ABSTRACT

The U.S. Food and Drug Administration (FDA) is charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. What does it do when there is a health risk associated with a food product? When a problem arises with a product regulated by FDA, the agency can take a number of actions to protect the public health. Initially, the agency works with the manufacturer to correct the problem voluntarily. If that fails, legal remedies include asking the manufacturer to recall a product, having federal marshals seize products if a voluntary recall is not done, and detaining imports at the port of entry until problems are corrected. If warranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately violate the law. When warranted, criminal penalties-including prison sentences-are sought.