Vitamins & Minerals

Vitamins and minerals have been anything but boring lately. Most notable is the—mostly positive—recent research that has come forth singling out these two segments. From cardiovascular disease to diabetes to cancer, vitamins and minerals are bringing new luster to the nutraceuticals market. Emerging research coupled with FDA’s new qualified health claim initiative will arm marketers with all of the ammunition they will need to promote vitamin and mineral products to consumers.

That said, the vitamins and minerals business will likely face some tough challenges in the future as well. These markets, like all segments of the nutraceuticals industry, will have to negotiate several obstacles, such as proposed rule for Good Manufacturing Practices (GMPs) for dietary supplements in the U.S. and the proposed upper safe limits (USLs) for vitamins and minerals in the EU.

Trends & Issues
Nutrition Business Journal (NBJ), San Diego, CA, said the vitamins segment brought in $6.2 billion in sales for 2002—a growth of 2.5% over the previous year—while the minerals category raked in $1.5 billion in sales—growing 9% over 2001 estimates. The top five vitamins were multivitamins, B vitamins, vitamin E, vitamin C and vitamin A/beta-carotene (see Table 1) and the top five minerals were calcium, magnesium, iron, chromium and zinc/potassium/selenium (see Table 2).

According to Lynda Doyle, director of marketing—New Ingredients & Business Development, Roche Vitamins, Parsippany, NJ, there is a trend toward custom formulas for the vitamins category. She highlighted recent consumer research (Multi-Sponsor Surveys), which indicated a jump in the number of regular vitamin users who take supplements formulated for a specific life stage (27% in 2002) or health benefit (28% in 2002). “Consumers are looking for custom formulations and solutions, rather than having to try and pull together several individual products for their needs,” she said.

An aging population, dosage form changes and bioavailability are also driving trends in the market, said Barry Titlow, CEO, Compound Solutions, Escondido, CA. “In terms of the aging population, there is more of a need to supplement, and this segment has more discretionary income than any other,” he offered.

As for dosage form changes, Mr. Titlow added that consumers are looking to establish supplementation through alternative means such as bars and drinks. As a consequence, he said, bioavailability can become an issue. “Companies are on the lookout for new forms of vitamins and minerals that will be, for example, soluble when used in a beverage,” he said. “The question here is whether or not the soluble vitamin or mineral is still bioavailable in its new form through this medium. As a result of this issue, I think companies will have to do more bioavailability studies going forward.”

Luis Velasquez, vice president, Amax NutraSource, Eugene, OR, commented on the fact that companies are really starting to undertake more research, a lot of which is more sophisticated. Because of this, he said, “Many diseases and ailments that affect us do so at the DNA level, so a lot of companies are really starting to look for products that have an effect at that level in the body.”

Mitch Skop, sales and new product development, Pharmachem, Kearny, NJ, discussed the trend of increased government involvement. “Maybe the best thing about government scrutiny of our industry is that several companies, including ours, are spending more money on clinical studies of new ingredients,” he said. “Clinical research is the only way for our industry to grow through serious research, safe and efficacious ingredients and responsible marketing claims. Only this way will we win consumers’ trust.”

Regulatory Developments
From a regulatory standpoint, companies will have to contend with several issues going forward, not only in the U.S. but also internationally. In the U.S. there are many uncertainties at the moment, especially with the proposed rule for GMPs for dietary supplements. If the GMP proposal becomes final as written, most experts feel the ramifications of such could prove to be disastrous for many suppliers and manufacturers. Comments to the proposed GMPs were filed August 11th and will (hopefully) be taken into consideration in composing the final rule.

Compound Solutions’ Mr. Titlow discussed some of the specifics of the GMP proposal, saying that the requirements as written are onerous and as a result, will negatively affect several companies in this industry. “The proposal requires a tremendous amount of testing. Not only will manufacturers of supplements have to test incoming raw materials, they will have to test in-process materials and finished goods. This is all well and good but the way the proposal is written companies will have to test every ingredient in a particular product, so every active and excipient will have to be analyzed for.” For the future, he predicted, “The very complex formulas that companies used to manufacture will be hard to get around if the proposal becomes final as is. As a result, companies will probably stick to simpler product formulas.”

