FIELD OF THE INVENTION This invention relates to the field of complete nutritional compositions and products and more particularly to complete nutritional compositions and products which are prepared using pasteurization or ultra-pasteurization processes. This invention further relates to the preparation of refrigeration-shelf-stable ready-to-drink complete nutritional compositions, including nutritional supplements (NS), foods for special dietary uses (FSDU), foods for special medical purposes (FSMP) and medical foods (MF).

BACKGROUND OF THE INVENTION Nutrition is one of the cornerstones of health, well-being, and the prevention of numerous chronic diseases. Nutritional products play an important role in these areas and attempts to provide readily available and convenient nutritional products to the general public has been a major focus in recent years. To remain healthy one must receive essential nutrients which are indispensable to human nutrition. Essential nutrients include both macro nutrients, such as fats, carbohydrates and proteins, and micro nutrients, such as vitamins and minerals (including trace elements and electrolytes). Table 1A shows a list of essential macro nutrients and micro nutrients and corresponding percent daily value (D. V.) of these essential nutrients based on a 2,000 calorie diet as currently specified by U. S. governmental regulations, 21 C. F. R. 101.9,1998. Table 1B shows a list of essential macro nutrients and micro nutrients and corresponding Nutrient Reference Valve (NRF) of these essential nutrients as currently specified by CODEX guidelines, CAC/GL 2-1985 (Rev. 1-1993).

Electrolytes include sodium, potassium and chloride.

Complete nutritional products, i. e. those which contain all the essential macro and micro nutrients, have heretofore been available only in sterilized products or frozen products.

Sterilized products are generally sold in cans and are intended to have a long room temperature shelf-life. Such products require expensive processing steps which must be carefully controlled to properly remove microorganisms and bacterial enzymes. As will be discussed further herein, sterilization processes, due to the severity of the heat treatment can cause undesirable physical, chemical, enzymatic and microbial changes which deleteriously affect the final product. Moreover, although such sterilized products are often marketed as "ready-to-drink", they are typically stored at room temperature and therefore require refrigeration for maximum taste. Moreover, enzymatic reactions still occur, albeit slower, during room temperature storage of sterilized products. Such reactions can result in a host of undesirable defects, such as the destruction of vitamins which are necessary to the integrity of the overall product. Since sterilized products are designed to have up to one and a half year of room temperature shelf-life, such a product will have a different actual content of degradable micro nutrients (vitamins) in the early part of its shelf-life as compared to the latter part. Thus, a consumer will obtain a different and unknown amount of vitamins depending on when the sterilized product is consumed. To account for this slow degradative process during long-term shelf-life, manufacturers of sterilized complete nutritional products often include up to 50% more of a given vitamin than would normally be included to account for the inherent degradation loss and to ensure the product is likely to contain at least the labeled amount of nutrients at the end of its shelf-life. Such large overdosing results in an imbalance in the taste of the product, particularly if consumed in the early stages of its shelf- life. Moreover, the cost factor of including such large overdoses is enormous. In addition to the high cost of sterilization, and increased overdosing of vitamins, sterilization processes require high cost packaging, such as in metal cans and room-temperature self-stable laminated packages, such as TetraBric & Combibloct).

Nutritionally complete and balanced foods are important for ensuring that the public receives all essential nutrients. The public should not be encouraged to receive incomplete or imbalanced nutrition with foods or liquids that are perceived or marketed to have nutritional benefits. Consumption of nutritionally incomplete foods or liquids that do not contain all the

essential nutrients as listed in Table 1A or 1B will not necessarily provide complete nutritional well-being. Furthermore, a nutritionally imbalanced product can result in over consumption or under consumption of essential nutrients because some nutrients are presented in very high concentrations while other nutrients are presented in very low concentrations. A balance of essential nutrients, especially micro nutrients, is often recommended for optimal nutritional well-being.

Milk products constitute a significant portion of the overall diet or caloric consumption of human beings. As such, milk products have a major role in maintaining the health of the public. Nutritionally optimal milk products will have a positive effect on the nutrition and the health of the public. Concentration of macro nutrients in any given milk product will often depend on the nature of the product and the desirable profile developed by the manufacturer. For example, levels of macro nutrients can be manipulated in products such as fat free milk, protein fortified chocolate milk and artificially sweetened ice cream.

Nutrition facts of commercially available flavored milks, including organic milk and soy milk, are presented in Tables 2A and 2B. The total fat contents vary with the product profile. For example, a fat free milk will have less total fat than a 1 % milk fat product, and both of these products will have lower total fat levels than a full milk fat product. Most of the milk products in Tables 2A and 2B, however, are deficient in a significant number of micro nutrients. Many of these micronutrient-deficient milk products contain only sodium, vitamin A, vitamin C, calcium and possibly iron as micro nutrients. These micronutrient-deficient milk products are not considered complete nutritional products and may not offer the full health benefits associated with complete nutritional products.

Some commercially available milk products, as presented in Table 2B, are, however, fortified with many of the essential micro nutrients. These fortified products generally have 35 to 50 percent of the daily value of many micro nutrients present in a single serving.

Nevertheless, even these fortified products are not complete nutritional products because some essential micro nutrients are lacking from the product or are only present in insignificant or trace amounts. For example, essential micro nutrients of vitamin K, folate,

selenium, manganese, chromium, molybdenum and chloride are missing from these fortified milk products, resulting in an incomplete nutritional product. Furthermore, consumption of just several servings per day of these over-fortified products can lead to levels of micro nutrients exceeding the recommended daily value for those fortified micro nutrients. Such over consumption of a nutritionally incomplete, but somewhat nutritionally fortified product, may not result in desirable nutrition levels in the consuming public.

As with commercially available flavored milks, commercially available ice creams and frozen yogurts (see Table 3A and 3B) and commercially available yogurts (see Tables 4A and 4B) typically have incomplete and imbalanced micronutrient profiles. These ice creams and yogurts do not offer the nutritional benefits of a nutritionally complete and balanced product.

There is a need for nutritionally complete and nutritionally balanced products for consumption by the public. The present invention meets these and other needs, as will come apparent in the description provided below.

THE SUMMARY OF THE INVENTION The present invention relates to complete nutritional milk compositions and products which have been either pasteurized or ultra-pasteurized and which are designed to include per serving size a specified percentage range of each essential micro-nutrient. The product is also designed to have a total calorie content of about 4% to 20% of the daily value per serving size. The daily value is based on a 2,000 calorie diet. The compositions of the present invention can optionally include non-essential but nutritionally functional components. The complete nutritional compositions of the present invention can be provided as unflavored milks, flavored milks, ice creams, yogurts, nutritional supplements, foods for special dietary uses, foods for special medical purposes and medical foods.

A nutritional dairy-product having a composition which includes a milk and being thermally treated under conditions of pasteurization or ultra-pasteurization comprising, per serving size from about 0.1 % to about 20% of the daily value of Sodium, Potassium, vitamin

A, and vitamin C; from about 0.1 % to about 40% of the daily value of Calcium; from about 0.1% to about 20% of the daily value of iron; from about 0.1 % to about 30% of the daily value of vitamin D; from about 0.1% to about 20% of the daily value of vitamin E, vitamin K and Thiamine; from about 0.1% to about 30% of the daily value of Riboflavin; from about 0.1% to about 20% of the daily value of Niacin, vitamin B6, Folate, vitamin B12, Biotin, and Pantothenic acid; from about 0.1% to about 30% of the daily value of Phosphorus; and from about 0.1 % to about 20% of the daily value of Iodine, Magnesium, Zinc, Selenium, Copper, Manganese, Chromium, Molybdenum, and Chloride; wherein the percent daily value (D. V.) is based on a 2,000 calorie diet.

A nutritional dairy-product having a composition which includes a milk and being thermally treated under conditions of pasteurization or ultra-pasteurization comprising, per serving size from about 0.1 % to about 20% of the nutrient reference value of vitamin A and vitamin C; from about 0.1 % to about 40% of the nutrient reference value of Calcium; from about 0.1 % to about 20% of the nutrient reference value of iron; from about 0.1 % to about 30% of the nutrient reference value of vitamin D; from about 0.1 % to about 20% of the nutrient reference value of Thiamine; from about 0.1 % to about 30% of the nutrient reference value of Riboflavin; from about 0.1 % to about 20% of the nutrient reference value of Niacin, vitamin B6, Folate and vitamin B 12; and from about 0.1 % to about 20% of the nutrient reference value of Iodine, Magnesium and; wherein the percent nutrient reference value (NRV) is based on a 2,000 calorie diet.

The nonfrozen compositions of the present invention are designed to be refrigeration- shelf-stable. That is, the shelf-life will generally be up to about 16 weeks at temperatures of about 1 °C to 7°C and preferably about 2° to about 3 °C. These are conventional refrigeration temperatures for dairy products. Shelf-life for pasteurized compositions of the present invention will generally be up to about 2 weeks, and for ultra-pasteurized compositions of the present invention, the shelf-life will be between about 4 to about 16 weeks.

The concentration of every single added vitamin must be calculated in a way that the effect of heat treatment and storage does not affect the label claim concentration of such

vitamin. Table 6 shows the source and quantity of each vitamin (in the vitamin premix) to be used in the inventive standard complete nutritional milk products. Likewise, the concentration of every single added mineral must be calculated in a way that contribution of the same mineral from other ingredients does not affect the label claim concentration of such mineral. Table 7 shows the source and quantity of each mineral (in the mineral premix) to be used in the inventive standard complete nutritional milk product. Similar vitamin and mineral premixes are used for the preparation of nutritional supplements, food for special dietary uses, food for special medical purposes and medical foods.

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to complete nutritional milk compositions and products which have been either pasteurized or ultra-pasteurized and which are designed to include per serving size a specified percentage range of each essential micro-nutrient. The compositions of the present invention can optionally include non-essential but nutritionally functional components. The complete nutritional milk compositions of the present invention can be provided as unflavored milks, flavored milks, ice creams and yogurts.

Moreover, the present invention relates to refrigeration-shelf-stable ready-to-drink complete nutritional compositions which have been either pasteurized or ultra-pasteurized and which are designed to include per 8 fluid ounces (about 240 ml) a specified percentage range of each essential macro and micro-nutrient. The product is also designed to have a total calorie contint of about 4% to 20% of the daily value. The daily value is based on a 2,000 calorie diet. The compositions of the present invention can optionally include fat, sodium, dietary fiber and other non-essential but nutritionally functional components.

The compositions of the present invention may be prepared by pasteurization or ultra- pasteurization processes. The main purpose of these processes is the killing of pathogens which are the microorganisms causing disease in humans. Pasteurized products must be entirely free from pathogens. In fact, pasteurization of milk is required by law in most countries. The traditional pathogens in raw milk are Mycobacterium bovis which causes bovine tuberculosis (which also affects humans), Brucella abortus which transmits

brucellosis (undulant fever) to man, Salmonella which are responsible for gastrointestinal diseases and typhoid fevers and Campylobacter jejuni, a common factor in enteritis.

Apart from pathogenic microorganisms, milk also contains other substances and microorganisms which may spoil the taste and shelf-life of the product. A secondary purpose of these processes is therefore to destroy as many as possible of these other organisms in order to safeguard product quality. This requires more intensive heat treatment than is necessary to kill the pathogenic bacteria.

To ensure the destruction of all pathogenic microorganisms, it is necessary to heat the product to a given temperature and hold it at that temperature for a certain length of time before it is cooled again. The combination of temperature and holding time is very important as it determines the intensity of the heat treatment. The nutritional compositions of the present invention are pasteurized at about 75 °C to about 95 °C for about 15 to about 55 seconds. Alternatively the inventive compositions may be ultra-pasteurized at about 130 °C to about 150 °C for about 2 to about 5 seconds. Pasteurized and ultra-pasteurized compositions are stored at refrigerated temperatures from about 1 °C to about 7°C. Such heat treatment and subsequent refrigeration results in a shelf-life of up to about 16 weeks for the nonfrozen inventive products.

The pasteurization and ultra-pasteurization with aseptic filling can operate on the principle of direct steam injection or steam infusion and on indirect heating through use of a heat exchanger. Alternatively, ohmic or microwave heating may suitably be used.

As used herein the term"shelf-life"of the product refers to as the time which a product can be stored without the quality falling below a certain acceptable, minimum level.

The concept is subjective--the shelf-life can be very long if the criteria of product quality are low. The physical and chemical limiting factors of shelf-life are gelling, increase of viscosity, sedimentation, and phase separation. The organoleptic limiting factors are deterioration of taste, smell, and color.

The containers for packaging of nutritional products of the present invention can include any suitable container for storing food products. Some non-limiting examples include a gable-top carton, a plastic container, a glass container, a cardboard container, a metal container, a metal can or a paper container. The container may be any suitable enclosure such as a jar, a can, a bottle or a sealed film (plastic or plastic with a metallized layer).

The compositions of the present invention have been formulated such that the resultant pH is essentially neutral, e. g., about 5.5 to about 7.5. Preservation of the inventive compositions is accomplished by pasteurization and refrigerated storage, ultra-pasteurization and refrigerated storage or sterilization methods and is not dependent on acidic pH for preservation.

NUTRITIONAL MILK COMPOSITIONS AND PRODUCTS The compositions of the present invention can suitably include milk from a variety of sources and of different types. For example, the milk used in the inventive compositions can include fat free milk, low fat milk, full fat milk, lactose-free milk (produced by hydrolyzing the lactose by lactase enzyme to glucose and galactose, or other method), concentrated milk, dry milk or organic milk. Fatfree milk is nonfat or skim milk product. Low-fat milk is typically defined as milk that contains from about l % to about 2% fat. Fullfat milk often contains about 3.4% fat. The animal source of the milk is typically a cow, but the inventive compositions are not limited just to cow's milk. For example, milk from sheep, goat, buffalo, camel, llama, mare, or deer may suitably be used. As used herein, the term"organic"refers to a food, such as a milk, produced without the use of pesticides, chemical fertilizers, herbicides or fungicides. Typically, land on which milk-producing animals are raised and grains or grasses used to feed these animals should be free of these prohibited substances, e. g., pesticides, chemical fertilizers, herbicides or fungicides, for a number of years, often three years, prior to the milk being labeled as organic. Such organic milk is usually produced from animals that are substantially free of synthetic hormones, such as recombinant bovine somatotropin hormone (rbST/rBGH), and antibiotics.

