BLOOMING PROSPECTS OF FUNCTIONAL FOODS
Ashish Mishra1, T.R. Genitha2
1. B. Tech. Food Tech Student, 2. Assistant Professor, Dept. of Food Process Engg, Sam Higginbottom Institute of Agriculture, Technology & Sciences, Allahabad 211007
Corresponding author: genithaimmanuel@yahoo.co.in

Introduction
The tenet "Let food be thy medicine and medicine be thy food," espoused by Hippocrates nearly 2,500 years ago, is receiving renewed interest, now popularly used for Functional foods. The term functional foods was first introduced in Japan in the mid-1980s and refers to processed foods containing ingredients that aid specific bodily functions in addition to being nutritious. The Institute of Medicine's Food and Nutrition Board (IOM/FNB, 1994), Japan defined functional foods as "any food or food ingredient that may provide a health benefit beyond the traditional nutrients it contains." Functional foods are foods that provide health benefits beyond basic nutrition due to certain physiologically active components, which may or may not have been manipulated or modified to enhance their bioactivity. These foods may help prevent disease, reduce the risk of developing disease, or enhance health. Rapid advances in food science and technology, an aging population, the rapid rise in health care costs, and changing government marketing and labeling regulations have also had an impact on the functional foods market.
Functional foods have been a part of Eastern cultures for centuries. Foods were used for medicinal purposes in traditional Indian medicine (Ayurveda) as early as 1000 b.c. From ancient times, the Indians have used foods for both preventive and therapeutic health effects, a view that is now being increasingly recognized around the world.

Table.1 Lists of Functional Foods with their Potential Health Benefits
Functional food Potential health benefit Labeling claim
Whole Foods
Oats

Soy

Fruits and vegetables

Fish

Garlic

Grapes/grape juice
Flaxseed

Tomatoes

Beef

Wine and Grapes.

Tea

Cranberry

Nuts

Enriched Foods
Grains

Fortified Foods
Juices with calcium

Grains with folic acid

Infant formulas with iron Reduces cholesterol and constipation, reduces risk of heart disease
Reduces cholesterol, reduces risk of osteoporosis, certain cancers, and heart disease
Reduces risk of certain cancers and heart disease; reduces hypertension
Reduces cholesterol and triglycerides
Reduces risk of heart disease and certain cancers, reduces cholesterol
Reduces risk of heart disease
Reduces risk of heart disease and certain cancers; reduces triglycerides; increases blood-glucose control
Lycopene, the primary carotenoid found in this fruit, and its role in cancer risk reduction May reduce the risk of heart disease

May reduce the risk of heart disease

May reduce the risk of some cancers; May reduce the risk of heart disease
None

None

Structure/function claim
None

May reduces risk of prostate cancer

None

May reduce platelet aggregation or clots

May reduce the risk of Heart disease, cancer, stomach disease
May reduce urinary tract infection
None

May reduce the risk of some cancers; May reduce the risk of heart disease

Helps maintain healthy bones and may reduce risk of osteoporosis
May reduce risk of brain and spinal cord birth defects
None

An anticarcinogenic fatty acid known as conjugated linoleic acid (CLA) was first isolated from grilled beef. CLA has been shown to be effective in suppressing fore stomach tumors.
There is growing evidence that wine, particularly red wine, can reduce the risk of cardiovascular disease
Have cancer chemo preventive effects

Efficacious in the treatment of urinary tract infections
Reduces risk of heart disease

Reduces risk of certain cancers, heart disease, and nutrient deficiencies

Reduces risk of osteoporosis, reduces hypertension

Reduces risk of heart disease and neural tube birth defects
Reduces risk of iron deficiency

Grains with added fiber

Milk with vitamin D

Juices with added fiber

Enhanced Foods
Dairy products with probiotics

Beverages and salad dressings with antioxidants

Foods and beverages containing herbal preparations
Sports bars
Spreads with stanol esters
Foods containing sugar alcohols in place of sugar
Eggs with omega-3 fatty acids
Reduces risk of certain cancers and heart disease; reduces cholesterol and constipation; increases blood-glucose control
Reduces risk of osteomalacia and osteoporosis

