratory Validation (SLV) will soon be conducted with Jules Skamarack of Eurofins serving as the Study Coordinator. Currently, Mr. Skamarack and Kelly Reins of SoftGel are drafting the SLV protocol for review, based on a quantitative method for the analysis of dietary supplements for trans-CoQ10 and qualitative for CoQ9 and cis-CoQ10, developed by Steve Lunetta of Pharmavite.

Isoflavones working group is chaired by Warren Lancaster, Vice President, Commercial and Corporate Development, Novogen.  The group identified several key manufacturers to include as part of this working group, including Acartis, ADM, Inverness, and Melbrosin.  AOAC has collected 17 methods to date.
 
Lutein/Lycopene’s working group is being chaired by Xiaolan Kou, Nature’s Sunshine.  Among the companies attending a November 9th working group meeting in Las Vegas include Schiff Nutrition, Kemin Health, and Piveg Inc.

MSM’s working group is being developed and chaired by David Lakey, President, Cardinal Nutrition. Companies expressing interest in validated methods for MSM include Schiff Nutrition, Flora Research, and NBTY.

Omega 3/6 is chaired by Eric Hagestuen, Cargill. This working group represents over 30 companies having interest in the standardization of methods for this ingredient and includes some of the largest manufacturers, including Cargill, Bioriginal, Lipid Nutrition, Ocean Nutrition, Pronova, Martek, Spectrum Organics, Napro Pharma, and Nordic Naturals.

Based on agreement by an Expert Review Panel (ERP), AOAC® Official MethodSM 996.06 is ready to begin a Single Laboratory Validation (SLV) as a matrix extension, with minor method refinements to extend its applicability from foods to dietary supplements.  Eric Hagestuen of Cargill has been invited to serve as the Study Coordinator. The ERP recommended investigating the use of C:23 as an internal standard, and elimination of the extraction steps in the method.

The ERP also discussed an alternative American Oil Chemists Society method, which is currently under consideration.

A Folin-Ciocalteau/ORAC working group is chaired by Chris Fields, Applied Food Sciences. This WG represents close to 15 companies having interest in the standardization of methods in this area. It includes some of the largest manufacturers, including Constellation Wines, Futureceuticals, and Welch’s.  For more information, see, http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=14013&zoneid=2

SAMe is being co-chaired by Peter Chang, Technical Director, Pharmavite and Om Reddy, Orchid Chemicals and Pharmaceuticals Ltd. This working group includes three of the largest bulk manufacturers of SAMe, including Orchid Chemicals and Pharmaceuticals Ltd., Gnosis, and Pliva Fine Chemicals, in addition to several manufacturers of SAMe containing supplements, including Pharmavite, Schiff, NOW Foods, and Nutramax.

A Single Laboratory Validation study for this ingredient will be conducted by USP and based on AOAC Expert Review Panel’s (ERP) recommendation (the ERP was held on April 11, 2005, in Gaithersburg, Maryland, chaired by Wayne Wolf of USDA) that the reversed phase HPLC method developed by Orchid involving an isocratic, ion-pair separation (method 208) be selected for further validation with specific modifications.  Steve Lunetta of Pharmavite incorporated those modifications in the method.

During the Supply Side West meetings, you will hear more about the status of various ingredients and opportunities to join the effort.  In addition, AOAC is hosting two Expert Review Panels where experts from the government, industry, and academia will be selecting fit-for-purpose methods for the analysis of both ginseng and echinacea.  These panels will be lead by James Neal-Kababick, Flora Research, and Stefan Gafner, Tom’s of Maine respectively. 

For more information, contact:

Anita Mishra
Principal Scientific Liaison, Government & Industry 
AOAC INTERNATIONAL
481 N. Frederick Ave. Ste. 500
Gaithersburg, MD  20877-2417
amishra@aoac.org
Phone: 301-924-7077 ext. 131