Sean Moloughney04.01.09
Traditionally considered the "bread and butter" of the nutraceuticals industry, vitamins and minerals have been burned recently by several clinical studies that question the ability of these nutrients to prevent chronic disease. At the same time, the category seems ready to progress with emerging stars like vitamin D, which shows great potential to impact public health. So, as consumers and the scientific community attempt to juggle the good news with the bad, just where will this $10 billion market land in the coming years?
The frequency at which large clinical trial results are published seems to have accelerated recently. As the National Institutes of Health (NIH) prepares to receive $10 billion for medical research, courtesy of the economic stimulus bill Congress passed in February, nutritional science shows no sign of slowing.
Paul Coates, PhD, director of the NIH Office of Dietary Supplements (ODS), noted that clinical evaluation of vitamins and minerals is "very dynamic and still moving." Charged with supporting and stimulating research while translating and disseminating information for consumers, Dr. Coates said, "We will continue to do whatever we can to explore the possible role of nutrients in chronic disease prevention."
With much still to look forward to, potentially, the full story behind scientific data needs to be viewed in broad context, according to Andrew Shao, PhD, vice president, scientific and regulatory affairs with the Washington, D.C.-based Council for Responsible Nutrition (CRN).
"It's important to remember that no one study is ever the final word, and every study has strengths and limitations, each one contributing to the evidence base in a unique way," he said. "Science is an evolutionary discipline; we learn things from one study and then seek to confirm those results, look in a different direction or test for even more possibilities."
With these sentiments in mind, several negative study findings have made headlines in mainstream media outlets recently. For instance, research published in February in the Archives of Internal Medicine concluded that multivitamin use has little or no influence on the risk of common cancers, cardiovascular disease (CVD) or total mortality in postmenopausal women. A much-circulated New York Times story ran with the headline: "Vitamin Pills: A False Hope?"
The study evaluated data from the Women's Health Initiative, which involved 161,808 participants-including three groups of 68,132 subjects in overlapping trials of hormone therapy, dietary modification and calcium and vitamin D supplementation-as well as 93,676 women from an observational study.
Subjects-including 41.5% who used multivitamins-were followed for an average of about eight years. After that time span, according to study conclusions, analyses revealed no association of multivitamin use with risk of cancers of the breast (invasive), colon/rectum, endometrium, kidney, bladder, stomach, ovary and lung; CVD (myocardial infarction, stroke and venous thromboembolism); or total mortality.
Despite the negative press, multivitamins continue to dominate the larger $10 billion vitamin and mineral market, generating $4.5 billion in U.S. sales in 2007-representing 4% growth over the previous year, according to Nutrition Business Journal (NBJ), Boulder, CO. Experts remain confident that consumers will continue their established supplement regimens, especially as most people are very much aware of their own dietary deficiencies.
Still, multivitamins don't reach all those who could benefit from them. According to a study published in February in the Archives of Pediatrics and Adolescent Medicine, about 34% of children between the ages of 2 and 17 use vitamin and mineral supplements. However, children who may benefit most from these supplements were less likely to take them. These data were based on the National Health and Nutrition Examination Survey (NHANES), which evaluated 10,828 U.S. children.
"These authors found that vitamin supplement use was associated with indicators of healthy behaviors, such as eating a well-balanced diet and being physically active," explained Michael McBurney, PhD, FACN, head of scientific affairs, DSM Nutritional Products, Parsippany, NJ. "They also found that children with food insecurity or living in food stamp eligible families were the least likely to take a supplement."
Meanwhile, despite a significant body of historical data supporting their efficacy, vitamin E and selenium may have suffered from the most recent clinical findings. Vitamin E sales of $391 million in 2007 are down 4% from the previous year. Likewise, selenium sales of $63 million are down 3% over the same period.
The highly anticipated, and since hotly debated, Selenium and Vitamin E Cancer Prevention Trial (SELECT) came to an abrupt halt this past October when the National Cancer Institute (NCI) terminated the study early based on an independent review of data.
This randomized, placebo-controlled trial assigned 35,533 men aged 50 and older to one of four groups-selenium, vitamin E, selenium + vitamin E, and placebo. Researchers administered 200 micrograms of oral selenium per day from L-selenomethionine and matched vitamin E placebo, 400 IU of vitamin E and matched selenium placebo, selenium + vitamin E, or placebo + placebo for a planned minimum follow-up of seven years.
