Clinical trials are essential for demonstrating the safety and efficacy of nutrition products, including functional foods, dietary supplements, and novel ingredients. However, navigating the regulatory environment for these trials can be complex.
Unlike pharmaceuticals, nutrition products often fall into different regulatory categories depending on the country, which directly impacts trial design, endpoints, and claims that can be made. For sponsors, understanding these differences is critical to ensuring both compliance and successful product development. Let’s take a closer look.
One of the first challenges in nutrition trials is that terms like dietary supplement, nutraceutical, or functional food do not always have consistent definitions worldwide. For example, in the United States, dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA), which treats them differently from drugs and foods.
In contrast, the European Union classifies many of these products as foods, subject to the European Food Safety Authority (EFSA) framework. These differences affect not only how products are labeled but also what type of clinical evidence is required to support claims.
Another major area of variation lies in health claims. In the U.S., companies can make structure/function claims (e.g., “supports digestive health”) without prior FDA approval, as long as the claims are truthful and substantiated. However, disease claims (e.g., “reduces risk of heart disease”) require much higher levels of evidence and are tightly restricted.
In the EU, the process is more stringent: all health claims must undergo EFSA evaluation and approval before being used on products. This means sponsors conducting nutrition trials for the European market must design studies that meet EFSA’s rigorous requirements, often with clearly defined endpoints, validated biomarkers, and reproducible evidence.
Ethics committees and regulatory authorities also have different expectations for nutrition trials depending on the region. While nutrition trials often involve healthy participants rather than patients, sponsors must still ensure safety, informed consent, and ethical oversight. Some countries require trial registration in public databases, while others emphasize specific safety assessments, especially for novel food ingredients.
For example, trials involving probiotics in Europe may require robust safety assessments due to concerns over microbiological risks, while in the U.S., probiotics with a long history of safe use may encounter fewer regulatory hurdles.
For sponsors planning international trials, these regulatory differences can have practical implications.
The global nutrition market is expanding, but regulatory differences mean sponsors must carefully align trial design with their product’s target market. Engaging with regulatory experts early in the process can save time and resources, ensuring that trial outcomes are not only scientifically sound but also compliant with the rules of the intended region.
For sponsors, awareness of these differences is not just about compliance—it is about maximizing the value of their clinical research and successfully bringing evidence-based nutrition products to market.
Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.