Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

Speaker

Instructor: Travis Austin MacKay
Product ID: 702154

Location
  • Duration: 90 Min
This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.
RECORDED TRAINING
Last Recorded Date: Aug-2021

 

$279.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why Should You Attend:

With the FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.

This 90 minute training will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling and acceptable marketing claims. An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed.

At the conclusion of this 75 minute presentation, there will be a 15 minute Q&A session with the speaker.

Areas Covered in the Webinar:

  • Dietary Supplement Overview
    • What is a dietary supplement?
    • Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods.
  • Regulatory Structure
    • FDA Structure regarding Dietary Supplements.
    • Industry Groups.
  • History of Dietary Supplement Regulation
    • Early History & DSHE.
    • Code of Federal Regulations.
  • Manufacturing/Distributor Considerations
    • Company & Facility Registration.
    • GMP Requirements.
  • 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 Requirements.
    • Labeling Claims.
    • Health vs. Disease vs. 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.
    • Disclosures & Claim Substantiation.
    • Testimonials.
  • Current Events
  • Questions & Answers.

Who will benefit:

This course will be beneficial to the following personnel in Dietary Supplement manufacturing companies:

  • Executives of Dietary Supplement companies
  • Regulatory Compliance Professionals
  • Quality Assurance Professionals
  • Dietary Supplement Manufacturers
  • Dietary Supplement Distributors
  • Sales/Marketing Personnel
Instructor Profile:
Travis Austin MacKay

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.

Frequently Asked Questions:

  1. Does total weight include excipients for proprietary blends and any overages added?
  2. Say one of the ingredients has 80% maltodextrin, and is present at 5% weight of supplement, thus maltodextrin is at 4% of finished supplement, would this be listed on ingredient listing?
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Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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