A Nutraceutical refers to a food-derived product that provides health benefits beyond basic nutrition. These products may help in preventing or managing diseases, but they are not classified as pharmaceuticals. The term “Nutraceutical” is not universally defined under a single regulatory framework, and its classification varies across different regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Food Safety Authority (EFSA), and India’s Food Safety and Standards Authority of India (FSSAI).
Nutraceuticals include dietary supplements, functional foods, medical foods, and fortified foods containing bioactive compounds like vitamins, minerals, probiotics, herbal extracts, and omega-3 fatty acids. Unlike pharmaceuticals, nutraceuticals do not require extensive clinical trials for approval, but they must comply with Good Manufacturing Practices (GMP), labeling regulations, and safety assessments.
In the U.S., the FDA regulates nutraceuticals under the Dietary Supplement Health and Education Act (DSHEA), which requires manufacturers to ensure product safety before marketing. However, claims about disease treatment or cure must be supported by scientific evidence and cannot be misleading. In the EU, nutraceuticals fall under food supplement regulations, requiring approval of health claims before they can be marketed.
Regulatory agencies focus on quality control, safety evaluations, and labeling compliance to prevent false claims and ensure consumer protection. Post-market surveillance and adverse event reporting are also critical in monitoring the safety of nutraceuticals. Ensuring compliance with international regulatory standards is essential for the global marketing and acceptance of nutraceutical products.
Masuu offers regulatory and quality assurance services to help companies ensure their nutraceutical products comply with international standards and successfully reach the market.
Their key services include:Product Registration – Assisting companies in obtaining regulatory approvals for nutraceutical products by preparing and submitting required documentation to agencies such as the FDA, EFSA, FSSAI, or other national regulatory bodies. This ensures that products meet the necessary legal and safety requirements before being marketed.
Labeling Compliance – Ensuring that product labels follow regulatory guidelines, including accurate ingredient listings, approved health claims, dosage recommendations, and required warnings. Compliance with labeling laws helps prevent misleading claims and ensures consumer transparency.
Quality Assurance – Implementing Good Manufacturing Practices (GMP), stability testing, ingredient verification, and safety assessments to maintain high-quality standards. This ensures that nutraceutical products are safe, effective, and consistent in composition.