Another recent development likely to affect the vitamins and minerals business is the new system devised by FDA to “grade” health claims for foods and dietary supplements. This ranking system—for example, through the equivalent of a “B,” “C” or “D” grading system—will have a significant impact on products in that they will now be able to carry qualified claims backed by varying degrees of scientific substantiation. The highest grade, “A” or the equivalent, means that there is significant scientific agreement (SSA) about a health claim and therefore no qualifying language is required. This system was created, according to FDA, to give consumers more and better information regarding dietary choices.

Praising FDA’s new initiative was Kathleen Moran, market segment manager—Dietary Supplements, Cognis Nutrition & Health, La Grange, IL. “We are pleased with FDA’s new program, which began September 1st,” she said. “This initiative is certain to help consumers make better informed purchasing decisions.”

In terms of vitamins specifically, good news came earlier this year when FDA approved a qualified health claim for antioxidant vitamins and cancer. A letter from the Office of Nutritional Products, Labeling and Dietary Supplements, of the Center for Food Safety and Applied Nutrition, College Park, MD, indicated its allowance of a qualified health claim specifying the relationship of antioxidant vitamins and a reduced risk of certain kinds of cancer, provided that products using the health claim use one of three disclaimers provided by FDA. The choices of disclaimers included (1) “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive” (2) “Some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer. However, FDA does not endorse this claim because this evidence is limited and not conclusive” (3) “FDA has determined that although some scientific evidence suggests that consumption of antioxidant vitamins may reduce the risk of certain forms of cancer, this evidence is limited and not conclusive.”

In other health claim developments, FDA also allowed the use of two qualified claims for selenium (in dosage amounts of 400 micrograms or less per day) and cancer. The first claim reads: “Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.” The second selenium claim says, “Selenium may produce anticarcinogenic effects in the body. However, FDA has determined that this evidence is limited and not conclusive.”

Internationally, there have also been some interesting developments as well. According to the NNFA, Newport Beach, CA, regulations that will adversely affect products exported to Europe are in the process of being implemented. “In accordance with the EU Directive for Food Supplements, the European community will limit the number of allowable dietary ingredients used in supplements and establish upper safe limits (USLs) for vitamins and minerals,” the association said. “As a result, 277 various nutrient forms (most notably vanadium, boron and silicon) are in jeopardy of being disallowed. Early indications from various expert groups strongly suggest that the USLs established for vitamins and minerals will fall well below accepted scientifically recognized levels. This could preclude many American made supplements from being sold abroad.”

Also on the discussion table in Europe is legislation to restrict claims on foods and dietary supplements. The European Commission feels the EU (European Union) rules on labeling and nutrition labeling, which do not define conditions for the use of nutrition claims and do not allow health claims to be made, are often not properly enorced. Therefore, it feels the consumer can be misled by claims that have not been properly substantiated.

The newly proposed regulation will provide legal security and address these issues by specifying the conditions for the use of nutrition and health claims, prohibiting certain claims and scientifically evaluating the use of claims in relation to the nutritional profile of foods. “No food product will as a consequence be prohibited but claims on food products will have a true meaning for the consumer,” the Commission stated.

With three years of the regulation entering into force, the Commission will make a positive list of such well established claims and more novel claims, such as “whole grain may keep your heart healthy/may reduce the risk of heart disease.” For the latter type, individual scientific evaluation and pre-marketing approval will be required and only claims that can be substantiated will be permitted on the EU level after being evaluated by the European Food Safety Authority (EFSA).

