<p>This review delivers an in-depth analysis of the safety and toxicity of functional foods and nutraceuticals, emphasizing their health benefits beyond basic nutrition. It distinguishes between functional foods, such as fortified cereals and beverages integrated into daily diets, and nutraceuticals, which are concentrated dietary supplements like capsules, tablets, and powders. To ensure these products are safe for human consumption, the review outlines a comprehensive risk assessment process. This process includes four key steps: hazard identification, hazard characterization, exposure assessment, and risk characterization. A thorough assessment of various hazards—biological, chemical, physical, ergonomic, and environmental—is essential to understanding the risks these products may pose, especially when consumed over long periods. The review underscores the importance of accounting for vulnerable populations, such as children, pregnant women, and the elderly, and potential long-term effects when evaluating safety. It highlights the critical role of regulatory agencies, such as the Food and Drug Administration in the United States and European Food Safety Authority in the Europe, in enforcing safety standards and conducting evaluations before these products can be marketed. The paper delves into specific hazards, including those associated with phytochemicals, probiotics, and prebiotics, highlighting their potential risks. It stresses the need for advanced analytical techniques and robust regulatory guidelines during hazard identification. This systematic approach is vital for safeguarding public health while ensuring that the health benefits of functional foods and nutraceuticals are achieved without compromising consumer safety. The review emphasizes the balance between maximizing health benefits and minimizing risks.</p> Graphical abstract <p></p>