After five years, results showed these nutrients not only failed to prevent prostate cancer, but also indicated a "statistically non-significant" increased risk of prostate cancer in the vitamin E group and the same for type 2 diabetes mellitus in the selenium group.
SELECT was initiated after secondary analyses of two randomized controlled trials and supportive epidemiologic and preclinical data indicated the potential of selenium and vitamin E to prevent prostate cancer. Critics of SELECT say previous evidence remains valid, often citing the form of selenium used as the root cause for outcome discrepancies.
"With the benefit of hindsight, it's easy to second-guess the investigators," said Gameil Fouad, PhD, president, Biotron Laboratories, Centerville, UT. "Still, one is tempted to ask why selenium yeast wasn't used in the SELECT trial as opposed to a single isolated form of selenium, given that SELECT was designed to be a more rigorous and truly hypothesis-driven project. The SELECT experience highlights another difficulty with these kinds of studies. The action of any given nutrient is susceptible to so many confounding factors that it is notoriously difficult to draw firm conclusions even in the most well executed trials."
Dr. Coates, of ODS, said he believes the SELECT trial was well conceived, but agreed that its conclusion does not close the book on the issue at hand. "The question is still out there to be answered. Would the combination of these nutrients prevent prostate cancer?"
According to Paul Willis, CEO of Fresno, CA-based Cypress Systems, which makes SelenoExcell high selenium yeast, the results from SELECT highlight an important issue regarding vitamin and mineral compounds: specific chemical composition is critical. "For the first time [SELECT] brought clarity to the position that form absolutely does matter," he said.
For example, in 1996, researchers at the University of Arizona and Cornell University reported in the Journal of the American Medical Association (JAMA) that regular use of 200 micrograms per day of selenium in the form of SelenoExcell (high selenium yeast) reduced the incidence of lung, colon and prostate cancers by 50-63%.
Following this NCI-funded Nutritional Prevention of Cancer (NPC) trial, conducted by Larry Clark along with Gerald Combs and others, oncology groups began submitting grant applications to NCI. In 1997, Cypress began an extensive standardization process with NCI, which resulted in the signing of a clinical trial agreement on SelenoExcell. As a result, it will be used as the sole intervention agent in a series of future cancer (colon, lung and prostate) prevention trials.
Cypress Systems has also initiated a consumer awareness campaign, looking to capitalize on media attention surrounding COO Mark Whitacre-the famed whistleblower in the Archer Daniels Midland (ADM) price-fixing scheme of the 1990s. The upcoming feature film, "The Informant," is based on his experiences.
"Cypress Systems has dedicated many years and resources into pharmaceutical grade research for selenium, which is almost unheard of for a supplement," said Mr. Whitacre. "I am passionate about the prevention of cancer, and we at Cypress will use this once-in-a-lifetime media platform that the upcoming movie creates in order to raise consumer awareness as to the prevention of cancer and the role that a simple ingredient like selenium plays in the prevention of this dreadful disease."
Faced with conflicting results, the jury may still be deliberating on selenium. But there is sure to be more evidence unveiled in the future. For instance, Kelatron Corporation, Ogden, UT, has been working with researchers at Brigham Young University by providing selenium for trials currently testing the hypothesis that selenium combined with soy-derived isoflavones could reduce prostate cancer risk.
CRN's Dr. Shao noted that many randomized controlled trials (RCTs) on vitamins and minerals have been undertaken because of strong positive evidence from epidemiological studies. And with observational data supporting the use of these supplements as part of a healthy lifestyle, "the reasons for the different results in clinical trials remain to be clarified," he said.
While the sources of such discrepancies remains a hot topic, experts often point to trial design as a critical issue worthy of discussion. "In our view, the negative findings from recent studies do more to inform trial design than speak directly to the benefits (or lack thereof) of a particular nutrient," said Biotron's Dr. Fouad. "Often, the headline-grabbing publications are meta-analyses or retrospective studies that are engaged in linking a certain nutrient and the presence or absence of a perceived benefit. Such examinations are not truly hypothesis-driven and often rely on data sets gathered for other purposes. This is not to say the studies themselves aren't valuable, but it is important to draw clear distinctions between the original endpoints a given study was designed to address, the populations that were involved and the conclusions."
