Food, Food Components, and Botanicals Affecting Drug Metabolism in Transplantation

In 2006, the US Food and Drug Administration (FDA) issued the draft guidance document “Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration” partly because of the increasingly widespread use of complementary and alternative medicine (CAM) providers and CAM products in the United States. CAM products are subject to regulation in the United States. The terms complementary and alternative represent 2 categories—1 complements traditional medicine and the other is an alternative to traditional medicine. One of the 4 domains of CAM includes biologically based products, such as botanicals and their extracts, animal-derived extracts, vitamins, minerals, fatty acids, and prebiotics and probiotics. It is important to understand how a product falls under the regulatory oversight of the FDA depending on its intended use. An item that is intended to treat a disease will generally be regulated as a drug, whereas that same item could be classified as a dietary supplement if the intended use is to “add further nutritional value to (supplement) the diet.” The same item may also be considered a food if the intended use is as an ingredient in a food product. However, a claim to treat, cure, palliate, or prevent disease or disease symptoms cannot be used on dietary supplement or food labels. Instead, this intended use would classify the product as a drug and require an Investigational New Drug approval from the FDA.
Source: Journal of Renal Nutrition - Category: Urology & Nephrology Authors: Tags: Patient Education Source Type: research