Читать книгу Food Regulation - Neal D. Fortin - Страница 82

The scope of FDA’s authority over food derives in large measure from the definition of “food” in the Federal FD&C Act. Therefore, the definition bears importance in determining the reach and limits of the FDA’s jurisdiction and authority.

The statutory definition of “food” in FD&C Act section 321(f) is a term of art that is broader than the common‐sense definition of food. This creates pitfalls for the unwary. For instance, the definition of “food” includes chewing gum and food additives. Moreover, “food additives” includes substances that are not food ingredients but otherwise affect the characteristics of a food.³

To a large extent, the use of a product will determine the regulatory category into which it will fall. The manufacturer’s representations and the intended use also play an important part of determining the classification. On occasion, a manufacturer may benefit from changing its representations so that their product falls into a different category. For example, a laxative gum can escape the definition of food by being represented unequivocally as a drug product.