The effects of nutrients in the human body are complex and influenced by many variables, said Dr. Shao. "RCTs may be inherently limited in their capacity to address the unique challenges presented by nutrients and dietary interventions. Nutrients appear to work best in combination with other nutrients, yet RCTs tend to examine effects of single compounds in isolation-which is more how pharmaceuticals work."
Moreover, establishing a true control or placebo group has become a unique challenge for researchers. "The problem is we don't have good metrics or measures to establish a baseline from which to draw comparisons," said Daniel Fabricant, vice president, Scientific & Regulatory Affairs, Natural Products Association, Washington, D.C. "It's a complicated issue and there's got to be some thinking about more adaptive trial designs."
Dr. Coates said he believes the RCT design has great value in determining the impact nutrients impart, as it eliminates confounding effects. "Information from observational studies and other pre-intervention trials can be very valuable in providing clues, determining endpoints and discerning populations. I'd be really interested in finding ways to enhance or look at alternatives to existing strategies. But I'm always cautious about building a case for health effects based simply on observational studies."
Most agree that vitamins and minerals aren't intended to be magic bullets. "I wouldn't necessarily want to see a dramatic, homerun effect," said Dr. Coates. "I'd be very worried to see a profound biological effect. Risk almost invariably follows the benefit. I'm comfortable with relatively small effect seen over a long period of time."
Alongside its role in SELECT, vitamin E was involved in another major, long-term trial that failed to indicate a positive effect on chronic illness prevention-this time paired with vitamin C. The Physicians' Health Study-II, a 10-year, randomized, double-blind, placebo-controlled factorial trial concluded that vitamins E and C failed to reduce risk of CVD in middle-aged and older men after evaluating 14,641 U.S. male physicians, who were aged 50 or older at the time of enrollment (including 754 men-5% with prevalent CVD at randomization).
Participants received 400 IU of vitamin E every other day and 500 mg of vitamin C daily. During a mean follow-up of eight years, there were 1245 confirmed major cardiovascular events. Findings were published in JAMA.
Despite these unflattering study results, Sharrann Simmons, senior marketing manager, Cognis Nutrition & Health, La Grange, IL, said traditional vitamins such as A, C and E could be making a resurgence.
"I think the average consumer today is getting numb," she said. "One day they hear about a study with good results, and the next day another with bad. They don't really know what to trust. People are reverting back to nutrition models they learned early in life-things they've been taught from their early days." Vitamins and minerals offer "affordable insurance," she added. "It's a good maintenance plan."
Vitamin E in particular could find new comfort in the beauty market, according to Ms. Simmons. "The whole idea of vitamin E as an antioxidant with anti-aging and skin health benefits has vastly overshadowed negative results," she said. "Cosmeceuticals has been and is growing in terms of a category. Vitamin E is finding a new position in the 'beauty from within' market. But consumers need to see good value. People need to understand the value before they pay a premium price."
For example, she said natural forms of vitamin E will continue to grow in popularity and overtake synthetic forms, as consumers revert to more trusted natural sources.
There are two major forms of vitamin D: D3 (cholecalciferol) and D2 (ergocalciferol). Both appear to be absorbed with equal efficiency, but vitamin D3 may be more potent and is significantly more efficient in raising serum levels of 25-hydroxyvitamin D.
Generating significant attention lately, vitamin D-also known as the "sunshine vitamin"-has shown great potential for various health conditions, as medical studies have raised awareness about deficiencies and associated risks.
The American Public Health Association (APHA) recently cited vitamin D deficiency and insufficiency as a leading concern among public health issues. In the past year, the American Medical Association, the American Academy of Pediatrics and the American Academy of Dermatology have also stressed the need for increased intake.
DSM's Dr. McBurney noted that mean serum (OH)D levels in the U.S. were lower in the period between 2000 and 2004 than between 1988 and 1994. "These negative changes are primarily attributable to increasing body mass index (BMI), declining milk intake and increasing sun protection. This means that more Americans are at increasing risk of adverse health outcomes and the nation faces increasing economic burdens related to vitamin D status."
While various health conditions have been associated with this rising star of the vitamin market, evidence has been strongest in the area of bone health. FDA even amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health. The revision authorizes the following health claim: "Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."
