Mineral Formulations

Exploring the trends and issues in the mineral fortification and supplement market.

By Marian Zboraj
Associate Editor

According to The Natural Marketing Institute’s (NMI) 2005 Health & Wellness Trends Database, 60% of the general population/primary grocery shoppers used minerals in the past year indicating that they are maintaining their position in the marketplace. Besides the new research that comes out everyday on the importance of minerals, consumers have also become aware that today’s food supply is more mineral deficient than ever before—requiring them to supplement their minerals to make up for the difference they are missing in their diet.

“Over the last 20 years, the yields of many of our staple crops have nearly doubled,” said Stuart Reeves, PhD, director of research and development, Embria Health Sciences, Cedar Rapids, IA. “We’re literally producing twice the amount of produce from the same soil and basically adding nitrogen, potassium and phosphorous, carbon dioxide from the air and very little else. So the minerals that come from the soil are becoming diluted due to the greater amount we’re producing and, in turn, producing a smaller amount of minerals in food.”

This dilemma has led experts to consider updating the recommended mineral intake levels. While experts are looking to improve the population’s mineral consumption, companies are trying to improve the formulation process to help deliver the most effective and appealing mineral products possible.

Fortification Factors

A major trend in the minerals market is the increasing popularity of fortified beverages and foods, but companies must overcome many manufacturing challenges when working with minerals. Unlike supplement formulation, mineral fortification products place a greater importance on visual appearance and taste.

“Minerals, after all, are metals and metals just taste bad,” said S.L. Wright, IV, president/CEO, The Wright Group, Crowley, LA. “They also tend to react with vitamins and other nutrients, especially in the presence of heat and moisture. There are serious bioavailability, solubility and tolerability issues to be addressed and sometimes addressing one set of concerns exacerbates another set. A formulator must take all these technical and nutritional factors into account in order to develop the most efficacious product possible.”

Ram Chaudhari, senior executive vice president, CSO & co-founder, Fortitech, Inc., Schenectady, NY, said that because there is an inverse relationship between bioavailability and functionality of a specific mineral, factors that are responsible for increasing solubility of a mineral salt will actually increase its reactivity or interactions. “In fact, the same solubilization will increase the potential for bioavailability,” he said. “Depending on the type of product, one can select functional food ingredients where you can make use of synergistic properties and improve the nutritional benefit.

“Each functional ingredient has its own chemical/physical/functional properties,” continued Mr. Chaudhari. “Depending on the finished product, the composition formulators and/or food scientists have to develop a protocol consisting of selected nutrients with defined nutritional/health benefits and scale-up the process where particle size, taste, texture and overall sensory acceptance parameters are finalized. For instance, if a product is designed for eye health, the choice of the functional food ingredients and its physiochemical properties would have an impact on the delivery system and other properties.”

Some technologies used to overcome some of the challenges posed by mineral fortification include microencapsulation, taste-masking, stabilization with other carriers (hydrolyzed proteins, polysaccharides), chelation, micropulverization and lyposome applications.

“Microencapsulation protects nutrients from hostile reactions, prevents organoleptic issues, increases shelf-life and will reduce the overages normally built in to assure meeting of label claims,” said Bill Murphy, director, Premix Business Unit, LycoRed Corp., Orange, NJ. “One obvious result is tastier, healthier foods.”

Joseph O’Neill, vice president of marketing, Orafti Active Food Ingredients, Malvern, PA, said to counteract unpleasant taste, appearance and/or texture, formulators try to combine flavoring, stabilizers and other ingredients with minerals to neutralize these negative effects.

Mineral chelates are also growing in popularity. “Chelated minerals claim to be more bioavailable or easier for the body to absorb,” said Emilio Gutierrez, vice president of east coast operations, BI Nutraceuticals, Long Beach, CA. “These ingredients provide a good basis of differentiation from the everyday products but sometimes pose new challenges. Typically, they are more soluble than traditional mineral salts but they also contain a lower percentage of active mineral and are generally much more expensive on an activity basis.”

Premixes can serve as a solution for distributing minerals uniformly throughout a product. “A quality premix assures the required consistency and uniformity,” said Mr. Murphy. “Maximum bioavailability of premix minerals is obtained by careful consideration of all the physical properties of each individual constituent. Then, the cross-effect of the ingredients to be blended is considered as well to assure a high quality outcome in the finished product, using a cost effective process.

“When formulating a mineral blend for fortification of a food, you must consider the complex macronutrient matrix of the food itself,” continued Mr. Murphy. “As each food presents its own unique macronutrient matrix, the formulator is faced with a unique formulation challenge, almost each and every time. This is not the case for dietary supplements which are typically contained within their own environment.”

When working with beverages, Watson Inc., West Haven, CT, will typically incorporate the macro minerals as micronized versions when possible. “This enables a better dispersion of the less soluble minerals,” said Alice Wilkinson, director of product development, Nutritional Ingredient Division, Watson Inc. “Typically the less soluble sources are preferred as they can carry counter ions that meet other label claims and being less soluble creates fewer issues with regard to changes in taste, color and pH.”

