AOAC INTERNATIONAL (AOAC) invites method developers to submit methods for consideration and possible evaluation through the AOAC Official MethodsSM program. Prospective methods must be able to determine folate in the forms of supplemental folic acid and/or 5-methyl-tetrahydrofolate in all forms of dietary supplements (i.e., tablets, capsules, softgels, gelcaps, liquids, powders, chewable gels, or other forms) intended to be taken by mouth.
For the purpose of this call for methods, Dietary supplements is defined as product for humans to be taken by mouth that contains a “dietary ingredient” intended to supplement the diet. Dietary supplements may be found in many forms [refer to USP <1151> Pharmaceutical Dosage Forms for definitions (usp.org)], such as tablets, capsules, gels, softgels, gelcaps, liquids, or powders. Dietary ingredients are defined as vitamin, mineral, herb, or other botanical; an amino acid; a dietary substance for use by humans to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients. Folate should be expressed as per the supplemental folic acid and/or r 5-methyl-tetrahydrofolate according to the published Standard Method Performance Requirements (SMPR®), AOAC 2022.002.
The intended use of any method meeting the SMPR is to establish a reference method for compliance with FDA Dietary Supplement cGMPs or other relevant regulatory agencies. Acceptable methods must be reliable, repeatable, and ultimately reproducible when used by trained analysts in accredited laboratories.
Reference the draft SMPR for definitions of the various applicable commodities and the proposed method validation requirements for parameters such as analytical range, limit of quantitation, recovery, repeatability and reproducibility, system suitability and reference materials. Any analytical technique that meets the method performance requirements is acceptable.
Interested method developers must provide their method and data demonstrating that the method can meet the performance requirements.
Method authors may submit methods for review to the Official Methods of Analysis℠ (OMA) program.
Official Methods of Analysis (OMA) Program
DEADLINE: October 14, 2022
Submit your method(s) for First Action status consideration. (Email submissions will not be accepted).
For general information or comments on the Official MethodsSM Program, contact Saliha Argubie, Coordinator at [email protected] or via telephone: 301-924-7077 ext 153.
View the Standard Method Performance Requirements (SMPR): AOAC 2022.002 – Standard Method Performance Requirements for Determination of Folic Acid in Dietary Supplements.