The compositions of the present invention can be formulated into different types of dairy products. For example, the dairy product can be an unflavored or a flavored milk.

Additionally, the dairy product can be a dairy drink, dairy beverage or a dairy cocktail. Such drinks, beverages or cocktails are products that contain the inventive compositions in a diluted form. Such diluted forms can include, as nonlimiting examples, a fruit juice or a carbonated soda as a diluent combined with the inventive compositions..

The inventive compositions can also be frozen to yield an ice cream or other frozen desert. The ice creams can be formulated into a standard ice cream containing about 10% milkfat, a premium ice cream containing about 15% milkfat and a super premium ice cream containing about 17% milkfat. Other milkfat levels are contemplated with the inventive compositions. Additionally, non-dairy fats, as example for use in mellorine, are also contemplated. Furthermore, other frozen deserts, such as sherbets, sundaes, or partially frozen deserts, such as milk shakes, may suitably be made from the inventive compositions.

Additionally, the incentive compositions can be formulated into a yogurt. Yogurt is produced by culturing the compositions of the present invention with a bacterial culture such as lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus.

Additionally, other nonlimiting examples of probiotic microorganisms include Bifidobacterium spp., Lactobacillus acidophilus and Bifidobacterium bifidum. Furthermore, probiotic microorganisms can include bacteria that produce therapeutic yogurts. Such microorganisms such as, for example, str. salivarius ssp. thermophilus, Lb. acidophilus, B. bifidium, in therapeutic yogurts are able to survive transit through the stomach, remain active in the presence of bile and have the ability to colonize the intestine. Furthermore, an organic yogurt, which is made from organic milk, may contain microorganisms such as, S.

Thermophilus, L. Bulgaricus, L. Acidophilus, Bifidus, L. Casei, L. Reuteri. Prebiotic ingredients should also be present to allow the probiotic microorganisms to remain active within the yogurt. As used herein the term"Prebiotic"refers to a non-digestive food that beneficially affects the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, such as fructo-oligosaccharides. As used herein the term"probiotic"refers to a mono or mixed culture of live microorganisms, when applied to

man or animal, beneficially affects the host by improving the properties of the indigenous microflora, such as bifidobacterium.

Yogurts using the inventive compositions can be set yogurts where the fermentation occurs in the final retail container or stirred yogurts where the fermentation occurs in bulk prior to packaging. Furthermore, these yogurts can contain flavors or fruits, can be frozen to provide a frozen yogurt or can be in the form of a drinkable fluid to provide a drinkable yogurt.

The protein source may be selected from a variety of materials, including without limitation, milk protein, whey protein, caseinate, soy protein, egg whites, gelatins, collagen and combinations thereof. Included in the protein source are lactose-free skim milk, milk protein isolate, and whey protein isolate. The inventive compositions can be fortified with these proteins. It is also contemplated to use soy milk with the present inventive compositions. As used herein, soy milk refers to a liquid made by grinding dehulled soy beans, mixing with water, cooking and recovering the dissolved soy milk out of the beans.

Such soy milk can be formed into a milk-like product, which has similar taste, texture and appearance to animal (dairy) milk, but is essentially free of animal (dairy) milk. Furthermore, a dairy-like product, which as used herein refers to a product having similar taste, texture and appearance to diary products made from animal milk, but does not contain animal milk, can be made from such milk-like products.

The carbohydrate source useful in the present invention may be selected from a wide variety of materials such as sucrose, corn syrup solids, glucose, fructose, maltodextrin and combinations thereof.

Artificial sweeteners such as saccharine, aspartame, asulfame K, sucrolose and their combination, as well as others, may be incorporated to enhance the organoleptic and sweetness quality of the compositions. Various fiber sources may be included in the compositions of the present invention. These sources may be selected from such materials as oat fiber, soy fiber, guar gum, pectin, soy polysaccharides, gum arabic, hydrolyzed fibers and

the like. Cellulose, hemicellulose, hydrocollides, methylcellulose, carboxymethyl cellulose and the like are contemplated. Also useful are fructo-oligosaccharides.

Compositions of the present invention can be formulated into a variety of different product forms. For example, forms can include, but are not limited to, high protein and fiber- containing, fat-free (skim), 1 % low fat, 2% low fat, full fat (3.4%), skim plus nonfat milk solids and lactose-free skim milks. Furthermore, where fatfree (nonfat or skim) milk is used, the milk may be partially evaporated or has added nonfat milk solids to yield a product with a rich creamy taste. The compositions can be flavored with natural or artificial ingredients.

Such ingredients may be combined with the inventive compositions to form a substantially uniform flavored product or may be present in a nonuniform manner, such as fruit on the bottom of a inventive yogurt composition. Nonlimiting examples of flavored compositions include chocolate, strawberry, peach, raspberry, vanilla, banana, coffee, mocha and combinations thereof.

One useful composition is a nutritional dairy-product having a composition which includes a milk and being thermally treated under conditions of pasteurization or ultra- pasteurization comprising, per serving size: from about 0.1% to about 20% of the daily value of Sodium, Potassium, vitamin A, and vitamin C; from about 0.1% to about 40% of the daily value of Calcium; from about 0.1 % to about 20% of the daily value of iron; from about 0.1 % to about 30% of the daily value of vitamin D; from about 0. 1 % to about 20% of the daily value of vitamin E, vitamin K, and Thiamine; from about 0.1 % to about 30% of the daily value of Riboflavin; from about 0.1 % to about 20% of the daily value of Niacin, vitamin B6, Folate, vitamin B12, Biotin, and Pantothenic acid; from about 0.1% to about 30% of the daily value of Phosphorus; and from about 0.1 % to about 20% of the daily value of Iodine, Magnesium, Zinc, Selenium, Copper, Manganese, Chromium, Molybdenum, and Chloride; wherein the percent daily value (D. V.) is based on a 2,000 calorie diet. The serving size for a milk is about one cup (about 8 fluid ounces or about 240 ml). The serving size for a yogurt is about one cup (about 8 fluid ounces or about 240 ml). The serving size for an ice cream or frozen dessert is about one-half (1/2) cup (about 4 fluid ounces or about 120 ml).

The serving size for a product may often vary by country. For example, a typical serving size in the U. S. for milk is about 240 ml as compared to 200 ml in European countries. The compositions and products of the present invention can be used with any specified or desired serving size. Desirably, the serving size for milk, yogurt and other non- frozen compositions or products is from about 100 ml to about 400 ml. Desirably, the serving size for frozen yogurts and frozen desserts is from about 50 ml to about 200 ml.

Another useful composition is a nutritional dairy-product having a composition which includes a milk and being thermally treated under conditions of pasteurization or ultra- pasteurization comprising, per serving size: from about 0.1% to about 20% of the nutrient reference value of vitamin A, and vitamin C; from about 0.1 % to about 40% of the nutrient reference value of Calcium; from about 0.1 % to about 20% of the nutrient reference value of iron; from about 0.1 % to about 30% of the nutrient reference value of vitamin D; from about 0.1 % to about 20% of the nutrient reference value of Thiamine; from about 0.1 % to about 30% of the nutrient reference value of Riboflavin; from about 0.1 % to about 20% of the nutrient reference value of Niacin, vitamin B6, Folate and vitamin B 12; and from about 0.1 % to about 20% of the nutrient reference value of Iodine, Magnesium and Zinc; wherein the percent nutrient reference value (NRV) is based on a 2,000 calorie diet. The serving size for a milk is about one cup (about 8 fluid ounces or about 240 ml). The serving size for a yogurt is about one cup (about 8 fluid ounces or about 240 ml). The serving size for an ice cream or frozen dessert is about one-half (/2) cup (about 4 fluid ounces or about 120 ml).

At the first glance, one may think higher concentration of vitamins and minerals (e. g, 35 to 50% D. V. or even higher) is more nutritious or has a better market appeal. However, over fortification of milk products is not recommended for the following reasons: 1. Regular diet provides the majority of vitamins and minerals. The goal of the inventive composition is not to substitute regular diet, but to ensure that no essential vitamins and minerals will be missing in the diet of the public.

2. Social responsibility dictates that for the long-term consumption by the public, milk products be moderately fortified with vitamins and minerals. Mild fortification of milk

products with vitamins and minerals will prevent over consumption of these nutrients by public.

3. Vitamins and minerals are naturally and inherently"bad-tasting"substances.

Mild fortification will not result in off taste of nutritional milk products.

4. Higher usage of vitamins and minerals means higher cost of ingredients.

In view of this rationale for fortification and against over-fortification, the inventive compositions, as shown in Table 5, contain about 10 to 25 percent of the daily value of essential vitamins and essential minerals. Most of the essential vitamins and essential minerals are provided at about 10 percent of the daily value, but some essential vitamins and minerals, such as riboflavin, vitamin B 12, vitamin D, calcium and phosphorus, are provided at higher concentrations because of the inherent properties of milk and consumer expectations. Nevertheless, the inventive compositions contain all essential vitamins and essential minerals in scientifically sound and socially responsible quantities.

Essential macronutrients are included in the inventive compositions. Levels of the essential macronutrients vary with the product profile.

Antioxidants useful in the present invention include, without limitation, butylhydroxy anisole (BHA), butylhydroxy toluene (BHT), tertiary butyl hydroquinone (TBHQ), propyl gallate and combinations thereof. Natural antioxidants can also be included through additional amounts of vitamin C, vitamin E, beta-carotene, selenium, zinc and combinations thereof. Various herbs, herb extracts, botanicals, botanical extracts, amino acids and the like, and combinations thereof, can also be included for their intended functions and various products using such dietary supplements can be formulated therefrom.

Various non-nutritive components can be included in the inventive compositions. For example, fillers, coloring agents, flavors, emulsifiers and the like are useful. Other nutritionally valuable, but non-essential components can be added, including choline, taurine, L-carnitine and the like. Combinations of these non-nutritive and non-essential components are contemplated.

Various nutraceuticals and phytochemicals can be incorporated into the inventive compositions for their intended function. Furthermore, it is contemplated that the inventive compositions can be used in other dairy products, such as but not limited to cheeses, creams, custards, and the like.

NUTRITIONAL SUPPLEMENTS. FOOD FOR SPECIAL DIETARY USES. FOOD FOR SPECIAL MEDICAL PURPOSES AND MEDICAL FOODS Furthermore, useful compositions include Nutritional Supplements, foods for Special Dietary use, foods for Special Medical Purposes and Medical Foods.

Nutritional Supplements (NS) There is no regulatory definition for the term Nutritional Supplement. For purpose of the present invention, the term"Nutritional Supplement"means: a complete diet which provides the total nutrient needs solely by the oral consumption of adequate amounts of a product. Nutritional Supplements will maintain an individual's good nutritional status.

Nutritional Supplements are different from, and are more complete than,"Dietary Supplements,"as described in the Dietary Supplement Health and Education Act of 1994.

In view of the above definition, nutritional supplements must minimally contain and declare on their packages (e. g., under % Daily Value in the Nutrition Facts table), the concentration of all nutritionally essential macro nutrients and micro nutrients (13 vitamins and 14 minerals), as indicated, for example, in the U. S. Code of Federal Regulations, 21 C. F. R. 101.9,1996 (Table 1A). In Nutritional Supplements, no essential nutrient is disregarded or is given the concentration of zero (except for fat in fat-free products, fiber in residue-free products and sodium in sodium-free products).

In addition, some non-essential, but valuable nutritional or functional compounds (such as choline, taurine, L-carnitine, emulsifiers, stabilizers, color, flavor, etc.) can be added to the formulation of nutritional supplements.

Foods for Special Dietarv Uses (FSDU) Unlike Nutritional Supplements, there is a regulatory definition for the term Foods for Special Dietary Uses. The term"Food for Special Dietary Uses"is defined in the U. S. Code of Federal Regulations (21 C. F. R. 105.3,1996) as the following, which shall be adopted in the present invention: (1) the term"Special Dietary Uses", as applied to food for man, means particular (as distinguished from general) uses of food, as follows: I) uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight; ii) Uses for supplying particular dietary needs which exist by reason of age, including but not limited to the ages of infancy and childhood; iii) Uses for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property. Any such particular use of a food is a special dietary use, regardless of whether such food also purports to be or is represented for general use.

(2) The use of an artificial sweetener in a food, except when specifically and solely used for achieving a physical characteristic in the food which cannot be achieved with sugar or other nutritive sweetener, shall be considered a use for regulation of the intake of calories and available carbohydrate, or for use in the diets of diabetics and is therefore a special dietary use.

Examples of the Foods for Special Dietary Use (FSDU) are hypoallergenic foods, infant foods, foods for reducing and maintaining body weight, foods for use in the diet of diabetics, and foods used to regulate sodium intake and the like.

Food for Special Medical Purposes (FSMP) The term"food for special medical purposes"is a category of foods for special dietary uses which are specially processed or formulated for the dietary management of patients and may be used under medical supervision. They are intended for the exclusive or partial feeding of patients with limited or impaired capacity to take, digest, absorb or metabolize ordinary foodstuff or certain nutrients contained therein, or have other specially medically determined nutrient requirements, the dietary management of whom cannot be achieved by the modification of the normal diet alone, by other foods for special dietary uses or by combination of the two.

Medical Foods (MF) There is also a regulatory definition for the term Medical Food. The term"Medical Food"is defined in the Orphan Drug Act Amendments of 1988 [21 U. S. C. 360ee (b) (3)].

This definition was incorporated by reference into the Nutrition Labeling and Education Act (P. L. 101-535) in November 1990. It is incorporated into the FDA's final rule on Mandatory Nutritional Labeling January, 1993.

For purposes of the present invention, the term"Medical Food"shall mean 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.

To be considered a Medical Food, a product must, at a minimum, meet the following criteria: a) The product is a food for oral or tube feeding;

b) The product is labeled for the dietary management of a medical disorder, disease, or condition; and c) The product is labeled to be used under medical supervision, and is primarily obtained through hospitals, clinics, and other medical and long term care facilities.

Medical Foods are distinguished from the broader category of Foods for Special Dietary Use and from foods that make health claims by the requirement that medical foods be used under medical supervision.

