Gaining Compliance For an Ingredient to be Added to Food, Feed, and Dietary Supplements

The objective of this review is to acquaint the reader with how food, feed, and dietary ingredients (i.e., in supplements) are made compliant with laws written by Congress and subsequent regulations promulgated by the Food and Drug Administration (FDA), thus allowing these substances to enter interstate commerce. Some laws do not need interpretation, such as the definition of a drug or food, whereas other laws are relatively vague and must be given more definition to produce effective regulations. Regulations are not necessarily confined to the substance per se but may be based on the intended use of a substance; that is, the FDA may impute the use (or purpose) of a substance rather than its claimed use (e.g., food or supplement compared to a drug). Human food and dietary (supplement) ingredients are regulated by the Federal government, whereas most animal feed ingredients are regulated by the States and "approved" by a private organization. This article is not meant to be an exhaustive examination of each law and regulation and their exceptions but a brief overview of the distinguishing concepts of each category.