Barbara Heidolph, market development manager, Food, ICL Performance Products LP, St. Louis, MO, also explains that solubility is an issue for those looking for clear solutions. “If you don’t get it solubilized, sedimentation occurs,” said Ms. Heidolph. “ICL has proprietary knowledge that can help a customer obtain a stable soluble calcium across a variety of pH levels.”

The Supplement Side

Many consumers choose mineral supplementation due to an “active” product perception. According to Nutrition Business Journal ( NBJ), U.S. sales of mineral supplements in 2004 were $1.7 billion, rising in 2005 to $1.8 billion, with growth likely continuing over the next several years. “A good percentage of mineral ingredients sales seem to be driven by the formulations of large name-brand vitamin products,” said BI’s Mr. Gutierrez. “There are many ‘me too’ generic equivalents out in the market that try to simulate the well known brands. When the large brands reformulate their products, the generic equivalents also follow with the same changes. Knowing this, we try to supply mineral ingredients in a form that is ideal for these applications. We sell a lot of mineral triturates that are dispersed or granulated in highly compressible fast-flowing excipients that are ideal for tablet manufacturing.”

Watson’s Ms. Wilkinson pointed out that triturated products are used to improve homogeneity. “The largest issue with trace minerals is homogeneity,” said Ms. Wilkinson. “If you consider that the recommended use rates for all of these nutrients are measured in micrograms, it becomes a challenge to get that small amount blended across a typical batch so that a label claim can be guaranteed.

Ms. Wilkinson also said macro minerals take up a lot of space in a formulation, causing a product to become dry/pasty, and will mute flavors. She advises people to choose non-reactive sources if possible (i.e., dimagnesium phosphate over magnesium oxide). “If a reactive source is chosen, we would use an encapsulated form if the processing conditions allow for it.”

When formulating with iron, which is present in two ionic forms—ferrous and ferric iron—the “European Mineral Fortification and Supplement Market” report from Frost & Sullivan claims ferrous sulfate is much better absorbed than ferric iron. According to the report, “The most common form used in iron supplements is ferrous sulfate. However, ferrous sulfate consumption has been associated with certain side effects such as constipation, nausea and bloating. Some forms of ferrous sulfate are enteric coated to delay tablet dissolving and prevent some of the side effects, but enteric coated iron may not absorb as well as iron from standard supplements. Other forms of iron supplements, such as ferrous fumarate, ferrous gluconate, haem iron concentrate and iron glycine amino acid chelate are readily absorbed and less likely to cause side effects.”

Formulators also have to take into account that some forms of minerals and trace elements can be toxic if taken in the wrong form or potency.

Market Update

Calcium continues to dominate the mineral market with U.S. sales of just over $1 billion, according to NBJ. A recent long-term study has provided concrete evidence that increased calcium absorption actually translates into tangible improvements in bone health. The human intervention study conducted at the Children’s Nutrition Research Center at Baylor University measured 100 adolescents who were given either 8 grams of Orafti’s Beneo Synergy1, a unique composition of oligofructose and inulin derived from the chicory root, or an equivalent amount of placebo every day for a year.

“Calcium absorption and bone mineral density were far higher in those who consumed Beneo Synergy1,” said Orafti’s Mr. O’Neill. “After one year, the increase in bone mineral density among the Beneo Synergy1 group was 45% higher compared to the controls. The researchers also measured bone mineral content and found that in the Beneo Synergy1 group the bone calcium accretion increased by an extra 30 mg per day, proof that extra calcium was actually deposited in the bones.”

According to Ashley Wike, market development specialist, Purac America, Inc., Lincolnshire, IL, the latest consumer trends suggest an increasing interest in the bioavailability of different mineral sources. To demonstrate this movement, Purac commissioned a study conducted by The Natural Marketing Institute (NMI), Harleysville, PA, to evaluate consumers’ attitudes, behavior and usage patterns of mineral fortified beverages. “The research study indicated that 59% of consumers are interested in learning more about how calcium is absorbed in the body, and 53% indicated they would try a beverage with a more bioavailable calcium source,” said Ms. Wike. “Consumers are also becoming more knowledgeable and aware that there are insoluble sources of calcium on the market, and that they may not be getting the intended levels they are seeking.”

Three other popular minerals are chromium, magnesium and zinc, which brought in $125 million, $202 million and $79 million, in U.S. sales in 2005, respectively, according to NBJ.

“Undoubtedly, one of the ‘hottest’ minerals to grab attention over the last decade has been chromium, an essential trace mineral required for normal insulin function,” said Massood Moshrefi, PhD, vice president of operations and technical services, InterHealth Nutraceuticals, Inc., Benicia, CA. “The diabetes epidemic and associated metabolic syndrome have further increased interest and attention.”