The term"Medical Food"does not pertain to all foods fed to sick patients. Medical Foods are foods that are specially formulated and processed (as opposed to a naturally occurring foods used in their natural state) for the patient who is seriously ill or who requires the product as a major treatment modality. Typical medical foods are enteral nutrition products, i. e., products provided through the gastrointestinal tract, taken by mouth, or provided through a tube or catheter that delivers nutrients beyond the oral cavity or directly to the stomach.

Medical foods can be classified into the following four groups: 1) Nutritionally complete formulas.

2) Nutritionally incomplete formulas, including individual"modular"type products that may be mixed with other products before use (e. g., protein, carbohydrate, or fat modular).

3) Formulas for metabolic (genetic) disorders in patients over 12 month of age.

4) Oral rehydration products.

In some Foods for Special Dietary Use (FSDU), and in some Medical Foods (MF), the need for some nutritionally essential macro nutrients and micro nutrients may decrease.

However, scientific literature does not indicate any chronic condition that the need for an essential macro nutrient or micro nutrient is totally eliminated. Consequently (similar to Nutritional Supplements (NS)), Foods for Special Dietary Use (FSDU), and Medical Foods

(MF) must minimally contain and declare on their package (e. g., under % Daily Value in the Nutrition Facts table), the concentration of all nutritionally essential macro nutrients and micro nutrients vitamins and minerals, as indicated in the U. S. Code of Federal Regulations (Table 1A) or Codex Regulations (Table 1B). In Foods for Special Dietary Use (FSDU), and Medical Foods (MF), no essential nutrient is disregarded or is given the concentration of zero (except, for a limited time, for fat in fat-free products, and fiber in residue-free products).

The fat source of the nutritional formulations may be any fat source or blend of fat sources which provide the desired amount of fat calories. Preferably, the fat source should be high in monounsaturated fatty acids. Fat sources may include vegetable oils, e. g., high oleic acid vegetable oils such as sunflower oil, canola oil and olive oil; safflower oil, cottonseed oil, corn oil or soybean oil, and medium chain triglycerides, e. g. C6-C, triglycerides. High oleic acid sunflower oil or canola oil are preferred. In addition, butter fat and other types of oils may be used. The protein source may be selected from a variety of materials, including without limitation, milk protein, whey protein, caseinate, soy protein, egg whites, gelatins, collagen and combinations thereof. The preferred protein source is milk protein concentrate in combination with isolated soy protein and calcium caseinate.

Included in the protein source are lactose-free skim milk, milk protein isolate, and whey protein isolate.

When the compositions is used as a nutritional supplement as defined herein, the protein source can also include enzymatically-hydrolyzed protein (peptides), amino acids and combinations thereof. These protein sources are often used in elemental diets. The amount of protein in eight fluid ounces (240 ml) is about 5 to about 40 percent of the daily value (DV). The energy contained in eight fluid ounces of compositions of the present invention is intended to be about 125-400 Kilo calories.

The carbohydrate source useful in the present invention may be selected from a wide variety of materials such as sucrose, corn syrup solids, glucose, fructose, maltodextrin and

combinations thereof. When using corn syrup solids or maltodextrin, it is preferred to use either sucrose, glucose or fructose in combination therewith.

Artificial sweeteners such as saccharine, aspartame, asulfame K, sucrolose and their combination, as well as others, may be incorporated to enhance the organoleptic and sweetness quality of the compositions. Various fiber sources may be included in the compositions of the present invention. These sources may be selected from such materials as oat fiber, soy fiber, guar gum, pectin, soy polysaccharides, gum arabic, hydrolyzed fibers and the like. Cellulose, hemicellulose, hydrocollides, methylcellulose, carboxymethylcellulose and the like are contemplated. Also useful are fructo-oligossaccharides.

Compositions of the present invention can be formulated into a variety of different product forms. For example, a basic or standard composition is one such form. Other forms include light/low-fat, fat-free, high protein, fiber-containing and extra strength (sometimes referred to as"plus"). In a desirable aspect the macro nutrients comprising fat, carbohydrate and protein are present in amounts of about 0.1% to about 12% of the daily value (D. V.) for fat, about 8% to about 20% of the daily value for carbohydrate and about 7% to about 35% of the daily value or nutrient reference value for protein. More desirably, fat is present in the amount of about 3 to about 11 % of the daily value; carbohydrate is present in amounts of about 10 to about 19% of the daily value; and protein is present in amounts of about 20 to about 30% of the daily value or the nutrient reference value. These daily value percentages are based on 8 fluid ounces (240 ml) and a 2,000 calorie diet per diem.

In another desirable aspect, Vitamin A is present preferably in amounts of 20% to about 40% of the daily value per 8 fluid ounces and more desirably in amounts of about 23% to about 30% of the daily value; beta-carotene is present desirably in amounts of about 20% to 40% of Vitamin A and more desirably about 25% to about 35% of Vitamin A of the daily value per 8 fluid ounces; Vitamin C is present desirably in amounts of about 20% to about 80% of the daily value and more desirably about 23% to about 70% of the daily value per 8 fluid ounces; Vitamin D is present desirably in amounts of about 20% to about 40% of the daily value and more desirably in amounts of about 23% to about 35% of the daily value per

8 fluid ounces; Vitamin E is present desirably in amounts of about 20% to about 80% of the daily value and more desirably in amounts of about 30% to about 70% of the daily value per 8 fluid ounces; Vitamin K is present desirably in amounts of about 20% to about 40% and more desirably in amounts of about 23% to about 35% of the daily value per 8 ounces; Thiamine is present desirably in amounts of about 20% to about 40% of the daily value and more desirably in amounts of about 23% to about 35% of the daily value per 8 ounces; riboflavin is present desirably in amounts of about 20% to about 40% of the daily value and more desirably in amounts of about 23% to about 35% of the daily values per 8 fluid ounces; niacin is present desirably in amounts of about 20% to about 40% of the daily value and more desirably in amounts of 23% to about 35% of the daily value per 8 fluid ounces; Vitamin B6 is present desirably in amounts of about 20% to about 40% of the daily value and more desirably in amounts of 23% to about 35% of the daily value per 8 fluid ounces; Folate is present desirably in amounts of about 20% to about 40% of the daily value and more desirably in amounts of 23% to 35% of the daily value per 8 fluid ounces; Vitamin B12 is present desirably in amounts of about 20% to about 40% and more desirably about 23% to about 35% of the daily value per 8 fluid ounces; Biotin is present desirably in amounts of about 20% to about 40% of the daily value and more desirably about 23% to about 35% of the daily value per 8 fluid ounces; and Pantothenic Acid is present desirably in amounts of about 20% to about 40% of the daily value and more desirably about 23% to about 35% of the daily value per 8 fluid ounces. As mentioned, all daily values are based on 2,000 calorie diet per diem and all quantities present in the composition are based on 8 fluid ounces (240 ml).

With respect to the mineral content in the compositions of the present invention, the following values represent desirable daily value percent contents in 8 fluid ounces (240 ml); Calcium in amounts of about 20% to about 80% and more desirably about 40% to about 70%; Potassium in the amounts of about 0.1 % to about 25% and more desirably about 0.1% to about 20%; Iron in amounts of about 20% to about 40% and more desirably about 23% to about 35%; Phosphorus in amounts of about 20% to about 40% and more desirably about 23% to about 35%; Iodine in amounts of about 20% to about 40% and more desirably in amounts of about 23% to about 35%; Magnesium in amounts of about 20% to about 40% and

more desirably in amounts of about 23% to 35%; Zinc in amounts of about 20% to about 40% and more desirably in amounts of about 23% to about 35%; Selenium in amounts of about 20% to about 40% and more desirably in amounts of about 23% to about 35%; Copper in amount of about 20% to about 40% and desirably in amounts of about 23% to about 35%; Manganese in amounts of about 20% to about 40% and desirably in amounts of 23% to about 35% Chromium in amounts of about 20% to about 40% and more desirably in amounts of about 23% to about 35%; Molybdenum in amounts of about 20% to about 40% and more desirably in amounts of about 23% to about 35%; and Chloride in amount of about 5% to about 40% and more desirably in amounts of about 10% to about 25% of the daily value per 8 fluid ounces, wherein the daily value is based on 2,000 calorie diet.

In yet another desirable aspect, Vitamin A is present preferably in amounts of 20% to about 40% of the nutrient reference value per 8 fluid ounces (240 ml) and more desirably in amounts of about 23% to about 30% of the nutrient reference value; Vitamin C is present desirably in amounts of about 20% to about 80% of the nutrient reference value and more desirably about 23% to about 70% of the nutrient reference value per 8 fluid ounces (240 ml); Vitamin D is present desirably in amounts of about 20% to about 40% of the nutrient reference value and more desirably in amounts of about 23% to about 35% of the nutrient reference value per 8 fluid ounces (240 ml); Thiamine is present desirably in amounts of about 20% to about 40% of the nutrient reference value and more desirably in amounts of about 23% to about 35% of the nutrient reference value per 8 ounces (240 ml); riboflavin is present desirably in amounts of about 20% to about 40% of the nutrient reference value and more desirably in amounts of about 23% to about 35% of the nutrient reference values per 8 fluid ounces (240 ml); niacin is present desirably in amounts of about 20% to about 40% of the nutrient reference value and more desirably in amounts of 23% to about 35% of the nutrient reference value per 8 fluid ounces (240 ml); Vitamin B6 is present desirably in amounts of about 20% to about 40% of the nutrient reference value and more desirably in amounts of 23% to about 35% of the nutrient reference value per 8 fluid ounces (240 ml); Folate is present desirably in amounts of about 20% to about 40% of the nutrient reference value and more desirably in amounts of 23% to 35% of the nutrient reference value per 8 fluid ounces (240 ml); and Vitamin B 12 is present desirably in amounts of about 20% to about 40% and

more desirably about 23% to about 35% of the nutrient reference value per 8 fluid ounces (240 ml). As mentioned, all nutrient reference values are based on 2,000 calorie diet per diem and all quantities present in the composition are based on 8 fluid ounces (240 ml).

With respect to the mineral content in the compositions of the present invention, the following values represent desirable nutrient reference value percent contents in 8 fluid ounces (240 ml); Calcium in amounts of about 20% to about 80% and more desirably about 40% to about 70%; Iron in amounts of about 20% to about 40% and more desirably about 23% to about 35%; Iodine in amounts of about 20% to about 40% and more desirably in amounts of about 23% to about 35%; Magnesium in amounts of about 20% to about 40% and more desirably in amounts of about 23% to 35%; and Zinc in amounts of about 20% to about 40% and more desirably in amounts of about 23% to about 35%; wherein the nutrient reference value is based on 2,000 calorie diet.

Antioxidants useful in the present invention include, without limitation, butylhydroxy anisole (BHA), butylhydroxy toluene (BHT), tertiary butyl hydroquinone (TBHQ), propyl gallate and combinations thereof. Natural antioxidants can also be included through additional amounts of vitamin C, E, beta-carotene, selenium, zinc and combinations thereof.

Various herbs, herb extracts, botanicals, botanical extracts, amino acids and the like, and combinations thereof, can also be included for their intended functions and various products using such dietary supplements can be formulated therefrom.

Various non-nutritive components can be included in the inventive compositions. For example, fillers, coloring agents, flavors, emulsifiers and the like are useful. Other nutritionally valuable, but non-essential components can be added, including choline, taurine, L-carnitine and the like. Combinations of these non-nutritive and non-essential components are contemplated.

Various nutraceuticals and phytochemicals can be incorporated into the inventive compositions for their intended function and as a treatment for patients with specific disorders. Such components are typically included when the composition is intended as a

medical food or a food for special dietary use. Various pharmaceuticals, such as antibiotics, anti-cancer agents, anti-oxidants and other pharmacologically and bioactive agents may be included for their intended purpose. The standard formulation as set forth in the tables can be augmented with a variety of additional components to specially tailor the composition as a medical food, food for special dietary use or nutritional supplement. Various specialized products can be formulated. For example when the composition is to be used as a food for special dietary use, it can be formulated into a hypoallergenic food. Other foods for special dietary use include infant foods, pediatric foods, geriatric foods, foods for reducing and maintaining weight, foods for diabetics, and foods for those on restricted sodium, fat or protein diets.

Various medical foods can be fashioned from the inventive compositions for cardiovascular patients, cancer patients, neurological patients, cachexia patients, surgery patients, patients with limited respiratory functions and chronic obstructive pulmonary disease, as well as those suffering from HIV-Aids, chronic hepatic disease, renal failure, ulcers and other diseases which require special diets. Additional uses for compositions of the present invention includes formulating the inventive compositions into products for diarrhea, constipation, inflammatory bowel disease, chronic pancreatitis, cystic fibrosis, dysphagia as well as other specialized products.

Although the inventive compositions are primarily intended for human use, the compositions can be administered to other animals as a nutritional supplement, food for special dietary use or as a medical food.

EXAMPLES (Nutritional Milk Compositions and Products) Batching and Processing Procedures: Proper batching is of utmost importance. For preparation of all pasteurized and/or ultra-pasteurized complete nutritional milk products, the total processing system was cleaned (CIP = Clean-In-Place).

For the preparation of all pasteurized and/or ultra-pasteurized complete nutritional milk products, high quality, food-grade ingredients were used. Order of addition of ingredients, their physical structure, temperature, and rate of addition are also very important.

A milk was the first ingredient to be introduced into the batching container. Although the batch volume could be adjusted at the end of the batching process, it is preferred that the amount of milk is precalculated in a way that addition of other ingredients automatically brings the volume of the batch to the desirable level.

Proteins, fats, carbohydrates, minerals, flavors, colors, and vitamins are added sequentially. After the addition of each ingredient, the combination was mixed or homogenized before the next ingredient was added to the system.

Upon obtaining a homogeneous batch of unprocessed complete nutritional milk product with desirable profile of nutrients and functional ingredients, the batch is immediately pasteurized (85 °C for 30 seconds) and/or ultra-pasteurized (135-150°C for up to 5 seconds). The pasteurized and/or ultra-pasteurized nutritional milk product is either promptly cooled and continuously kept at refrigerated temperature (1-7°C, preferably 2-3°C); or promptly frozen and continuously kept a freezing temperature (-18°C); and/or while still warm (about 5 5 ° C), is cultured and kept at 37°C for several hours before cooled to refrigerated temperatures.

