Having a hunger and thirst for regulatory is a must for this discipline. Experts are ready to serve you the latest updates in the ever-changing global regulatory environment for health-related foods. Choose from our sessions about dietary supplements, medical foods and new dietary ingredients.

8:30­­–10:00 am

Functional Foods and Dietary Supplements: Manufacturing, Claims and Marketing

Come gain regulatory insights from experts in the field on manufacturing, labeling and claims for dietary supplements across key markets. Markets covered will include US, EU and China. Key learnings from this session will be: The EFSA claims review process, an overview of marketing a functional food in China from the Institute of Nutrition and updates on the US GMPs and labeling. Join us if you’re planning on marketing dietary supplements in one of these key markets.

Laura Alvarez, head of health products and self care, Normon Laboratories Spain
Gretchen Miller Bowker, MS, RAC, FRAPS, chief operating officer and co-founder, Pearl IRB
Junsheng Huo, PhD, director, Department of Food Science and Technology, Institute of Nutrition and Food Safety, Chinese Center for Disease Control and Prevention
Andrea Wong, PhD, vice president, scientific and regulatory affairs, Council for Responsible Nutrition

10:30 am–12:00 pm

Exporting Food Safety to the Global Supply Chain

Long gone are the days of getting all of our food from the local farm markets. Today our food and the ingredients that make up our food come from all over the world including many emerging markets. The Food and Drug Administration’s Foreign Supplier Verification Program recognizes that food safety is a global effort. What are emerging markets doing to address food safety? During this session, you will learn about some of the efforts and challenges emerging markets face when developing modern food safety systems to produce domestic and exported food supplies. We will also discuss partnerships that exist to assist to build the capacity of a global food safety system.

Junshi Chen, MD, head, International Life Sciences Institute Focal Point, China
Claire Narrod, PhD, research scientist and manager, risk analysis program, JIFSAN
Vish Prakash, MD, PhD, FRSC, FIFT, FINAE, FIAFoST, FNAAS, FAFST(I), FINAS, FNAS, distinguished scientist of CSIR-INDIA, Mysore, INDIA director of research, development, management and innovation, JSS-MVP
Chad Weida, associate director, regulatory affairs, Abbott 

1:15–2:45 pm

Introduction of Supply Chain Complexity by Multiple Food-Grade Specifications: Is There a Path Forward?

Establishing specifications (purity and impurities) for food ingredients and additives is important for creating effective food safety systems. There are many internationally-recognized agencies that have the responsibility of establishing these specifications, such as FCC, JECFA, and USP. All of these agencies rely on similar risk assessment and risk management processes to evaluate and establish specifications. However, for many food ingredients there are often differences between the specifications established by different agencies. With increasing emphasis in certain regulatory frameworks on meeting the specifications established by a particular agency, food manufacturers face challenges in terms of ensuring global compliance to multiple specifications. This session aims to improve the understanding of the similarities in the processes used by the different agencies to establish these specifications, and whether different specifications can be considered equivalent in terms of ensuring consumer safety.


Junshi Chen, MD, head, International Life Sciences Institute Focal Point, China
Daniel Folmer, PhD, review chemist, Division of Petition Review, Office of Food Additive Safety, CFSAN, FDA
Paul Hanlon, associate director regulatory affairs, Abbott Nutrition
Kristie Laurvick, MS, acting director, science-food standards, USP
Markus Lipp, PhD, senior food safety officer, FAO

4:00–5:30 pm

Medical Foods/FSMPs—Access and Convenience Matters

Medical food, also known as food for special medical purposes (FSMP), is a category of foods for special dietary uses which are specially processed or formulated and presented for the dietary management of patients and may be used only under medical supervision. Healthcare practitioners are closest to their patients to decide on their safety and best usage of a medical food ‘in case dietary change is impossible, unrealistic or very difficult.’ In that case food targeting a medical condition is no longer simply for convenience but may become a medical necessity to allow access of the patient to his/her best possible disease management. This session will explore the benefits of science-based medical foods for patients and healthcare systems as well as global issues to apply the law to emerging scientific and regulatory matters for the dietary disease management of patients. 

Junshi Chen, MD, head, International Life Sciences Institute Focal Point, China
Eric H.W. Kossoff, MD, professor, neurology and pediatrics, Johns Hopkins Medicine
Mark Pohl, Esq, biotech general counsel, PPA, LLC—Pharmaceutical Life Cycle Management Solutions(TM)
Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS, global head regulatory advocacy, Nestlé Health Science, Switzerland
William Yan, PhD, director, Bureau of Nutritional Sciences, Food Directorate, Health Canada