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.
Environmental Monitoring Programs: Best Offense is a Good Defense
By Lindsay Jo Ludeman
Given the potent mix of water, temperature and time, microorganisms can grow and survive in food plant environments and lead to contamination issues. To safeguard their products and protect their brand, both dry and wet processors should assiduously invest in sanitation programs and methods to assure their efficacy. Designing, and maintaining an effective environmental monitoring program should be a critical part of these programs.
Taking Up House
Eliminating opportunities for spoilage and pathogenic microorganisms to grow in the food plant is at the heart of environmental monitoring programs. These microbes are generally split into two main groups: transient and resident. Spoilage or indicator organisms (i.e., coliforms and fecal coliforms) are characterized as transient microbes because they generally endure for short period of time in most plant environments and can be controlled by adhering to good hygiene practices (GHPs).
Resident organisms, such as Listeria monocytogenes and Staphylococcus aureus, are more persistent and much hardier than transient microbes. Typically, they migrate to and flourish in hard to clean and reach plant areas (e.g., equipment crevices, walls, floor drains, etc.). Once they take hold, resident or "house" organisms are more difficult to eliminate and can cause long-term product contamination issues.
In the Zone
Putting together an effective monitoring program requires sampling for the right microbes from the correct areas at an effective interval. While the task can be daunting, correct implementation will pay safety dividends. Ideally, samples should be taken from three zones:
Zone one includes all product-machine contact surfaces
Zone two includes areas in within the production region but not contact surfaces
Zone three consists of contact surfaces, including forklifts and drains
Zone 4 is the farthest from the production area and includes all non-product contact surfaces outside the processing room (i.e., locker rooms, cafeterias, loading docks, etc.)
Keep in mind areas of high traffic and any areas where food or microbes could get caught and create niches or hard to clean areas. To further ensure effectiveness, areas samples are taken from should be rotated frequently to ensure widespread effective sampling.
Deciding on the number of samples to take depends upon the type of your plant (wet vs. dry), size of your plant, and the number of vulnerable areas. A third party set of eyes may come in help during this process as they will be able to more easily point out weaker areas. As a rule of thumb, the most samples should be dedicated to zone one, and more samples should be dedicated to zone two than zone three.
The frequency with which you swab your areas is also plant-dependent, varying from multiple times a day to once a week. The general rule is to sample often enough to ensure your sanitizing practices are effective. Let experience be the judge, try testing more frequently at first and use data to determine a better interval if necessary. This information is invaluable in establishing statistical baselines.
Deciding what to test for can also present a challenge. With the incredible multitude of bacteria possibly present at any time, it is hard to say what will give you the most valuable information. APC tests or aerobic plate counts, can give you information on how many bacteria are present and indicate inadequate cleaning and possible contamination. However, if your product requires the presence of robust bacteria, this test will also indicate the presence of those bacteria. In such cases, it is helpful to use an indicator organism.
Testing your finished product for total microbial counts, spoilage organisms, and pathogens can also help in the prevention of an outbreak. It is important to realize, however, that these representative samples do not prove the safety of the entire lot. In the event pathogens are found on product contact surfaces, implicating finished product, appropriate product holds should be in place.
Depending upon your product and sanitizer, testing for additional microbes may also be necessary. Contact your sanitizer supplier to discuss the best sanitizer for your plant, the necessity of rotating sanitizers to prevent the immunity, and what the susceptibilities of these sanitizers might be.
Best Protection is Prevention
Environmental monitoring programs are just one part of the all-important food safety pyramid. In today's litigation charged world, food companies must take requisite steps to help ensure the production of safe and quality products.
Quality Suppliers: Companies should work with suppliers to develop programs to develop and define product specifications.
Good Manufacturing Practices: GMPs provide guidelines for everything from facility design, preventative maintenance and quality control, to cleaning, sanitizing and employee training. The enforcement and close monitoring of these practices is critical in successful food safety programs.
HACCP: Food plants should determine what its potential hazards are and develop a HACCP program to assess and address them.
Audits: Independent audits are a valuable tool providing third-party assessments of your food safety management programs.
Knowing where your food plant deficiencies lie is the best offense in building a great defense against harmful food contaminants.
Michele Hoppenrath has joined Silliker Group Corp. as Director of Quality Assurance for North America. In her new role, Hoppenrath will lead Quality group efforts related to information technology, auditing, and client services. Prior to joining Silliker, she served as Director of Quality Affairs for Nanophase Technologies, a leader in nanoparticle manufacturing, for seven years. Hoppenrath holds a Masters of Quality Management from Loyola University in New Orleans, LA.
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).
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 Zone