NSD 225 Lecture 2: Dietary Supplements
14 Feb 2017
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Herbs or botanicals: teas, tinctures, extracts. By the food and drug administration (fda) Governed by law for foods, not drugs. Do not require proof of safety or effectiveness to be sold. Use good manufacturing process (gmp: standards for manufacturing, preparing and storing to ensure quality, guarantee the identity, purity, strength, and composition of supplements. Required to have supplements facts panel that is truthful and not misleading. Burden of proof is on the fda: once a product is on the market the fda must prove it is unsafe in order to restrict its use or remove it from the market. Investigate history of use: laboratory studies, animal experiments, *review individual case reports, *observational studies, *clinical trials. From 2004-2013 ~ 23,000 admissions to er annually. Do not require approval but must notify fda when used on dietary supplements labels. Must include disclaimers: the fda has no evaluated the claim, the product is not intended to diagnose, treat, cure, or prevent any disease.
