The regulation of functional foods varies by country, but generally, they fall under food regulations rather than pharmaceutical regulations. In the United States, for instance, the Food and Drug Administration (FDA) regulates these products as foods, with specific guidelines ensuring safety and proper labeling. In the European Union, the European Food Safety Authority (EFSA) plays a similar role. However, these regulations primarily focus on safety and labeling rather than efficacy, which raises concerns about the claims made by some functional food products.