EXAMPLE 1A Pursuing the batching and processing guideline explained above, a fatfree complete nutritional milk composition was developed. The ingredients, including fatfree (skim) milk, used for the preparation of this product is shown in Table 8.

EXAMPLE 1B Pursuing the batching and processing guideline explained above, a fatfree complete nutritional milk composition was developed. The ingredients, including fatfree milk with nonfat milk solids, used for the preparation of this product is shown in Table 9.

EXAMPLE 1C Pursuing the batching and processing guideline explained above, a fatfree complete nutritional milk composition was developed. The ingredients, including lactose-free fatfree milk, used for the preparation of this product is shown in Table 10.

EXAMPLE 1D Pursuing the batching and processing guideline explained above, a lowfat (1% fat) complete nutritional milk composition was developed. The ingredients, including 1% fat milk, used for the preparation of this product is shown in Table 11.

EXAMPLEIE Pursuing the batching and processing guideline explained above, a lowfat (2% fat) complete nutritional milk composition was developed. The ingredients, including 2% fat milk, used for the preparation of this product is shown in Table 12.

EXAMPLE 1F Pursuing the batching and processing guideline explained above, a fullfat (3.4% fat) complete nutritional milk composition was developed. The ingredients, including fullfat (3.4% fat) milk, used for the preparation of this product is shown in Table 13.

EXAMPLE 2A Pursuing the batching and processing guideline explained above, a lowfat (1% fat) complete nutritional milk (chocolate flavor) composition was developed. The ingredients, including l % fat chocolate milk, used for the preparation of this product is shown in Table 14.

EXAMPLE 2B Pursuing the batching and processing guideline explained above, a lowfat (1% fat) complete nutritional milk (strawberry flavor) composition was developed. The ingredients, including 1 % fat strawberry milk, used for the preparation of this product is shown in Table 15.

EXAMPLE 2C Pursuing the batching and processing guideline explained above, a lowfat (1% fat) complete nutritional milk (vanilla flavor) composition was developed. The ingredients, including l % fat vanilla milk, used for the preparation of this product is shown in Table 16.

EXAMPLE 2D Pursuing the batching and processing guideline explained above, a lowfat (1% fat) complete nutritional milk (banana flavor) composition was developed. The ingredients, including 1 % fat banana milk, used for the preparation of this product is shown in Table 17.

EXAMPLE 3A Pursuing the batching and processing guideline explained above, a complete nutritional light vanilla ice cream composition was developed. The ingredients, including full fat milk and Half & Half, used for the preparation of this product is shown in Table 18.

EXAMPLE 3B Pursuing the batching and processing guideline explained above, a fat-free, lactose- free, complete nutritional chocolate fudgesicle ice cream composition was developed. The ingredients, including 100% fat-free, lactose-free milk, used for the preparation of this product is shown in Table 19.

EXAMPLE 3C Pursuing the batching and processing guideline explained above, a lowfat, complete nutritional peach frozen yogurt composition was developed. The ingredients, including lowfat (2%) vanilla yogurt, used for the preparation of this product is shown in Table 20.

EXAMPLE 4A Pursuing the batching and processing guideline explained above, a fatfree (nonfat or skim), complete nutritional vanilla yogurt composition was developed. The ingredients, including fatfree (skim) milk, used for the preparation of this product is shown in Table 21.

EXAMPLE 4B Pursuing the batching and processing guideline explained above, a 1 % fat, complete nutritional strawberry yogurt composition was developed. The ingredients, including 1 % fat milk and strawberry preserve, used for the preparation of this product is shown in Table 22.

EXAMPLE 4C Pursuing the batching and processing guideline explained above, a 2% fat, complete nutritional raspberry yogurt composition was developed. The ingredients, including 2% fat milk and raspberry preserve, used for the preparation of this product is shown in Table 23.

EXAMPLE 4D Pursuing the batching and processing guideline explained above, a full-fat, complete nutritional organic yogurt composition was developed. The ingredients, including fullfat organic milk, used for the preparation of this product is shown in Table 24.

EXAMPLES (Pasteurized and/or Ultra-Pasteurized Complete Nutritional Compositions) The following six (6) classes of pasteurized and/or ultra-pasteurized complete nutritional compositions, by way of example and not limitation, were prepared:

Complete Nutritional Composition Applications 1.) Regular/Standard/Basic for people who require a general purpose, no- residue, nutritional supplement to maintain good nutritional status. Also for athletic lifestyles, lactose intolerance, and malnutrition 2.) Light/Low-Fat for people who are on a modified fat diet, restricting their intake of saturated fats and cholesterol, but a requiring normal concentration of protein, vitamins, and minerals 3.) Fat-Free for people who, for a limited time, can benefit from a completely fat-restricted diet, but require a normal concentration of protein, vitamins, and minerals 4.) High Protein for people who require additional protein, such as those who are recovering form illness or general surgery or are at risk of pressure ulcers 5.) Plus/Extra Strength for people who require extra calories and nutrients in a limited volume 6.) With Fiber for people who can benefit from increased dietary fiber (moderate bowel function, extended inactivity).

BatchingProcedure: Proper batching is of utmost importance. For preparation of all pasteurized and/or ultra-pasteurized complete nutritional products, the total processing system was cleaned (CIP = Clean-In-Place).

For the preparation of all pasteurized and/or ultra-pasteurized complete nutritional products, high quality, food-grade ingredients were used. Order of addition of ingredients, their physical structure, temperature, and rate of addition are also very important.

Water (or lactose-free skim milk) was the first ingredient to be introduced into the batching container. Although the batch volume could be adjusted at the end of the batching

process, it is preferred that the amount of water is precalculated in a way that addition of other ingredients automatically brings the volume of the batch to the desirable level.

Proteins, fats, carbohydrates, minerals, flavors, colors, and vitamins are added sequentially. After the addition of each ingredient, attempts were made to homogenize the mixture before the next ingredient was added to the system.

Upon obtaining a homogeneous batch of unprocessed complete nutritional product with desirable profile of nutrients and functional ingredients, the batch is immediately pasteurized (85 °C for 30 seconds) and/or ultra-pasteurized (135-150°C for up to 5 seconds).

The pasteurized and/or ultra-pasteurized nutritional product is promptly cooled, and continuously kept at refrigerated temperature (1-7°C, preferably 2-3°C).

EXAMPLES 5-8 Pursuing the batching and processing guidelines explained above, four different flavors (vanilla, strawberry, chocolate, banana) of the inventive refrigerated ready-to-drink pasteurized and/or ultra-pasteurized standard complete nutritional compositions were developed. The nutrition facts and the ingredients used for preparation of these products are shown in Table 27.

EXAMPLES 9-12 Pursuing the batching and processing guidelines explained above, four different flavors (vanilla, strawberry, chocolate, banana) of the inventive refrigerated ready-to-drink pasteurized and/or ultra-pasteurized light/low-fat complete nutritional compositions were developed. The nutrition facts and the ingredients used for preparation of these products are shown in Table 28.

EXAMPLES 13-16 Pursuing the batching and processing guidelines explained above, four different flavors (vanilla, strawberry, chocolate, banana) of refrigerated ready-to-drink pasteurized and/or ultra-pasteurized fat-free complete nutritional compositions were developed. The

nutrition facts and the ingredients used for preparation of these products are shown in Table 29.

EXAMPLES 17-20 Pursuing the batching and processing guidelines explained above, four different flavors (vanilla, strawberry, chocolate, banana) of refrigerated ready-to-drink pasteurized and/or ultra-pasteurized high protein complete nutritional compositions were developed. The nutrition facts and the ingredients used for preparation of these products are shown in Table 30.

EXAMPLES 21-24 Pursuing the batching and processing guidelines explained above, four different flavors (vanilla, strawberry, chocolate, banana) of refrigerated ready-to-drink pasteurized and/or ultra-pasteurized plus complete nutritional compositions were developed. The nutrition facts and the ingredients used for preparation of these products are shown in Table 31.

EXAMPLES 25-28 Pursuing the batching and processing guidelines explained above, four different flavors (vanilla, strawberry, chocolate, banana) of refrigerated ready-to-drink pasteurized and/or ultra-pasteurized with fiber complete nutritional compositions were developed. The nutrition facts and the ingredients used for preparation of these products are shown in Table 32.

EXAMPLES 29-32 Pursuing the batching and processing guidelines explained above, four different flavors (vanilla, strawberry, chocolate, banana) of the invention refrigerated ready-to-drink pasteurized and/or ultra-pasteurized standard complete nutritional compositions were developed, using lactose-free milk as the basis of the formulation. The nutrition facts and the ingredients used for preparation of these products are shown in Table 33.

Although this invention has certain preferred embodiments, it will be obvious to those skilled in the art that various changes and modifications may be made therein without departing from the invention, and all such changes and modifications are intended to fall within the true spirit and scope of the invention.

Table 1A) The list of nutritionally essential macro nutrients and micro nutrients, as described in the Code of Federal Regulation (21 C. F. R. 101.9,1998).

Essential Nutrient 100% (D. V Total Fat 65 g Saturated Fat 20 g Cholesterol 300 mg Sodium 2,400 mg Potassium 3,500 mg Total Carbohydrate 300 g Dietary Fiber 25 g Sugars Protein 50 g Vitamin A 5,000 IU** Vitamin C 60 mg Calcium 1,000 mg Iron 18 mg Vitamin D 400 IU** Vitamin E 30 IU** Vitamin K 80 mcg Thiamine (Vitamin Bl) 1.5 mg Riboflavin (Vitamin B2) 1.7 mg Niacin 20 mg Vitamin B6 2.0 mg Folate 400 mcg Vitamin B 12 6.0 mcg Biotin 300 mcg Pantothenic Acid 10 mg Phosphorus 1,000 mg Iodine 150 mcg Magnesium 400 mg Zinc 15 mg Selenium 70 mcg Copper 2.0 mg Manganese 2.0 mg Chromium 120 mcg Molybdenum 75 mcg Chloride 3,400 mg *) Percent Daily Values are based on a 2,000 calorie diet.

* *) 1 International Unit (IU) of vitamin A = 0.3 mcg of all-trans retinol = 0.6 mcg of all trans beta-carotene 1 International Unit (IU) of vitamin D = 0.025 mcg cholecalciferol 1 International Unit (IU) of vitamin E = 1 mg of all-rac-alpha Tocopherol acetate Table 1B) The list of nutritionally essential macro nutrients and micro nutrients, as described in the CODEX Guidelines on Nutritional Labelling (CAC/GL 2-1985, Rev. 1- 1993).

100% Nutrient Essential Nutrient Reference Value Protein 50 g Vitamin A 800 mcg Vitamin C 60 mg Calcium 800 mg Iron 14 mg Vitamin D 53 mcg Thiamine (Vitamin Bl) 1.4 mg Riboflavin (Vitamin B2) 1.6 mg Niacin 18 mg Vitamin B6 2.0 mg Folate 200 mcg Vitamin B 12 1.0 mcg Iodine 150 mcg Magnesium 300 mg Zinc 15 mg Table 2A) Nutrition Facts of Commercially Available Flavored Milks COMPANY: Yoo-HooWawaDairySealtestHershey's ReducedYoo-Hoo1%Milkfat1%milkfatPRODUCT:Quick# Fat (chocolate)(chocolate)(chocolate)(chocolate)(chocolate)NUTRI TIONFACTS Serving Size. cup cup 8floz Cup Container (240ml)(240ml)(237ml)(240ml)(240ml) Serving per container two two four two one 230190130160180Calories2,000 Calories from Fat600 70 40 10 25 %DV* %DV %DV %DV %DV %DV 65g100%127154TotalFat Saturated Fat 20 g 100% 25 15 3 8 9 mg100%105024Cholesterol300 mg100%567810Sodium2,400 Potassium 3,500 mg 4 300g100%111010910TotalCarbohydrate 25g100%44000DietaryFiber Sugars g 30 g25 20 g26 g 25 g Protein 50 g 100% 4162016 Vitamin A 5,000 IU** 100% 6 101010 60mg100%001044VitaminC mg100%2525102935Calcium1,000 Iron 18 mg 100%0 2 3 0 400IU**100%25102525VitaminD 30IU**100%VitaminE 80mcg100%VitaminK mg100%Thiamine1.5 mg100%10Riboflavin1.7 niacin 20 mg 100% 10 2.0mg100%VitaminB6 mcg100%Folate400 6.0mcg100%VitaminB12 mcg100%Bitoin300 10mg100%PantothenicAcid mg100%10Phosphorus1,000 mcg100%Iodine150 Magnesium 400 mg 100% mg100%Zinc15 mcg100%Selenium70 mg100%Copper2.0 Manganese mg 100% mcg100%Chromium120 Molybdenum 75 mcg 100% Chloride mg 100% *) Percent Daily Values (D. V.) are based on a 2,000 calorie diet.

**) 1 International Unit (IU) of vitamin A = 0.3 mcg of all-trans retinol = 0.6 mcg of all-trans beta-carotene 1 International Unit (IU) of vitamin D = 0.025 mcg of cholecalciferol I International Unit (IU) of vitamin E = I mg of all-rac-alpha Tocopherol acetate Table 2B) Nutrition Facts of Commercially Availaale Flavored Milks COMPANY: Say Yes Power Power Organic White Nutrition Nutrition Cow of Vt Wave PRODUCT: Fat Free Power Power Milk Organic Silk FatfreeMilksoymilkMilkPlus NUTRITIONNUTRITIONFACTS (chocolate) (chocolate)(chocolate)(chocolate) Serving Size. 8floz8floz1cup1cupcup (236ml) (236 ml) (237ml) containerfouroneonefourfourServingper Calories 2,000 160280108250 Fat600055014024Caloriesfrom %DV%DV%DV%DV%DV%DV* 65g100%090234TotalFat Saturated Fat 20 080480100% Cholesterol 300 mg 100% 20 0 Sodium 2,400 mg 100% 6 7 6 5 4 Potassium 3,500 mg 1413 Total g100%8131196300 25g100%07934DietaryFiber 23g25g20g25g15gSugarsg g100%1617171710Protein50 Vitamin A 5,00 1020100% 20 10 10 60mg100%0505040VitaminC mg100%2530304030Calcium1,000 mg100%210102Iron18 400IU**100%253535430VitaminD 30IU**100%3535VitaminE Titamin K 100%mcg mg100%3535Thiamine1.5 Riboflavin 1.7 mg 100% 50 50 30 mg100%3535Niacin20 Vitamin B6 2. 0 mg 100% 35 35 Folate 400 mcg 100% 4 ..... Vitamin B12 6. 0 mcg 100% 50 50. 50 mcg100%3535Biotin300 10mg100%3535PentothenicAcid Phosphorus 1,000 mg 2530 mcg100%3535Iodine150 mg100%2020Magnesium400 mg100%1515Zinc15 mcg100%tracetraceSelenium70 mg100%1010Copper2.0 mg100%tracetraceManganese2.0 mcg10%tracetraceChromium120 Chloride 3, 400 mg 100% : *) Percent Daily Values (D. V.) are based on a 2,000 calorie diet.

