Comparing the FDA's process for health claim submission and the FFC's guidelines for regulating functional foods


  • Sarah Stratton
  • Danik Martirosyan PhD, Functional Food Institute, Dallas, TX, United States



Health claims are essential for providing accurate information about the relationship between nutrients and health outcomes to consumers. They facilitate informed decision-making and support individuals in making healthy dietary choices. The U.S. Food and Drug Administration (FDA) regulates health claims to guide consumers in maintaining healthy dietary practices. Health claims on food labels help consumers understand the potential health benefits associated with specific products and make informed choices aligned with their health goals. These claims also promote transparency and trust in the food industry by providing evidence-based information. The process of submitting a health claim to the FDA involves complying with regulatory requirements and providing robust scientific evidence. Scientific evidence plays a crucial role in substantiating health claims and should be based on well-designed clinical trials, epidemiological studies, and mechanistic research. Adhering to FDA labeling requirements ensures the accurate and informative presentation of health claims on food labels. The Functional Food Center (FFC) is working on theoretical aspects of creating ideal functional food (FF) products as well as how these products should be identified with special FF labels. While the FDA focuses on evaluating health claims, the FFC emphasizes the safe and effective use of functional foods. Understanding the FDA's evaluation process and the FFC's guidelines is crucial for researchers, food manufacturers, and policymakers to navigate the regulatory landscape and promote informed consumer choices. Compliance with regulatory guidelines, adherence to scientific standards, and clear communication of health claims contribute to a more informed and health-conscious society.

Keywords: Health claims, health outcomes, regulatory requirements, functional foods, health benefits





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