Functional Ingredient Focus

Vitamin & Mineral Fortification
by Brooke K. Deets

The mandatory fortification of grain products to help reduce the incidence of the neural tube defect spina bifida has set the groundwork for the functional food and beverage market. Although adding the basics to various food products still is quite popular, more food manufacturers are opting to incorporate customized or specialty blends, such as an antioxidant formula or a blend targeting cardiovascular health. The expertise and many different blends, services and options premix suppliers offer make the possibilities for food and beverage fortification almost endless, though rules and regulations may complicate things, particularly if formulating a product to be sold overseas.

There are two basic purposes for supplemental vitamin and mineral fortification, according to Dave Pfefer, general sales manager of ADMs Specialty Ingredients Division. The first is to restore the potency of vitamins and minerals lost during processing and manufacturing. Milling, extrusion, cooking and chemical processing of foods can adversely affect their nutritional properties, Pfefer said. The second reason is to boost the foods nutritional value and desirability. Such items such as meal replacement bars, sports beverages, weight gain powders and the like are often fortified or super fortified to pack as much wallop into them as possible.

In January of 1998, the Food and Drug Administration (FDA) began requiring most grain products, including most enriched breads, flours, rice, pasta and many breakfast cereals, to be fortified with folic acid to reduce the incidence of spina bifida, a birth defect that has been associated with low levels of folic acid. According to FDA, these foods were chosen for fortification because they are staple products for most of the U.S. population and because they have a long history of being successful vehicles for improving nutrition to reduce the risk of classic nutrient deficiency diseases. And fortification of such foods has made a difference in reducing neural tube defects (NTD), according to a recent study conducted by researchers from St. Lukes Roosevelt Hospital Center at Columbia University in New York.¹ The introduction of folic acid fortification has produced a profound decrease in the number of high MSAFP values [MSAFP is a prenatal blood test performed in the second trimester to screen for birth defects, including spina bifida; researchers found the risk for having a NTD-affected fetus was approximately 4.5 percent for an MSAFP value above 2.5 MoM], reflective of a decreased incidence of neural tube defects, wrote the researchers. Folic acid fortified breakfast cereal has also been shown to increase plasma vitamin B concentrations and decrease homocysteine concentrations.²

Fortification Challenges

Before fortifying a food or beverage, there are regulatory issues that must be considered. For example, FDAs fortification policy should be considered, as should restricted uses in the Code of Federal Regulations (CFR) for certain vitamins and/or minerals, and whether an ingredient is GRAS (generally recognized as safe) and for which foods they have gotten this approval, according to Diane Hnat, senior marketing manager, food industry unit, North America, for DSM Nutritional Products Inc. Where the finished product will be sold must also be taken into consideration, as there are some nutrients that may not be allowed for the intended purpose in the country the item will be sold in, according to Max Motyka, director of the Human Products Division at Albion Advanced Nutrition in St. Clair Shores, Mich. In addition, there are different laws for different foods. By way of example, you can only fortify milk with vitamins A and D in product for sale in the United States. Levels of nutrients allowed can vary as well, Motyka said.

The challenges of adding vitamins and/or minerals to foods and beverages can be seen from two different perspectives, although they go hand-in-hand: the view of the fortfificant (or fortifier) and the view of the finished product. The challenges encountered involve formulating a vitamin/mineral premix that will deliver its required potency after the food has been processed and on into its maximum shelf life while still tasting good, Pfefer said. Alice Wilkinson, director of R&D, Nutritional Ingredients, Watson Foods Co. agreed, and added another challenge is making sure the premix will meet the goal for the required label claim.

In terms of finished product, the nutrients shelf life and the corresponding rate of nutrient degradation are important factors to consider when deciding how to fortify a food or beverage. Nutrient potency and bioavailability can be diminished if and when the finished product is exposed to heat, light, oxygen and degradative packaging. This, in turn, often requires more of the nutrient premix to be added to the finished product, or, higher concentrations of the nutrients to be added; this is called overage. Accounting for overages is like solving a complicated math problem--it involves many calculations and oftentimes trial and error. Fortunately, most premix suppliers know how much a certain material will degrade under various manufacturing processes, which they take into account when figuring the correct overages for a product. The more that is able to be shared about ingredient composition, as well as processing, packaging, storage and ultimately whether the food is ready-to-eat or must be further cooked will be useful information in building in the correct overages to last throughout the foods shelf life, Hnat said. Fortifying beverages brings with it additional challenges, including nutrient solubility and cross reactivity among nutrients, according to Bill Downs, president of Allied Nutraceutical Ingredients, the exclusive distributor of Sierra Mountain Minerals bulk sales.