In Europe, Ms. Moran said manufacturers and marketers of dietary supplements and functional foods must work together with government on The European Health Claims Directive Proposal. “There has never been a more critical time for our industry to help shape the regulatory climate,” she commented. “We must be united in demonstrating that products backed by credible science deserve to have reasonable health claims.”

Recognizing that there are some challenges at present in Europe, Gary Troxel, executive vice president, InterHealth Nutraceuticals, Benicia, CA, said companies’ willingness to abide by the new rules could pay off in the long run. “Europe is an especially important region because there are over 400 million consumers in that market. Once the EU becomes harmonized there will be significant opportunities,” he said.

Research Update
Vitamins and minerals do not suffer as several segments in the nutraceuticals business do when it comes to having a solid foundation of science. Indeed, research coming forth on these two segments is almost a daily occurrence. What follows is a brief synopsis of some of the most recent research highlights.

Vitamins and chronic disease prevention. In the July 1st issue of the Annals of Internal Medicine a report from the U.S. Preventive Services Task Force (USPSTF) was published concluding that while there was little reason to discourage people from taking vitamin supplements that there was not sufficient evidence to recommend for or against the use of vitamins for the specific purpose of preventing cancer and heart disease. This report made a very different conclusion from a similar one that had been published almost one year before. That report, entitled “Vitamins for Chronic Disease Prevention in Adults: Clinical Applications,” which was published in the June 19th 2002 issue of JAMA, concluded that, “pending strong evidence of effectiveness from randomized trials, it appears prudent for all adults to take vitamin supplements.”

In response to USPSTF’s report, which only made conclusions about cancer and heart disease, the Council for Responsible Nutrition (CRN), Washington, D.C., noted that vitamins have been recognized for serving a wider range of benefits. These include strengthening immune function, protecting against cataracts and macular degeneration, improving cognitive function, building strong bones and helping women of childbearing age protect against having a baby with neural tube defects. CRN also maintained that regular use of dietary supplements, with a multivitamin as the foundation of a smart nutrition program, makes good sense for the overall promotion of good health and prevention of disease.

Vitamin A and hip fracture. The back and forth nature of research has also affected the perception of vitamin A. Last year, a study published in JAMA linked high levels of vitamin A in postmenopausal women to an increased risk of hip fracture, suggesting that the amounts of retinol in fortified foods and vitamin supplements be reassessed. Fast forward to the U.S. Endocrine Society’s meeting held in June where researchers concluded that low levels of vitamin A could also increase hip fracture risk in women. Combining these two conclusions, researchers suggested that women with the highest and lowest levels of vitamin A were twice as likely to experience hip fracture as compared to women with average levels, again recommending that vitamin A supplementation levels be reassessed.

Multivitamins and myocardial infarction. In the August issue of the Journal of Nutrition, epidemiological evidence in Sweden pointed toward a reduced risk of myocardial infarction (MI) for those men and women who took multivitamins. The results of the study were based on data from a large population-based, case-control study of subjects aged 45-70 years residing in Sweden, which, researchers noted, is a country in which consumption of fruits and vegetables is relatively low and foods are not fortified with folic acid. The study included 1296 cases with a first non-fatal myocardial infarction (MI) and 1685 controls. Regardless of their diets, subjects who took multivitamins had a significantly lower risk of MI than those who did not take supplements.

Vitamin C and E and blood vessel function in children. Heart health was also the focus of a study published in the September 2nd issue of Circulation, which studied the impact of vitamins C and E on blood vessel function in children who had inherited lipid disorders. Moderate doses of vitamins C and E were administered for a period of six weeks. The results showed improved blood vessel function, which is an important indicator of cardiovascular health. Researchers concluded that antioxidant therapy with vitamins C and E restored endothelial function in hyperlipidemic children. As a result, they said, “Early detection and treatment of endothelial dysfunction in high risk children may retard the progression of atherosclerosis.”

