gms | German Medical Science

Approval of medicinal products and medical devices requires proof of efficacy and safety based on the results of clinical trials conducted according to internationally accepted ethical and scientific standards. The legal and regulatory framework as well as the role and responsibility of Independent Ethics Committees (IEC) within this process are clearly defined. IEC review requires the submission of research related documents for consideration, comment, guidance and approval to safeguard the rights, safety, and well-being of trial subjects and to take into account potential risks and benefits for the community.

For dietary supplements, the situation is not as clear as detailed guidance and regulations are not available and differentiation between supplement and drug might not always be evident at first sight. Furthermore, dietary supplements are not risk-free and can lead to health problems if not used appropriately. An increasing number of foods and dietary supplements bear nutrition and health claims. Thus, in order to ensure a high level of protection for consumers, products put on the market must be safe and adequately labelled and health claims are only authorised, if they are based on scientific evidence. Reliable scientific evidence adequate to substantiate a claim requires information derived from human studies, which need to follow the same standards as studies for medicinal products and medical devices. As such an IEC needs to be engaged in review and approval.