**)) International Unit (IU) of vitamin A=0.3 mcg of all-trans retinol=0.6 mcg of all-trans beta-carotene I International Unit (IU) of vitamin D=0.025 mcg of cholecalcipherol I International Unit (IU) of vitamin E=1 mg of all-rac-alpha Tocopherol acetate Table 3A) Nutrition Facts of Commercially Available Ice Creams and Frozen Yogurts COMPANY: Good Edy's Ben& Haagan-Daz ConAgra Humor Grand Jerry PRODUCT: Breyers# Edy's Ben & Haagan-Daz Healthy Jerry Choice NUTRITION FACTS ChocChipPistachioVanillaBeanVanilla Leoche Bean Cookie Servingcup1/2cup1/2cup1/2cup1/2cup1/2 containerServingper 160140300290110Calories2,000 Calories from Fat 701401802050 % DV* %DV %DV %DV %DV %DV 65g100%91224313TotalFat Saturated Fat 20 g 100% 19 23 49 55 5 Cholesterol 300 mg 100% 79 237 Sodium 2,400 mg 100% 3 1 4 3 2 mg100%Potassium3,500 Total Carbohydrate 300 g 100% 8 5 @ Dietary Fiber 25 g 3 Sugars g 20 g 14 g 26 g 18 g 18 g Protein 50 g 100% 4 4 10 6 VitaminVitaminA 5,000 6615156100% Vitamin C 60 mg 100% 0 0 00 Calcium 1,000 mg 100% 8 6 10 10 10 Iron 18 mg 100% 0 0 6 2 0 Vitamin D 400 IU** 100% Vitamin E 30 IU** 100% 80mcg100%VitaminK Thiamine 1.5 mg 100% mg100%Riboflavin1.7 Niacin 20 mg 100% 2.0mg100%VitaminB6 Folate 400 mcg 100% Thiamine 1. 5mg 100% Biotin100%mcg 100mg100%PantothenicAcid mg100%Phosphorus1,000 Iodine 100%mcg mg100%magnesium400 Zinc 15 mg 105 mcg100%Selenium70 Copper 2.0 mg 100% Manganese 2.0 mg 100% Chromium mcg 100% Molybdenum 75 mcg 100% Chloride 3,400 mg 100% *) Percent Daily Values (D. V.) are based on a 2, UUU calorie diet.

**) 1 International Unit (IU) of vitamin A=0.3 mcg of all-trans retinol=0.6 mcg of all-trans beta-carotene I International Unit (IU) of vitamin D=0.025 mcg of cholecalcipherol 1 International Unit (IU) of vitamin E= I mg of all-rac-alpha Tocopherol acetate Table 3B) Nutrition Facts of Commercially Available Ice Creams and Frozen Yogurts COMPANY: Starbucks Haagen-Dazs Haagen-Dazs ............................................................ ............................................................ ............................................................ ..................... PRODUCT.. : Frozen Yogurt. Frozen Yogurt JavaToffeeVanillaVanillaRaspberryNUTRITIONFACTS NUTRITION FACTS Java Toffee Vanilla Vanilla Raspberry 1/2ServingSize. cup 1/2 cup 1/2 cup Serving per container 260140130Calories2,000 Servingper container %DV%DV* %DV %DV Total Fat 65 g 100% 2 0 0 ........................................ mg100%2111Cholesterol300 SodiumSodium2,400 mg 100% 4 2 1 mg100%Potassium3,500 300g100%10109TotalCarbohydrate dietary Fiber g 100% Sugars g 29 g17 g 19 g g100%8128Protein50 5,000IU**100%1000VitaminA 60mg100%000VitaminC Calcium 1,000 mg100% 10 10 Iron 18 mg 100% 0 0 .. 400IU**100%VitaminD 30IU**100%VitaminE 80mcg100%VitaminK mg100%Thiamine1.5 Riboflavin 1.7 mg 100% Niacin 20 mg 100% Vitamin B6 2.0 mg 100% Folate 400 mcg 100% Vitamin B12 6.0 mcg 100% Biotin 300 mcg 100% Pantothenic Acid 10 mg 100% Phosphorus 1,000 mg 100% Iodine 150 mcg 100% Magnesium 400 mg 100% Zinc 15 mg 100% Selenium 70 mcg 100% Copper 2.0 mg 100% Manganese 2.0 mg 100% Chromium 120 mcg 100% Molybdenum 75 mcg 100% Chloride 3,400 mg 100% *) Percent Daily Values (D. V.) are based on a 2,000 calorie diet.

**) 1 International Unit (IU) of vitamin A=0.3 mcg of all-trans retinol=0.6 mcg of all-trans beta-carotene I International Unit (IU) of vitamin D=0.025 mcg of cholecalcipherol 1 International Unit (IU) of vitamin E=l mg of all-rac-alpha Tocopherol acetate Table 4A) Nutrition Facts of Commercially Available Yogurts COMPANY: StonyfieldDannon#Colombo# PRODUCT: Reguler Lowfat Organic 99% fatfree Yogurt NUTRITIONNUTRITIONFACTS Plain Plain Plain blueberry Serving Size. 1 cup 1 cup 1 cup 1 cup containerServingper Calories 2,000 150 130 240 Calories from Fat 600 70 35 90 25 % DV*. % DV % DV Total Fat 65 g 100% 13 6 15 Saturated Fat 20 g 100% 26 13 9 mg100%115135Cholesterol300 Sodium 2,400 mg 100%5 75 Potassium 3,500 mg 100% 11 13 300g100%TotalCarbohydrate 4 4 4 15 Dietary Fiber 25 g 100% 4 Sugars g11g12g43g11 g100%16201818Protein50 5,000IU**100%6082VitaminA 60mg100%4044VitaminC Calcium 1,000 mg 100% 30 35 35 35 Iron 18 mg 100% 0 00 Vitamin D 400 100% 30IU**100%VitaminE 80mcg100%VitaminK mg100%Thiamine1.5 Riboflavin 1.7 25100% Niacin 20 mg 100% voitaminmg100%2.0 Folate 400 mcg 100% .................................-............' !..--........-.............................................. ............................................................ . 6.0VitaminB12 100% Biotin 300 mcg 100% 10mg100%PantothenicAcid mg100%25Phosphorus1,000 mcg100%Iodine150 mg100%Magnesium400 mg100%Zinc15 mcg100%Selenium70 Copper 2. 0 mg 100% Manganese 100%mg Chromium 120 mcg 100% Molybdenum 75 mcg 100% mg100%chloride3,400 *) Percent Daily Values (D. V.) are based on a 2,000 calorie diet.

**) 1 International Unit (IU) of vitamin A=0.3 mcg of all-trans retinol=0.6 mcg of all-trans beta-carotene 1 International Unit (IU) of vitamin D=0.025 mcg of cholecalcipherol I International Unit (IU) of vitamin E= I mg of all-rac-alpha Tocopherol acetate Table 4B) Nutrition Facts of Commercially Available Yogurts COMPANY: Colombos Breyers@ PRODUCT: Fat Free 99% fatfree NUTRITION FACTS blueberry Smooth & Creamy 1cup1cupServingSize. containerServingper Calories 2, 000 200 230 Fat600020Caloriesfrom %DV%DV%DV* Total Fat 65 g 100% 0 3 SaturatedFat 20 g 100% 0 5 mg100%27Cholesterol300 Sodium2, 400 mg 100% 5 5 mg100%11Potassium3,500 Total Carbohydrate 300 g 100% : 15 25g100%DietaryFiber 36g40gSugarsg g100%1418Protein50 5,000IU**100%00VitaminA 60mg100%00VitaminC mg100%2025Calcium1,000 mg100%00Iron18 400IU**100%VitaminD ira Vitamin E 30 IU** 100% 80mcg100%VitaminK Thiamine 1.5 mg 100% Riboflavin 1.7 mg 100% mg100%Niacin20 VitaminB62. 0 mg 100% Folate 400 mcg 100% Vitamin B 126. 0 mcg 100% Biotin 300 mc 100/o. Pantothenic Acid 10 mg 100% .hog....... 100 Iodine 150 mcg 100% mg100%Magnesium400 mg100%Zinc15 mcg100%Selenium70 mg100%Copper2.0 Manganese 2. 0 mg 100% mcg100%Chromium120 Molybdenum 75 mcg 100% ChlorideChloride3,400 mg 100% *) Percent Daily Values (D. V.) are based on a 2,000 calorie diet.

**) I International Unit (IU) of vitamin A=0.3 mcg of all-trans retinol=0.6 mcg of all-trans beta-carotene 1 International Unit (IU) of vitamin D=0.025 mcg of cholecalcipherol 1 International Unit (IU) of vitamin E= I mg of all-rac-alpha Tocopherol acetate Table 5) Nutrition Facts of Complete Milk Products of the Present Invention COMPANY: InventiveInventive PRODUCT: CreamYogutIce NUTRITION(vanilla)(vanilla)(chocolate) 8floz1/2cup1cupServingSize. containeroneServingper Calories 2 000 170 varies varies 20 Calories from Fat 600 20 varies varies %DV%DV%DV%DV* Total Fat 65 g 100% 3 varies varies Saturated Fat 20 g 100% 7 varies varies mg100%3variesvariesCholesterol300 ... mg100%855Sodium2,400 mg100%101010Potassium3,500 Total Carbohydrate 300 10variesvaries100% Dietary Fiber 25 g 100% 0 varies varies Sugars g 30 g varies varies g100%16variesvariesProtein50 5,000IU**100%101010VitaminA 60mg100%101010VitaminC mg100%252525Calcium1,000 mg100%101010Iron18 400IU**100%252525VitaminD Vitamin E 100%101010IU** 80mcg100%10100VitaminK mg100%101010Thiamine1.5 mg100%242424Riboflavin1.7 mg100%101010Niacin20 2.0mg100%101010VitaminB6 mcg100%101010Folate400 6.0mcg100%141414VitaminB12 Biotin 100%101010mcg 10mg100%101010PantothenicAcid mg100%252525Phosphorus1,000 mcgIodine150 101010 mg100%101010Magnesium400 zinc 15 mg 100% 10 10 10 mcg100%101010Selenium70 Manganese 2. 0 mg100% 101010 Magnesium 400 mg 100% 10 10 10 Zinc 15 mg 100% 10 10 10 Selenium 70 mcg 100% 10 10 10 Copper 2.0 mg 100% 10 10 10 Manganese 2.0 mg 100% 10 10 10 mcg100%101010Chromium120 mcg100%101010Molybdenum75 mg100%101010Chloride3,400 *) Percent Daily Values (D. V.) are based on a 2,000 calorie diet.

**) 1 International Unit (IU) of vitamin A=0.3 mcg of all-trans retinol=0.6 mcg of all-trans beta-carotene 1 International Unit (IU) of vitamin D=0.025 mcg of cholecalcipherol I International Unit (IU) of vitamin E=1 mg of all-rac-alpha Tocopherol acetate Table 6) The source and quantity of each vitamin (in the vitamin premix) to be used in the inventive complete<BR> composition. Fine-tuning of vitamins and minerals concentration will be done in the final products. VITAMIN PREMIX* UNIT LABEL FOOD-GRADE SOURCE TO PROCESSING @ CLAIM SOURCE/COMPOUND VITAMIN & STORAGE Q@ UNITS/L CONVERSION OVERDOSE FACTOR FACTOR @ Vitamin A IU 2115 Vitamin A Palmitate 1.9 1.2 Vitamin C mg 25.4 Sodium Ascorbate 1.12 2 Vitamin D IU 422.5 Vitamin D3 (cholecalciferol) 1 1.2 Vitamin E IU 12.7 alpha-tocopheryl acetate 1 1.2 Vitamin K mcg 33.84 Phyiloquinone (phytonadione) 1 1.1 Thiamine mg 0.635 Thiamin monoltrate 1 1.2 Riboflavin mg 1.72 Niacin mg 8.46 Niacinamide 1 1.1 Vitamin B6 mg 0.846 Pyridoxine hydrochloride 1.21 1.2 Folate mcg 169 Folic Acid 1 1.2 Vitamin B12 mcg 3.55 Biotin mcg 127 Biotin 1 1.2 Pantothenic Acid mg 4.23 Calcium Pantothenate 1.09 1.2 1 International Unit (IU) of vitamin A = 0.3 mcg of all-trans retinol = 0.6 mcg of all-trans beta-carotene<BR> 1 International Unit (IU) of vitamin D = 0.025 mcg cholecalciferol<BR> 1 International Unit (IU) of vitamin E - 1 mg of all-rac-alpha Tocopherol acetate<BR> *Riboflavin and Vitamin B12 are generally fully contributed from milk.

