ABSTRACT
This chapter aims to provide an overview of how probiotics are controlled within the United States (US) regulatory landscape. It focuses on the regulatory landscape, as driven by food and dietary supplement regulations. In the US, trends have demonstrated that probiotics are increasingly added to products geared toward consumer health and wellness. The regulation of animal food in the US is unique in that while Food and Drug Administration (FDA) does take a major role in overseeing animal food, partnerships with state and local agencies are essential for effective regulation, especially within the animal feed industry. FDA has released a Guidance for Industry that addresses key exemptions for medical foods, including the Nutrition Labeling of Food under certain limiting conditions, the labeling requirements for content claims, and health claims as listed in the Nutrition Labeling and Education Act of 1990.
