+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

Regulatory Compliance for Dietary Supplements in the US, EU and Canada (Salt Lake City, UT, United States - February 20-21, 2020)

  • ID: 4858775
  • Conference
  • Location: Salt Lake City, UT, United States
  • 2 Days
  • Compliance Online
  • Conference Dates: February 20-21, 2020
1 of 5

A growing public demand for supplements has resulted in a flurry of companies creating and marketing dietary supplements in the United States, EU and Canada. With the regulatory authorities beginning to take a stronger stance on enforcement of regulatory policies, procedures and GMP compliance, it is important for companies to verify that their products comply with the latest regulations and provisions if they plan to market Supplements in these countries.

This 2-day interactive live seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada and discuss how to verify that products are compliant with these regulations. Differences with food and drug regulation in these countries will be noted as well.

We will also cover what qualifies as a dietary supplement or dietary ingredient, how to ensure GMP compliance as well as detailed requirements for labeling and acceptable marketing claims. An update on current events within the Supplement industry and the potential impacts to Manufacturers and Distributors in the US, EU and Canada will also be presented and discussed.

Note: Product cover images may vary from those shown
2 of 5

Day 01(8:30 AM - 5:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Dietary Supplement Regulation in the U.S.

Dietary Supplement Overview

  • What is a dietary supplement?
  • Supplements vs.
    • Pharmaceuticals
    • OTC Drugs
    • Conventional Foods
    • Medical foods
    • Natural products
    • Herbal medicinal products

Organizations and Regulatory Structure

  • FDA Structure regarding Dietary Supplements
  • Industry Groups

History of Dietary Supplement Regulation

  • Early History
  • DSHEA
  • Code of Federal Regulations

Manufacturing Considerations

  • Company & Facility Registration
  • GMP Requirements
  • GMP inspections

Dietary Ingredients

  • What qualifies as a dietary ingredient?
  • Old dietary ingredients vs. New dietary ingredients
  • New Dietary Ingredient Notification (NDIN)
  • Updated New Dietary Ingredient Guidance from FDA

Labeling Considerations

  • Display Panels & Layout
  • Supplement Facts Panel
  • Labeling Claims
    • Health claims
    • Disease Claims
    • Structure/Function claims
    • Disclaimers/Substantiation
  • Notification of labeling claims to FDA
  • Dietary Supplement Labeling Act

Advertising Considerations

  • FDA vs. FTC jurisdiction
  • Enforcement
  • Expressed vs. Implied Claims
    • Exercises and Examples
  • Disclosures
  • Claim Substantiation
  • Testimonials

Day 02(8:30 AM - 4:30 PM)

Food Supplement regulation in the EU

Overview

  • What is a food supplement?
  • Borderline products
  • Medicinal Foods

Organizations and Regulatory Structure

  • EU Regulatory Structure
  • Industry Groups

Supplement Regulation

  • Early History
  • Food Supplement Directive

Manufacturing Considerations

  • Company & Facility Registration
  • GMP Requirements

Dietary Ingredients

  • What qualifies as a dietary ingredient?
  • Ingredient safety
  • RDA vs RDI
  • DRV vs % Daily Value

Labeling Considerations

  • Display Panels & Layout
  • Labeling Claims
    • Health claims
    • Disease Claims
    • Reduction of Disease Risk Claims
    • Nutrition Claims
  • Notification requirements

Advertising Considerations

  • Enforcement
  • Claim Substantiation

Natural Health Product regulation in Canada

Overview

  • What is a Natural Health Product?

Organizations and Regulatory Structure

  • Canadian Regulatory Structure
    • Health Canada
    • Canadian Health Products Directorate

Supplement Regulation

  • National Health Products Regulation
  • Differences between Canada and US
  • Supplements monographs
  • Requirements for pre-market approval

Manufacturing Requirements for Natural Health Products in Canada

Dietary Ingredients

Labeling Considerations

Advertising Considerations

Enforcement and Post-Marketing Surveillance

Review of Current Events and other Industry Topics Questions and Answers

Note: Product cover images may vary from those shown
3 of 5

Loading
LOADING...

4 of 5
  • Ben Marandi Mr Ben Marandi,
    Owner and Manager ,
    BSD Group


    Ben, owner and Managing Director of BSD Group is a food professional consultant. He has solid understanding of food and beverage industry with good knowledge of food and beverage product development and compliance. He has two main focus for his clients. First to make sure that regulatory compliance for its clients in the North America, European communities, and GCC countries. Secondly, he provides market research for companies planning to export their products to overseas markets.

    This provides one shop station for clients who plan to go countries with no knowledge of markets, competition and regulations. He understand the importance of regulatory compliance for companies which plan to sell or export their products to these markets. Ben has 20 years of experience in food and beverage industry, with 12 years' international experience as senior advisor to Codex Alimentarius and European Commission.

    Ben's main expertise is in product development, food laws and food additives regulations, food safety, market research, international trade and nutrition, food law and regulations of Canada, US (FDA , FSMA) , EU and Codex Alimentarius.

Note: Product cover images may vary from those shown
5 of 5
  • Executives/Managers within Dietary Supplement or Natural Product companies
  • Regulatory Compliance Professionals in the Supplements or Natural Products area
  • Quality Assurance or Quality Control Professionals
  • Dietary Supplement or Natural Product Manufacturers & Distributors
  • Sales/Marketing Personnel in the Supplement or Natural Product Industries
Note: Product cover images may vary from those shown
6 of 5

ADDRESS

Salt Lake City Marriott City Center
220 State Street
Salt Lake City, UT
84111
United States

Note: Product cover images may vary from those shown
Adroll
adroll