SOURCE: Xtalks

Xtalks Webinars

September 25, 2017 07:00 ET

Claims Substantiation - An Integrated Clinical and Regulatory Approach, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - September 25, 2017) - During a live broadcast on Wednesday, October 11, 2017, featured speakers from Nutrasource will discuss how:

  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

"Product claims are integral to effective product positioning," said Josh Baisley, director of clinical trials for Nutrasource. "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," Baisley added.

When defining the claim, consider the entire label. Also, recognize that being specific about the claimed effect, conditions of use, formulation and duration will make the claim easier to prove, especially when 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 to successfully execute 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

Nutrasource is a full-service contract research organization and consulting firm specializing in health products. Its experienced team partners with sponsors to bring pharmaceutical and nutraceutical products to market through strategic product development, regulatory and clinical trial consulting and analytical and bioanalytical testing.

To learn more about this free webinar, visit: Claims Substantiation - An Integrated Clinical and Regulatory Approach.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers..

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