Journal of Intellectual Property Rights Vo16 July 2001 pp 286-291

Functional Foods---:-The IPR Angle

G A Krishna and V Prakash

Central Food Technological Research Institute, Mysore 570 013

(Received 19 April 2001)

As the health and safety aspects of foods become very important, the importance of functional food is reaching to higher heights. The functional food even though appears to be of recent origin, has history and origin of some of the active ingredients being present in traditional, ethnic and in conventional food in different countries. This raises a very important question from IPR angle of how one can on the one hand protect the traditional knowledge and on the other hand g ive credit to innovators who show the functional attributes of a food by isolating a biomolecule. It is this aspect that requires an analysis in terms of the source of such functional food and additives, the guidelines on health claims and the need to correlate the end result of claimed functionality through the technological intervention especially from a commercial angle of the fu nctional food in this competitive market. The article addresses these issues from various angles.

Consumer concern about maintaining health and controlling chronic disease through a regular and safe diet of high qual­ity food gave rise to development of func­tional food. Edibles with elements that provide a heath benefit beyond basic nutri­tion are generally termed as functional foods. Products with improved health and nutritional benefits to the consumer are be­ing introduced more and more to our mar­ket. Consumer who wants to know more and more about functionality of every product is demanding more of such products. Espe-

cially if health benefits can be incorporated into the foods, the marketability of foods increases many folds as has been evident in the recent trends.

DUling the past few years, India has under­gone a radical change in its quest to improve health of the population. Consumers have started realizing that they could control their health by certain dietary behaviour and could reduce the risk of chronic diseases. Consumers are also seeking more proactive strategy for improving health through foods. This strategy involved switching from un-

KRISHNA AND PRAKASH: FUNCTIONAL FOODS - T HE IPR ANGLE 287

healthy food eating to positive eating or seeking out foods that offer a demonstrated health benefits. People are beginning to choose foods and supplements, they believe, will achieve a desirable pharmacological ef­fect. Thus one can observe number of proc­essed foods such as neutraceuticals, pharma foods, designer foods, nutritional foods, functional foods, medical foods, hyper- nutri­tional foods, therapeutic foods, super foods, prescriptive foods - all terms are used in one context or another for the nutritionally charged foods.

Functional food was first introduced in Ja­pan 1 in the mid 1980 and refers to processed food containing ingredients that aid specific bodily functions in addition to being nutri­tious. Although such foods owe the OIigin to b·aditional Indian foods originally as early as 5-6 BC, Japan is the only country that has fo rmulated a specific regulatory approval process for functional foods. In Japan it is known as Foods for Specified Health Use (FOSHU). Nearly 100 products are licensed as FOSHU foods in Japan. Other countries may follow and are gearing up for such spe­cialty foods regulations.

Functional foods can be defined as "food products that provide specific health bene­fi ts beyond the traditional nutrients they contain" or foods containing significant lev­els of biologically active components that impart health benefits beyond basic nutri­tion. The unwillingness of the consumer to change dietary habits suggests that there is a great market potential for food s, especially those of indigenous nature, having a b-ad i­tional association with the country of origin and available natural food resources.

According to American Dietetic Associa­tion2

, functional foods could help prevent a number of diseases, including asthma, can-

cer and Parkinson's disease. Their benefits range from naturally occurring minerals, ac­ids, oils and other components found in foods such as avocados, tomatoes or the cocoa bean, or supplemented elements such as vitamins and minerals added to milk and juices.

Source of Functional Foods from Fruits and Vegetables3

Citrus fruits contain limonoids, which in­crease the activity of enzymes that eliminate carcinogens, help deactivate carcinogens, protect lung tissue, and inhibit tumour growth.

Oranges and grapefruit contain phytochemi­cals that may reduce inflammation that causes asthma, arthritis, and allergies.

Asparagus contains a variety of phytochemi­cals that may prevent cervical cancer.

Broccoli contains dithiolthiones, which may speed up production of enzymes that protect DNA from damage; sulforaphanes, which may prevent breast cancer; and isothiocy­anates, which may accelerate the actions of enzymes that eliminate carcinogens.

Cabbage and cauliflower contain indoles, which might lower the risk of breast cancer and detoxify carcinogens; and isothiocy­anates, which help protect DNA.

Carrot contains beta-carotene, an antioxi­dant, which may prevent and treat cancer and lower cholesterol.

Garlic and onion contain allyl sulfides, which have antibiotic properties and may help an enzyme that removes carcinogens; and thiols, which lower cholesterol levels, de­crease blood clotting, and have antibacterial and antifungal properties.

Pepper contains a variety of phytochemicals that may prevent carcinogens from activity;

288 J INTELLEC PROP RIGHTS, JULY 2001

and capsaicin, which is used to treat arthri­tis.

Spinach contains lutein and zeaxan thin, which may protect against the risk of cata­racts and macular degeneration. Tomato contains lycopene, which may in­hibit prostate cancer.

