This course explores the U.S. regulatory landscape governing botanical and dietary supplement products, including FDA guidelines, Dietary Supplement and Health Education Act (DSHEA), new dietary ingredient approval process, current Good Manufacturing Practices (GMP), and claims substantiation. Students analyze how regulations inform research design, product development, and market access for botanical therapeutic products.
Analyze how regulations shape research design, product development, and market access for botanical therapeutics.
Evaluate the evidence needed for structure-function and health claims in order to substantiate marketing claims lawfully.
Apply risk-based analysis to botanical safety and supply chain factors in order to design appropriate specifications and controls.
Create core GMP documentation, SOPs, batch records, logs, and change controls,in order to run a traceable quality system.
Formulate a supply chain strategy in order to support a botanical product’s responsible path to market.
Assess new dietary ingredients and product-classification pathways to guide compliant product development.
Required Course Pack:
Required Textbooks:
View the required textbooks for this class, including ISBN, edition, and retail price, by visiting our Required Textbooks page.
Total Course Price:
View the total course price including tuition, fees, course materials, and shipping online here.
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