Reduces risk of certain cancers and heart disease; reduces cholesterol, hypertension, and constipation

Reduces risk of colon cancer and candidal vaginitis; controls inflammation; treatment of respiratory allergies, diarrheal disorders, and eczema
May support overall health

Varies with ingredients

Varies with ingredients
Reduces cholesterol
Reduces risk of tooth decay

Reduces risk of heart disease
May reduce the risk of some cancers; May reduce the risk of heart disease

Helps maintain healthy bones and may reduce risk of osteoporosis
May reduce risk of some cancers

Structure/function claim

Structure/function claim

Structure/function claim

Structure/function claim
Structure/function claim
May reduce risk of tooth decay
Structure/function claim
The Intersection of Food and Genes
Diet is one of the key environmental factors to which genes are exposed. Nutrients affect gene expression and formation of various proteins at discrete points in the processes of their formation. Discoveries in genetics make it possible to understand the effects of nutrients in processes at the molecular level and also the variable effects of dietary components on each individual. Disciplines such as nutrigenomics (study of interaction of dietary components with genes); proteomics (study of the proteins encoded and expressed by a genome); and metabolomics or metabonomics (metabolite profiling, measuring potential outcome of changes suggested by genomics and proteomics) have and will continue to contribute to the rapid development of functional foods.
Bioinformatics, a tool that uses computer database technology to integrate data from multiple disciplines, also plays an important role in this development. Early functional studies have focused on single genes; however, many common diseases are influenced by complex interactions among multiple genes, combined with environmental and lifestyle factors. There is a need for researchers to simultaneously study the functional interactions, networks and pathways. This research will reveal the effects of nutrients on the molecular-level processes in the body and document variable effects of nutrients under different conditions.
Regulations Related to Functional Foods
As it might be expected, Japan has led the way for establishing strict procedures for approval and marketing of functional foods under "Food For Specified Health Use” or “FOSHU" which was conceptualized in 1991. Under FOSHU, there are several categories and these are for gut health or for metabolic syndrome and lifestyle-related diseases. The categories so specified are products for gastrointestinal conditions, dental caries and mineral absorption and those for bone health and strength, blood pressure, blood glucose, blood cholesterol and blood triacylglycerol (triglyceride; TAG). Functional foods are now regulated by the United States Food and Drug Administration (FDA) under the authority of two laws. The Federal Food, Drug, and Cosmetic Act (FD&C) of 1938 provides for the regulation of all foods and food additives. The Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the FD&C Act to cover dietary supplements and ingredients of dietary supplements. Functional foods may be categorized as whole foods, enriched foods, fortified foods, or enhanced foods. Labeling claims that are used on functional foods are of two types: (1) Structure and function claims, which describe effects on normal functioning of the body, but not claims that the food can treat, diagnose, prevent, or cure a disease (claims such as "promotes regularity," "helps maintain cardiovascular health," and "supports the immune system " fit into this category).; and (2) Disease-risk reduction claims, which imply a relationship between dietary components and a disease or health condition. Structure and function claims do not require preapproval by the FDA, and they require much less stringent scientific consensus than disease-risk reduction claims. Under the FD&C Act, structure and function claims cannot be false or misleading. However, the law does not define the nature or extent of evidence necessary to support these claims.
Disease-risk reduction claims, typically called health claims, do require FDA approval before they can be used on products and must reflect scientific consensus. For example, the health claim for soy protein and its relation to cardiovascular disease reads: "Diets low in saturated fat and cholesterol that includes 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides ___ grams of soy protein." This claim may appear only on soy products that provide at least 6.25 grams of soy protein per serving. Other FDA-approved health claims include those related to fruits and vegetables and a reduced risk of cancer; saturated fat and an increased risk of heart disease; sodium and increased risk for hypertension , and folic acid–fortified foods and reduced risk of neural tube defects.
Many developed functional foods seem to have benefits for human health. For example, calcium-fortified orange juice provides approximately the same amount of calcium as milk. Additionally, some herbal ingredients can be harmful, such as kava, which has been associated with liver damage, and belladonna, which is toxic.
