Balancing Nutrition, Formulation in Fortified Products

Providing essential vitamins and minerals in easy-to- consume forms is driving the fortified and functional food and beverage market, and suppliers are coming up with innovative products and ways to overcome formulation challenges.

Vitamins and minerals are essential to human health. Witness the impact of a deficiency in vitamin C causing scurvy, or an overload of sodium taxing blood pressure. Similarly, higher intakes of essential nutrients may prevent the development of chronic diseases such as cardiovascular disease (CVD) or osteoporosis. However, in addition to their individual roles, vitamins and minerals also work together to support different health concerns and, as with many things in life, balance is the key to optimizing the benefits.

Consider the synchronicity of calcium and vitamin D in maximizing bone mineral density and preventing onset of osteoporosis. In addition to these players, the body needs magnesium and phosphorus—in the right quantities—as well as vitamin K to assist in bone building, and antioxidant vitamins C and E to help curb structural damage to bone.

Unfortunately, even as scientists discover the key roles basic vitamins and minerals play in long-term health, Americans are getting fewer of these nutrients through their diet. There are several reasons behind this, including decreased intake of good sources of basic nutrients, and declining levels of vitamins and minerals in the food supply. For example, a study in the British Food Journal compared the mineral content of 40 fruits and vegetables grown in the 1930s and the 1980s, and found statistically significant reductions in the levels of calcium, copper, magnesium and sodium in vegetables, and of magnesium, iron, copper and potassium in fruit.¹Food Magazine, a U.K. publication, reported on an unpublished study that found the mineral content of milk and meats fell dramatically between 1940 and 2002, with up to 80-percent less iron in meat, milk and cheese; 10- percent less copper and 60-percent less magnesium in meat products; and 25-percent less magnesium and 90-percent less copper in dairy products. Similar results were reported by U.S. researchers, who found from 1909 to 1994, across the whole food supply, vitamin B12 levels decreased about 5 percent, magnesium decreased by 3 percent, zinc decreased by 3 percent and potassium decreased by 7 percent.²

Adding to that issue is the declining intake of these important nutrients. The U.S. Department of Agriculture’s (USDA) Agricultural Research Service (ARS) estimates 93 percent of Americans have inadequate intakes of vitamin E from food, based on the Estimated Average Requirements (EARs).³ The same study, “What We Eat In America, NHANES 2001-2002”, shows 56 percent of Americans have inadequate intake of magnesium, 44 percent are missing the bar on vitamin A and 31 percent don’t get enough vitamin C. Similar findings were reported by researchers from Tufts University, Boston, who found women have EARs lower than the daily value or highest Recommended Daily Allowance (RDA) for vitamin A, folate, calcium, iron and zinc; they do note that since implementation of mandatory folate fortification in 1998, folate levels in women have significantly increased.⁴

Mandatory enrichment of cereal-grain products with five important B vitamins has significantly reduced the number of Americans deficient in those nutrients, according to USDA. The impressive results have led some researchers to propose making other enrichments mandatory. Rutgers scientists suggest calcium and vitamin D—which are currently optional for enrichment—be mandatory in enriched cereal-grain products in the United States.⁵ They suggest by making the prescribed optional amounts mandatory, the country would see significant reductions in the incidence of osteoporosis and colon cancer, at a cost of only around $19 million annually.

Such fortification has increased consumer awareness about the benefits of increasing intake of basic nutrients through foods and beverages. “Consumer and manufacturer awareness of the ability of foods and beverages to deliver essential nutrition is rapidly growing,” said Juliana Zeiher, ingredient technologies manager at GTC Nutrition. “Today’s consumers are more health savvy, and therefore they not only expect foods and beverages to offer essential nutrition, they also thoroughly review product labels to ensure products are delivering their promises.”

Diane Hnat, senior marketing manager in new business development for DSM Nutritional Products, noted consumers are becoming more educated about the importance of nutrition through their own investigation. She said: “Access to the Internet in the area of nutrients and health benefits has increased consumer awareness of the ability of foods and beverages to deliver essential nutrition and additional nutrition when balance is not happening in the consumer’s current diet or a specific health condition would like to be addressed by the consumer in his everyday food consumption.”