Vitamin D promotes calcium absorption in the gut and maintains adequate serum calcium and phosphate concentrations to enable normal mineralization of bones. Health effects associated with a lack of vitamin D can often remain dormant, according to Vladimir Badmaev, MD, PhD, vice president, Medical & Scientific Affairs, Sabinsa Corporation, Piscataway, NJ. "Vitamin D osteopathy, a collection of vitamin D deficiency symptoms, is a condition occurring when there isn't enough vitamin D to make the hormones that maintain healthy calcium balance," he noted. "This condition takes place over a very long time. For a period of up to five years, there may be a shortage of calcium going into the bones, but there are no symptoms."
FDA's amended rule also suggests that all populations may benefit from consuming calcium and vitamin D, not just women and children. Overall, researchers have estimated that nearly half (40-50%) of adults and more than 30% of children in the U.S. are at risk of vitamin D deficiency. Risk is especially high in dark-skinned people who live far from the equator, said Dr. Badmaev. "In the U.S., 42% of African American women between 15 and 49 years of age were vitamin D deficient compared to 4% of white women."
A recent study also found that one in seven American adolescents is deficient in vitamin D, a potential risk factor for high blood pressure, high blood sugar and metabolic syndrome. Low vitamin D status in children has also led to the reemergence of rickets, a bone-weakening disease.
In response to new information, the American Academy of Pediatrics has doubled the amount of vitamin D recommended for infants, children and adolescents, from 200 IU to 400 IU, starting in the first few days of life. Clinical data suggest that 400 IU of vitamin D a day will prevent and treat rickets.
Science indicates the sunshine vitamin plays other roles in human health too, including modulation of neuromuscular and immune function and reduction of inflammation. For example, a secondary analysis of the Third National Health and Nutrition Examination Survey (NHANES) found that individuals with low blood levels of the vitamin D marker 25-hydroxyvitamin D were more likely to have an upper respiratory tract infection (URTI). Specifically, the analysis found that compared to those with levels greater than 30 nanograms/milliliter (ng/ml), individuals with less than 10 ng/ml had a 36% higher risk of having a recent URTI; those with 10 ng/ml to less than 30 ng/ml had 24% higher odds.
Dr. Badmaev also noted a possible association between vitamin D deficiency and occurrence of depression, bipolar disorder and schizophrenia. "Vitamin D activates receptors on neurons in regions implicated in the regulation of behavior, stimulates neurotrophin release, and protects the brain by buffering antioxidant and anti-inflammatory defenses against vascular injury."
In addition, optimum vitamin D levels have been linked to maintaining cardiovascular, colon, breast, prostate and ovarian health. "I'm pleased there have been some interesting results obtained about the possible role of vitamin D in cancer prevention," said Dr. Coates, of ODS. "It also appears to play a role in metabolic and immunologic pathways."
Still, Dr. Coates urged caution in "over-interpreting" study findings. "[These] results need to be verified and validated in other populations. We are trying to aggressively pursue information and health gaps associated with vitamin D."
In August last year, for example, experts convened by NIH reviewed data to find such gaps in clinical evidence and published its proceedings in a supplement to the American Journal of Clinical Nutrition.
CRN's Dr. Shao said the Daily Recommended Intake (DRI) for vitamin D, last published in 1997, is "woefully outdated" and requires prompt revision. "New recommendations currently being considered by the Institute of Medicine's Food and Nutrition Board (FNB) must go beyond avoidance of diseases of overt deficiency affecting only bone related outcomes, and must address avoidance of long-term inadequacy or insufficiency, a consequence of which may be increased risk for several chronic diseases." CRN has also called for reassessment of calcium DRIs.
Dr. Coates said all the available evidence must be weighed carefully before any revisions are formalized and disseminated to the public. "At the end of the day, dietary reference intakes are intended to be recommendations for all Americans," he noted.
Representing more than half of the overall U.S. market for minerals, calcium sales reached $1.1 billion in 2007-a 5% increase from the prior year, according to NBJ.
"Calcium is essential in helping premenopausal women achieve peak bone density early in life," said Biotron's Dr. Fouad. "Maximizing bone density is the best protection against osteoporosis down the road and it seems this principle is understood by consumers. Because calcium is required in relatively large amounts, getting adequate calcium from the diet alone remains difficult for many."