Some nutrients are also more difficult to formulate with because of the potency or quantity of the desired nutrient. For example, the daily value for calcium is 1,000 mg, so offering 10 percent of the daily value requires 100 mg of calcium. The most concentrated source of calcium is calcium carbonate (which may or may not be the appropriate source for the product being fortified) and calcium carbonate is only 40-percent calcium, calculating into a 250 mg use rate for this single nutrient, Wilkinson said. Some applications will not allow for high usage rates, which makes balancing the formulations difficult. Large quantities of the nutrient may also be more than a single serving of the food can bear, both from the taste and texture perspective, according to Hnat.

Another area of challenge involves the selection of the food fortificant, according to Motyka, who suggests the manufacturer should consider the following criteria when selecting the fortificant/fortifier: good bioavailability during the normal shelf life of the product; no interaction with flavor or color systems; affordable cost; acceptable color, solubility and particle size; if the fortificant is bioavailable in the face of the food or beverage systems components (phytates in corn, for example, can block inorganic mineral absorption); palatability; and micronutrient interaction.

The choice between natural or synthetic vitamins and minerals may also be raised during preliminary fortification research. There arent many commercially feasible or cost-effective natural-source vitamins, Hnat said, which is why most vitamins used in the industry are of the synthetic variety due to their lower costs. Many minerals are also considered synthetic for the most part, as the raw materials are mined and then chemically reacted to create different compounds, according to Wilkinson. Vitamin C is an exception in that a natural form (typically derived from acerola cherry or rose hips) is available. The natural forms are difficult to standardize and are less stable than their synthetic counterparts. Add this to the increase in cost and they are not commonly used ingredients, Wilkinson said. Natural forms of vitamin C from a component of a plant, berry or leaf are also less potent and have inconsistent color, Hnat added.

Types of Premixes & Common Blends

Premixes occur in both liquid and powder forms. Liquid forms are used in liquid beverages and wet products such as margarines, where they blend in more easily [are water soluble] than powders. If a powdered premix is to be used in a beverage product, consideration will be given to the use of soluble forms of the minerals contained in it, Pfefer said. Solid food manufacturers, on the other hand, have more fortification ingredient options, since the ingredients can be added at different stages and dont necessarily need to be water soluble.

Whether the premix is liquid- or powder-based, most companies fortifying their products use a combination of many ingredients. There are so many ingredients that can be added to functional foods that it makes sense to add more than just one or two ingredients to a product. It makes the label look more powerful when multiple ingredients are added instead of just one, said Brad Knudsen, R&D manager for Seltzer Nutritional Technologies (SNT), a division of Seltzer Chemicals in Carlsbad, Calif. Some ingredients [also] have a synergistic effect with each other and therefore can make the product more effective. For example, studies have shown that vitamin E and selenium, when used in combination, have a much more powerful antioxidant activity and may produce synergistic beneficial results. Therefore, we suggest that combination whenever a customer wants an antioxidant or cardiovascular health blend. Other times, having the choice between a combination blend or individual blend just isnt an option, as is the case when formulating with SierraSil^TM, a naturally-occurring mineral composite targeting joint support, available from Sierra Mountain Minerals. SierraSil supplies a wide range of bioavailable and biologically active minerals as a result of the unique properties of its natural mineral matrix. So it is much more biologically comprehensive than any single nutrient, Downs said.

The number of nutrients in a blend is not too critical in regard to impacting the way a blend must be mixed and delivered, aside the consideration for the possible stratification of a blended group of nutrients, according to Motyka. In these cases, it may be necessary to process the blend to provide a uniform particle size and density to prevent stratification.

