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PROJECTS/PROGRAMS

Measurements and Standards for Botanical Dietary Supplements

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Summary

Photograph of ginkgo leaves with overlayed chromatogram labeled with ginkolide designations.
Liquid chromatographic separation of ginkolides superimposed on a photograph of gingko biloba leaves
Credit: Lane Sander

As part of a multi-year interagency agreement among the National Institute of Standards and Technology (NIST), the National Institutes of Health's Office of Dietary Supplements (NIH/ODS), the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN), and the FDA Center for Drug Evaluation and Research (CDER), NIST is developing Standard Reference Materials (SRMs) for botanical dietary supplements.

SRMs with assigned values for concentrations of active and/or marker compounds, pesticides, and toxic elements are being produced to assist in the verification of manufacturers' label claims and for use in quality control during the manufacturing process in support of the Good Manufacturing Practices released by the FDA in 2007.

Description

Many consumers believe that botanical dietary supplements will improve their health and that these "natural" remedies are both effective and free from the side effects that may occur with other medications. There are occasional reports of inaccurate labeling, adulteration, contamination (with pesticides, heavy metals, or toxic botanicals), and drug interactions. Congress recognized the lack of publicly available, validated analytical methods for dietary supplements – and a lack of reference materials for validation of analytical methods – in 1994 when the Dietary Supplement Health and Education Act (DSHEA) was enacted. As part of DSHEA, NIH/ODS was directed to fund development of analytical methods and reference materials for dietary supplements. NIST's dietary supplement program began in 2001 as a collaborative effort between NIST and NIH/ODS to underpin the then-anticipated GMPs. Subparts E and J of the GMPs require manufacturers to establish specifications for identity, purity, strength, and composition; to set limits on contaminants and adulterants for every ingredient in their products; and to analyze both "materials in process" and finished products to determine whether specifications are met. The validity of analytical methods must be verified and then routinely used for monitoring against the manufacturer's specifications. Thus, the SRMs can be used both to demonstrate that a method is appropriate for its intended use and as a quality control material when demonstrating that specifications are met, ultimately reducing public health risks that may be associated with these products.

Major Accomplishments

  • More than 20 natural-matrix SRMs have been produced with more in progress.
  • Analytical methods have been developed for the measurement of citrus alkaloids, flavonoids, catechins, phytosterols, xanthines, and organic acids.
  • Certificates of Analysis for these materials can be found here or by clicking the SRM numbers in the list to the right.

 

ADDITIONAL TECHNICAL DETAILS 

In most cases, these SRMs are provided as suites of materials (plant, extract, finished product) that represent different analytical challenges. The constituents for which values are assigned are also listed. The constituents in all of these materials have been determined by multiple independent methods with measurements performed by NIST and collaborating laboratories. The methods utilized different sample extraction and cleanup steps in addition to different instrumental analytical techniques and approaches to quantification. These materials are provided primarily for use in method development and as control materials to support the measurement of these constituents in other similar products.  

Suites of materials based on black cohosh, soy, kudzu, and red clover are currently in progress. 

GOALS 

  • Increase the types and availability of botanical dietary supplement SRMs to meet the needs of analytical laboratories, manufacturers, and regulators 

  • Develop methods of analysis for these materials 

  • Enable the establishment of a link to label information on botanical dietary supplements 

  • Provide calibration solutions for selected constituents in the botanical products 

ASSOCIATED PRODUCT(S) 

SRM 

Description 

 

 

3232 

Kelp Powder (Thallus laminariae ) 

3235 

Soy Milk 

3246 

Ginkgo biloba (Leaves) 

3247 

Ginkgo biloba (Extract) 

