Functional food definition by FFC

History of Functional Food Definition

Functional Food was first termed in Japan in the 1980s. In 1993, Nature published a paper on “Japan is exploring limits between food and medicine”. The Japanese food industry had begun to curate functional food products to meet the demands of the public and more science had to be done to learn about the health benefits of certain foods. Currently in Japan, functional food falls under the formal legislative food category called FOSHU (Food for Specified Health Use). Under FOSHU guidelines a Japanese food functional food product must first “demonstrate: 1) Effectiveness in clinical studies, 2) Safety in clinical and non-clinical studies, and 3) Determination of active/effective components".

The popularity of functional food started to expand in the global market and became more popular in Europe in the 1990s. In 1997, the European Commission defined functional foods as “A nutrient can only be easily considered functional if it was satisfactorily proved that it can positively change one or more target functions, besides nutritional effects, as to consistently improve health, well-being while reducing any affection risk. A functional food should ideally be a nutrient and should not change its efficacy when entering into a diet; it should not be either a pill or a capsule”. The European Commission based on this idea of functional food decided that a consistent scientific approach towards functional food was the best approach.

In the United States, United States Department of Agriculture- Agricultural Research Service (USDA –ARS) define functional foods as “designed to have physiological benefits and/or reduce the risk of chronic disease beyond basic nutritional functions, and may be similar in appearance to conventional food and consumed as part of a regular diet”. Currently, the United States has not accepted one legal definition of functional foods, which has caused challenges for food scientists and the functional food industry.

Since 1998 Functional Food Center (FFC) has been working professionally in the field of functional food science and all efforts, jointly with the Academic Society of Functional Foods and Bioactive Compounds (ASFFBC) and Journal of Functional Food in Health and Disease, are towards standardizing the functional foods definition for scientists, functional food manufacturers, policy makers, and the public.

Definition of Functional Foods by Functional Food Center

The Functional Food Center (FFC) defines functional foods as “natural or processed foods that contain known or unknown biologically-active compounds; which, in defined amounts, provide a clinically proven and documented health benefit for the prevention, management, or treatment of chronic disease”. This definition is unique to other definitions by emphasizing bioactive compounds as the "backbone" of functional food research.

The definition was first widely discussed in 2012 at the FFC’s 10th International Conference in Santa Barbara, CA. Attendees, including medical professionals, researchers, students, and public health professionals accepted this definition, which has help cement the FFC’s call for global acceptance of this new definition. During the 17th International Conference of FFC in 2014, jointly organized by the United States Department of Agriculture- Agricultural Research Service (USDA-ARS), the definition was revised to include “natural or processed foods that contain known or unknown biologically-active compounds; which, in defined, effective non-toxic amounts, provide a clinically proven and documented health benefit for the prevention, management, or treatment of chronic disease”. This latest version accentuates the importance of bioactive compound dosage for consumer or patient consumption of functional food.

Breakdown of the Definition

The definition first highlights that functional foods can be considered “natural or processed”. Under this definition, foods in changed or unchanged forms can be classified functional. Examples of natural unchanged foods are pure oranges or avocados, while folate-fortified cereals are an example of changed or processed food.

Second, it should be mentioned that “functional foods can have known or unknown biologically active (bioactive) compounds”. Bioactive compounds are the source of the functional affect of functional food. Bioactive compounds can include: phenolic compounds, lipids, proteins and peptides, carbohydrates, flavonoids, capsaicinoids, lignin, tepenoids, carotenoids, chlorophylls, vitamins, stilbene, phenolic acids, fibers, sterols, lipids, fatty acids, and polysaccharides. The definition includes known or unknown bioactive compounds because the research may have not yet identified certain compounds or discovered the mechanism and physiology of the effects of the described compound.

Third, the definition emphasizes that in non-toxic amounts should functional foods with bioactive compounds be consumed. Correct dosages of bioactive compounds, especially in functional foods, are pertinent to follow for therapeutic purposes. These dosages may also change if the functional food prevents one or more diseases. For example, if a functional food is found to prevent Type II Diabetes and certain forms of cancer then research needs to be done to correctly describe the dosage for each therapeutic purpose. More research needs to be done to find what dosage of the functional food is appropriate for better therapeutic strategies for the prevention, management, and treatment of chronic diseases.

Furthermore, the definition stresses that functional food must “provide a clinically proven and documented health benefit”. The health effect and purpose of the functional food with bioactive compound must be demonstrated successfully in extensive clinical studies, involving human trials, to be accepted by the functional food science community, healthcare professionals, policy makers, and consumers. Casual relationships between functional foods and the prevention, management, or treatment of chronic disease must be established through high scientific standards of pre-clinical and clinical trials. Epidemiological and cohort studies on the effects of the functional food in human populations should also be studied.

