Nutraceuticals are crucial for human health and well-being due to their nutritional, medicinal, and safety benefits. They offer advantages over synthetic medications. However, they require high-quality products, readily available chemical forms, high-quality raw materials, and the absence of contaminants. A pre-market approval mechanism backed by clinical and scientific evidence is required to ensure safety and effectiveness. Legal definitions for nutraceuticals and functional foods vary globally, necessitating strict international guidelines to avoid confusion. These guidelines should be shared to substantiate health claims on product labels and safety guidelines in packaged products, ensuring proper information is used. This chapter confers regulatory bodies, statements, information, formulation challenges, and pharmacopeial specifications for nutraceuticals and dietary supplements for the reader’s convenience.