Cathy Bloom, senior sales representative, DNP International, agreed that education is helping drive sales. “Today’s consumers are more educated regarding what is right for their health,” she said. “And if someone is in the grocery store seeing labels marked ‘fortified’, there is a greater chance that product will sell.”

In fact, the choices of available products marked “fortified” are increasing almost exponentially. S.L. “Sam” Wright, IV, chief executive officer (CEO) and president, The Wright Group, recalled grain and cereal products as mandated or allowed by the government were the initial area for fortification, with meal replacement bars and beverages—particularly those positioned as dietary supplements— expanding the offerings.

“Until recently, consumers had limited options other than taking a supplement to get their desired daily fortification,” said Charles Barber, technical services manager for functional food and food technology, Cognis Nutrition & Health. “Through product development and improvements in processing, we are able to formulate our functional ingredients into a seemingly infinite number of great-tasting food products.”

How true it is. Dairy products, juices, chewing gum, candies, pastas, cereals—it seems every food category is aiming to get into the fortification game. “Whereas the market was previously dominated by mostly bar, beverage and cereal applications, now the applications range from fortified candies to pet food to ice creams and yogurts,” observed Jessica Calhoun, premix formulator, and Scott M. Larkin, vice president of marketing and business development, both with LycoRed. “Frozen ice cream bars, energy bars, energy candies, energy drinks, children’s food products and soups are all newer areas seeing fortification.”

Ram Chaudhari, Ph.D., senior executive vice president, chief scientific officer and co-founder of Fortitech, agreed with the assessment. “The sky is the limit when it comes to fortification,” he said. “In order to be successful in the marketplace, one has to think in terms of health innovation, flavor innovation, ingredient innovation and specific age groups.”

Rodger Jonas, national business development manager with P.L. Thomas (PLT), noted companies are taking steps to maximize that innovation. “Several major food companies have established nutrition centers to analyze the new items for fortification while making certain they meet FDA label and claim requirements,” he said. “Beverage companies are focusing on vitamin inclusion and the ratio of minerals and vitamins for accurate claim decisions.”

The beverage area in particular has seen a rising tide of product offerings. Consider the popularity of orange juice with calcium and vitamin D, or the huge influx of waters with vitamins and minerals. “This trend is reflective of consumer desire to maintain and improve energy, reinvigorate and replenish body fluids, manage weight gain and enhance the nutritional value of popular beverages,” noted Mark Fanion, Fortitech’s corporate communications manager.

“The population is much more aware of their health and their diets’ effects on their overall well-being,” observed Alice L. Wilkinson, director of product development, Watson Inc., Nutritional Ingredient Division. “Adding nutrients to a product is an effective way to add value to the consumer who wants increased health benefits from their foods.The challenge is to deliver these nutrients in the most appealing format so they are un-detectable to the consumer.”

Meeting the Challenges

Wilkinson’s point is well taken; in fact, there are a number of challenges involved in delivering bioactive nutrients to the consumer in an acceptable matrix. Chaudhari noted these include texture, taste, mouthfeel, bioavailability and stability. “Depending on the type of product, one has to use an appropriate nutrient profile to overcome the challenges,” he said. “Physical and chemical stability along with microbiological quality is just as important.”

Leonard Johnson, director of technical marketing with DSM Nutritional Products, noted: “Nutrient forms need to be carefully chosen to match the application, processing, packaging and shelf-life of the finished products. Some nutrients can be added to a food in their ‘pure’ state, while others have to be protected from moisture and oxygen.”

One challenge is incorporating lipid-based ingredients, such as carotenoids, into a water-based matrix. “The lipid-soluble vitamins have long been difficult when developing clear beverages,” Wilkinson said. “Along the same line, beta-carotene would be an obvious choice as a source of vitamin A in many applications, but the natural color becomes prohibitive.” To address these challenges, suppliers are turning to new technology. For example, Watson developed a vitamin E that is clear in beverages at a 15-percent daily value, as well as a colloidal beta-carotene that is reduced in color.

