Читать книгу Food Regulation - Neal D. Fortin - Страница 89

In determining whether a product is a “drug” because of intended use, the FDA is not bound by a manufacturer’s subjective claims of intent.¹⁶ Actual therapeutic intent may be found on the basis of any objective evidence. Such evidence may be inferred from “labeling, promotional material, advertising, and any other relevant source.”¹⁷

Unlike the definition of “drug,” the FD&C Act definition of “food” lacks any reference to intent. Nonetheless, a court may consider the intended use of the product in considering whether it is a food. However, a manufacturer’s subjective intent that a product should not be consumed will not allow the product to avoid the reach of the FD&C Act if the product looks like food and smells like food.