Vitamin C and ulcers. Research on vitamin C and its effects on Helicobacter pylori—the bacteria that causes peptic ulcers and stomach cancer—was featured in the August 1st issue of the Journal of the American College of Nutrition. Researchers tested blood samples from a wide range of people for H. pylori infection. Nearly one-third (32%) of the 6746 subjects tested positive for antibodies to H. pylori, indicating that their immune systems had previously mounted an attack against the bacteria. The researchers also analyzed vitamin C, or ascorbic acid, levels in the blood of these participants. After accounting for age, ethnicity, weight and other factors, they found that white participants with the highest blood levels of vitamin C had 25% lower prevalence of infection.

Vitamin E, beta-carotene and heart health. Focusing on vitamin E and beta-carotene, Dr. Yousry Naguib, technical services manager—New Product Development, Soft Gel Technologies, Los Angeles, CA, said epidemiological studies have linked populations with a large intake of these antioxidants to a reduced incidence of heart disease. However, he said, clinical trials of vitamin E and beta-carotene in preventing specific diseases, such as coronary artery disease, have generated conflicting and mixed outcomes.

In a recent study published in the June 14th issue of the Lancet , Dr. Naguib said, researchers reported the results of a meta-analysis of randomized trials of vitamin E and beta-carotene to assess their effect on long term cardiovascular morbidity and mortality. According to Dr. Naguib, “Researchers found that vitamin E provided no benefit in overall mortality and cardiovascular death, while beta-carotene led to a small but significant increase in all-cause and cardiovascular death.” As a result, he said, researchers do not recommend supplementation with vitamin E to reduce cardiovascular risk. “Surprisingly,” Dr. Naguib said, “this same medical journal published a study in 1996 that suggested vitamin E might protect against heart disease. In that study, men and women with cardiovascular disease who took vitamin E each day cut their risk of a second heart attack almost in half.” He added, “Despite the disappointing outcomes of these recent clinical studies, some cardiologists think it is still worth taking, especially by people who have heart disease.”

W.H. Leong, vice president, Carotech, Edison, NJ offered his opinion as to why vitamin E may not have faired well in recent studies. “Recently, six large-scale, well-designed epidemiological studies have reported that regular vitamin E (i.e., alpha-tocopherol) did not provide any protection against heart attacks,” he said. “Numerous objections were raised against these trials—most notably the doses used—but the real problem may have been that alpha-tocopherol does not in itself provide the right vitamin E activity and protection for the heart. Gamma-tocopherol and tocotrienols were missing in all these trials.”

Mr. Leong added, “When one considers all of the heart-protective properties of the other vitamin E family members (i.e., tocotrienols and gamma-tocopherol), one might expect that alpha-tocopherol alone is not going to be the heart’s cure-all many people expect it to be. It may well turn out that we need a full spectrum of tocopherols and tocotrienols that function synergistically to confer vitamin E’s heart health properties.”

Vitamin D and bone health. Vitamin D deficiency has long been known to be the cause of rickets and as such a critical partner to calcium in building strong bones. Vitamin D is essential because it is hard to obtain from a regular diet as it is not naturally present in many foods. Recognizing this, Minute Maid, Houston, TX, added the vitamin to its calcium-fortified juice line. Following this, an article in the June issue of the American Journal of Clinical Nutrition assessed the bioavailability of vitamin D in orange juice. According to researchers, “Vitamin D fortification at 1000 IU/240 mL orange juice for 12 weeks safely increased concentrations in adults.”

Vitamin K and bone health. Also making its way into the bone health arena is vitamin K. Eric Anderson, marketing director, Natural, Inc., Vernon Hills, IL, discussed emerging science on this vitamin. “The research on vitamin K, in particular vitamin K2, to reduce bone loss is very promising,” he said, adding, “Traditionally, vitamin K has been widely used as a treatment for helping blood coagulation. However, recently researchers have also found that vitamin K is important for maintaining healthy bones. Vitamin K is found in green, leafy vegetables such as broccoli, Brussels sprouts, collard greens, lettuce and spinach.”

