Abstract
The US Food, Drug, and Cosmetic Act mandates that drugs be proven safe and effective for their labeled use before marketing. This requirement does not apply to herbs, because herbal products do not fall under the definition of a drug as long as they are not marketed for the prevention, diagnosis, cure, treatment, or mitigation of a disease. Thus, herbal products do not have to be proven safe or effective before marketing (Kurtzweil, 1999).
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Cupp, M.J. (2000). Legal/Regulatory Aspects of Herbal Products. In: Cupp, M.J. (eds) Toxicology and Clinical Pharmacology of Herbal Products. Forensic Science and Medicine. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-020-9_1
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DOI: https://doi.org/10.1007/978-1-59259-020-9_1
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-61737-190-5
Online ISBN: 978-1-59259-020-9
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