The information provided below is based on a position paper published this month in the Journal of the American Dietetic Association (ADA).
To read our article on 'Regulation and health claims for functional foods' click here.To read our article on 'Types of research needed for functional food claims' click here.To read our article on ‘FDA still reviewing functional food regulatory requirements’ click here.
The US Food and Drug Administration (FDA) does not provide a legal definition for the term ‘functional foods’, which is currently used primarily as a marketing idiom for the category.
However, a number of working definitions have been developed by different organizations, including ADA, the International Food Information Council (IFIC), and the Institute of Food Technologists (IFT).
ADA: ADA classifies all foods as functional at some physiological level because they provide nutrients or other substances that furnish energy, sustain growth, or maintain/repair vital processes. However, functional foods move beyond necessity to provide additional health benefits that may reduce disease risk and/or promote optimal health. (More information here.)
IFIC: The IFIC considers functional foods to include any food or food component that may have health benefits beyond basic nutrition. (More information here.)
IFT: A recent report published by IFT defines functional foods as “foods and food components that provide a health benefit beyond basic nutrition (for the intended population). These substances provide essential nutrients often beyond quantities necessary for normal maintenance, growth, and development, and/or other biologically active components that impart health benefits or desirable physiological effects.” (More information here.)
In the US, Medical Foods and Foods for Special Dietary Use are considered to be two sub-categories of functional foods.
Medical Foods are defined by the Orphan Drug Act “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation”. (More information here.)
Foods for Special Dietary Use are defined by the Federal Food, Drug, and Cosmetic Act [Section 411(c)(3)] as “a particular use for which a food purports or is represented to be used, including but not limited to the following: 1. Supplying a special dietary need that exists by reason of a physical, physiological, pathological, or other condition . . . ; 2. Supplying a vitamin, mineral, or other ingredient for use by humans to supplement the diet by increasing the total dietary intake. 3. Supplying a special dietary need by reason of being a food for use as the sole item of the diet . . .”. Examples of such foods include infant foods, hypoallergenic foods such as gluten-free foods and lactose-free foods, and foods offered for reducing weight.
Health Canada defines functional foods as “similar in appearance to, or may be, a conventional food, is consumed as part of a usual diet, and is demonstrated to have physiological benefits and/or reduce the risk of chronic disease beyond basic nutritional functions”. (More information here.)
The European Commission Concerted Action on Functional Food Science in Europe regards a food as functional if it is satisfactorily demonstrated to affect beneficially one or more target functions in the body, beyond adequate nutritional effects, in a way that is relevant to either an improved state of health and well-being and/or reduction of risk of disease.
In this context, functional foods are not pills or capsules, but must remain foods and they must demonstrate their effects in amounts that can normally be expected to be consumed in the diet. (More information here.)
Japan is the only country that recognizes functional foods as a distinct category, and the Japanese functional food market is now one of the most advanced in the world, according to the ADA position paper.
“Known as Foods for Specified Health Use, these are foods composed of functional ingredients that affect the structure and/or function of the body and are used to maintain or regulate specific health conditions, such as gastrointestinal health, blood pressure, and blood cholesterol levels.” (More information here.)