Limitations of Current Policies
The existing terminology, policies and regulatory frameworks limit the scope and accuracy of consumer information and hinders development and marketing of functional foods. Current FDA policy requires that health benefits attributed to a food be derived from its ‘nutritive value’ in order for the food to be exempt from regulation as a drug. This policy unduly restricts the health effects of foods to the limited concept of nutritive value and appears to be inconsistent with the courts’ interpretation of the Federal Food, Drug and Cosmetic Act (FDC Act). The FDC Act defines a drug to exclude ‘food’ intended to affect the structure or any function of the body of man. The courts have held that this exclusion from the drug definition applies to ‘food’ broadly, not just to the nutritive components or nutritive value of a food.
With regard to health claims, the FDC Act describes a health claim in terms of the relationship between a particular ‘nutrient’ and disease or other health-related condition. FDA policy requires that substances intended to be consumed at other than decreased levels contribute taste, aroma, nutritive value or a technical effect to the food in order to be eligible for a health claim. For this purpose, FDA defines nutritive value as “value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients or providing energy.” The FDC Act provides that, in general, express or implied claims that a food can cure, mitigate, treat or prevent any disease are drug claims that make the food subject to regulation as a drug. Traditionally, what constitutes an implied drug claim has been interpreted very broadly by FDA. For example, FDA took the position that a claim that a food lowers cholesterol would be considered a drug claim because it implies treatment of abnormal cholesterol levels, which the agency considers to be a ‘disease’. Therefore, functional foods that affect cholesterol levels could only state that the food “maintains normal cholesterol levels,” which is a permissible structure/function claim. However, such a statement is potentially misleading if the food in fact lowers cholesterol levels. A petition for a health claim was filed linking consumption of phytostanol and phytosterol esters to a reduced risk of heart disease. After the time-consuming and costly health claim petition was approved, the cholesterol-lowering ‘disease’ claim was allowed, but only in general terms of coronary heart disease risk reduction. As long as claims are scientifically valid, enormous public health benefits would result from consumers understanding and acting on the claimed product benefit.
Consumers may be misled if qualified health claims are not adequately differentiated from approved health claims. To promote consumer understanding, the wording of qualified health claims should clearly indicate the degree of scientific support or certainty associated with a biological effect or modification of disease risk. The current scientific standard applied by FDA in evaluating qualified health claims is the “Weight Of The Scientific Evidence (WOSE), tempered by credible evidence.” Properly applied, this standard should operate to preclude dissemination of misleading information based on poor science.
Process for Bringing Functional Foods to Market
Panel of Experts identified a seven-step process that would address critical aspects in the design, development and marketing of functional foods. After identifying a potential new bioactive ingredient (step 1), the ingredient’s efficacy and safety must be evaluated (steps 2 and 3). When selecting an appropriate food vehicle for the bioactive substance (step 4), characteristics of the food, the ingredient and the intended consumer must be considered. An independent peer review and, if required, regulatory oversight (step 5) ensures the accuracy of health claims, which must be properly communicated to consumers (step 6). Finally, in-market surveillance confirms the findings of the pre-market assessments (step 7). Although all seven steps would be undertaken for each new bioactive substance and the resulting functional foods, the specific requirements within each step vary depending upon the physical, chemical and biological characteristics of the functional component, the applicable regulatory requirements and the health claims to be made.
Safety Issues and Efficacy of Functional Foods
In general, the safety of functional foods should be based on the long-standing principle that foods are safe. Further, the safety assessment should accept the safety of components already established through Generally Recognized As Safe (GRAS) determinations and food additive approvals. That said, an objective, science-based evaluation process must establish that functional components are safe at their projected use levels. The safety assessment must also be sufficiently flexible to consider the many factors associated with consumer responses to food and food ingredients, including genetic predisposition, age, sex, nutrition status and lifestyle. The safety assessment would be concluded through current procedures for establishing GRAS status or as obtaining food additive approval.