Micah Osborne, president, ESM Technologies, Carthage, MO, said calcium carbonate has higher elemental calcium levels (35%) compared to other forms, such as calcium citrate (24%). ESM offers its ESC ingredient, a highly bioavailable form of calcium carbonate derived from a natural, renewable source: the shell of chicken eggs. "The chicken adds protein to the egg membrane, which allows for better calcium absorption through the epithelial wall," he said. As a result, this bone health ingredient can be taken in a relatively small dose while still offering high potency.
In contrast to some reports, recent evidence suggests calcium may play a role outside its traditional position in supporting bone health. Previous observational studies have shown an inconsistent relationship between calcium intake and cancer. But data published in the Archives of Internal Medicine suggest that women with higher intakes of calcium from both food and supplements-up to 1300 mg/day-appear to have a lower risk of cancer overall, and both men and women with high calcium intakes have lower risks of colorectal cancer and other cancers of the digestive system.
This large prospective study, part of the NIH AARP Diet and Health Study, followed 293,907 men and 198,903 women, ages 50 to 71. After seven years of follow-up, the study also found that women who were in the top one-fifth of calcium consumption (1881 mg/day from a combination of conventional food and supplements) had a 23% lower risk of digestive types of cancer, particularly colorectal cancer, than those in the bottom one-fifth (494 mg/day). Men who consumed the most calcium from conventional foods and supplements (about 1530 mg/day) also had a 16% lower risk of digestive types of cancer than those who consumed the least calcium.
In addition to calcium and vitamin D, several studies published over the past few years suggest that higher intake of vitamin K may increase bone mineral density and reduce the risk of fracture.
Vitamin K denotes a group of fat-soluble vitamins (K1 and K2) primarily responsible for the carboxylation (activation) of certain proteins that block precipitation of calcium in the arteries, allowing it to bind to the mineral structure of bone.
"The risk of death after major bone fractures increases by 65% for women and 70% for men," according to Cecilia McCollum, executive vice president, Blue California, Rancho Santa Margarita, CA, which produces Natural Vitamin K2 1% (menaquinone-4). "As a matter of fact, any bone fracture increases the risk of death for patients over 75 years old. We believe supplementation with vitamin K2 provides men and women with the opportunity to build stronger bone structure, and possibly prevent fractures and reduce the risk of injury and death from falls."
Research also indicates that vitamin K has clear benefits for children. In a recent study published in Clinical and Experimental Rheumatology, high vitamin K status in healthy children and those with juvenile idiopathic arthritis correlated with better bone properties, whereas low blood concentrations of active osteocalcin-indicative of poor vitamin K status-were associated with a significant impairment in bone quality.
There are several forms of vitamin K2-designated as menaquinones-1 through -10. Vitamin K2 in the form of menaquinone-7 is believed to have a longer half-life than vitamin K1 or the menaquinone-4 form of vitamin K2, resulting in more stable serum levels. But according to Ms. McCollum, a product standardized to 1% menaquinone-4 delivers more vitamin K than a product with .1% menaquinone-7. Blue California has started a review to attain GRAS (Generally Recognized as Safe) self-affirmation for use of its product in foods.
While data indicates typical Western diets are deficient in vitamin K, the traditional Japanese food natto, made from fermented soybeans, has been one of the best sources of menoquinone-7. PL Thomas, Morristown, NJ, and Norway-based NattoPharma have teamed up to offer MenaQ7 natural vitamin K2 extracted from natto, which is available for use in food and supplements. MenaQ7 provides optimal vitamin K status with a recommended daily dose of 45-90 micrograms.
Different chemical compositions of specific vitamin or mineral compounds affect the human body in unique ways. This is perhaps best seen in the B vitamin category, which constitutes a market worth more than $1 billion in the U.S.
"The B vitamin group receives steady attention as nutritional supplements, especially for its role in metabolism of carbohydrates, and support of the cardiovascular system and the digestive tract," said Sabinsa's Dr. Badmaev.
One of the most versatile nutrients involved in physical and mental well-being, vitamin B6 is fundamental to a properly functioning central nervous system. It participates in the formation of red blood cells and plays an important role in cancer immunity and cardiovascular health by inhibiting the formation of homocysteine, Dr. Badmaev said. It also helps maintain a healthy immune system and may help prevent allergies and asthma, he added.
