Nutrition Formulators, Inc. an NNFA-GMP certified nutraceutical company, and HCIS, Miami based clinical laboratory since 1993, have partnered to offer clinical trial services to the nutraceutical industry.
Until recently there was a lack of interest in researching supplements and functional foods; but nowadays, issues such as qualified health claims and regulatory concerns, have motivated companies to perform thorough research and testing before launching a product in the market.
Nutrition Formulators’ CEO, Adolfo Graubard, has stated that “it is certainly critical to develop products that are effective and consistent. Everyone is aware that the consumer is expecting reassurance when making a purchase decision. The days when anecdotal data of a product's virtue were enough for the public have disappeared. Around the corner are the days of proving a product's effectiveness. NFI and HCIS will provide pharmaceutical and nutraceutical manufacturers with an affordable solution to the high cost of clinical trials today. We are aware of the reduced margins we must all work with in the nutritional industry. For the Industry to move forward, this is a must.”
Trials will be conducted overseas. A US based Institutional Review Board will ensure the protection of rights and safety of human research subjects and will examine and approve study protocols.
Graubard explained that studies will be conducted and supervised by experienced research professionals.
Current principal areas of concern for companies in the industry are the substantiation of qualified health claims in product labels, final product testing, supplement/drug interaction and toxicology and safety issues, as government regulations are heading to increased proof of product efficacy and safety.
It is important to highlight that many companies still remain naïve when it comes to investing in clinical trials and research. In this sense, companies must realize that, according to experts, it is research that will strengthen the marketing efforts in the future, as credibility is a crucial factor for the market.
Mr. Graubard finally pointed out that “the message for those companies is that our model will provide them with the adequate information to make proper decisions and launch their products safely and in an affordable way”.