Max Motyka, director human products division, Albion Advanced Nutrition, St. Clair Shores, MI, agreed. “The trend in mineral supplementation is reflective of the growing problem in the health of Americans. This includes metabolic syndrome X, which involves insulin resistance leading to type II diabetes, hypertension, heart disease and atherosclerosis,” said Mr. Motyka. “Chromium is of importance to this syndrome, but the research trend is showing that magnesium and zinc are probably even more crucial to this problem.”

Experiencing 15% growth in sales from 2004 to 2005, magnesium usage is also rising due to its association with the prevention of cardiovascular disease. “Health organizations are considering recommendations to fortify with magnesium in order to prevent deaths related to heart attacks,” said ICL’s Ms. Heidolph.

The scientific community is also more conscious of the relevance of selenium and so is the consumer. NBJ reports that selenium experienced 8% growth from 2004 to 2005, going from $62 million in sales to $68 million in sales. A major reason for this growth has to do with selenium’s role in the prevention of prostate cancer.

Sabinsa Corp., Payson, UT, continues to provide its selenium product, SeleniumSelect, for the ongoing SELECT trial (Selenium and Vitamin E Cancer Prevention Trial). “This is a 12-year prospective study in the prevention of prostate cancer conducted under the auspices of the National Cancer Institute (NCI) and the National Institutes of Health (NIH),” said Dr. Vladimir Badmaev, vice president of scientific and medical affairs, Sabinsa. “This study was put together based on previous studies suggesting that selenium and vitamin E may reduce the risk of developing prostate cancer by 60% and 30%, respectively, but only a large clinical trial such as SELECT can confirm those initial findings.” SELECT closed enrollment in June 2004 with 35,534 men over 50 years old from North America.

Another trial still underway is called PREADVISE (Prevention of Alzheimer’s Disease by Vitamin E and Selenium), an important addition to the SELECT trial. According to Dr. Badmaev, the purpose of PREADVISE is to determine if taking selenium and/or vitamin E supplements can prevent Alzheimer’s disease and other less common forms of dementia. More than 10,000 of the more than 35,000 men in SELECT are taking part in the PREADVISE trial.

But selenium’s role in health goes beyond cancer prevention, according to Embria’s Dr. Reeves. “There is also an increasing awareness that selenium status can have an important effect on the progression on viral infections,” he said. “Scientific literature shows that people with low selenium status who are HIV positive progress to full blown AIDS more quickly than people with an adequate selenium status—an aspect of viral infection.”

There are many areas in the world where soil is selenium deficient and supplementing food can be approached as a public health exercise. “One example is in Finland where the soil is very deficient in selenium and the average selenium intake is way below what it should be,” said Dr. Reeves. “Finland dealt with this by fortifying fertilizer with selenium. That’s a long way to the food chain, but it is a way of getting a better mineral balance in the population.”

Dr. Chris Meletis, research science officer, Trace Minerals, Ogden, UT, predicts the next “hot” mineral to gain recognition for its therapeutic benefits will be strontium, which is best known for its positive effects in bone health.

“Many trace, colloidal, and ionic minerals and electrolytes were, in the past, considered to be inessential to human health,” LycoRed’s Mr. Murphy pointed out. “Today, scientists are presenting a very different picture and consequently, many more of these trace minerals are being reclassified as beneficial or essential to good health.”

“But selenium and chromium continue to grow the most aggressively when it comes to solid and progressive scientific and clinical evidence,” said Dr. Meletis. “It is all about the science. The only minerals and nutrients that will sustain their position in the marketplace and in the realm of true tools to support health are those that have strong roots in medical literature.”

Looking Ahead

In the coming years, Mr. Wright expects more sophisticated, value-added delivery forms to arise, including more use of amino acid chelates. “These products are the most biologically compatible forms available and really mimic how the body absorbs minerals from the food supply,” he said. “There will also be more attention paid to trace elements such as boron, silicon, vanadium, germanium and molybdenum, as companies try to develop unique positionings around specific minerals.”

LycoRed’s Mr. Murphy offered a similar perspective. “In general, more minerals will be used in synergistic ratios and combinations that allow for optimal absorption,” he commented. “Concerns for bioavailability and optimization of absorption efficiency will lead to more controlled-release minerals.”

Industry experts are all in agreement that the food and beverage area in particular will continue to grow worldwide. “At one time, fortification was seen as a means to prevent nutrient deficiencies,” said Mr. Murphy. “In 2006, we are way beyond that point. Today, consumers are not satisfied with simply preventing deficiencies and deficiency related disease, they are demanding optimum health. Food manufacturers are responding with a wide array of fortified foods and beverages.”

As more peer-reviewed science reveals the true functionality of certain ingredients, many believe more companies will petition the FDA for allowed health claims. “But even if companies are not be able to make a claim, there is recognition that more consumers are reading nutrition labels and making purchasing decisions based upon what they see,” said ICL’s Ms. Heidolph.