What has more impact on a blend is the concentration of each component, according to Pfefer. Premixes are designed to be extremely homogenous after blending since very small quantities are going to be found in each unit of the finished product, Pfefer said. If an ingredient in our premix is present at trace amounts, we will first incorporate it into a minor premix, which is then added to our major batch. This allows for a more uniform dispersion of that ingredient throughout the entire batch. In some cases we will even make three or four progressive dilutions to insure that we achieve total uniformity. Pfefer also noted ADM provides a continuous blending line for large scale products where the many ingredients are simultaneously added to a dynamic blender, which allows for a lower cost of production per pound of premix.

Another option is to provide two different mixes for the same product, which may better satisfy label needs, according to Wilkinson. Perhaps the more stable mineral portion of a premix can be added to the baked portion of a bar, and the less stable vitamins can be included in a fondant icing in their encapsulated forms.

The mainstays of fortification--the basic vitamins and minerals that have an established U.S. RDI (recommended daily intake)--are the most common food and beverage fortifiers. Many premix suppliers also offer condition-specific blends, such as those targeting cardiovascular, immune and joint health--which are becoming more popular-- as well as more-specialized blends, such as an antioxidant blend or a blend formulated for children or seniors. But the opportunities are endless, particularly because most blends and premixes are done on a custom basis. SNT offers stock blends including a Cardio formula, an Antioxidant formula and a 100-percent RDI formula, but most of our blends are done on a custom basis, Knudsen said. Our stock blends (we call them idea kits) are used mainly as a starting point for a company trying to add a fortification blend to their product.

Working With the Customer

In this extremely customized industry, finished-product manufacturers have many options, one of them being how much they want to involve the premix supplier throughout the fortification process. When the premix is being formulated, both companies work very closely to gather the necessary information to formulate the optimal blend. But once the premix is completed, depending on the needs of the company making the finished goods, they can either work with the premix supplier a lot or a little, depending on his familiarity with using micro-ingredients. Some customers will provide us with a specific formula which they want us to produce, Pfefer said. Others will provide only the label claim they want to achieve and we will formulate the premix in house. Still others come to us just saying they want to produce a food product with a certain attribute and we will formulate the complete item.

To help food and beverage manufactures choose the best blend for their products, premix suppliers can supply numerous research findings on nutrient stability, bioavailability, possible interactions and optimal blend choices for various applications. SNT has formulated products for many different types of foods and beverages, so we are very familiar with how much a certain material will degrade under various manufacturing processes, such as pasteurization, aseptic packaging, baking, spraying and extrusion, Knudsen said. In addition, we will make suggestions about what forms of an ingredient will work best for their product and we also assist them in determining the proper overage amounts to meet their desired label claim. Some premix suppliers may also conduct custom research not only on the premix itself, but also on the finished product. But even if a premix supplier is not involved in the entire product development (such as Albion), the company still needs to advise the customer of physical and chemical considerations for the food and the premix, according to Motyka.

Other options premix suppliers can provide for food and beverage manufacturers include offering various sizes and forms of delivery of the premix blend itself. Dry blends and liquid blends range from bulk truckloads to totes, drums, cartons, pouches and tablets. Whatever method suits the customer is the way we pack the product, Pfefer said. Pre-measured packages are also an attractive option, according to Knudsen. SNT offers a standard 25 kg box for bulk blends, as well as unitized packages that can hold as little as 100 grams to make it easier for the finished product manufacturer to just tear open and add the pre-weighed amount, instead of having to weigh out the premix for every batch, Knudsen said. So if you combine the ease of using a multi-ingredient premix with a unitized package, a processor can really save a lot of labor time and reduces cost.

Many premix suppliers also offer help when formulating label claims for finished products. Label claims are important because they can make (or break) a products and companys reputation. Manufacturers of grain products fortified with folic acid, for example, can make claims on their labels that fortified products contain folic acid and that adequate intake of the nutrient may reduce the risk of neural tube defects. If the label claims are not accurate, however, that is when legal problems can arise. The benefits relayed on the label will be something that is done by the finished product manufacturer, Knudsen said. However, SNT offers technical services such as assistance with locating research studies that can help them with information on their labels. Guaranteeing a premixs potency and making sure it meets its designated composition and claim throughout a designated shelf life at a recommended temperature is also to be expected. However, Hnat cautioned, It is ultimately the responsibility of the company selling the finished product to ensure it meets the label claim 100 percent for added nutrients.

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