3248 

Ginkgo-Containing Tablets 

3250 

Saw Palmetto (Serenoa repens ) Fruit 

3251 

Saw Palmetto (Serenoa repen s) Extract 

3254 

Green Tea (Camellia sinensis )Leaves 

3255 

Green Tea (Camellia sinensis ) Extract 

3256 

Green Tea-Containing Solid Oral Dosage Form 

3262 

St. John's Wort (Hypericum perforatum) Aerial Parts 

3268 

Kudzu (Pueraria montana ) Extract 

3275 

Omega-3 and Omega-6 Fatty Acids in Fish Oil 

3279 

Chromium Dietary Supplement 

3281 

Cranberry (Fruit) 

3282 

Low-Calorie Cranberry Juice Cocktail 

3283 

Cranberry Extract 

3284 

Cranberry-Containing Solid Oral Dosage Form 

3285 

Mixed-Berry Containing Solid Oral Dosage Form 

3289 

Multivitamin Tablets 

3291 

Bilberry Extract 

3294 

Multielement Tablets 

3299 

Ground Turmeric (Curcuma longa L. ) Rhizome 

3300 

Curcumin Extract of Turmeric (Curcuma long L.) Rhizome 

3384 

Ground Asian Ginseng (Panax ginseng C.A. Meyer) Rhizome 

3385 

Asian Ginseng (Panax ginseng ) Extract 

3389 

Ginsenosides Calibration Solutions 

3398 

Ginger (Zingiber officinale) Rhizome 

3530 

Iodized Table Salt (Iodide) 

8037 

Krill Oil 

8183 

Omega-3 and Omega-6 Fatty Acids in Botanical Oils 

8186 

Soy Protein Isolate 

8187 

Soy Protein Concentrate 

8188 

Soy-Containing Solid Oral Dosage Form 

8650 

Ground Kudzu (Pueraria montana var. lobata ) Rhizome 

8652 

Kudzu-Containing Solid Oral Dosage Form 

8664 

Ginseng-Containing Solid Oral Dosage Form 

8666 

Ginger (Zingiber officinale ) Extract 

publications

1. Lippert, J. A., Rimmer, C. A., Phillips, M. M., Nelson, M. A., Barber, C. A., Wood, L. J., Long, S. E., Bryan, C. E., Sharpless, K. E., Yen, J., Kuszak, A. J., and Wise, S. A., "Development of Kudzu (Pueraria Montana var. lobata) Reference Materials for the Determination of Isoflavones and Toxic Elements," Journal of Aoac International, 105, 1162-1174 (2022).  

2. Wise, S. A., "From urban dust and marine sediment to Ginkgo biloba and human serum-a top ten list of Standard Reference Materials (SRMs)," Analytical and Bioanalytical Chemistry, 414, 31-52 (2022).  

3. Cruz, M. B., Place, B. J., Wood, L. J., Urbas, A., Wasik, A., and Rocha, W. F. D., "A nontargeted approach to determine the authenticity of Ginkgo bilobaL. plant materials and dried leaf extracts by liquid chromatography-high-resolution mass spectrometry (LC-HRMS) and chemometrics," Analytical and Bioanalytical Chemistry, 412, 6969-6982 (2020).  

4. Duewer, D. L., Murray, J. A., Wood, L. J., Wise, S. A., Sander, L. C., Lippa, K., Hein, S., Koch, M., Philipp, R., Werneburg, M., Hackenberg, R., Polzer, J., Avila, M. A., Serrano, V., Kakoulides, E., Alexopoulos, C., Giannikopoulou, P., Gui, E. M., Lu, T., Teo, T. L., Hua, T., Chen, D. Z., Li, C. X., Ye, C. J., Li, H. M., Nammoonnoy, J., Quinn, L., Swiegelaar, C., Fernandes-Whaley, M., Goren, A. C., and Gokcen, T., "CCQM-K95.1 Low-polarity analytes in a botanical matrix: polycyclic aromatic hydrocarbons (PAHs) in tea," Metrologia, 56, (2019).  

5. Betz, J. M., Rimmer, C. A., Saldanha, L. G., Phillips, M. M., Andrews, K. W., Wise, S. A., Wood, L. J., Kuszak, A. J., Gusev, P. A., and Pehrsson, P. R., "Challenges in Developing Analytically Validated Laboratory-Derived Dietary Supplement Databases," Journal of Nutrition, 148, 1406S-1412S (2018).  