Mr. Anderson continued, “Specifically natto, a traditional Japanese fermented soybean product with a high concentration of vitamin K2 and MK-7, increases the amount of vitamin K2 in the body. Vitamin K2 has been shown in studies to increase the carboxylation ratio of osteocalcin and prevent bone loss.”

Mr. Anderson added that women living in regions of Japan noted for high consumption of natto have demonstrated excellent blood concentrations of vitamin K2 and a correlating decreased incidence of hip fracture compared with regions with low or no intake of natto.

Vitamin PQQ. Word spread in April regarding the discovery of a “new” vitamin called PQQ, or pyrroloquinoline quinone. According to researchers, who published information regarding the discovery of PQQ as a vitamin in the April 24th issue of Nature, it was originally discovered in 1979 from a bacterium. Given the definition of vitamins as essential nutrients, which assist specific enzymes in the body, PQQ became a candidate for being categorized as a vitamin. A mystery remained, however, as to what enzyme PQQ was connected, preventing it from being recognized as a vitamin at the time. All of that changed when researchers Takaoki Kasahara and Tadafumi Kato discovered a mammalian PQQ-linked enzyme. This enzyme, they said, is in involved in the degradation of the amino acid lysine, and it requires PQQ to function normally. In previous studies, a PQQ deficiency was linked to hair loss, skin fragility, hunched postures and retarded growth, while new research carried out by Drs. Kasahara and Kato also reveals a deficiency in the vitamin to result in impaired immunity and reduced fertility. Today PQQ can be found in foods such as green tea, parsley, green peppers and kiwi fruit.

Multivitamins and academic performance in children. In other research developments, The University of Medicine and Dentistry of New Jersey (UMDNJ), Newark, NJ, was recently awarded a research contract to conduct The Healthy Foundation’s Better Student Research Initiative™, a research study mandated by Congress to determine if daily vitamins improve the academic performance of at-risk children. Tishcon Corp., Westbury, NY, a project partner in this initiative, donated the multivitamins as well as the placebos for this study. Another contributer, the United States Pharmacopeia (USP), donated the testing of the vitamins and placebos for purity and content.

In this double-blind study, 1500 fourth-grade students will be randomly selected from an urban school district in New Jersey. From December 2003 through May 2004, the students will receive either a daily placebo or vitamins. At the end of the study, the state’s standardized test will be administered to the students. In addition, changes in grade point averages, instances of tardiness, absenteeism and misbehavior will be measured. The Better Student Research Initiative is a study funded through a Congressional earmarked appropriation of $500,000 to The Healthy Foundation through The U.S. Department of Education. Congressman Frank Pallone (D-NJ) and Senator Tom Harkin (D-IA) sponsored the appropriation.

Multivitamin/minerals and infection/quality of life. Straddling the vitamins and minerals category was a study published in the March 4th issue of the Annals of Internal Medicine, which assessed the impact of multivitamins/minerals on infection and quality of life in adults. In a randomized, double-blind, placebo-controlled trial 130 community-dwelling adults stratified by age (45-65 years) and presence of type II diabetes were studied. Subjects either took a multivitamin and mineral supplement or a placebo daily for one year. More participants receiving placebo reported an infectious illness over the study year than did participants receiving multivitamin and mineral supplements (73% vs. 43%). Infection-related absenteeism was also higher in the placebo group than in the treatment group (57% vs. 21%). Among diabetic participants receiving placebo, 93% reported an infection compared with 17% of those receiving supplements. Researchers concluded that a multivitamin and mineral supplement reduced the incidence of participant-reported infection and related absenteeism in a sample of people with type II diabetes mellitus and a high prevalence of sub-clinical macronutrient deficiency.