Table 7) The source and quantity of each mineral (in the mineral premix) to be used in the inventive standard<BR> nutritional milk composition. Fine-tuning of vitamins and minerals concentration will be done in the final pro MINERALS UNIT Label Contribution LABEL FOOD-GRADE MOL SOURCE TO FREMIX Claim Via mlik* CLAM SOURCE/COMPOUND WT. MINERAL Unit/L Unit/L MINIS CONVERSION CONTRIS. FACTOR VIA MILK UNIT/L Sodium mg 580 580 0 Potassium mg 1400 1400 0 Calcium mg 1177 1177 0 Iron mg 7.6 7.6 Ferrous Sulfate (FeSO4.7 H2O) 278 4.98 Phosphorus mg 951 951 0 Indine mcg 63.45 63.45 Potassium Iodide (KI), anhydrous 166 1.31 Magnesium mg 169 121 48 Magnesium Chloride (MgCl2.6 H2O) 203 8.46 Zinc mg 6.35 6.35 Zinc Sulfate (ZnSO4.1 H2O) 179.44 2.76 Selenium mcg 29.6 29.6 Sodium Solenate (Na2SeO4), anhydrous 188.9 2.4 Copper mg 0.846 0.846 Cupric Sulfate (CuSO4), anhydrous 159.6 2.51 Manganese mg 0.846 0.846 Manganese Sulfate (MnSO4.1 H2O) 169 3.07 Chromium mcg 50.76 50.76 Chromium Chloride [Cr(H2O)4Cl2].2H2O 266.45 5.12 Molyhdenum mcg 31.72 31.72 Sodium Molybdate (Na2MoO4.2 H2O) 241.95 2.52 Chloride mg 1187 1045 142 *) H.E. Swaiagood, Characteristics of edible fluids of animal origin: Milk, In: Food Chemistry, ed: O.R. Fennema, 2nd edition, Dekker, 1985 Table 8) Preparation and Processing Procedure for Example 1A Vitamins & Minerals For Preparation of Fatfree Complete Nutritional Milk Ingredient/Premix Unit Batch (1 Liter) Mineral Premix g 1. 407 0.407MgCl2g Mineral Premix & ; g ; 1. 407 Balance Vitamin Premix; g 1 Batching & Processing Procedure For Fatfree Complete Nutritional Milk BatchPre-BatchingConditionBatchingProcessIngredient/PremixUn it (1Conditions Liter) totalsystemCIPthe Fatfree (skim) milk ml 950 refrigerated Add to the : tank Mineral & Balance Dissolvein25mlRoomMixtouniformity1.407 fatfreemilkPremixTemperature Vitamin 1g Dissolve in 25 ml RoomMix to uniformity milkTemperaturefatfree PATEURIZE& HOMOGENIZE: Heat Heat (e. g., center of85°Cto seconds),for30 andand cool immediatelv.

Table 9) Preparation and Processing Procedure for Example 1B Vitamins & Minerals For Preparation of Fatfree Complete Nutritional Milk Ingredient/Premix Unit Batch (1 Liter) : Mineral Premix g 0.407MgCl2g Mineral Premix & g 1.407 Balance Vitamin Premix; g 1 Batching & Processing Procedure For Fatfree Complete Nutritional Milk Ingredient/Premix Unit Batch Pre-Batching Batching Process ConditionConditions(1Liter) CIP CIP the total system ! Fatfree (with nonfat ml 950 refrigerated Add to the milk solid) milk batching tank Mineral & Balance g 1.407 Dissolve in 25 ml Mix to uniformity PremixRoom Temperature milkfatfree(w/nonfat solid)milk Vitamin Premix Dissolve in 25 ml Mix to uniformity RoomRoom Temperature fatfree (w/nonfat milk solid)milk PASTEURIZE& HOMOGENIZE: centerHeat(e.g., ouf of product to 85 °C seconds),for30 andand cool immediately.

Table 10) Preparation and Processing Procedure for Example 1C Vitamins & Minerals For Preparation of Fatfree Complete Nutritional Milk Ingredient/Premix Unit Batch (1Liter) Mineral 1g MgCl2 g 0.407 Mineral Premix & g 1.407 Balance g1VitaminPremix Batching & Processing Procedure For Fatfree Complete Nutritional Milk Ingredient/Premix Unit Batch Pre-Batching Batching ConditionProcess(1Liter) ! Conditions CIP the total system ! Fatfree (lactose-ml 950 refrigerated Add to the free) milk batching tank mineral & Balance g 1.407 Dissolve in 25 touniformityMix TemperaturePremixRoom fatfree (lactose-free) ............................................................ .............................. Vitamin Premix Dissolvein25mlMixtouniformity1 Room Temperature fatfree(lactose-free) milk PASTEURIZE& HOMOGENIZE: Heat Heat (e. g., center ofto 3085°Cfor ... seconds) and coolimmediately.

Table 11) Preparation and Processing Procedure for Example 1D Vitamins & Minerals For Preparation of Lowfat (1% Fat) Complete Nutritional Milk Ingredient/Premix Unit Batch (liter) Mineral Premix 1 0.407MgCl2g Mineral Premix & 1.407 Balance Vitamin Premix g 1 Batching & Processing Procedure For Lowfat (1% Fat) Complete Nutritional Milk Ingredient/Premix Unit BatchingProcessPre-Batching (1 Liter) Condition Conditions CIP the total system Lowfat (1% fat) milk ml 950 refrigerated Add to the batchingtank Mineral & Balance 1.407 Dissolve in 25 ml Room Mix to uniformity 1%fatPremixTemperature milk Vitamin Premix Dissolve in 25 ml Room Mix to uniformity fatTemperature1% milk i PASTEURIZE & i HOMOGENIZE : Heat Heat (e. g., center of product to 85 °C seconds),for30 andcool immediately.

Table 12) Preparation and Processing Procedure for Example 1E Vitamins & Minerals For Preparation of Lowfat (2% Fat) Complete Nutritional Milk Ingredient/Premix Unit Batch (1 Liter) : Mineral Premix 1 0.407MgCl2g Mineral Premix & g 1.407 Balance g1VitaminPremix Batching & Processing Procedure For Lowfat (2% Fat) Complete Nutritional ............................................................ ............................................................ ............................................................ ... Ingredient/Premix Unit Batch Pre-Batching Batching Process . (1 Liter) Condition Conditions CIP the total ! system Lowfat (2% fat) milk ml 950 refrigerated Add to the .........................................batching tank Mineral & Balance 1. 407 Dissolve in 25 ml Mix to uniformity Premix Room Temperature 2% fatfat milk Vitamin Premix Dissoivein25mlMixtouniformity1 Room @ Temperature 2% ! : faut milk ! : PASTEURIZE & HOMOGENIZE: ; ; ! Heat (e. g., center of of product to 85°C seconds),for30 andcool immediatelv.

Table 13) Preparation and Processing Procedure for Example IF Vitamins & Minerals For Preparation of Fullfat (3.4% Fat) Complete Nutritional Milk Ingredient/Premix Unit Batch (1 Liter) : Mineral1g 0.407MgCl2g Mineral Premix & 1.407 Balance Vitamin1g Batching & Processing Procedure For Fullfat (3.4% Fat) Complete Nutritional Milk Ingredient/Premix UnitBatch ProcessBatching (1 Liter) Condition Conditions CIP the total system ! Fullfat refrigerated Add to the milk ; batching tank Mineral & Balance g 1.407 Dissolve in 25 ml Mix to uniformity Premix Room Temperature ; fullfat milk ; Vitamin 1g Dissolve in 25 ml uniformityto Room Temperature fullfat milk ! PATEURIZE& HOMOGENIZE: Heat (e. g., center of product to 85 °C for 30 seconds), and cool immediately.

Table 14) Preparation and Processing Procedure for Example 2A Vitamins & Minerals For Preparation of Lowfat (1% Fat) Complete Nutritional Milk (Chocolate Flavor) Ingredient/ Unit Batch Premix (1 Liter) Mineral Premix g 1 Flavor) BatchIngredient/Unit Premix (1 Liter) : Minteral Premix 1 0.407MgCl2g Mineral Premix & g 1. 407 Balance ; Vitamin Premix g 1 Batching & Processing Procedure For Lowfat (1% Fat) Complete Nutritional Milk (Chocolate Flavor) Ingredient/ Unit Batch Pre-Batching Batching Process Premix (1 Liter) Condition Conditions CIP the total system i Lowfat (1% fat) ml 950 refrigerated Add to the batching chocolate milk tank Mineral & g 1.407 Dissolve in 25 ml 1% Mix to uniformity Balance Premix fat chocolate milk ; Vitamin Premix 9 Dissolve in 25 ml 1% Mix to uniformity fat chocolate milk ! PASTEURIZE & HOMOGENIZE: Heat Heat (e. g., center of product to 85 °C for and30seconds), coolcool immediately.

Table 15) Preparation and Processing Procedure for Example 2B Vitamins & Minerals For Preparation of Lowfat (1% Fat) Complete Nutritional Milk (Strawberry Flavor) Ingredient/ Unit Batch Premix (1 Liter) Mineral Premix g 1 0.407MgCl2g Mineral Premix g 1.407 Balance Premix (1 Liter) : g1MineralPremix 0.407MgCl2g Mineral Premix & g 1. 407 Balance Vitamin Premix 1 Batching & Processing Procedure For Lowfat (1% Fat) Complete Nutritional Milk (Strawberry ; Flavor) ! Ingredient/Unit Batch Pre-Batching Batching Process Premix (1 Liter) Condition Conditions CIP the system Lowfat (I % fat) ml 950 refrigerated Add to the batching strawberry tank Mineral & g 1.407 Dissolve in 25 ml 1% Mix to uniformity Balance Premix fat strawberry milk ; Vitamin 1Dissolvein25ml1%Mixtouniformityg fat strawberry milk PASTEURIZE& HOMOGENIZE: Heat (e. g., center of ; product to 85 °C for 30 seconds), and ! cool immediately.

Table 16) Preparation and Processing Procedure for Example 2C Vitamins & Minerals For Preparation of Lowfat (1% Fat) Complete Nutritional Milk (VanilaFlavor) BatchIngredient/Unit Premix (1 Liter) 5 Mineral Premix g MgCL g0. 407 Mineral Premix Balance Vitamin Premix 1 Batching & Processing Procedure For Lowfat (1% Fat) Complete Nutritional Milk (VanillaFlavor) Ingredient/Unit Batch Pre-Batching Batching Process Liter)ConditionConditionsPremix(1 CIP the total system ; Lowfat refrigerated Add to the batching vanilla tank Mineral & g 1.407 Dissolve in 25 ml 1% Mix to uniformity Balance Premixfat vanilla milk Vitamin Premix Dissolve in 25 ml 1% Mix to uniformity fat vanilla milk ; PASTEURIZE& HOMOGENIZE: Heat Heat (e. g., center of 85°Cforproductto and30seconds), coolcool immediately.

Table 17) Preparation and Processing Procedure for Example 2D Vitamins & Minerals For Preparation of Lowfat (1% Fat) Complete Nutritional Milk (Banana Flavor) Ingredient/Premix Unit Batch (1Liter) Mineral Premix g 0.407MgCl2g Mineral Premix &: g : 1.407 Balance Vitamin Premix g 1 Batching & Processing Procedure For Lowfat (1% Fat) Complete Nutritional Milk (BananaFlavor) Ingredient/Premix Unit Batch Pre-Batching Batching Process (1 Liter) Condition Conditions CIP the total system Lowfat (1% fat) ml 950 refrigerated Add to the batching banana milk tank Mineral & Balance 1. 407 Dissolve in 25 ml Mix to uniformity Premix 1% fat banana milk ; g1Dissolvein25mlMixtouniformityVitaminPremix 1% fat banana milk PASTEURIZE& HOMOGENIZE: Heat (e. g.. center of product to 85'C for and30seconds), ! cool immediately.

