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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