Dietary Supplements Regulations| US| EU| Canada

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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.

Who will Benefit

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

Seminar Fee Includes:

Lunch

AM-PM Tea/Coffee

Seminar Material

USB with seminar presentation

Hard copy of presentation

Attendance Certificate

$100 Gift Cert for next seminar

Download Brochure

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 & 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

Ben Marandi
President, BSD Group Inc

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.

Register Now

1
January 29-30, 2020
Salt Lake City, UT

Online using Credit card

$1,899.00

Seminar One Registration

January 29-30, 2020, Salt Lake City, UT
(Registrations till October 25, 2019 - $1899)
(Registrations after October 25, 2019 - $2099)

Early bird seats are limited and based on first-come, first-serve.

Your registration fee includes the workshop, all course materials and lunch.

For discounts on multiple registrations, contact customer care at +1-888-717-2436.

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Offers:

Early bird seats are limited and based on first-come, first-serve.

Multiple offers cannot be combined.

Location:

Salt Lake City, UT
(Venue to be announced shortly)

January 29-30, 2020

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