# Science based authentication of botanical ingredients

> **NIH FDA U01** · UNIVERSITY OF MISSISSIPPI · 2020 · $2,758,000

## Abstract

PRJECT SUMMARY/ABSTRACT
For 21 years under the provisions of DSHEA, the FDA has had primary responsibility for ensuring that
appropriate regulatory actions are taken against marketed products that present significant health risks or bear
false or misleading label claims. Foundational to the evaluation of such risks and claims is an adequate
scientific base for decision-making. For botanical dietary ingredients, development of such a science base is
wide-ranging because of several unique features, including the variability of sourcing, lack of manufacturing
controls, complexity of the constituents, lack of availability of reference materials widespread usage in the
marketplace and unknown adverse effects due to herb-herb, or herb-drug interactions. In 2010 the FDA fully
implemented the current good manufacturing practices (cGMP) for the botanical dietary supplement industry
placing the onus of “botanical identity and authenticity” on the manufacturers of dietary supplements containing
various botanical ingredients. However, these cGMP's have highlighted the ambiguity of exactly what
constitutes a “scientifically valid method” for the determination of the identity authenticity and safety of
botanical materials. To address these complex issues surrounding botanical identity, authenticity, and safety
and in continuation of our cooperative agreement with the FDA, the NCNPR has established the following
specific aims to aid in the research needs of the FDA:
1) Assist in the identification and development of a list of dietary herbal supplements and botanical
 ingredients, based on safety concerns, trends, and knowledge of botanicals being marketed in the U.S.,
 to prioritize for further research.
2) Acquire, validate, and characterize authenticated reference materials, including raw and processed
 plant materials and purified natural products of relevance to FDA, for the assessment of their
 fingerprinting, adulteration, safety and toxicity.
3) Exchange technical and scientific information, analytical methods, and reference material with FDA
 scientists and other stakeholders.
4) Collaborate with FDA scientists in research areas of mutual interest.
5) Coordinate scientific workshops and conferences on BDS-related topics of

## Key facts

- **NIH application ID:** 9994265
- **Project number:** 5U01FD004246-10
- **Recipient organization:** UNIVERSITY OF MISSISSIPPI
- **Principal Investigator:** Amar G. Chittiboyina
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $2,758,000
- **Award type:** 5
- **Project period:** 2011-09-15 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994265

## Citation

> US National Institutes of Health, RePORTER application 9994265, Science based authentication of botanical ingredients (5U01FD004246-10). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9994265. Licensed CC0.

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