This seminar aims to assist delegates to an understanding of how the borderline between medicines and foods may be defined and how best to tailor the presentation of their products to the regulatory structure appropriate to them
9 Dec 2019
Medicines treat, cure or prevent illness. Foods provide nutrition. But are the distinctions so clear?
Foods also have a physiological effect and a role in disease risk reduction – and substances whose purpose is nutritional may be presented as medicines. An understanding of where the borderline lies between medicines and foods is essential for the successful marketing of specialist health products: getting it wrong is a costly route to market failure. However,the regulatory framework is detailed and complex, requiring a knowledge of the relevant legislation.
This seminar will highlight the most important regulatory issues, with particular focus on the borderline between botanical food supplements and herbal medicinal products, and on health claims and the long outstanding question of what the authorisation process for botanical claims will be.
Topics to be covered at this seminar:
Where is the borderline?
The borderline: food for thought
Health claims in Europe: implications for marketing and research and development strategies
EU borderline law on medicines and foods
Case study: discussion on borderline products
David Richardson runs a specialist consultancy in nutrition and food science, DR Nutrition. He holds a visiting professorship at the University of Reading, School of Chemistry, Food and Pharmacy. He began his teaching and research career at the University of London and at the Massachusetts Institute of Technology. He then worked for Nestlé UK Ltd, ultimately becoming Group Chief Scientist. From 2000 to 2005, Professor Richardson chaired a section of an EU Concerted Action Programme (PASSCLAIM), to develop a process for the scientific substantiation of health claims on foods, and from 2009 to 2011 he was a participant and an author in the ILSI Europe PROCLAIM project, which developed further guidance on the science needed to underpin EU and global regulatory frameworks for nutrition and health claims. In 2005, Professor Richardson was appointed a member of the Royal Swedish Academy of Agriculture and Forestry. He is also a Fellow of the Royal Society of Medicine and a member of the UK Nutrition Society. He sits on several industrial and university scientific advisory boards and is scientific advisor to a number of European and international organisations in the area of foods and food supplements.
After a career in industry as General Manager of a company making licensed natural medicines, food supplements and cosmetics, Penny Viner spent 7 years as Director of the Health Food Manufacturers’ Association (HFMA), whose members manufacture food and food supplement products, and remains its Vice President, with particular responsibility for herbal issues.
Penny also chairs the UK Herbal Forum, and is Director and Secretary of the British Association of Homoeopathic Manufacturers. Previously she was a Director and Secretary of the UK branch of the European Food Law Association.
She was a member of the British Pharmacopoeia Commission Expert Advisory Group on Herbal and Complementary Medicines and a member of the Ministerial Herbal Medicines and Practitioners Working Group, and is currently a member of MHRA’s Manufacturing Industry Liaison Group.
Until end 2013 she was a Project manager for the International Alliance of Dietary/Food Supplement Associations (IADSA), writing its monthly newsletter and coordinating its Scientific Group.
She now writes an International Regulatory Supplement for the European Federation of Associations of Health Product Manufacturers, is Vice-Chairman of its Botanicals Working Group, and is a botanicals expert for the European Botanical Forum.
Penny is also an independent consultant of food and medicines regulation.
Brian Kelly is Regulatory Lawyer at Covington and Burling LLP, one of the leading life science law firms in the world. His practice focuses on EU food and drug law, public and administrative proceedings, European Union law and product liability and safety.
Mr Kelly’s advice on general regulatory matters includes borderline determinations – in particular borderline between medicines and food, borderline between foods (e.g., food supplements and PARNUTS) – health claims, food labelling and promotion/advertising, novel food determinations, and recalls.
He represents clients before food and medicine regulatory authorities and national and EU courts. He is ranked in Chambers UK and the Legal 500 for food regulatory advice and is a lecturer at University College London in life science regulation.