Vitamin B6 comprises three chemically, metabolically and functionally related forms: pyridoxine, pyridoxal and pyridoxamine. After a Citizen's Petition was filed in 2005, FDA effectively banned pyridoxamine from use in dietary supplements in January, saying it has been authorized for investigation as a new drug for which substantial clinical investigations have been conducted and that there is no independent, verifiable evidence of prior marketing as a food or dietary supplement. The issue has raised concern among trade associations, which fear the decision could establish precedent for challenges to the status of other dietary ingredients.
However, B vitamins as a family remain very functional. For example, previous observational studies have suggested an association between lower homocysteine concentrations in the blood and lower risk of age-related macular degeneration (AMD). In a recent randomized, double-blind, placebo-controlled trial, 5442 female healthcare professionals age 40 years or older received a placebo or a combination of vitamin B9 (folic acid) (2.5 mg/day), vitamin B6 (50 mg/day) and vitamin B12 (1 mg/day). After more than 7 years of follow-up, women taking the supplements had a 41% lower risk of visually significant AMD.
This trial was part of the Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS), which failed to show any association between the use of these vitamins and reduced risk of major vascular events among women who either had a history of CVD or were considered at high risk. Moreover, the larger Women's Antioxidant Cardiovascular Study (WACS), which involved 8171 females, also failed to show correlation between CVD risk and use of antioxidant vitamins A, C or E after a mean follow-up of nine years.
Still, according to the U.S. Public Health Service Act, all women of childbearing age should consume 400 micrograms of folic acid a day. Studies have shown that if taken before and during early pregnancy, folic acid can significantly reduce the number of birth defects of the brain and spine, also known as neural tube defects, by up to 70%.
The minerals segment grew 5% to nearly $2 billion in 2007. Alongside calcium, magnesium has held a strong market share, growing 13% to reach $271 million in sales. Likewise, iron is up about 7% to $253 million and potassium has grown 4% to $78 million. However, chromium has declined 6% to $108 million and zinc dipped a modest 2% to $72 million.
Dave Johnson, vice president of business development, Kelatron Corporation, Ogden, UT, said the mineral market continues to attract consumers based on years of efficacy studies.
"Magnesium, iron, potassium, calcium and zinc all play vital roles in cellular function and continue to be needed as supplements, as the foods we eat become more processed and less nutritious," he said. In the meantime, Kelatron continues to invest in chelated minerals, increasing bioavailability, reduced gut intolerance and solubility.
Patrick Stano, vice president, Sales and Marketing, North America, with Dr. Paul Lohmann Inc., Islandia, NY, said he is seeing the most interest for magnesium, calcium, potassium and iron. "There are several recent studies that might explain the interest in these particular minerals," he said. "One is a recent study by the North Central Cancer Research Group, which showed that magnesium may help reduce the risk of cerebral palsy. Another recent study shows that potassium may actually lower blood pressure."In an effort to continue attracting consumers, manufacturers-focused on convenience-are utilizing new delivery systems such as powdered stick packs that can be added to bottles of water, liquid supplements, quick dissolving strips and chewable tablets, said Mr. Stano.
"The number of liquid supplements has increased and as a result, so has demand for mineral salts with better solubility," he said. "One of the ways to achieve better solubility is through minerals with finer particle size and we have seen an increase in the sales of our micronized grades. We have also seen an increased interest in our microencapsulated minerals for taste masking, as well as our premixed mineral blends where we combine minerals and other functional ingredients together to provide a synergistic effect, such as our calcium-inulin product, which is available in a granular form."
In general, traditional pill formats for vitamins and minerals have given some ground to functional food and beverages.
"Starting with the enrichment of bread, the fortification of everything ranging from a ready-to-drink (RTD) replacement shake to a simple jar of peanut butter, numerous products have had value added ingredients incorporated into them," said Vanessa Teter, food technologist, Watson Incorporated, West Haven, CT. "While the same obstacles exist (i.e., off flavors and odors), vitamin and mineral sources have improved and can now be included in a simple water beverage without detection, which has always appealed to consumers."
The use of spray drying to encapsulate oil-soluble vitamins into a starch matrix has improved the solubility of these vitamins in many RTD products, regardless of the product base, she added. "Vitamins A, D, E and K can now be used in thick shake-like products along with juices with little to no detection in the final product. Lipid encapsulation has helped the bar industry with meal replacement bars containing high levels of vitamins and minerals with a much improved flavor profile."
