AOAC Analytical Methods First Targeting Seven Supplement Ingredients

AOAC International initially will focus on developing analytical methods for chondroitin sulfate, ginkgo biloba, glucosamine, SAMe, St. John's wort, saw palmetto constituents and kava kava, according to the organization.

The seven supplement ingredients were identified as being most urgently in need of validated methods by AOAC's Ingredient Ranking Subcommittee (IRS). The panel based its decision on four factors: market share/industry needs; availability of methods; National Institutes of Health clinical trial data; and FDA Center for Food Safety & Applied Nutrition safety concern/Center for Drug Evaluation & Research need.

Each factor was "assigned a weight, given their relative importance to each other," after which the weighted scores were "rank ordered to yield a priority list," AOAC explained.

The seven top-priority ingredients were taken from a list of 19 ingredients that AOAC's Dietary Supplement Task Group determined should have validated analytical methods.

Other ingredients for which the association expects to validate methods over the next five years include aconite, beta carotene, black cohosh, coenzyme Q10, eleuthero (Siberian ginseng), Panax and Quinquefolius (American) ginseng, milk thistle, valerian and yohimbe.

During the prioritization process in November, IRS used a five-point scoring system for each of the four factors being considered. For example, an unweighted score of 20 would mean the panel found the ingredient is a top-seller, already has a pool of methods that can be chosen from, needs to be characterized for a planned or ongoing NIH trial, or is either the focus of a CFSAN safety concern or requires a method due to an NDA linked to an NIH trial.

IRS plans to meet and revisit its prioritization list every six months and make changes as necessary, according to AOAC.

The creation of the list of ingredients is stipulated in a contract signed in late September. The contract expands an agreement that was reached between AOAC, CFSAN and NIH's Office of Dietary Supplements in November 2001 to develop analytical methods for ephedra and aristolochic acid (¹ (Also see "FDA Dietary Supplement Method Validation Manual Under Development" - Pink Sheet, 12 Nov, 2001.), p. 14).

Of the two ephedra methods currently being examined, AOAC noted one is in the full collaborative study phase, which takes five to six weeks to complete and another month to prepare before publication, while the other is approaching the collaborative study phase. The aristolochic acid method is in the single lab validation phase, the association said.

Under the new contract, AOAC must finish validation of two methods in the first year, five methods in the second year and 20 methods by the conclusion of the fifth and final year of the agreement.

To develop and validate the dietary supplement methods, AOAC will first request that its various government and industry stakeholders create or submit methods for ingredients identified by the Dietary Supplement Task Force.

After interested parties suggest methods for particular ingredients, an expert peer-review committee will meet and select the best candidate(s). AOAC is currently forming committees for different ingredients. The association said each panel likely will consist of six or fewer experts representing academia, industry and government.

After selecting a method for validation, AOAC will issue a call to parties interested in researching the method. Once responses are reviewed, the organization will then decide which parties will receive the NIH funding to validate the method.

Completed methods will be published in the Journal of AOAC International and eventually entered into AOAC's Web-based electronic Compilation of Analytical Methods (eCAM), which the association said is slated to launch by July 2004.

Consumer Healthcare Products Association VP-Nutritional Sciences Leila Saldanha, PhD, who chaired the initial IRS meeting, noted that, after development, the methods will be legally enforceable in the U.S. and recognized by CODEX and the European Union. Saldanha also said the eCAM database will serve as a "central reference point to access...supplement methods that industry and other key stakeholders can use."