Phosphorus and bone health.
An important nutrient that is often overlooked in the area of bone health is phosphorus. Dr. Robert Heaney, professor, Creighton University, Omaha, NE, and one of the leading researchers on the calcium/phosphorus connection, said both nutrients are needed to build strong bone and the reason this has been ignored is that, unlike calcium, the human diet is generally rich in phosphorus. However, he said, “In individuals taking ordinary calcium supplements, especially those people with limited dairy and meat intakes (the principal food sources of phosphorus), phosphorus deficiency can develop.” He added, “This is because usual calcium supplements tie up food phosphorus in the intestine and reduce or prevent its absorption in the body. Thus, taking calcium supplements without the necessary phosphorus may prevent the body’s replacing of lost bone, countering the very purpose for which they are being used.”

Chromium picolinate and diabetes. With diabetes becoming such a pressing health issue, several ingredients are stepping up to the plate. One of those is chromium picolinate. According to Nutrition 21, Purchase, NY, a scientific review of “Chromium & Aging” was recently presented at the “Second International Congress on Nutrition and Aging.” The review indicated that insulin function is central to many biological factors that contribute to disease. As such, it was suggested that some of the diseases viewed solely as a natural result of the aging process are, in fact, affected by insulin function and chromium intake. Nutrition 21 claims that while aging has a negative effect on disease risk factors for cardiovascular disease and type 2 diabetes, chromium has been shown to have positive effects on the same factors. The company also says that although the preventive potential of chromium has been realized in some research—supplementation increased lifespan in rats by 33%—further study is needed.

Chromium picolinate/biotin and diabetes.
Diabetes was also the focus of a study presented at the Experimental Biology Meeting in April, which looked at Diachromeâ„¢ (chromium picolinate and biotin combination) and its effects on cholesterol levels in type 2 diabetics. In this study, 34 participants with type 2 diabetes were randomized to receive a nutritional beverage fortified with Diachrome, or the same beverage without Diachrome, for 12 weeks. The group receiving the beverage containing Diachrome revealed significant decreases in total cholesterol and low density lipoprotein (LDL) cholesterol, and an increase in high density lipoprotein (HDL) cholesterol, compared to the control group.

Iron and fatigue. In the May 24th issue of the British Medical Journal an article was published describing the effects of iron on fatigue in women. Specifically, the double-blind, randomized, placebo-controlled study aimed to determine the subjective response to iron therapy in non-anemic women with unexplained fatigue. One hundred and forty-four women aged 18-55 were assigned to take either oral ferrous sulphate (80 mg/day of elemental iron daily) or placebo for four weeks. After one month researchers noted a 29% decrease in the level of fatigue in the iron group compared with 13% in the placebo group. Researchers concluded that non-anemic women with unexplained fatigue may benefit from iron supplementation. However, they qualified, the effect may be restricted to women with low or borderline serum ferritin concentrations.

Calcium and lipid metabolism and body composition.
According to an article published in the June 2003 issue of the American Journal of Clinical Nutrition, recent statistics have suggested that calcium intake has an influence on lipid metabolism and body composition. As a result, a study was conducted to assess the association between daily calcium intake and both body composition and serum lipid concentrations. Two hundred and thirty-five men and 235 women aged 20-65 participated in the study. Only non-consumers of vitamin and mineral supplements were allowed to be in the study. The subjects were divided into three groups, based on their daily calcium consumption. Group A consumed less than 600 mg of calcium per day, Group B consumed between 600-1000 mg per day and Group C consumed more than 10000 mg per day. Researchers observed that low daily dietary calcium correlated with adiposity, especially in women. In addition, researchers noted that high calcium intake was associated with plasma lipid profiles that are predictive of a lower risk of coronary heart disease.

Formulation Challenges
Formulators have their work cut out for them when it comes to vitamins and minerals. Although these categories are mainstays in the nutraceuticals industry and have a lot of history, emerging dosage forms and modes of delivery are both helping and hampering product formulators.