Source of Functional Food from Grains, Legumes and Nuts

Beans contain lignins, which help reduce ca ncers related to estrogen levels; and phytates, free radical blockers linked to de­creased risk of cancer, diabetes, arthritis, and age-related illnesses. Soybean contains genistein, which may be able to block tumor growth, lower choles­terol levels, and protect against heart dis­ease; and phytates free radical blockers lined to decreased risk of cancer, diabetes, arthritis, and age-related illnesses. Grains contain phytates, free radical block­ers linked to decreased risk of cancer, diabe­tes, arthritis, and age-related illnesses; and phenolic acid, which may help protect DNA from carcinogens. ·

Nuts and seeds contain isoflavones, which may be related to decrease in tumours. Black and green tea contain catechins, which can reduce the risk of cancer. Fish contains Omega-3 fatty acids which can reduce the risk for cancer and heart disease. Oats and oat containing food have soluble fibre beta glucan, which can reduce choles­terol.

Yogurt and fermented dairy products con­tain probiotics, which improves gastrointes­tinal health.

Guidelines for Health Claims4

A health claim can be made in only two situations. One, a health claim can be made

if it has been approved by Food and Drug Administration (FDA) in a regulation . Until late last year when the Federal Food Drug and Cosmetic Act (FFDCA) was amended, that used to be the only way a health claim could be made. Today a health claim can be made if the claim is based upon a published, authori tative statement by a scientific body of the U.S. government and the FDA has not prohibited the claim. To make claims under the second option, companies must notify the FDA 120 days in advance that they will be making the claim and explain to the FDA the basis of the claim, naming the authorita­tive statement for claim and who issued it and providing the exact wording of the claim. After this process, if the FDA does not object, a company can make a claim. Health­claims provisions apply to dietary supple­ments and to conventional foods, but they do not apply to medical foods. In the law and in FDA's regulations, medical foods are ex­empt from the health claims provisions.

Statements of Nutritional Support and Structure-Function Claims 4

Another type of claim that may be made is statement of nutritional support. Basi ally, these apply only to dietary supplements. These are statements describing the role of a dietary ingredient intended to affect a structure or function and, therefore, are gen­erally referred to as structure-function claims. Structure-function claims may also discuss the mechanism by which the ingre­dient acts to maintain a structure or function. Statements of nutritional support explicitly authorized in the FFDCA are only for dietalY supplements. These statements must be ac­companied by a disclaimer, which may be seen on labels and also in advertising, even though such a disclaimer is not required in advertising. The disclaimer states that the FDA has not evaluated the statement and

KRlSH A AND PRAKASH : FUNCfIONAL FOODS - THE IPR ANGLE 289

that the product is not intended to treat, cure, or prevent any disease. The FDA must also be notified of these claims. Thousands of such notifications have been filed with FDA.

India has the following compulsory legisla­tion for food related article. The important acts are:

Prevention of Food Adulteration Act, 1954 (PF A)5.6

The Act is the basic statute intended to pro­tect the common consumer against supply of adulterated food and specifies different standards on various articles of food. The standards are of minimum quality level in­tended for ensuring safety in the consump­tion of these food items and for safeguarding against harmful impurities, adulteration, etc. The Central Committee for Food Standards under the Directorate General of Health Services, Ministry of Health and Family Wel­fare, is responsible for operation of this Act. Provisions of the Act are mandatory and contravention of the rules can lead to both fine and imprisonment. Under PFA rule5,6 No.32A the definition of Nutritional food is "The food claimed to be enriched with nutrients, such as minerals. proteins, or vitamins shall give the quantities of such added nutrients in the label.

Essential Commodities Act, 19545,6

A number of control orders have been for­mulated under the provisions of this Act, main objectives of which are to regulate manufacture, commerce and distJ'ibution of essential commodities including food. These orders include:

(a) Fruit Products Order, 1955

- This order regulates manufacture and distribution of all fruit and vegetahle

products, sweetened aerated waters, vinegar and synthetic-syrups.

- Manufacture or relabelling of these products can be carried out only after obtaining a valid license from the Min­istry of Food Processing Industries.

- The licence is issued only after the licensing officer is satisfied with re­gard to the quality of product, sanita­tion, personnel, machinery and equipment and work area standards.

(b) Solvent Extracted Oils, De-oiled Meal and Edible Flour Control Order, 1967 and Vegetable Products Control Or­der, 1976

- These Orders control the production and distribution of solvent extracted oils, deoiled meal, edible flours and hydrogenated vegetable oils (vanaspati) .

- Both the orders are operated by the Directorate of Vanaspati and Vegeta­ble Oils under the Department of Civil Supplies in the Ministry of Food and CivilSupplies.

- For production and distribution of the above products, a licence is necessary from the Directorate, which is granted if the product conforms to the specifi­cation laid down in the Schedules. The Directorate also regulates the price of vanaspati under the Order.

(c) Meat Products Control Order, 1973

- This order regulates manufacture, quality and sale of all meat products and is operated by the Directorate of Marketing and Inspection.