A major recommendation pertains to the demonstration of scientific sufficiency of evidence for efficacy. This recommendation if implemented, is believed, would encourage public confidence in the labeling of functional foods and would conserve government resources. It is recommended that independent expert panels be established to make Generally Recognized As Efficacious (GRAE) determinations. These panels would be composed of respected scientists qualified to determine efficacy of the component under consideration. The multi-disciplinary nature of the panel would provide a broad context for data evaluation and assure that the resulting conclusions are scientifically defensible and relevant to consumer practices. The GRAE panel would apply the Hill criteria to determine if the proposed claims are supported by the available evidence. GRAE panels could be assembled and managed in a variety of ways as long as the panel’s independence is assured and conflicts of interest avoided. GRAE panels could be organized by a professional organization, by a private consulting organization or by the company developing the functional food (provided the panel is given complete autonomy).
The panel of independent experts with appropriate scientific expertise would be fully disclosed. The GRAE panel reports (accompanied by relevant scientific literature and data) would be submitted to FDA under a GRAE notification process similar to that used for GRAS notifications.
Role of Research
Extensive research is needed to achieve vast potential as well as to ensure safety and efficacy of the product. The following research areas are identified as vital to the development of functional foods:
• Understanding the mechanisms of action, dose/response relationship, clinical outcomes and individual response for nutrient and bioactive substances.
• Identification and development of additional biomarkers and surrogate markers, as well as further defining acceptable ones.
• Identification and tailoring food vehicles for delivery of bioactive ingredients.
• Expansion and use of exiting food composition and dietary intake databases to identify relationships between diet and health.
• Use of nutrigenomics to provide nutrient plans and products based on interaction of genetics and diets for groups and individuals (mass customization).
Further, research is needed in the areas of ethics, regulatory and legal implications of nutrigenomics. Appropriate incentives such as market exclusivity to the food industry for health and nutrition research would greatly enhance development of functional foods.
The Future
The future of functional foods will undoubtedly involve a continuation of the labeling and safety debates. As consumers become more health conscious, the demand and market value for health-promoting foods and food components is expected to grow. Before the full market potential can be realized, however, consumers need to be assured of the safety and efficacy of functional foods. Future research will focus on mechanisms by which food components such as photochemical positively affect health, and whether these components work independently or synergistically. According to the American Dietetic Association, dietetics professionals will be increasingly called upon to develop preventive meal plans, to recommend changes in food intake, to enhance phytochemical and functional food intake, and to evaluate the appropriateness of functional foods and dietary supplements to meet preventive (and therapeutic) intake levels for both healthy persons and those diagnosed with disease.
Conclusion
Mounting evidence supports the observation that functional foods containing physiologically-active components, either from plant or animal sources, may enhance health. It should be stressed, however, that functional foods are not a magic bullet or universal panacea for poor health habits.
Health-conscious consumers are increasingly seeking functional foods in an effort to control their own health and well-being. The field of functional foods, however, is in its infancy. Claims about health benefits of functional foods must be based on sound scientific criteria (Clydesdale, 1997). A number of factors complicate the establishment of a strong scientific foundation, however. These factors include the complexity of the food substance, effects on the food, compensatory metabolic changes that may occur with dietary changes, and, lack of surrogate markers of disease development. Additional research is necessary to substantiate the potential health benefits of those foods for which the diet-health relationships are not sufficiently scientifically validated. Finally, those foods whose health benefits are supported by sufficient scientific substantiation have the potential to be an increasingly important component of a healthy lifestyle and to be beneficial to the public and the food industry.
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