Speaking to this was Compound Solutions’ Mr. Titlow. “As companies experiment with different forms of vitamins and minerals, they must consider that applying heat and moisture will dramatically increase the probability of interaction,” he said. “As a result of interaction, companies must keep in mind that they may lose stability and/or bioavailability in the process.”
Bioavailability was also on the mind of Carotech’s Mr. Leong. “We should endeavor to increase the absorption of ingredients, especially fat-soluble vitamins, such as vitamin E in formulations. Simply put, we should be concerned with what we absorb,” he said. “Hence, the revised saying ‘You are what you absorb and not what you eat.’”

Cognis’ Ms. Moran pointed out the obstacles companies are likely to face from both a functional food and dietary supplement perspective. “Formulation challenges for functional foods include stability, taste, texture, mouthfeel, bioavailability and delivering an efficacious dose. Another issue is how easily the ingredient can be incorporated into a recipe,” she said. “Formulation challenges for dietary supplements include stability (especially in formulations with several ingredients), ease of tableting or encapsulating, bioavailability and keeping the dosage size as small as possible.”

Barry Kaufman, senior product manager, BASF, Mount Olive, NJ, agreed. “It is very important to make sure that adding a particular vitamin makes sense. For example, adding extra vitamin C to orange juice makes sense,” he said. “Formulators should also make sure there is enough of the nutrient in the product to make a difference.” He added, “It is also paramount that appearance and taste of the final product remain unaffected as well.”

On an ingredient-specific level, Pete Zambetti, national sales director—Nutrients, Balchem, New Hampton, NY, discussed issues that arise when formulating with B vitamins. “The B vitamins in particular pose a challenge because they are extremely bad tasting, especially in nutrition bars,” he said. “Companies that are producing high protein, low-carbohydrate bars are having some taste issues because of the amount of B vitamins they are putting into them for their energy benefit.” To get around this, Mr. Zambetti suggested microencapsulation as a means to resolve some of the taste issues as well as extend the shelf-life of the final product.

On the minerals side, Brent Hagen, vice president—Technical Services, Kelatron, Ogden, UT, offered his view on formulation challenges. “Food companies in the past have had a tendency to choose mineral forms that are less biologically active or bioavailable in order to avoid issues with taste, texture and appearance. Therefore the challenge for suppliers is to bring forms of minerals to market that have the efficacy that a company is looking for but that also work well from an organoleptic perspective,” he said, adding. “Food fortification has posed a host of challenges but I think this is a good thing. At least the work that is being done is bringing the issues to the surface.”

When considering minerals for formulations, especially in the case of fortification, there are several characteristics of which to be aware. Jennifer Thomas, market development specialist, Purac America, Lincolnshire, IL, said, “Many mineral fortifiers are available on the market. However, in developing a successful functional food the mineral fortifier must provide the following characteristics: high bioavailability, high biocompatibility (no irritation to the gastro-intestinal tract, non-toxic) and a high compatibility with other ingredients.” For an application where a soluble mineral fortifier is needed—for example in clear beverages—Ms. Thomas said other characteristics are even more important, including neutral taste, high dissolution rate and high solubility. “Organic mineral sources, for example mineral lactates and gluconates, can fulfil these needs. Further, mineral lactates and gluconates provide a natural way of fortifying food as both are produced via fermentation (biologic oxidation) of glucose,” she explained.

Discussing formulation in general was Ram Chaudhari, senior executive vice president—Research and Development, Fortitech, Schenectady, NY, who said most issues center around choosing the right ingredient. “Companies should choose an ingredient based on the market in which they will be selling the finished product,” he said. “In order to avoid problems, they must also focus on choosing the right mix of ingredients in the right balance in order for the product to be truly successful.”

Although challenges abound, Karen Todd, senior marketing manager—New Ingredients, Roche Vitamins, was very positive about the future. “Vitamins and minerals will continue to play a major role in consumers’ health,” she said. “The essential nature of select vitamins and minerals and the potential of others to help reduce the risk for disease and increase quality of life will be the focus of future research.”

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