Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States

Speaker

Instructor: Travis Austin MacKay
Product ID: 706585
Training Level: Intermediate

Location
  • Duration: 60 Min
Dietary Supplement companies must ensure that any product claims they make are “truthful and not misleading” under FDA and FTC regulations. To meet these standards, the FTC has stated that claims must be substantiated by “competent and reliable scientific evidence.” This course provides strategies to: 1) identify claims; 2) characterize/rank claims; and 3) determine the level of scientific evidence needed to substantiate different types of claims.
RECORDED TRAINING
Last Recorded Date: Nov-2020

 

$229.00
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)

$299.00
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)

 

 

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Why Should You Attend:

Your organization has developed a truly innovative dietary supplement and wants to advertise its benefits broadly through multiple media channels. As a regulatory professional, you need to make sure that all efficacy claims used in advertising and labelling are compliant and do not draw unwanted attention from the Federal Trade Commission and the Food and Drug Administration.

The Federal Food, Drug, and Cosmetic Act requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim has substantiation that the claim is truthful and not misleading. Additionally, the FTC Act strictly prohibits unfair or deceptive acts or practices.

The FTC has brought several enforcement actions against dietary supplement companies, and in some cases levied multi-million-dollar fines and penalties for violative advertisements. Simply put, any advertisement for your product must be “truthful and not misleading”. To meet this requirement, the FTC has stated that product efficacy claims must be substantiated by “competent and reliable scientific evidence”. But how do you know if your scientific evidence meets FTC’s expectations. This course provides strategies to: 1) identify claims; 2) characterize and rank the different types of claims; and 3) determine the level of scientific evidence needed to substantiate different types of claims.

  • Is your dietary supplement substantiation “unhealthy” for your organization?
  • Are your dietary supplement claims based on competent and reliable scientific evidence?
  • How does FTC’s “competent and reliable scientific evidence” standard apply to your dietary supplement claims?
  • Does the FTC have your dietary supplement claims in its cross-hairs? Learn effective strategies to substantiate product claims and minimize risk.

Areas Covered in the Webinar:

  • Regulatory requirements for substantiating dietary supplement claims for advertising and labeling
  • Identifying different types of dietary supplement claims
  • Competent and Reliable Scientific Evidence
  • How to characterize/rank product claims
  • Risk-based approach to scientific substantiation
  • Scientific evidence recommendations (based on risk)
  • Qualifying claims
  • Linking scientific evidence to finished products
  • Linking scientific evidence to botanical extracts

Who will benefit:

  • Regulatory Affairs Professionals
  • Corporate Counsel
  • Legal Affairs
  • Technical/Scientific Affairs Professionals
  • Research & Development
  • Marketing/Product/Brand Management
  • Copy/Technical Writers
  • CEOs
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.

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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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