SPDS eBook March 2017

3/10/2017

Regulatory Guidance (if any)

▪ For dietary supplements, the relevant regulations need to be followed, e.g., ▪ Food, Drug & Cosmetic Act (FDC Act) ▪ Nutrition Labeling and Education Act (NLEA) of 1990 ▪ Dietary Supplement Health and Education (DSHEA) Act of 1994 ▪ Food and Drug Administration Modernization Act (FDAMA) of 1997 ▪ Food Safety Modernization Act (FSMA) of 2011 ▪ Topical echinacea products are regulated as cosmetics (claim dependent)

Proposed Fitness for Purpose

Quantitation of phenolic compounds (i.e., caftaric acid, chlorogenic acid, cichoric acid, cynarine, and echinacoside) in Echinacea angustifolia , Echinacea pallida , and Echinacea purpurea raw materials and finished dietary supplement products

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