Substantiating Product Health Claims with Human Clinical Nutrition Studies
By John Williams Jr.
In the 18th Century, Lavoisier, a French chemist, first documented the relationship between food and the human metabolism (1). By the early 1900s, scientists had learned that diseases, such as beri-beri, rickets, scurvy and pellagra, were associated with diets that lacked an assortment of essential nutrients – vitamin B1 (thiamine), vitamin D, vitamin C, and vitamin B3 (niacin).
Since that time, researchers and scientists have gone on to discover the benefits of scores of nutrients – many of which are now categorized as functional ingredients – in preventing diseases and promoting general good health. Today, products enriched with vitamin E, formulated with omega-3 fatty oils, or supplemented with probiotics are in abundant supply in supermarkets, grocery stores, and retail outlets worldwide.
While the functional food market is enjoying tremendous growth globally, consumer and regulatory calls for companies to produce data and other scientific evidence to substantiate the nutritional claims of their products have grown significantly over the past several years.
Scientific Evidence
Under the European Nutrition and Health Claims Regulation, which was established in 2006, companies must ensure that any claim made on a food label in the EU is clear, accurate and based on generally accepted scientific evidence (2). In the U.S., the Food and Drug Administration (FDA) imposes a rigorous substantiation standard for health claims (3). All claims must be supported by competent and reliable scientific evidence, such as tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area (3).
In the EU, companies are required to submit a dossier of evidence to support their nutrition claims to the European Food Safety Authority (EFSA). To the chagrin of many companies, EFSA has rejected many of these documents, stating they lacked sufficient scientific mustard. Last year, in announcing a crackdown on unsubstantiated and misleading health claims, the FDA stated it will pursue necessary legal action to make sure companies "manufacture and distribute safe, truthfully labeled products" to consumers (4).
Faced with a decidedly higher scientific bar, more companies are turning to human clinical nutrition trials – studies that examine how food is processed, stored and discarded by the body in the context of overall wellness – to help substantiate their claims and meet regulatory requirements (5). Historically, these trials have predominately fallen within the domain of private universities, both in the U.S. and abroad. More recently, however, dedicated Contract Research Organizations (CROs), such as Biofortis, have entered this important field of study.
Clinical Nutrition Pioneer
Based in France and recognized as a pioneer in human clinical nutrition trials, Biofortis was acquired by Silliker, the leading international provider of food safety and quality assurance services, earlier this year. Under the direction of Murielle Cazaubiel, the innovative CRO:
Manages clinical trials to obtain scientific proof of claims for food products, pharmaceuticals, health ingredients, and additives
Develops specific biological markers to indicate the presence of certain diseases
For Silliker, the addition of Biofortis marked a key milestone in its mission to provide the food industry with unique research services around the globe. "The Biofortis acquisition completes and reinforces our capabilities on a worldwide basis to support food ingredient and manufacturing companies throughout the product development process," said Philippe Sans, Chief Executive Officer of Silliker Group Corp.
Employing recognized practices transposed from the pharmaceutical industry, Biofortis has completed over 100 clinical studies since its 2002 founding. From the selection of a coordinating investigator to compiling a detailed final report, Biofortis creates a functioning operational network to ensure every client study is professionally managed (Figure 1). The laboratory's areas of expertise include:
Gut health and immunity, including pre- and probiotics
Weight management and satiety
Cardiovascular disease
Menopause
Bone and joint mineralization
Lipid and carbohydrate metabolism disorders
The ISO 9001-2008 complaint CRO conforms to international Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs). Staffed by a highly trained team of scientists and technicians, Biofortis utilizes highly specialized methodologies at its state-of-the-art facilities in Nantes.
Gold Standard
Tougher approval and oversight stances by regulatory bodies in Europe and the U.S. are prompting food ingredient and food manufacturers to intensify their evidence gathering efforts to substantiate their product health claims. Highly competent and equipped CROs can assist them with "gold standard" clinical studies to support and prove their product health claims.
Sources: 1. University of Maryland Medical Center. www.umm.edu/altmed/articles/nutrition-000357.htm. Accessed on October 22, 2009. 2. Clarke, R. 2009. Food companies turn to experts for help amid health-claims crisis. Functional Ingredients, September. 3. Federal Food, Drug and Cosmetic Act. 4. Food Consulting News. www.foodconsulting.com/archive/2008_03.htm#anchor2. Accessed on October 20, 2009.
Regulatory News: Food and Drug Administration to Define Nutritional Criteria for Front-of-Package Claims
Due to the wide variety of symbols and questionable criteria for front-of-package nutrition labeling, the U.S. Food and Drug Administration will draft regulations to establish nutritional standards for claims posted on the front of food packages. FDA Commissioner Margaret Hamburg recently disclosed that the agency is drafting regulations for front-of-package labeling and indicated the agency would work with the industry to develop standardized labels for healthy foods. In the meantime, FDA will take enforcement action against any food products displaying claims that violate federal food labeling rules.
In recent years, food companies and retailers have introduced a wide variety of symbols, numerical ratings, icons and other nutritional labeling schemes. While the goal of the labeling schemes is to quickly promote the nutritional values of foods, the FDA is concerned that consumers will be misled by the inconsistency of the symbols and lack of standardized nutritional criteria. Commissioner Hamburg has advocated the implementation of a simple motif similar to the UK traffic light system for food labels. The Grocery Manufacturers of America (GMA) has pledged to collaborate with the FDA to develop uniform nutrient criteria and symbols for front-of-package labels.
Earlier this month, the FDA disclosed plans to investigate the nutrient criteria of front-of-package food label schemes, including the Smart Choices program. In December 2008, FDA issued an industry guidance to notify food companies that front-of-package symbols could constitute explicit or implied nutrient content claims.
A new government website designed to streamline food safety information for consumers can now be accessed at www.foodsafety.gov. The site places food-related information from all federal agencies in one place, including recall and contamination alerts and tips on how to safely handle food. The website is a joint effort between the Department of Health and Human Services, Department of Agriculture and Food and Drug Administration.
For Silliker, the addition of Biofortis marked a key milestone in its mission to provide the food industry with unique research services around the globe. "The Biofortis acquisition completes and reinforces our capabilities on a worldwide basis to support food ingredient and manufacturing companies throughout the product development process," said Philippe Sans, Chief Executive Officer of Silliker Group Corp.
In the 18th Century, Lavoisier, a French chemist, first documented the relationship between food and the human metabolism (1). By the early 1900s, scientists had learned that diseases, such as beri-beri, rickets, scurvy and pellagra, were associated with diets that lacked an assortment of essential nutrients – vitamin B1 (thiamine), vitamin D, vitamin C, and vitamin B3 (niacin).
Due to the wide variety of symbols and questionable criteria for front-of-package nutrition labeling, the U.S. Food and Drug Administration will draft regulations to establish nutritional standards for claims posted on the front of food packages. FDA Commissioner Margaret Hamburg recently disclosed that the agency is drafting regulations for front-of-package labeling and indicated the agency would work with the industry to develop standardized labels for healthy foods. In the meantime, FDA will take enforcement action against any food products displaying claims that violate federal food labeling rules.