A human clinical study, also known as a clinical trial, is a research study that involves human participants to evaluate the safety and efficacy of a product, ingredient, or intervention. These studies are designed to answer specific research questions and generate scientific evidence to support product claims, labeling, and marketing.
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Human clinical studies go beyond GRAS clinical testing by evaluating not only safety but also the efficacy of products, such as their health benefits or performance claims. While GRAS clinical testing focuses on demonstrating safety for food ingredients, human clinical studies are often used for broader applications, including health claims and regulatory approvals.
Yes, human clinical studies are vital for novel food applications as they provide evidence of safety, nutritional benefits, and any specific health claims. This data ensures compliance with EFSA guidelines for novel foods and supports global regulatory frameworks requiring scientific validation of product safety and efficacy.
Human clinical studies are not always mandatory but can be critical when existing safety data is insufficient or when specific health or efficacy claims are made. For FDA, studies may be required for GRAS certifications or Investigational New Drug (IND) applications. EFSA often requires human clinical studies to support health claims or novel food applications. Health Canada mandates these studies for Clinical Trial Applications (CTA) and certain food additive submissions. Conducting these studies can strengthen the application and demonstrate compliance with regional regulatory standards.
Preparation involves designing a robust study protocol, conducting a food safety audit to ensure compliance with manufacturing standards, and selecting the right research site. Partnering with regulatory experts ensures that all requirements are met, from study design to final analysis, minimizing risks during the approval process.
Human clinical studies provide scientific evidence that supports health or performance claims for food and dietary supplements. By testing under controlled conditions, these studies confirm the benefits claimed on product labels, ensuring compliance with regulatory standards for safety and efficacy.
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