Regulatory Compliance for Dietary Supplements in the US, EU and Canada: 2-day In-person Seminar

By: Travis Austin MacKay, Director of Regulatory Affairs, Plexus Worldwide
Location :- Salt Lake City Marriott City Center, UT | Thursday, February 20, 2020 | Friday, February 21, 2020

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Course Description:

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

Course Outline:

Day One (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.
  1. Dietary Supplement Overview
    1. What is a dietary supplement?
    2. Supplements vs.
      1. Pharmaceuticals
      2. OTC Drugs
      3. Conventional Foods
      4. Medical foods
      5. Natural products
      6. Herbal medicinal products
  2. Organizations and Regulatory Structure
    1. FDA Structure regarding Dietary Supplements
    2. Industry Groups
  3. History of Dietary Supplement Regulation
    1. Early History
    2. DSHEA
    3. Code of Federal Regulations
  4. Manufacturing Considerations
    1. Company & Facility Registration
    2. GMP Requirements
    3. GMP inspections
  5. Dietary Ingredients
    1. What qualifies as a dietary ingredient?
    2. Old dietary ingredients vs. New dietary ingredients
    3. New Dietary Ingredient Notification (NDIN)
    4. Updated New Dietary Ingredient Guidance from FDA
  6. Labeling Considerations
    1. Display Panels & Layout
    2. Supplement Facts Panel
    3. Labeling Claims
      1. Health claims
      2. Disease Claims
      3. Structure/Function claims
      4. Disclaimers/Substantiation
    4. Notification of labeling claims to FDA
    5. Dietary Supplement Labeling Act
  7. Advertising Considerations
    1. FDA vs. FTC jurisdiction
    2. Enforcement
    3. Expressed vs. Implied Claims
      • Exercises & examples
    4. Disclosures
    5. Claim Substantiation
    6. Testimonials
Day Two (8:30 AM – 4:30 PM)
Food Supplement regulation in the EU
  1. Overview
    1. What is a food supplement?
    2. Borderline products
    3. Medicinal Foods
  2. Organizations and Regulatory Structure
    1. EU Regulatory Structure
    2. Industry Groups
  3. Supplement Regulation
    1. Early History
    2. Food Supplement Directive
  4. Manufacturing Considerations
    1. Company & Facility Registration
    2. GMP Requirements
  5. Dietary Ingredients
    1. What qualifies as a dietary ingredient?
    2. Ingredient safety
    3. RDA vs RDI
    4. DRV vs % Daily Value
  6. Labeling Considerations
    1. Display Panels & Layout
    2. Labeling Claims
      • Health claims
      • Disease Claims
      • Reduction of Disease Risk Claims
      • Nutrition Claims
    3. Notification requirements
  7. Advertising Considerations
    1. Enforcement
    2. Claim Substantiation
Natural Health Product regulation in Canada
  1. Overview
    1. What is a Natural Health Product?
  2. Organizations and Regulatory Structure
    1. Canadian Regulatory Structure
      • Health Canada
      • Canadian Health Products Directorate
  3. Supplement Regulation
    1. National Health Products Regulation
    2. Differences between Canada and US
    3. Supplements monographs
    4. Requirements for pre-market approval
  4. Manufacturing Requirements for Natural Health Products in Canada
  5. Dietary Ingredients
  6. Labeling Considerations
  7. Advertising Considerations
  8. Enforcement and Post-Marketing Surveillance
Review of Current Events and other Industry Topics
Questions and Answers

Meet Your Instructor

Ben Marandi
Travis Austin MacKay,
Director of Regulatory Affairs, Plexus Worldwide

Travis MacKay is the Director of Regulatory Affairs for Plexus Worldwide, a leading direct sales company with a range of products dedicated to helping others obtain health and happiness. He currently oversees international regulatory compliance activities driving strategic direction focused on claims development and substantiation strategy, product development and commercialization, international formulation considerations, and quality testing & validation.

Travis has 20 years of quality and regulatory experience, including prior regulatory affairs leadership positions within well-respected, global consumer product companies. He has a passion for mentoring regulatory professionals to develop robust compliance systems that keep business moving forward.

Travis Graduated from the University of Utah in 2002 with a B.S. in Behavioral Science and Health (Human Health Emphasis). He is a fly-fishing enthusiast, a college football fan, an exercise junky, and a lover of classic cars. He escapes the noise by spending time with his family in the outdoors of beautiful Arizona.

Venue

Location :

Salt Lake City Marriott City Center
220 State Street,
Salt Lake City, UT 84111, USA
Tel: +1-801-366-8057

February 20-21, 2020



How to Reach

General Driving Directions:

Driving Directions from Salt Lake City International Airport - SLC: 7 miles E
  • Take I-80 East to the City Center/600 South exit.
  • Continue on 600 South and turn left on State Street.
  • Hotel is 3 blocks north on the left hand side.
  • Make a legal u-turn to your left to enter property.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. GRC Seminars is not responsible for any inaccuracies in the same.
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Local Attractions of Salt Lake City, UT

Temple Square and Related Sites
Temple Square is Salt Lake City's most popular attraction. With its grand six-spired temple, two visitor's centers, lovely flower gardens and fountains - and nearby sites related to the Church of Jesus Christ of Latter-Day Saints. Area attractions include the Assembly Hall, Tabernacle, Museum of Church History and Art, Family Search Center, Beehive House, Lion House, Brigham Young Historic Park, LDS Conference Center and Joseph Smith Memorial Building. Temple Square offers hundreds of free movies, dramatic programs and music events every year.

The Gateway
The Gateway on the west side of downtown Salt Lake is the city's best outdoor shopping center.

City Creek Center
It's designed to be a walkable shopper's paradise, with six acres of green space, the namesake creek, two 18-foot waterfalls, and a massive retractable roof.

Capitol Hill
The Utah State Capitol, at 300 N. State St., sits atop a hill overlooking the Salt Lake Valley. The building was constructed in 1912-1916 and renovated in 2004-2008.

Hogle Zoo
Utah's Hogle Zoo dates from 1931 and is located at the mouth of Emigration Canyon at 2600 E. Sunnyside Avenue. The Zoo is one of the most visited attractions in Utah and the top paid-for tourist attraction in Salt Lake City. It covers 42 acres and includes more than 800 animals.

This is the Place Heritage Park
This is the Place Heritage Park includes a restored pioneer village with live demonstrations of pioneer life and a restored Brigham Young farmhouse.