Reputable research and quality-assured ingredients are critical components of any product-development effort. This holds true particularly for a category such as cognitive health, where consumers might not be educated about factors such as efficacious dosages and the benefits of long-term supplementation. INSIDER asked a few industry professionals for their take on the matter.
Consumer trust is the cornerstone of the marketplace. However, according to Najla Guthrie, president and CEO of KGK Synergize Inc., “Industry has been under a lot of scrutiny lately as it is perceived as non-regulated. As a result, consumer confidence in natural health products is eroding."
Science is one of the best ways to assuage customer concern about product safety and efficacy. “A placebo-controlled, randomized control trial (RCT) is the ‘gold standard’ for clinical studies because it can correlate the primary outcome of the study to the investigational product with minimal bias," Guthrie explained. “However, companies do not always adopt this model and conduct open-label or non-randomized studies for evaluation of their products. In addition, selecting the appropriate endpoints, population, duration as well as inclusion and exclusion criteria can largely frame how well your study is designed and how generalizable the results will be."
Guthrie’s parting advice for companies looking to substantiate a cognitive health claim? Ensure the primary outcomes for the trial are feasible and can be evaluated using rigorous scientific methods. “In line with selecting the appropriate endpoints to support a claim is also doing a sample size calculation. This will allow the clinical trial to be powered well enough so that when it is time to do statistical analysis, you can see meaningful trends in the data," she concluded.
Vetting Prospective Suppliers
With adulteration and clean label concerns at an all-time high, ingredient sourcing is another universal challenge. Alice Chin, quality control (QC) director at ingredientsonline.com, said U.S. buyers may find it difficult to perform audits—particularly when working with Chinese ingredient manufacturers—but document review and confirmation of the product specs are essential. “Different companies have different QC procedures, so select a trustworthy manufacturer/supplier that can meet your own quality requirements and make sure they have been in business at least 3 to 5 years," she said.
Bob Capelli, BGG consultant, also suggested ensuring at least two positive human clinical trials exist, as well investigating which structure/function claims can be used to market a finished product.
Besides ensuring the relevant research, Bryan See, ExcelVite regional product manager, recommended asking potential suppliers the following questions:
• Does the dosage make sense (feasible, cost-effective)?
• Is the ingredient extracted from an edible food source? Is it natural or synthetic? Genetically modified organism (GMO) status? Kosher certification?
• Is the supplier a GMP (good manufacturing practice)-certified producer? Does the ingredient meet GMP requirements?
• Can the supplier provide evidence of ingredient bioavailability?
• Can the supplier assist in formulating a cognitive health product that will deliver the same dosage for cognitive health benefits as indicated in the literature?
For information about leading suppliers and solutions providers, visit the Cognitive Health SupplySide Storefront. Also available is a free Digital Summit, Cognitive Health Chronicles, featuring detailed presentations from several market specialists.