6. Saldanha, L., Dwyer, J., Andrews, K., Betz, J., Harnly, J., Pehrsson, P., Rimmer, C., and Savarala, S., "Feasibility of Including Green Tea Products for an Analytically Verified Dietary Supplement Database," Journal of Food Science, 80, H883-H888 (2015).  

7. Zhang, L. X., Burdette, C. Q., Phillips, M. M., Rimmer, C. A., and Marcus, R. K., "Determination of Isoflavone Content in SRM 3238 Using Liquid Chromatography-Particle Beam/Electron Ionization Mass Spectrometry," Journal of Aoac International, 98, 1483-1490 (2015).  

8. Sander, L. C., Bedner, M., Duewer, D. L., Lippa, K. A., Phillips, M. M., Phinney, K. W., Rimmer, C. A., Schantz, M. M., Sharpless, K. E., Tai, S. S. C., Thomas, J. B., Wise, S. A., Wood, L. J., Betz, J. M., and Coates, P. M., "The development and implementation of quality assurance programs to support nutritional measurements," Analytical and Bioanalytical Chemistry, 405, 4437-4441 (2013).  

9. Schantz, M. M., Sander, L. C., Sharpless, K. E., Wise, S. A., Yen, J. H., NguyenPho, A., and Betz, J. M., "Development of botanical and fish oil standard reference materials for fatty acids," Analytical and Bioanalytical Chemistry, 405, 4531-4538 (2013).  

10. Rinimer, C. A., Sander, L. C., Sharpless, K. E., and Wise, S. A., "Analytical challenges in the certification of botanical dietary supplement standard reference materials," Planta Medica, 74, 313 (2008).  

11. Rimmer, C. A., Howerton, S. B., Sharpless, K. E., Sander, L. C., Long, S. E., Murphy, K. E., Porter, B. J., Putzbach, K., Rearick, M. S., Wise, S. A., Wood, L. J., Zeisler, R., Hancock, D. K., Yen, J. H., Betz, J. M., NguyenPho, A., Yang, L., Scriver, C., Willie, S., Sturgeon, R., Schaneberg, B., Nelson, C., Skamarack, J., Pan, M., Levanseler, K., Gray, D., Waysek, E. H., Blatter, A., and Reich, E., "Characterization of a suite of ginkgo-containing standard reference materials," Analytical and Bioanalytical Chemistry, 389, 179-196 (2007).  

12. Sharpless, K. E., Thomas, J. B., Christopher, S. J., Greenberg, R. R., Sander, L. C., Schantz, M. M., Welch, M. J., and Wise, S. A., "Standard reference materials for foods and dietary supplements," Analytical and Bioanalytical Chemistry, 389, 171-178 (2007).  

13. Rimmer, C. A., Howerton, S. B., and Sander, L. C., "Determination of ginkgolides and flavonol glycosides in Ginkgo biloba standard reference materials," Abstracts of Papers of the American Chemical Society, 230, U209-U210 (2005).  

14. Sander, L. C., Sharpless, K. E., Satterfield, M. B., Ihara, T., Phinney, K. W., Yen, J. H., Wise, S. A., Gay, M. L., Lam, J. W., McCooeye, M., Gardner, G., Fraser, C., Sturgeon, R., and Roman, M., "Determination of ephedrine alkaloids in dietary supplement standard reference materials," Analytical Chemistry, 77, 3101-3112 (2005).  

15. Wise, S. A., Sharpless, K. E., Sander, L. C., and May, W. E., "Standard Reference Materials to support US regulations for nutrients and contaminants in food and dietary supplements," Accreditation and Quality Assurance, 9, 543-550 (2004).  

 

SRMs

Analytical chemistry, Food and nutrition and Reference materials
Created May 30, 2012, Updated November 3, 2023