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FSMA and Botanical Raw Materials

Author: Cathy Weir 

What does this mean to you and your manufacturing process?

With the roll-out of Food Safety Modernization Act (FSMA), FDA has initiated a risk-based prevention strategy to ensure safety and quality control of raw botanical materials used in dietary supplements, foods and beverages.   Simply put, these new requirements will require a sharper focus on traceability systems and food safety measures within your manufacturing operations.

The rules require that you not only substantiate the species-specific identification of the botanical in a raw material but also substantiate the safety of exact plant parts (i.e., stem, leaf, root). In addition, FSMA requires your Food Safety Plan to specifically address potential botanical contamination (i.e., economically motivated adulteration, known adulterants, cross contamination).  This calls for alignment across industry standards (i.e., U.S. Pharmacopeial Convention (USP), American Herbal Pharmacopoiea (AHP) monographs) and a need to communicate with your suppliers.  Your organization may require additional training among key stakeholders (i.e., QA, Analytical Science, Product Development, Supply Chain) along with suppliers outside of the United States.  To meet this need numerous FSMA training opportunities are available at the IFPTI website. To develop good communications and promote harmonization, now is the perfect time to pro-actively host a stakeholder and supplier training meeting.



American Herbal Products Association. March 2017. Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials.

AHPA Botanical Identity References Compendium, on-line resource

American Herbal Pharmacopoeia: Botanical Pharmacognosy – Microscopic Characterization of Botanical Medicines, R. Upton, A. Graff, G. Jolliffe, R. Länger, E. Williamson (Eds.). CRC Press, Boca Raton, FL, USA (2011).

USP Food Fraud Database

Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food, 21 C.F.R. 117 (2015).


Submitted by:

Cathy Weir, Ph.D., R.D.

FSPCA Lead Instructor Preventive Controls for Human Food

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