Development of reference materials for dietary supplements-analytical challenges, use, limitations, and future needs

Area of Science:

• Analytical Chemistry
• Reference Materials Science
• Pharmacognosy

Background:

• The National Institute of Standards and Technology (NIST) and the National Institutes of Health Office of Dietary Supplements have partnered for 20 years.
• This collaboration focuses on developing crucial reference materials for dietary supplements.
• Initial efforts concentrated on botanical and non-botanical supplements, establishing foundational analytical methods.

Purpose of the Study:

• To review the historical development and analytical challenges of dietary supplement reference materials.
• To describe the evolution from first-generation Standard Reference Materials (SRMs) to second-generation Certified Reference Materials (CRMs).
• To discuss future needs and advancements in the field of dietary supplement reference materials.

Main Methods:

• Development of over 20 Standard Reference Materials (SRMs) for botanical and multivitamin supplements.
• Application of multiple analytical techniques for value assignment of marker compounds and toxic elements.
• Review and analysis of challenges encountered in producing complex supplement matrices.

Main Results:

• Successful development of a range of botanical (e.g., ginkgo, green tea, soy) and multivitamin/multimineral (MVM) SRMs.
• Identification of key analytical challenges, including matrix complexity and compound variability.
• Establishment of a model for the subsequent generation of CRMs, incorporating lessons learned.

Conclusions:

• The two-decade collaboration has significantly advanced the availability and reliability of dietary supplement reference materials.
• Improvements in the second generation of CRMs address limitations of earlier materials, offering enhanced accuracy and scope.
• Continued development is essential to meet future needs in the emerging research sector of supplement quality control.