“Those in the beverage industry know that formulating for beverages can be complex because of ingredient interactions and other challenges that can lead to a host of complications, such as sedimentation, poor taste, cloudiness or lack of uniformity of ingredient incorporation into the beverage,” Chaudhari said. “For example, formulators commonly use riboflavin to fortify beverages. However, it is very unstable in UV light. To overcome this problem, beverages containing riboflavin or vitamin B12 should be packed in brown bottles or in bottles with UV barriers to protect against degradation. In addition, mineral fortification can change the color, flavor and appearance, unless the formulator accounts for the particular challenge of single or combined minerals.”

There are a number of issues that crop up in beverage fortification, Johnson added. “The main issues include solubility and/or dispersibility, color, flavor, oxidative stability and potential deleterious interactions,” he said. “Clear waters are a challenge for fortification due to color and clarity issues. Dairy beverages are generally short shelf life, but have delicate flavors that must be protected. And juice beverages have color, flavor and shelf-life issues.”

Wright agreed that each type of beverage poses its own challenges. “Individual considerations with beverages include the low pH of fruit beverages vs. the neutral buffering of milk and dairy beverages,” he said. “With water, the challenge is the color or lack of color, the clarity of the solution and the flavors imparted by nutrients in a flavorless system. Solubility vs. lack of solubility and the particle size of suspended particles are issues with all beverages. High solid systems require longer and higher temperatures during heat processing with increased possibility of nutrient destruction. Encapsulation with water-soluble coatings can protect nutrients used in beverage powders that will be stored on the shelf. Hydrophobic encapsulations and encapsulation with emulsifiers can work in mid- to high-viscosity beverages where the particles can be suspended.”

Gadot has developed several ingredients specifically for the beverage market to overcome challenges posed by certain nutrients. For example, the company supplies Gadocal Gold, a soluble form of calcium citrate, which was designed for fortification of juices and clear beverages, as well as more specific calcium citrates specifically for orange juice and for milk.

Similarly, GTC developed a blend of marine mineral source calcium with short-chain fructooligosaccharides (scFOS®) for neutral and acidic pH beverage applications. Zeiher noted the blend, sold as CalciLife®, provides efficacy at lower doses than might otherwise be required, and has the ability to enhance flavors and mask off-notes.

The issue of dosages combines both bioavailability of nutrients in a matrix, as well as nutrient interactions and overage considerations. “Bioavailability is ensured by considering all physical properties of all individual constituents being collectively added and then choosing the proper form and delivery of each constituent accordingly,” said Calhoun and Larkin. “In many cases, molecular weight and particle size coupled with specific dosages of a nutrient will greatly affect bioavailability.”

Nutrient combinations may assist with bioavailability, according to Massood Moshrefi, Ph.D., vice president of operations at InterHealth Nutraceuticals. “Bioavailability challenges are often met by chemically combining the molecules of one or more nutrients together,” he said. “Chelated minerals and amino acids are examples of this technology. The stability of these highly sensitive mixes can be further enhanced or compromised by packaging or handling.”

Sourcing is also a key component in bioavailability, Wright said. “There is considerable variability in bioavailability among sources, especially relating to minerals,” he said. “In very general terms, the more soluble a nutrient source, the greater its bioavailability. In the same general regard, the more bioavailable a nutrient source, the greater the potential impact on the taste of the final product.”

Bioavailability of nutrients can also be impacted by the other ingredients in a fortified product. “One typical example of a nutrient interaction is that between ascorbic acid and iron,” Johnson said. “These nutrients are often used together, as vitamin C can improve the bioavailability of iron. However, iron catalyzes the destruction of vitamin C.Thus, the dilemma for the food scientist is how to add these important nutrients to foods successfully. Depending on the application, overages and form selection are key to success in using these nutrients together in a food. For example, in a nutrition bar, a coated form of either or both vitamin C and the iron form will help protect the nutrition, flavor and quality of the end product.”

Other examples of nutrient interaction Chaudhari cited include the ability of vitamin E to increase the bioavailability of vitamin A, and how calcium may inhibit iron absorption. He also said there are several challenges specific to the B vitamins. “Ascorbic acid has been shown to destabilize folic acid and vitamin B12,” he said. “Degradation products of B1 have also been shown to accelerate the rate of degradation of folic acid and B12, whereas the presence of iron salts in solution seems to have a stabilizing effect on B12. In solutions of the B vitamins, riboflavin can cause the oxidation and consequent loss of thiamin, but if ascorbic acid is included in the solution, a reaction does not occur.”