(d) Milk and Milk Product Order, 1992

- This order provides for setting up an advisory board to advise the govern-

290 .J INTELLEC PROP RIGHTS, JULY 2001

ment on the production, sale, purchase and distribution of milk powder. Units with an installed capacity for handling milk of over 10,000 litres per day or milk products containing milk solids excess of 500 tonnes per year are re­quired to obtain registration under this order from the Department of Animal Husbandry.

The other regulatory systems such as BIS, AGMARK and lSI specification for certain commodities have all to be ultimately har­monized into one system with a holistic ap­proach without sacrificing the knowledge content and the legal aspect of these regula­tOIY systems.

Structure-Function3 Claim of Functional Attributes in Conventional Foods

The second definition of drug in the FFDCA is an article, other than a food, intended to affect the structure or any function of the body. So, if a company has a food that is intended to affect the structure or function of the body, it is not a drug. So a company can make a structure-function claim for a conventional food without FDA authoriza­tion , provided, of course, that it is not a drug claim for a health claim and that the product is a food. Now, because the definition of food in the FFDCA is not velY informative, the federal courts have devised a definition for "food", indicating that foods are articles used in the ordinary way most people use food, primarily for taste, aroma, or nutritive value. So, if the product possesses taste, aroma, or nutri tive value, it meets the definition of food in the FFDCA, and the producer of the prod­uct may make a structure-function claim if the product is a conventional food. A struc­ture- function claim may also be made for a dietary supplement if the producer compa-

nies with the requirements for statements of nutritional support.

Patent Protection, Confidentiality and Proprietary Information

Getting a patent protection 7 in the area of functional food or nutraceuticals or health food is going to be tough. Almost anything in this field is a prior art or prior knowledge or prior use and is in public domain. This may hamper the growth of functional foods. However, a careful review ofthe patents fi led in these areas suggests that patent protec­tion can be sought in the process of isolation, purification and mechanism of incorporation as long as there is novelty, and, uniqueness about it.

No patent or equivalent protectionS is pro­vided by mandatOlY pre- market clearance in Canada. However, specific nature of certain entries in the Tables of Food Additives may afford an unintended measure of protection equivalent to a patent. No protection would be available for claims on functional foods (assuring the category and attendant claims would be in the public domain. No market exclusivity would exist in Canada if func­tional foods were to be established as a cate­gory of foo ds with recognized h ealth claims).

Technological Opportunities

India being rich in biodiversity and tradi­tional knowledge has a vast potential in de­velopment of numerous processed foods imparting health benefits. Fruits like custard apple, sapota, mango, banana, guava, water­melon, kendu, ramphal, ber, and jackiruit, vegetables like drumstick, paIval, ladies tin­gel', tinda, kachhu, legumes like rajmah, 10-bia, chickpea, flat bean, long bean, kesari, tur, moong, udad, millets like bajra, ragi,

KRlSHNAAND PRAKASH : FUNCTIONALFOODS-THE IPRANGLE 291

oilseeds like mu stard, sesame, mahua , neem are yet to be exploited for their health benefits . There are number of traditional food in our country, which can provide health benefits, needs R&D effort to isolate the compound which could be responsible for health. This can lead to number of pat­ents and processes.

Analysis of the patents 9,10 from the year 1996 to 2000 in the area of functional food gives a positive trend in developing healthy foods. Most of the functional foods patented in US, Europe, Japan and per are from the Japanese inventors and comprises source both from plant and animal. Most of them are on isolation and purification of com­pounds useful for health.

Conclusions

The paradigm shift from fighting patents to filing patents requires immediate attention of the researchers to ensure that we protect the innovator's invention and also open up sufficient channels for protection of docu­mented and traditional knowledge informa­tions so that what is in public domain and what is in innovation, especially in the area of traditional foods, ethnic foods, traditional medicine, conventional practices, all be­come a well documented system both fo r value addition to knowledge and for protec­tion of the intellectual property. At the same time to ultimately purge the benefits of such

intellectual property rights issue to the inno­vators who could be a scientist, who could be a tribal origin or who could also be a group of people working in a cottage indus­tries. This approach would ultimately pro­tect the knowledge wealth of the country.

References

1 Clare M Hasler,Scientific status sum-mery, Functional foods: their role in disease prevention and health promo-tion ( Publication of Institute of Food Technologists, USA) Nov 1998

2 http:// www.abcnews.go.com

3 http://www.cjnetworks.com/-jsulli van/pmff.html

4 Functional food a global perspective, C F W report, Cereal Foods World, 101, Publication no.W-1999-0118-010.

5 http://mofpi.nic.in/venturesetup/ compulsory / compuUegislation.htm

6 Prevention of Food Adultration Act, 1954 & Rules, 1955( Alankar Publica-tion) Delhi ,October 2000.

7 Shukla T P, Food Technology, 43, 388, 1998.

8 Marcio A F Belem, Trends in food sci-ence and technology, 10,1999, 10l.

9 www. delphion. com

10 www.uspto.gov