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Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

A Plant is NOT Medicine: Plant vs. Constituent Element

Abstract

David V Gauvin

Alternative medicines remain under the regulatory control of the US Food and Drug Administration. A number of competent and professional researchers in the field of drug development have touted and proclaimed the safety and efficacy of smoked Cannabis sativa and kratom. In 2017, under international and national statutes, neither Cannabis sativa nor kratom are medicines. The community of scientists must maintain an objective scientific, verifiable and legally-sound methodology and lexicon in developing supportive data to advance constituents of the plant for NDA approvals. Use of the term “medical marijuana” is inappropriate.

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Citations: 533

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