A list of the top 12 dietary supplement ingredients, in order of those most urgently in need of validated methods, was developed by the AOAC Ingredient Ranking Subgroup (IRS), chaired by Leila Saldanha, National Institutes of Health (NIH). Chondroitin, chromium salts, sildenafil, and aloe were ranked highest on July 26, 2011, at AOAC headquarters in Gaithersburg, Maryland, USA, under a National Institutes of Health (NIH) initiative on dietary supplements. Overall, 75 ingredients were reviewed and scored, including ingredients last ranked by the group in March 2010.

Source of funding is a major factor driving decisions. Other criteria in ranking include relative market share of the ingredient, general availability of methods from which to select a method, any NIH clinical trials planned or underway requiring a method to characterize the material used in the trial, and any ingredient safety concerns.

Prior to the July 2011 meeting, interested parties were invited to submit their recommendations for ingredients for ranking, with a brief justification/need statement as to why these ingredients should be considered. Ten new ingredients were submitted by the U.S. Food and Drug Administration (FDA).

All ingredients were ranked, or placed into one of three categories: score at a later date, placed on hold, or eliminate.

The ingredient ranking table developed from the previously held ranking on March 25, 2010, was reviewed to determine if any ingredients should, therefore, be moved to or from the list. The group decided to rank the new nominations, while ingredients already on the list but for which the analyte is not clearly identified, and other information may be required, would be “placed on hold” until such information is submitted. Items in this category include angelica/dong quai, oregano oil, holy basil, taxine alkaloids, phosphatidylserine/choline, goji, cinnamon, and kava. The IRS agreed to remove ingredients designated to be scored at a later date from ranking.

The IRS meets annually in support of the Indefinite Delivery, Indefinite Quantity (IDIQ) contract between AOAC and FDA, with task orders focusing on the NIH-FDA-AOAC initiative on dietary supplements. For more information, contact Bob Rathbone, senior director of publications and method validation, at rrathbone@aoac.org. 

Full coverage, including a list of the top 12 ingredients ranked, is scheduled for the September/October 2011 issue of Inside Laboratory Management.

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