Human Intervention Studies and EFSA Health Claims
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Duration: 30 min
Abstract: The European Food Safety Authority (EFSA) states that human intervention studies are ‘central’ to health claim substantiation and are also the ‘top of the hierarchy’ that informs decisions.Just how much data in necessary to deliver a positive health claim opinion and what can we learn from tracking past published opinions of EFSA’s NDA Panel.What are the key deliverables for any human intervention study or package of human studies?
The key takeaways:
- Health claims may not be quite as challenging to achieve as some people may think - as long as you design and deliver a consistent package of good quality human intervention studies.
- Published scientific opinions from EFSA’s NDA Panel covering previous health claim applications offer a great resource to future health claim applicants.
- The principle of GCP (Good Clinical Practice), are vital to delivering a study that will meet the expectations of EFSA reviewers.
STEVE MORRISON | Regulatory Consultant to Atlantia Food Clinical Trials
Steve holds a degree in Medical Biochemistry from Royal Holloway College (University of London) and a post-graduate qualification in Clinical Science (University of Wales). Over 20 years in the pharmaceutical industry, Steve developed a career in clinical research and global project management, whilst working on some unconventional drug products originating from natural ‘bio-extracted’ sources e.g. the Alzheimer’s Disease treatment, galantamine hydrobromide, discovered in the snowdrop/daffodil bulb.
In 2008 Steve transferred his development skills to the functional food sector, joining Provexis plc, as Chief Operating Officer. Under Steve’s guidance Provexis became the first company to gain a proprietary (Article 13.5) health claim, from EFSA under EC Regulation 1924/2006. That blood circulation claim, for the proprietary tomato extract (Fruitflow™)* , remains one of very few to be positively reviewed by EFSA.
Since 2012 Steve has run his own consulting business (P2F Ventures Limited) supporting clients seeking to have similar health claims success.
*Fruitflow is a trade mark of Provexis plc