What are "Natural Health Products"? Natural Health Products are those products used as foods, drugs, cosmetics or medical devices derived from natural sources.
Examples include products from plants (botanicals, herbals, phytomedicines), from animals (fish oils, certain hormones, tissues, blood). Most dietary ingredients are from natural sources. Back to Top
How are Natural Health Products regulated in the United States? Natural Health Products (NHPs) are regulated by their "intended use," based on claims made about the product. Therefore, NHPs can be regulated as foods--including dietary supplements, prescription and nonprescription drugs, biologics, medical devices, and cosmetics. Back to Top
What is a "botanical"? There are scientific and regulatory definitions of botanicals. The United States Food and Drug Administration has developed a regulatory definition of "botanical" as: any product that contains ingredients of vegetable matter or its constituents as a finished product.
Botanicals are comprised of plant materials--- either juices, gums, fatty oils, scent oils, etc., also algae or macroscopic fungi and similar products as the finisihed product.
From a regulatory point of view, botanicals DO NOT INCLUDE the following:
yeast or bacteria,
products of fermentation,
highly purified or chemically modified substances
derived from botanical sources (paclitaxel);
homeopathic drugs or elixirs.
The regulatory principles governing these latter products differ from those governing "botanical" products in the United States.
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What is a "dietary supplement?" The Dietary Supplement Health & Education Act of 1994, passed by the US Congress, defines dietary supplements as a category of Foods. Dietary Supplements are products (other than tobacco) that are intended to supplement the diet. They can be comprised of: vitamins, minerals, herbs or other botanicals, amino acids, dietary substance or concentrates, metabolites, constituents, extracts, or combinations of these ingredients.
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