Moshrefi noted the instability of the B vitamins does pose a challenge in formulation. “Some B vitamins such as B1 and B6 are more stable under acidic conditions, while folic and pantothenic acid are most stable under slightly alkaline conditions,” he said.

Minerals also have their instability issues. “The reactive minerals can always be a problem,” Wilkinson said. “The ones that come to mind first are magnesium in oxide form and soluble forms of iron, zinc and copper. Unfortunately, it is perceived—not necessarily proven— that more soluble mineral forms are more bioavailable. There are some highly-bioavailable sources of iron that are non-, or at least less, reactive, and those would be first choice. On the positive side, it is very well accepted that most nutrients are much more available for absorption when taken in with foods, so fortified foods are a logical choice.”

As formulators deal with nutrient interaction and degradation, they confront the question of how to ensure a product will meet label claim during the length of shelf life—a question that has often been answered by adding more of a nutrient than is necessary. This issue of overages is one that is of great concern—particularly financial concern—in formulation; however, addressing it is relatively complex. “The type of food product, the processing conditions, the packaging and the required shelf life all play a role in determining overages,” Johnson said. “Even similar products from different food manufacturers can require different overages because of process variations in their manufacturing plants. It is best for the manufacturer to work closely with their supplier to develop nutrient blends that will meet their needs without excessive overages.”

Wilkinson agreed there are myriad considerations in determining overages: “Larger overages are required on the less-stable vitamins, as most will endure some sort of heat processing,” she said. “For example, in a ready-to-drink product, vitamin C can require 100-percent or even larger overage depending on the processing conditions. If the liquefied product is held in large tanks before packaging, the vitamin C will continue to scavenge oxygen from that headspace. Should the equipment go down overnight, you may lose most or all of the vitamin C unless a nitrogen blanket can be floated over the top.Powdered beverages require less overage as, in the solid state, the vitamins and minerals will have significantly less physical contact and, thus, cross reactivity.”

Wright estimated typical vitamin overages are in the range of 10 to 100 percent. “They can range from as low as 5 percent to account for mineral processing losses, up to 150 or 200 percent at the request of the customer to ensure that a sensitive nutrient can be measured analytically at the end of the code,” he said.

“Overages vary greatly depending on each nutrient itself coupled with the application, processing conditions and combination of nutrients involved,” agreed Calhoun and Larkin. “Lycored’s recent technology with encapsulates will allow reduced overages with the same ability to meet label claim. This in itself should allow for more competitive pricing.”

Using Technology, Outsourcing

The use of encapsulation or microencapsulation assists in fortification and may address nutrient interaction issues and aid formulation. “Encapsulation becomes a critical support step in allowing key fortification ingredients to be included in standard beverage and juice formulations without impacting color, flavor and clarity of the beverage,” Jonas said. “Solubility and active levels are critical to performance and where encapsulation is employed. In addition, overages are reduced when encapsulated product is used, because the ingredients are somewhat protected against oxidation and lower use levels are required to achieve the end shelf-life ingredient declaration.”

Johnson cited vitamin A as one particularly tricky ingredient— because of its susceptibility to oxidation—that benefits from encapsulation to protect the nutrient during production and on the shelf. DSM has developed patented systems for encapsulation of vitamins, carotenoids and other nutraceuticals; for example, Johnson mentioned a dry form of vitamin E that would be clear in a beverage and could be included in a dry premix.

“Microencapuslation, adding correct forms of nutrients and adding proper antioxidants as a protective agent are considered top options when trying to avoid stability issues,” Chaudhari noted. “Other technologies may be chelation, micropulverization, stabilization with other carriers such as hydrolyzed proteins, taste masking flavors or liposome applications.”

Fortunately for many food and beverage formulators, there are experts in the nutrient technology and blending field who can offer solutions to their formulation challenges. Specifically, the use of premixes is on the rise in the food and beverage arena. “The premix market is asking for more and more comprehensive premixes that deliver multiple nutrients, more premixes that address a wider array of product types and market types, and more premixes that extend beyond the realm of vitamins and minerals by incorporating various functional ingredients and botanicals,” Calhoun and Larkin said. “Successful premix design is based on thorough communication to carefully understand processing conditions, storage conditions and composition of the end product desired.”