Table 18) Preparation and Processing Procedure for Example 3A Vitamins & Minerals For Preparation of Complete Nutritional light Vanilla Ice Cream BatchIngredient/Unit Comments Liter)Premix(1 Mineral Premix g 2 Since the serving size of ice cream/frozen dessert is 0.8141/2cup,wehavedoubledtheamountofaddedMgCl2g MgCl2 g 0.814 minerals(comparedtonutritionalvitaminsand ordertohavesimilarD.V.valuein1/2cupmilks),in Mineral Premix g 2.814 serving Balance : serving of product. Vitamin Premix g. 2 Batching & Processing Procedure For Complete Nutritional light Vanilla Ice Cream Ingredient/Unit Batch Pre-Batching Batching Process Premix (I Liter) Condition Conditions CIP the total svstem Half & Half ml 500 refrigerated Place in the batching (10% fat) tank Fullfat Milk ml 250refrigerated Add to the batching tank (3.4%fat) 185AddtothebatchingtankSugarg Vanilla extract. ml. 5. Add to the batching tank Mineral & g 2.814 Dissolve in 50 ml Room Mix to uniformity/Add to Balance Premix Temperature fullfat batch milk Vitamin Premix g 2 Dissolve in 50 ml Room Mix to uniformity/Add to Temperature fullfat batch milk -Mix all ingredients to uniformity -Pasteurize mix (85°C./30 sec.) -Pour mixture into freezer Cuisinart#Frozenbowelof Yogurt-Ice Cream&Sorbet Maker -Run the machine until Mixture thicken (About 25 minutes) -Transfer ice cream to an airtight container and place in freezer until firm (2hrs.) Table 19) Preparation and Processing Procedure for Example 3B Vitamins & Minerals For Preparation of Complete Nutritional Fat-Free, Lactose-Free Chocolate Fudgesicle Ice Cream BatchIngredient/PremixUnit Comments (1 Liter) Mineral Premix g 2 Since the serving size of ice cream/frozen dessert is wehavedouble1/2cup, the amount of added 0.814MgCl2g vitamins (comparedtonutritionalminerals milks), in order to have similar D.V. value cup1/2 Mineral Premix & g 2.814 servingof product. Balance Vitamin Premix g 2 Batching & Processing Procedure For Complete Nutritional Fat-Free, Lactose-Free Chocolate Fudgesicle Ice Cream BatchPre-BatchingBatchingProcessConditionsIngredient/PremixU nit (1Conditions Liter) CIP the total system : 100% Fat-Free, ml 800 refrigerated Ptace in the batching tank Lactose-Free Milk Chocolate Pudding g 176 Add to the batching tank ............................................................ ............................................................ ............................................................ ......... Vanilla extract ml 2 Add to the batching tank Mineral & Balance g 2. 814 Dissolve in 50 ml Mix to uniformity/Add to TemperaturebatchPremixRoom FF/LFmilk Vitamin Premix 9 2 Dissolve in 50 ml Mix to uniformity/Add to batchRoomTemperature FF/LFmilk -Mix all ingredients to uniformity -Pasteurize mix (85°C./30 sec.) -Pour mixture into freezer bowel of Cuisinart@ Frozen Yogurt-Ice Cream&Sorbet Maker -Run the machine until Mixture thicken (about 25 minutes) -Transfer ice cream to an airtight container and place in freezer inti) firm (2-4 hrs.) Table 20) Preparation and Processing Procedure for Example 3C Vitamins & Minerals For Preparation of Complete Nutritional lowfat Peach Frozen Yogurt BatchIngredient/PremixUnit Comments (1Liter) Mineral Premix 2 Since the serving size of ice cream/frozen dessert is 1/2 havedoubledtheamountofaddedvitaminsandcup,we MgCl2 g 0.814 tonutritionalmilks),inordertohaveminerals(compared Mineral Premix & g 2.814 similar D.V. value in 1/2 cup serving of product. Balance Vitamin Premix g 2 Batching & Processing Procedure For Complete Nutritional lowfat Peach Frozen Yogurt Ingredient/Premix Unit Batch Pre-Batching Condition Batching Process (1 Liter) Conditions .. CIP the total system Lowfat (2°0) vanilla g 400. refrigerated Placeinthebatchingtank yogurt Minced canned peach g 425 refrigerated Add to the batching tank Sugar g 75 Add to the batching tank Mineral & Balance 9 1.407 Dissolve in 50 ml 2% Mix to uniformity/Add to Premix vanilla yogurt batch Vitamin Premix 9 Dissolve in 50 ml 2% Mix to uniformity/Add to vanilla yogurt batch Blend the mix to uniformity -Pour mixture into freezer bowel of CuisinartX Frozen Yogurt-Ice Cream&Sorbet Maker -Run the machine until Mixture thicken (about 25 minutes) -Transfer ice cream to an airtight container and place in freezer until firm (2hrs.) Table 21) Preparation and Processing Procedure for Example 4A Vitamins & Minerals For Preparation of Fatfree (Nonfat or Skim) Complete Nutritional Vanilla Yogurt Ingredient/Unit Batch Comments Premix (1 Liter) Mineral Premix g We initially assume the same profile and concentration -4 of vitamins and minerals as milk. Fine tuning of concentration of vitamins and minerals must be done ofuponanalysis the final products due to factors such Mineral Premix & g 1.407 as micronutrientsbybacterialcultureof Balance oftheproduct.andacidity Vitamin Premix g Batching & Processing Procedure For Fatfree (Nonfat or Skim) Complete Nutritional VanillaYogurt Ingredient/Unit Batch Pre-Batching Condition Batching Process Liter)ConditionsPremix(1 . CIP the total system Fatfree (skim) m) 785 Refrigerated Add to the batching milk tank 10AddtothebatchingPrebioticg ingredient (e.g., tank Fructo- oligosaccharides Radtilose#P95) Vanilla extract g 5 Add to the batching tank Mineral & g 1.407 Dissolve in 50 ml fatfree Mix to Balance Premix milk uniformity/Add to batch Vitamin Premix Dissolve in 50 ml fatfree Mix to milk uniformity/Add to batch Pasteurize (85°C for 30 seconds), cool slowly. Bacterial culture g 100 Stir to uniformity, room Add when the batch is (skim yogurt temperature still warm (55°C), containing L. Store at 27°C for 12 acidophilus) rs, refrigerate afterwards.

Table 22) Preparation and Processing Procedure for Example 4B Vitamins & Minerals For Preparation of 1% Fat Complete Nutritional Strawberry (Fruit on FOB)Yogurt= Ingredient/Unit Batch Comments Premix. (1 Liter). Mineral Premix. g I We initially assume the same profile and concentration of vitamins and minerals as milk. MgCl2 g 0.407 ofconcentrationofvitaminsandFinetuning minerals must be done upon analysis of the final &g1.407MineralPremix tofactorssuchasconsumptionofproductsdue Balance bacterialcultureandacidityofmicronutrientsby theproduct. g1VitaminPremix Batching & Processing Procedure For 1% Fat Complete Nutritional Strawberry (Fruit =FOB)YogurtonBottom Ingredient/Unit Batch Pre-Batching Batching Process Liter)ConditionConditionsPremix(1 totalsystemCIPthe fat)ml800RefrigeratedAddtothebatchingtankMilk(1% Mineral 407 Dissolve in 50 ml Mix to uniformity/Add milktobatchPremixfat Vitamin Premix g 1 Dissolve in 50 ml 1% Mix to uniformity/Add tobatchfatmilk Pasteurize (85° C for 30 slowly.seconds),cool Bacterial culture g. 100 Stir to uniformity, Add when the batch is (skim yogurt room temperature still warm (55°C), Pour batch gently oftop containing L. Acidophilus)Acidophilus)the Preserve (FOB), 37°Cfor12hrs,Storeat Strawberry g 60 refrigerate afterwards. Preserve Table 23) Preparation and Processing Procedure for Example 4C Vitamins & Minerals For Preparation of 2% Fat Complete Nutritional Raspberry (Fruit on Bottom = FOB) Yogurt BatchCommentsIngredient/Unit Liter)Premix(1 Mineral Premix g. I We initially assume the same profile and concentration of vitamins and minerals as milk. Fine tuning of concentration of vitamins and minerals must be done upon analysis of the final products due due factors factors such consumption consumption micronutrients by bacterial culture and acidity of the product. Vitamin Premix g 1 Dissolve in 50ml 2% Mix to uniformity/Add Batching & Processing Procedure For 2% Fat Complete Nutritional Raspberry (Fruit on Bottom = FOB) Yogurt Ingredient/Unit Batch Pre-Batching Batching Process Premix. (1 Liter) Condition Conditions CIP the total system Milk (2% fat) ml 800 Refrigerated Add to the batching tank Mineral & Balance g 1.407 Dissolve in 50 ml 2% Mix to uniformity/Add Premix fat milk to batch Vitamin Premix g ! Disso) ve in 50 ml 2% Mix to uniformity/Add fat milk to batch . Pasteurize (85°C for 30 slowly.seconds),cool Bacterial culture g 100 Stir to uniformity, room Add when the batch is temperature still warm (55°C). Pour containing L. batch gently on top of the Preserve (FOB), Acidophilus) 37°Cfor12hrs,Storeat Raspberry g 60 refrigerateafterwards. Preserve Table 24) Preparation and Processing Procedure for Example 4D Vitamins & Minerals For Preparation ofFull Fat Complete Nutritional Organic Yogurt Ingredient/Unit Batch Comments Liter)Premix(1 Mineral Premix g 1 We initially assume the same profile and concentrationconcentrationof vitamins and minerals as MgCl2 g 0.407 tuningofconcentrationofmilk.Fine mineralsmustvitaminsand be done upon Mineral Premix & g 1.407 analysis of the final products due to factors Balance consumptionofmicronutrientsbysuchas bacterial culture and acidity of the product. Vitamin Premix g 1 Batching & Processing Procedure For Full Fat Complete Nutritional Organic Yogurt Ingredient/Unit Batch Pre-Batching Batching Process Premix (1 Liter) Condition Conditions CIP the total system Fullfat Organic ml 800 Refrigerated Add to the batching Milk(3.4%) tank Mineral & Balance g 1.407 Dissolve in 50 ml Mix to Premix fullfat organic milk uniformity/Add to batch Vitamin Premix g 1 Dissolve in 50 ml Mix to fullfat organic milk uniformity/Add to batch Pasteurize985°C for 30 seconds), cool slowly, Culture with g 100 Mix to uniformity, Add when the batch Probiotic bacteria room temperature is still warm (e. g., bifidobacter): (55°C), Store at Fullfat organic 37°C for 12 hrs, yogurt(S. refrigerate Thermophilus, L. afterwards. Bulgaricus, L. Acidophilus, Bifidus, L. Casei, L. Reuteri) Table 25) The source and quantity of each vitamin (in the vitamin premix) to be used in the inventive standard complete nutrition@ SOURCE TO VITAMIN PROCESSING & LABEL CLAIM FOOD-GRADE CONVERSION STORAGE @ VITAMIN PREMIX UNIT UNITS/LITER SOURCE/COMPOUND FACTOR OVERDOSE SO Vitamin A: (75% As Vitamin A) IU 3966 Vitamin A Palmitate 1.9 1.2 (25% As Beta mcg 794 Beta Carotene 1 1.1 Carotene) Vitamin C mg 127 Sodium Ascorbate 1.12 2 Vitamin D IU 423 Vitamin D3 (cholecalciferol) 1 1.2 Vitamin B IU 32 alpha-tocopheryl acetate 1 1.2 Vitamin K mcg 85 Phylioquinone (phytonadione) 1 1.1 Thiamine mg 1.6 Thiamin monoitrate 1 1.2 Riboflavin mg 1.3 Riboflavin 1 1.2 Niacin mg 21.2 Niacinamide 1 1.1 Vitamin B6 mg 2.2 Pyridoxine hydrochloride 1.21 1.2 Folate mcg 423 Folic Acid 1 1.2 Vitamin B12 mcg 6.4 Cyanocobalamin 1 1.2 Biotin mcg 318 Biotin 1 1.2 Pantothenic Acid mg 10.6 Calcium Pantothenate 1.09 1.2 1 International Unit (IU) of vitamin A = 0.3 mcg of all-trans retinol = 0.6 mcg of all-trans beta-carotene<BR> 1 International Unit (IU) of vitamin D = 0.025 mcg cholecalciferol<BR> 1 International Unit (IU) of vitamin E = 1 mg of all-rac-alpha Tocopherol acetae<BR> Vitamin A Palmitate (Retinol Palmitate) M.W. = (286.4+256.4 = 542.8). Theoretically, the Conversion Factor for Vitamin A Palmitate to Vitamin A is 542.8/@<BR> (Retinol), 1 IU = 0.3 mcg, or, 3.3 IU/mcg, or, 3.3 million IU/g. Commercial Vitamin A Palmitate comes in 1.7 million IU/gram, or, 1.7 IU/mcg, Therefore, @<BR> Vitamin A to the commercial Vitamin A Palmitate is 3.3/1.7 = 1.9 Table 26) The source and quantity of each mineral (in ther mineral premix) to be used in the inventive standard complete nu<BR> composition. SOURCE TO EXAC MINERAL REQUI@ LABEL CLAIM MOL. WT. CONVERSION QUANTI@ MINERAIS UNIT UNITS/LITER FOOD-GRADE FACTOR SOURCE/CO@ PREMIX SOURCE/COMPOUND Sodium Potassium Calcium Iron mg 19 Ferrous Sulfats (FeSO4.7 H2O) 278 4.98 94.6 Phosphorus -0- Iodine mcg 159 Potassium Iodide (KI), anhydrous 166 1.31 208.2 Magnesium -0- Zinc mg 15.9 Zinc Sulfate (ZnSO4.1 H2O) 179.44 2.76 43.88 Selenium mcg 74 Sodium Selenate (Na2SeO4), 188.9 2.4 177@ anhydrous Copper mg 2.12 Cupric Sulfate (CuSO4), anhydrous 159.6 2.51 5.321 Manganese mg 2.12 Manganese Sulfate (MnSO4.1 H2O), 169 3.07 6.50@ anhydrous Chromium mcg 127 Chromium Chloride [Cr(H2O)4Cl2] 266.45 5.12 650.@ 2H2O Molybdenum mcg 79.4 Sodium Molybdate (Na2MoO4.2 241.95 2.52 200.0 H2O) Chloride Table 27) The Nutrition Facts and Ingredients used for the preparation of the inventive refrigerated ready-to-drink (RTD) pasteurized and/or ultra-pasteurized standard nutritional composition (Vanilla Flavor): Nutrition Facts Ingredients Serving Size: 8 fl oz. Water Amount per Serving Corn Syrup solids Calories 250 Calories from Fat 47 Sugar (sucrose) CalciumCaseinate%DailyValue* Total Fat 5. 2 g 8% Canola Oil Saturated Fat 0. 5 g 3% Milk Protein Concentrate Cholesterol Smg 2% Natural & Artificial Flavor Sodium 140 mg 6% Isolated Soy Proteins Potassium 400 mg I 1% Corn Oil Total Carbohydrate 40.8 g 14% Potassium Phosphates Dietary Fiber 0 g 0% Magnesium Chloride Sugars 8.5 g Soy Lecithin Protein 20%CalciumCitrateg Vitamin A. 25% Sodium Chloride (25% as Beta Carotene) Sodium Phosphate Vitamin C 50% Sodium Ascorbate Calcium 50% Carrageenan Iron 25% Ferrous Sulfate VitaminZinc Sulfate Vitamin E 50% Vitamin E (alpha-tocopheryl acetate) Vitamin K 25% Niacinamide Thiamine 25% Calcium Pantothenate Riboflavin 25% Maganese Sulfate Niacin 25% Copper Sulfate Vitamin B6 25% Vitamin A Paimitate Folate 25% Pyridoxine hydrochloride Vitamin B12 25% Vitamin B2 (Riboflavin) Biotin 25% Vitamin B1 (Thiamin monoitrate) Pantothenic Acid 25% Beta Carotene Phosphorus 25% Chromium Chloride Iodine 25% Folic Acid Magnesium 25% Biotin Zinc 25% Potassium Iodide Selenium 25% Sodium Molvbdate Copper 25% Sodium Selenate Manganese 25% Vitamin KI (Phytonadione) Chromium 25% Vitamin D3 (Cholecalciferol) Moivbdenum 25% Vitamin B12 (Cyanocobalamin) Chloride2% *) Percent Daily Values are based on a 2.000 calorie diet.

