USA - Food-Derived Bioactive Components and Health ClaimsThe Role of Regulatory Agencies

The market and demand for products formulated with food-derived bioactive components are increasing substantially. Functional foods may be marketed in the United States as dietary supplements containing herbs or other botanicals and metabolites. With the growing influx of these products claiming one health benefit or the other, regulatory bodies must act swiftly to ensure and assure consumers of product quality, efficacy, and safety using evidence-based studies that substantiate those health claims and, where these claims are not allowed, issue citations to violators of the law. The approval of and guidance on functional foods, natural health products (NHPs), herbal products, food/health supplements and good manufacturing practices (GMPs), and other roles and requirements vary by jurisdiction and organizational framework – the Food and Drug Administration (FDA) applies and enforces its regulatory requirements in the USA but no authority to approve dietary supplements for safety, effectiveness, and labeling. Other countries and territories such as China, Japan, and the European Union (EU), as well as the World Health Organization (WHO) have formulated their own requirements and regulations. The complexity in size and market, limited safety, bioactivity, and efficacy information, and the lack of harmonized regulations remain an impediment. This chapter highlights the role of regulatory bodies in ensuring accurate, authorized, and qualified health claims and recommendations for these products and consumer safety.

Author(s):  Aryee, Alberta., Ofori, K. F., Otchere, Emmanuel., Dare, K.O and Akanbi, T. O.

Published in: Plant Food Phytochemicals and Bioactive Compounds in Nutrition and Health