Claims Substantiation – An Integrated Clinical and Regulatory Approach

Food Ingredients and Innovations, Food Safety and Regulation, Food ,
  • October 11, 2017

Product claims are integral to effective product positioning. With a strong, proven claim, companies can differentiate their brand while reinforcing the product’s health and nutritional benefits and performance. Successful claim substantiation may also enable companies to reposition existing products into new product categories and gain access to new markets.

When defining the claim, consider the entire label. Also, recognize that being specific about the claimed effect, conditions of use, formulation and duration will be easier to prove by following an integrated and well-designed regulatory and clinical approach.

Claim substantiation begins by first determining what claims are permitted in each regulatory region that the products will be marketed in, as regulations vary widely among regions. Understanding what types of claims can be made and what evidence is required to make specific claims is essential. Claims to treat, prevent and cure, for example, typically require a higher level of evidence than structure function claims. Human intervention studies are generally required, while animal studies or in vitro studies may be considered only supportive evidence to justify health claims.

It is also necessary to recognize the risks associated with claim substantiation. Proper clinical trial design is essential for successfully executing a claims substantiation trial.

Common pitfalls leading to claims rejection by regulatory authorities include:

  • Failure to critically assess prior literature
  • Inappropriate patient population or inclusion/exclusion criteria
  • Lack of control group
  • Insufficient method of randomization
  • Inappropriate statistical tests and reporting of results
  • Primary measures not consistent with the target claim
  • Failure to use validated questionnaires and validated biomarkers
  • Insufficient study duration

 

Speakers

Josh Baisley, B.Sc., Director of Clinical Trials, Nutrasource

Joshua Baisley joined Nutrasource in 2013, bringing over 12 years of quality assurance, clinical, preclinical and regulatory natural health product experience and an additional four years of antibody/biologics development experience. Josh has been an active member of the probiotic community as a member of the International Probiotics Association (IPA) Board of Directors, blogging for the IPA, and presenting at the probiotic workshop as well as at the Probiotics Resource Center at SupplySide West in 2016 and 2017 and Vitafoods Europe in 2017. 

 Having depth in both regulatory filings and project management of clinical trials provides Josh with an understanding of regulatory body thinking and has led to his respected relationship with Health Canada. From 2011-2014, Josh participated on a Health Canada expert working group as a member representing the dietary supplement industry to work toward harmonization of safety reporting for supplements, drugs and biologics. Josh’s regulatory filings throughout his career account for over 10 percent of all applications received by Health Canada’s Natural and Non-prescription Health Products Directorate for clinical research trials. Josh has a Hons. B.Sc. from the University of Guelph, specializing in microbiology and a certificate in regulatory affairs. 

 

 

Will Rowe, B.A., President, CEO and Co-Founder, Nutrasource

William Rowe co-founded Nutrasource Diagnostics Inc. with Dr. Bruce J. Holub in May 2002 with the intent to market a novel diagnostic test called the Omega Score. Since that time, Nutrasource has grown to become a world leader in servicing the global health products industry in clinical, regulatory, analytical and bioanalytical services as well as Omega-3 and GMO product certification programs. Throughout his tenure as president and CEO, William has been nominated for The Ernst and Young Entrepreneur of Year Award twice and has led Nutrasource to place on the PROFIT 500 list of Canada’s Fastest Growing Companies over the last five years.

 

 

Rachel Rebry, M.Sc., Associate Director, Regulatory Affairs, Nutrasource

Rachel Rebry has extensive working knowledge of the regulatory frameworks for both Canada and the United States. Since joining the Nutrasource team in 2009, Rachel has acted as the project manager on product and site license applications to Health Canada’s Natural and Non-prescription Health Products Directorate, involving ingredient safety and efficacy assessment, claim development, quality review, and compliance with Good Manufacturing Practices. She also has experience in working with new food health claim applications, GRAS assessments, supplemented foods, cosmetics, infant formula, low-risk veterinary natural health products, food additives and medical foods.

 Throughout her career, Rachel has also been the lead on jurisdictional investigations to determine the pathway of optimal positioning in the marketplace for new consumer health products. In addition, she has excelled in open collaboration with regulatory agencies and over 75 sponsors determining need, requirement and comprehension of the best possible regulatory pathway for success.

 

 

Who Should Attend?

  • Ingredient/Raw Materials Suppliers
  • Food and Beverage Manufacturers
  • Dietary Supplement/Natural Health Product (NHP) Manufacturers
  • Pharmaceutical Manufacturers (with Nutraceutical Divisions)

 Relevant job areas include:

  • Clinical R&D
  • Regulatory

 

What You Will Learn

  1. Successful product claims can enhance a product’s brand, can enable companies to reposition a product into a new product category and can allow companies to enter new markets
  2. An integrated and well-designed regulatory and clinical research approach is critical to success
  3. To meet regulations, which vary by region, by understanding the evidence required and recognizing the risks
  4. Probiotic research carries its own nuances in trial design and conduct that must be considered

Xtalks Partners

Nutrasource

 Nutrasource is a full-service contract research organization and consulting firm specializing in health products. With 100+ employees in four offices across three countries, our experienced team partners with sponsors to bring products to market through strategic product development, regulatory and clinical trial consulting and analytical and bioanalytical testing. For a full list of services, visit www.nutrasource.ca.

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