Regulatory Compliance for Dietary Supplements in the US, EU, and Canada

Why Should You Attend:

An aging population has increasingly become a global phenomenon, not just in developed countries, but also among emerging regions. The shift to an elderly population adds to healthcare burdens, but also creates opportunities for functional food and dietary supplement producers. As consumers in today’s climate are increasingly concerned about how to improve the quality of life, instead of simply satisfying their basic health needs, the market for supplements that meet consumer demands for enhanced nutrition and well ness has boomed over the last several decades and is projected to show continuing growth.

The course will cover basic regulatory requirements for marketing dietary supplements in the US and Canada including product safety, manufacturing, product claims, and labelling requirements. A general overview of EU regulations will also be given. The course will cover several key topics including key requirements for how dietary supplements are regulated in the US. The course will also cover NHP licensing and submission requirements, manufacturing requirements, site license requirements, labelling requirements, and consumer advertising of NHP products in Canada as well as regulatory framework, the EU Food Supplements Directive, and the role of the EFSA on regulating dietary supplements in the EU.

Learning Objectives:

• Understand the regulations required for dietary supplements in the United States, Canada, and the EU
• A side-by-side comparison of the similarities and differences in regulation among the three regions and what manufacturers need to know in order to comply with regulations in each region
• An overview of the regulatory agencies that govern requirements within each region and the role that each agency plays in setting and enforcing rules for dietary supplements

Areas Covered in the Webinar:

• US Dietary Supplement background and regulation including:
• Compliance guidelines for dietary supplements
• Requirements for labeling and adverse event reporting
• Manufacturing and GMPs for dietary supplements in the United States
• Canada’s Natural Health Product Regulations which include:
• Product and site licensing requirements
• How the NHP regulations differ from FDA regulations
• Canadian labeling and advertising requirements
• An overview of the EU Dietary Supplements Directive, governing vitamin and mineral supplements

Who Will Benefit:

• Executives of Dietary Supplement Companies
• Regulatory Compliance Professionals
• Quality Assurance Professionals
• Dietary Supplement Manufacturers
• Dietary Supplement Distributors
• Sales/Marketing Personnel

Derrick Swint
Principal Consultant, Zoetic Global Consulting

Derrick Swint's career has been shaped by his floor experience in the food manufacturing industry. Through the course of his career, he has worked several leadership roles in Sanitation, Pest Control, and Environmental Services. His many responsibilities include coordinating programs such as developing and scheduling the Master Sanitation Program Schedule, SSOP development, scheduling sanitation in SAP, developing and scheduling housekeeping audits, internal audits, corrective/preventive action programming, and CIP administrator.

Derrick has extensive years of bakery experience. He has been responsible for implementing many programs internally. Along with assisting PCQI development, his food safety credentials include Certified Sanitarian, HACCP, Certified CIP Manager and Licensed Pest Control Operator and has additionally obtained certifications in BRC, SQF, and ISO 22000.

Topic Background:

Consumers walking into any nutritional supplement store today are faced with thousands of herbal remedies to treat common ailments: Echinacea for colds, dandelion root to help with water retention, grapeseed to promote healthy aging. Because of the increase in consumers including dietary supplements in their daily routine, dietary supplements have now become a $5 billion industry.

How do consumers know exactly what's in the supplement pills they are taking? A group of Canadian researchers put out a recent study that used DNA bar-coding to test what was really in those bottles. The researchers found that only two out of twelve companies put what they claimed was in their supplements in the bottles. The rest either had contaminants or substitutes, like rice or wheat. Given the statistics, how can consumers know what is really in purchased supplements? What regulations are currently in place; how can consumers keep both safe and informed? Regulatory agencies in the United States, Canada, and the EU have begun to tighten and enforce regulations on dietary supplement manufacturers to ensure consumer safety and nutritional legality.

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