Discussions and Presentations on the Definition of Functional Food by FFC

At the 18th International Conference of FFC in the Joseph B. Martin Conference Center at Harvard Medical School, Danik M. Martirosyan, PhD, President, Functional Food Center, Dallas, TX, USA, presented a paper called, “A new definition of functional food by FFC: what makes a new definition unique?”. During the presentation, Dr. Martirosyan delved into the background and history of the emerging science of functional food. Dr. Martirosyan explained how this new definition of functional food by the Functional Food Center would "improve the communication and research collaboration between the scientific, medical communities, industry, and the public for better population health". Functional Food Center’s mission is to legitimize functional food science globally by exploring the safety and health benefits of bioactive compounds to improve the treatment of chronic diseases around the world. There was also a panel discussion on the safety of bioactive compounds at efficacious levels levels by panelists: Hisham R. Ibrahim (Professor, Kagoshima University, Japan), Danik Martirosyan (PhD, Functional Food Center, USA), Jin-Rong Zhou (Associate Professor of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston MA, USA), Debasis Bagchi (Professor, University of Houston College of Pharmacy, Houston, TX, USA), Francesco Marotta (MD, PhD, Chief Scientific Officer of ReGenera Research Group for Aging Intervention, Milano, Italy), and Garth Nicolson (Professor, The Institute for Molecular Medicine, Huntington Beach, CA, USA). The panelists discussed where the science community is presently at in terms of the definition of functional food and research involving the safe and efficacious consumption of bioactive compounds.

At the 19th International Conference of FFC at Kobe University, Japan, Danik M. Martirosyan, PhD, President, Functional Food Center/Functional Food Institute, Dallas, TX, USA, gave a talk on “A new definition for functional food by FFC: Creating functional food products using new definition”. A new definition for functional food will help functional food products be approved for consumer use and improve the already successful food industry. Dr. Martirosyan also discussed how to bring functional food products to market. Additionally, there was a panel discussion on the efficacy and safety of bioactive food compounds. There are exceedingly important questions about the efficacy and safety of functional foods and bioactive compounds involving the definition of functional food, so there was organized a special panel discussion on the efficacy and safety of bioactive food compounds. Panelists included: Kenichi Yoshida (Professor, Kobe University, Japan), Ro Osawa (Professor, Kobe University, Japan), Francesco Marotta (MD, PhD, ReGenera Research Group for Aging, Italy), Pamela Starke-Reed (PhD, Deputy Administrator, Nutrition, Food Safety and Quality, USDA, USA), Danik Martirosyan (PhD, Functional Food Center, USA), and Hiroshi Maeda (Professor, Sojo University, Japan).

Other Promotion of the Definition

In order to promote the definition to students and the public, a large-scale project was taken on to publish the textbook, Introduction to Functional Food Science. The book has been used in many classrooms all over the world, including the following countries: the United States, Japan, Denmark, Brazil, Sweden, Saudi Arabia, Oman, Korea, Turkey, Italy, Germany, Hong Kong, Canada, Austria, Switzerland, Poland, Mexico, India, Finland, Croatia, Nova Scotia, Thailand, Israel, and more. A chapter was dedicated to all of the details on the important issues surrounding the definition of functional food including the “challenges due to the absence of a proper definition”, “expanding worldwide consumer acceptance”, and the “steps to bringing functional foods to market”. The key steps to bring a functional food product to market are:

“(1) Identify the relationship between the bioactive compound and the health benefit, (2) Demonstrate efficacy, determine the intake level necessary to achieve desired effect, and demonstrate that the functional foods/bioactive compound(s) is not toxic at the efficacy level (3) Make approved health claims, (4) Get a special label for functional foods.”

A uniform definition among scientists and policy makers will lead to providing functional food researchers to produce reliable research while bringing credible functional foods to the public.

According to a position paper published by Clare M. Hasler, the exploration of the functional food definition was said to be a that provides a physiological benefit. "However, foods are now being examined intensively for added physiologic benefits, which may reduce chronic disease risk or otherwise optimize health." In this paper, Hasler explains that several institutions founded a definition for the construct of functional foods. These definitions possess a similar perspective on what functional foods are in comparison to FFC's definition, however there are some minor differences. "In 1994, the National Academy of Sciences’ Food and Nutrition Board defined functional foods as 'any modified food or food ingredient that may provide a health benefit beyond the traditional nutrients it contains.'" "The International Life Sciences Institute defines them as 'foods that, by virtue of the presence of physiologically-active components, provide a health benefit beyond basic nutrition.'" In a 1999 position paper, the American Dietetic Association defined functional foods as foods that are “whole, fortified, enriched, or enhanced,” but more importantly, states that such foods must be consumed as “… part of a varied diet on a regular basis, at effective levels' for consumers to reap their potential health benefits."

In a 1999 policy paper, Zeisel astutely distinguished whole foods from the isolated components derived from them in his following definition of nutraceuticals: “those diet supplements that deliver a concentrated form of a presumed bioactive agent from a food, presented in a nonfood matrix, and used to enhance health in dosages that exceed those that could be obtained from normal food.”

References

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