It’s been three years since Nestlé found itself on the losing end a 2009 decision by the U.S. FDA when it was deemed that the company’s drinks for children were labeled with misleading health claims. In a show of carefully executed planning, the company had bounced back with the creation of a new Clinical Development Unit (CDU) in Lausanne, Switzerland, proving it’s ready to meet not only the science-based requirements of the U.S. FDA but also the increasingly tough health claim challenges of European food regulatory system.
The company’s Clinical Development Unit (CDU) was created to manage its clinical trial endeavors, affording the company a more centralized workspace to “effectively and efficiently evaluate the impact of its foods and ingredients on human biology and health, as well as on taste and pleasure.”
Nestlé has a long history of clinical trial work and publication. Last year alone the company had more than 100 ongoing clinical trials and said it expected to carry out even more in the future. The CDU marks the first time Nestlé has consolidated the management of its global clinical trials program under one roof.
“Our clinical development work ultimately provides the scientific evidence as to whether our ingredients, new products, and product reformulations are effective in delivering consumer benefits,” commented Nestlé’s Chief Technology Officer Werner Bauer via press release. “The new CDU is a strategic fit with our research and development commitment to provide innovative solutions for nutrition, health and wellness.”
Mr. Bauer went on to add that the CDU was a “strategic fit” to the Nestlé’s research and development commitment in the areas of nutrition, health and wellness. The CDU will provide medical expertise in different therapeutic areas. It will also offer specialist knowhow in project management, data management and biostatistics – the use of statistics in the analysis of biological data.
In an interview with Nutraceuticals World, Dr. Rafael Crabbé, the head of the new unit, said that given the difficulty associated with proving food health claims, Nestlé’s CDU lays the groundwork for a more cohesive and unified approach to clinical trials. “Until now our clinical trials were managed by several different functions including the Nestlé Research Centre, Strategic Business Units (e.g. Dairy), Nestlé Nutrition, and locally by the markets,” he said. “Our new CDU brings the management of these clinical trials under one roof, and streamlines the managerial process making it both more efficient and more effective.”
He also underscored the great importance of the clinical work he plans to oversee at the new unit. “We want to communicate the health benefits of our products, and clinical trials are a robust way of evaluating the impact of food and beverages on human health,” he said. “In addition to our clinical trials, we constantly review the scientific literature to ensure that our claims are always science-based and meet the regulatory requirements.”
Because food health claims are often more complex to prove, Dr. Crabbé will no doubt draw on his past experience in the pharmaceutical industry as he leads the new unit. He told a Reuter’s reporter Nestle scientists planned to follow the same standards and methodologies for trials as drug companies. “When it comes to showing specific health benefits, food is a complex environment. The benefits of food are more subtle, more complicated,” he said.
When asked by Nutraceuticals World which health claims and/or foods studies might be among the unit’s top research priorities, Dr. Crabbé was mum on details. “Our top priority for the Clinical Development Unit is to strengthen the management of Nestlé’s global portfolio of clinical trials. The Clinical Development Unit oversees many different types of clinical trials, including randomized controlled trials (double-blind and crossover),” he said. “In our trials, we include measurements of clinical biochemistry or physiological function, as well as tolerance and acceptability of diets and dietary compliance.”
Nestlé’s CDU also houses a Metabolic Unit for metabolic studies in healthy people, as well in those with health conditions such as obesity, diabetes and osteoporosis. The unit has exercise equipment to test strength, speed and endurance, and specialist scanners for measuring bone density and body composition. It also has “indirect calorimetry” equipment for scientists to measure the energy people expend at rest and during exercise. It includes sensory booths, a kitchen and a dining area, and a clinical observation space for metabolic studies.