Table 28) The Nutrition Facts and Ingredients used for the preparation of the inventive refrigerated ready-to-drink (RTD) pasteurized and/or ultra-pasteurized light/low-fat nutritional composition (Vanilla Flavor) Nutrition Facts Ingredients Serving Size: 8 fl oz. Water Amount per Servine Corn Syrup solids Calories 200 Calories from Fat 17 Calcium Caseinate % Daily Value'Sugar (sucrose) Total Fat 1.9 g 3% Milk Protein Concentrate Saturated Fat 0. I g I % Natural & Artificial Flavor Cholesterol I mg 1% Canola Oil Sodium 140 mg 6% Isolated Soy Proteins Potassium 400 mg 11% Potassium Phosphates Total Carbohydrate 36.8 g 12% Magnesium Chloride Dietary Fiber 0 e 0% Corn Oil Sugars 7.5 g Calcium Citrate Protein 10 g 20% Sodium Chloride Vitamin A. 25% Soy Lecithin (25% as Beta Carotene) Sodium Phosphate Vitamin C 50% Sodium Ascorbate Calcium 50% Carrageenan Iron 25% Ferrous Sulfate Vitamin D 25% Zinc Sulfate Vitamin E 50% Vitamin E (alpha-tocopheryl acetate) Vitamin K 25% Niacinamide Thiamine 25% Calcium Pantothenate Riboflavin 25% Maganese Sulfate Niacin 25% Copper Sulfate Vitamin B6 25% Vitamin A Palmitate Folate 25% Pyridoxine hydrochloride Vitamin B 12 25% Vitamin B2 (Riboflavin) Biotin 25% Vitamin B I (Thiamin monoitrate) Pantothenic Acid 25% Beta Carotene Phosphorus 25% Chromium Chloride Iodine 25% Folic Acid Magnesium 25% Biotin Zinc 25% Potassium Iodide Selenium 25% Sodium Molybdate Copper 25% Sodium Selenate Manganese 25% Vitamin K) (Phytonadione) Chromium 25% Vitamin D3 (Cholecalciferol) Molvbdenum 25% Vitamin B12 (Cyanocobalamin) Chloride 12% *) Percent Daily Values are based on a 2, 000 calorie diet.

Table 29) The Nutrition Facts and Ingredients used for the preparation of the inventive refrigerated ready-to-drink (RTD) pasteurized and/or ultra-pasteurized fat free nutritional composition (Vanilla Flavor) Nutrition Facts Ingredients Serving Size: 8 fl oz. Water Amount per Serving Corn Syrup solids Calories 180 Calories from Fat 0 Calcium Caseinate Sugar(sucrose)%DailyValue* Total Fat 0 g 0% Milk Protein Concentrate Saturatedg0%CanolOil0 Cholesterol 0 mg 0% Natural & Artificial Flavor Sodium 140 mg 6% Isolated Soy Proteins Potassium 400 mg 11% Potassium Phosphates Totalg12%MagnesiumChloride35 Dietary Fiber 0 g 0% Catcium Citrate Sugars 7.1 g Sodium Chloride Protein 10 g 20% Sodium Phosphate Vitamin A. 25% Sodium Ascorbate (25% as Beta Carotene) Carrageenan Vitamin C 50% Ferrous Sulfate Calcium 50% Zinc Sulfate Iron 25% Vitamin E (alpha-tocopheryl acetate) Vitamin D 25% Niacinamide Vitamin E 50% Calcium Pantothenate Vitamin K 25% Maganese Sulfate Thiamine 25% Copper Sulfate Riboflavin 25% Vitamin A Palmitate Niacin 25% Pyridoxine hydrochloride Vitamin B6 25% Vitamin B2 (Riboflavin) Folate 25% Vitamin BI (Thiamin monoitrate) Vitamin B12 25% Beta Carotene Biotin 25% Chromium Chloride 25%FolicAcidPantothenicAcid Phosphorus 25% Biotin Iodine 25% Potassium lodide Magnesium 25% Sodium Molybdate Zinc 25% Sodium Selenate) Selenium 25% Vitamin K (Phvtonadione Copper 25% Vitamin D3 (Cholecalciferol) Manganese 25% Vitamin B12 (Cvanocobalamin) Chromium 25% Molvbdenum 25% Chloride 12% *) Percent Daily Values are based on a 2.000 calorie diet.

Table 30) The Nutrition Facts and Ingredients used for the preparation of the inventive refrigerated ready-to-drink (RTD) pasteurized and/or ultra-pasteurized high protein nutritional composition (Vanilla Flavor) Nutrition Facts Ingredients Serving Size: 8 fl oz. Water Amount per Serving Com Syrup solids Calories 225 Calories from Fat 47 Calcium Caseinate % Dailv Value* Sugar (sucrose) Total Fat 5. 2 g 8% Milk Protein Concentrate Saturated Fat 0. 5 g 3% Natural & Artificial Flavor Cholesterol 5 mg 2% Isolated Soy Proteins Sodium 120 mg 5% Potassium Phosphates Potassium 290 mg 8% Magnesium Chloride Total Carbohydrate 29.3 g 10% Calcium Citrate Dietary Fiber 0 g 0% Sodium Chloride Sugars 8.5 g Sodium Phosphate Protein 15 g 30% Sodium Ascorbate Vitamin A. 25% Carrageenan (25% as Beta Carotene) Ferrous Sulfate Vitamin C 50% Zinc Sulfate Calcium 50% Vitamin E (alpha-tocopheryl acetate) Iron 25% Niacinamide Vitamin D 25% Calcium Pantothenate Vitamin E 50% Maganese Sulfate Vitamin K 25% Copper Sulfate Thiamine 25% Vitamin A Palmitate Riboflavin 25% Pyridoxine hydrochloride Niacin 25% Vitamin B2 (Riboflavin) Vitamin B6 25% Vitamin B I (Thiamin monoitrate) Folate 25% Beta Carotene Vitamin B12 25% Chromium Chloride Biotin 25% Folic Acid Pantothenic Acid 25% Biotin Phosphorus 25% Potassium Iodide Iodine 25% Sodium Molvbdate Magnesium 25% Sodium Selenate Zinc 25% Vitamin (Phytonadione) Selenium 25% Vitamin D3 (Cholecalciferol) Copper 25% Vitamin B12 (Cvanocobalamin) Manganese 25% Chromium 25% Molvbdenum 25% Chloride"% *) Percent Daily Values are based on a 2,000 calorie diet.

Table 31) The Nutrition Facts and Ingredients used for the preparation of the inventive refrigerated ready-to-drink (RTD) pasteurized and/or ultra-pasteurized plus nutritional composition (Vanilla Flavor) Nutrition Ingredients Serving Size: 8 fl oz. Water Amount per Serving Corn Syrup solids Calories 350 Calories from Fat 66 Sugar (sucrose) % Daily Value* Calcium Caseinate TotalFat 7. 3 g 1 I% Canola Oil Saturated Fat 0.7 g 4% Milk Protein Concentrate Cholesterol 7 mg 2% Natural & Artificial Flavor Sodium 200 mg 8% Isolated Soy Proteins Potassium 640 mg 18% Corn Oil Total Carbohydrate 57.1 g 19% Potassium Phosphates Dietary Fiber 0 g 0% Magnesium Chloride Sugars 10.6 g Soy Lecithin Protein 14 g 28% Calcium Citrate Vitamin A. 35% Sodium Chloride (25% as Beta Carotene) Sodium Phosphate Vitamin C 70% Sodium Ascorbate Calcium 70% Carrageenan Iron 35% Ferrous Sulfate Vitamin D 35% Zinc Sulfate Vitamin E 70% Vitamin E (alpha-tocopheryl acetate) Vitamin K 35% Niacinamide Thiamine 35% Calcium Pantothenate Riboflavin 35% Maganese Sulfate Niacin 35% Copper Sulfate Vitamin B6 35% Vitamin A Palmitate Folate 35% Pyridoxine hydrochloride Vitamin B12 35% Vitamin B2 (Riboflavin) Biotin 35% Vitamin B1 (Thiamin monoitrate) Pantothenic Acid 35% Beta Carotene Phosphorus 35% Chromium Chloride Iodine 35% Folic Acid Magnesium 35% Biotin Zinc 35% Potassium lodide Selenium 35% Sodium Molybdate Copper 35% Sodium Selenate Manganese 35% Vitamin K1 (Phytonadione) Chromium 35% Vitamin D3 (Cholecalciferol) Molybdenum 35% Vitamin B12 (Cyanocobalamin) Chloride 17% *) Percent Daily Values are based on a 2,000 calorie diet.

Table 32) The Nutrition Facts and Ingredients used for the preparation of the inventive refrigerated ready-to-drink (RTD) pasteurized and/or ultra-pasteurized with fiber nutritional composition (Vanilla Flavor) Nutrition Facts Ingredients Serving Size: 8 fl oz. Water Amount per Serving Corn Syrup solids Calories 250 Calories from Fat 47 Sugar (sucrose) % Daily Value'Calcium Caseinate Total Fat 5. 2 g 8% Canola Oil Saturated Fat 0.5 g 3% Oat Fiber Cholesterol 5 mg 2% Milk Protein Concentrate Sodium 140 mg 6% Natural & Artificial Flavor Potassium 400 mg 11% Isolated Soy Proteins Total Carbohvdrate 43. 3 g 14% Com Oil Dietary Fiber 2.5 g 10% Potassium Phosphates Sugars 8. 5 g Magnesium Chloride Protein 10 g 20% Soy Lecithin Vitamin A, 25% Calcium Citrate (25% as Beta Carotene) Sodium Chloride Vitamin C 50% Sodium Phosphate Calcium 50% Sodium Ascorbate Iron 25% Carrageenan Vitamin D 25% Ferrous Sulfate Vitamin E 50% Zinc Sulfate Vitamin K 25% Vitamin E (alpha-tocophervl acetate) Thiamine 25% Niacinamide Riboflavin 25% Calcium Pantothenate Niacin 25% Maganese Sulfate Vitamin B6 25% Copper Sulfate Folate 25% Vitamin A Palmitate Vitamin B12 25% Pyridoxine hydrochioride Biotin 25% Vitamin B2 (Riboflavin) Pantothenic Acid 25% Vitamin B I (Thiamin monoitrate) Phosphorus 25% Beta Carotene Iodine 25% Chromium Chloride Magnesium 25% Folic Acid Zinc 25% Biotin Selenium 25% Potassium lodide Copper 25% Sodium Molybdate Manganese 25% Sodium Selenate Chromium 25% Vitamin K) (Phytonadione) Molybdenum 25% Vitamin D3 (Cholecalciferol) Chloride 12% Vitamin B12 (Cvanocobalamin) *) Percent Daily Values are based on a 2,000 calorie diet.

Table 33) The Nutrition Facts and Ingredients used for the preparation of the inventive refrigerated ready-to-drink (RTD) pasteurized and/or ultra-pasteurized standard nutritional composition (Vanilla Flavor), using lactose-free milk as the base. Nutrition Facts Ingredients Serving Size : 8 fl oz. Lactose-Free Skim Milk Amount per Serving Corn Syrup solids Calories 250 Calories from Fat 47 Canola Oil % Daily Value* Sugar (sucrose) TotalFat 5. 2 g 8% Natural & Artificial Flavor Saturated Fat 0.5 g 3% Calcium Caseinate Cholesterol 5 mg 2% Isolated Soy Proteins Sodium 140 mg 6% Corn Oil Potassium 400 mg 11% Potassium Phosphates Total Carbohydrate 43.3 g 14% Calcium Citrate Dietary Fiber 2.5 g O% Magnesium Chloride Sugars 8.5 g Soy Lecithin Protein 10 g 20% Sodium Chloride Vitamin A. 25% Sodium Phosphate (25% as Beta Carotene) Sodium Ascorbate Vitamin C 50% Carrageenan Calcium 50% Ferrous Sulfate IronIron25% Zinc Sulfate Vitamin Vitamin25% E (alpha-tocopheryl acetate) Vitamin E 50% Niacinamide Vitamin K 25% Calcium Pantothenate Thiamine 25% Maganese Sulfate Riboflavin 25% Copper Sulfate Niacin 25% Vitamin A Palmitate Vitamin B6 25% Pvridoxine hvdrochloride Folate 25% Vitamin B2 (Riboflavin) Vitamin B 12 25% Vitamin B I (Thiamin monoitrate) Biotin 25% Beta Carotene Pantothenic Acid 25% Chromium Chloride Phosphorus 25% Folic Acid Iodine 25% Biotin Magnesium 25% Potassium Iodide Zinc 25% Sodium Molvbdate Selenium 25% Sodium Selenate Copper 25% Vitamin K1 (Phytonadione) Manganese 25% Vitamin D3 (Cholecalciferol) Chromium 25% Vitamin B12 (Cyanocobalamin) Molybdenum 25% Chloride 12% *) Percent Daily Values are based on a 2,000 calorie diet.

Table 34) The Nutrition Facts and Ingredients used for the preparation of the inventive refrigerated ready-to-drink (RTD) pasteurized and/or ultra-pasteurized standard nutritional composition with improved flavor (Chocolate Flavor) Nutrition Facts Ingredients Serving Size: 8 fl oz. Water Amount per Serving Com Syrup solids Calories 170 Calories from Fat 20 Calcium Caseinate % Daily Value* Sugar (sucrose) Total Fat 1. 9 g 3% Milk Protein Concentrate Saturated Fat 1.4 g 7% Natural & Artificial Flavor Cholesterol9mg 3% Canola Oil Sodium 190 mg 8% Isolated Soy Proteins Potassium 350 mg 10% Potassium Phosphates Total Carbohydrate 30 g 10% Magnesium Chloride Dietarv Fiber 0 g O% Com Oil Sugars 30 g Calcium Citrate Protein 8 g 16% Sodium Chloride Vitamin A. 10% Soy Lecithin (25% as Beta Carotene) Sodium Phosphate Vitamin C 10% Sodium Ascorbate Calcium 25% Carrageenan Iron 10% Ferrous Sulfate Vitamin D 25% Zinc Sulfate Vitamin E 10% Vitamin E (alpha-tocopheryl acetate) Vitamin K 10% Niacinamide Thiamine 10% Calcium Pantothenate Riboflavin 10% Maeanese Sulfate Niacin 10% Copper Sulfate Vitamin B6 10% Vitamin A Palmitate Folate 10% Pyridoxine hydrochloride Vitamin B12 10% Vitamin B2 (Riboflavin) Biotin 10% Vitamin B I (Thiamin monoitrate) Pantothenic Acid 10% Beta Carotene Phosphorus 25% Chromium Chloride Iodine 10% Folic Acid Magnesium 10% Biotin Zinc 10% Potassium Iodide Selenium 10% Sodium Molybdate Copper 10% Sodium Selenate Manganese 10% Vitamin K) (Phytonadione) Chromium 10% Vitamin D3 (Cholecalciferol) VitaminB12(Cyanocobalamin)Molybdenum10% Chloride *) Percent Daily Values are based on a 2,000 calorie diet.