According to Chaudhari, nutritional premixes offer numerous benefits to manufacturers. “The production process is streamlined because a nutrient system provides a single source of multiple nutrients; savings on labor, inventory and testing result,” he said. “Premixes offer greater consistency and address issues of product taste and texture early in the development stage. They eliminate any chance of error during the manufacturing process where missing a small amount of an ingredient or weighing incorrectly may cause a potential deficit of that nutrient and a possible recall.”

Wilkinson agreed that premixes help take some of the angst out of the production process. “Premixes reduce human variability because they become one ingredient,” she said. “They are easier to distribute homogenously in the finished product and can be custom packaged for batch dosing. Formulation itself is complex, and balancing multiple nutrients can be difficult if you are not familiar with them. ... [But] we can typically optimize a custom premix with ease, reducing the amount of costly finished goods assays necessary before a new product is launched. We have the value-added nutrients at our fingertips and can produce custom encapsulations when needed.”

Many of these premix suppliers are also developing standard formulas to meet different manufacturer needs. Jonas noted PLT offers pre-blends for different fortification categories, including bakery, beverage and dairy, which have been formulated to achieve desired active levels. And Wright observed the market is turning to premixes to meet consumer desires. “Functional or condition-specific blends targeting joint health, bone density, visual acuity and retention of cognitive function in the elderly are becoming more common in premixes as the industry searches for niche markets,” he said. “And as the organic and natural markets grow, there are increased requests for documented non-genetically modified, irradiation free and natural forms of vitamins.”

However, even as consumers are looking for added value in their foods and beverages, if a product doesn’t taste good, they won’t make a repeat purchase. “Most consumers will only use what tastes and looks good,” Bloom said. “If the product has a bad taste or does not look appetizing, they will not purchase it.”

This is the final challenge in formulated fortified products, according to industry suppliers. “Most vitamins and minerals do not enhance the flavor of a product,” Jonas said. “Many vitamins and minerals cause flavor issues and can absorb a flavor that is employed in the food product. If the ingredient can be isolated, there is less chance for interaction. Temperature can also affect flavor and color by driving the reaction and, thus, must be compensated for with a means to protect the active ingredient. Numerous calculations are made to determine how many servings must be used to ‘spread out’ or lessen the impact of a fortification ingredient on the flavor and texture of a food. Minerals often have a chalky or metallic taste, vitamins can be bitter, and the impact of processing can result in flavor interaction that causes a sour note or other unintended effect. Fortification, while growing, poses numerous hurdles for ensuring a goodtasting product.”

Fortunately, suppliers are generally eager to work with customers in this arena to overcome the challenges and develop successful finished goods. “Close cooperation with the customer is always required,” said Ronny Hacham, vice president of business development and marketing with Gadot Biochemical. “Supplying samples is not enough; the supplier has to provide a solution. Suppliers should supply the product together with the procedure of how to use it in the specific conditions typical to each customer.”

And at the end of the day, this means realizing greater success on a wide scope. “Around the globe, consumers are more knowledgeable about health and nutrition than ever before,” Fanion said. “As a result, they are constantly looking for ways to eat better and take advantage of the health and wellness benefits of many nutrients. Food, beverage and pharmaceutical manufacturers are striving to respond to that need by developing a wide variety of fortified products. This is a trend that has grown exponentially ... with literally no end in sight.”

References

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2. Gerrior S, Bente L. “Nutrient Content of the U.S. Food Supply, 1909-94.” U.S. Department of Agriculture, Center for Nutrition Policy and Promotion. Home Economics Report No. 53. 1997. www.usda.gov

3. Moshfegh A, Goldman J, Cleveland L. “What We Eat In America, NHANES 2001-2002: Usual Nutrient Intakes from Food Compared to Dietary Reference Intakes.” U.S. Department of Agriculture, Agricultural Research Service, 2005. www.ars.usda.gov.

4. Kennedy E, Meyers L. “Dietary Reference Intakes: development and uses for assessment of micronutrient status of women—a global perspective.” AJCN. 81, 5:1194S-97S, 2005. www.ajcn.org

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