While the fortification of foods and beverages will certainly continue to advance, according to Cognis' Ms. Simmons, "People are relying on both supplements and functional foods, not at the exclusion of one over the other."
Ultimately, technological and scientific innovation will drive the broad, still profitable market for vitamins and minerals forward-past any rocky terrain it encounters.
The frequency at which large clinical trial results are published seems to have accelerated recently. As the National Institutes of Health (NIH) prepares to receive $10 billion for medical research, courtesy of the economic stimulus bill Congress passed in February, nutritional science shows no sign of slowing.
Paul Coates, PhD, director of the NIH Office of Dietary Supplements (ODS), noted that clinical evaluation of vitamins and minerals is "very dynamic and still moving." Charged with supporting and stimulating research while translating and disseminating information for consumers, Dr. Coates said, "We will continue to do whatever we can to explore the possible role of nutrients in chronic disease prevention."
With much still to look forward to, potentially, the full story behind scientific data needs to be viewed in broad context, according to Andrew Shao, PhD, vice president, scientific and regulatory affairs with the Washington, D.C.-based Council for Responsible Nutrition (CRN).
"It's important to remember that no one study is ever the final word, and every study has strengths and limitations, each one contributing to the evidence base in a unique way," he said. "Science is an evolutionary discipline; we learn things from one study and then seek to confirm those results, look in a different direction or test for even more possibilities."
'False Hope?'
With these sentiments in mind, several negative study findings have made headlines in mainstream media outlets recently. For instance, research published in February in the Archives of Internal Medicine concluded that multivitamin use has little or no influence on the risk of common cancers, cardiovascular disease (CVD) or total mortality in postmenopausal women. A much-circulated New York Times story ran with the headline: "Vitamin Pills: A False Hope?"
The study evaluated data from the Women's Health Initiative, which involved 161,808 participants-including three groups of 68,132 subjects in overlapping trials of hormone therapy, dietary modification and calcium and vitamin D supplementation-as well as 93,676 women from an observational study.
Subjects-including 41.5% who used multivitamins-were followed for an average of about eight years. After that time span, according to study conclusions, analyses revealed no association of multivitamin use with risk of cancers of the breast (invasive), colon/rectum, endometrium, kidney, bladder, stomach, ovary and lung; CVD (myocardial infarction, stroke and venous thromboembolism); or total mortality.
Despite the negative press, multivitamins continue to dominate the larger $10 billion vitamin and mineral market, generating $4.5 billion in U.S. sales in 2007-representing 4% growth over the previous year, according to Nutrition Business Journal (NBJ), Boulder, CO. Experts remain confident that consumers will continue their established supplement regimens, especially as most people are very much aware of their own dietary deficiencies.
Still, multivitamins don't reach all those who could benefit from them. According to a study published in February in the Archives of Pediatrics and Adolescent Medicine, about 34% of children between the ages of 2 and 17 use vitamin and mineral supplements. However, children who may benefit most from these supplements were less likely to take them. These data were based on the National Health and Nutrition Examination Survey (NHANES), which evaluated 10,828 U.S. children.
"These authors found that vitamin supplement use was associated with indicators of healthy behaviors, such as eating a well-balanced diet and being physically active," explained Michael McBurney, PhD, FACN, head of scientific affairs, DSM Nutritional Products, Parsippany, NJ. "They also found that children with food insecurity or living in food stamp eligible families were the least likely to take a supplement."
SELECT on Trial
Meanwhile, despite a significant body of historical data supporting their efficacy, vitamin E and selenium may have suffered from the most recent clinical findings. Vitamin E sales of $391 million in 2007 are down 4% from the previous year. Likewise, selenium sales of $63 million are down 3% over the same period.
The highly anticipated, and since hotly debated, Selenium and Vitamin E Cancer Prevention Trial (SELECT) came to an abrupt halt this past October when the National Cancer Institute (NCI) terminated the study early based on an independent review of data.
This randomized, placebo-controlled trial assigned 35,533 men aged 50 and older to one of four groups-selenium, vitamin E, selenium + vitamin E, and placebo. Researchers administered 200 micrograms of oral selenium per day from L-selenomethionine and matched vitamin E placebo, 400 IU of vitamin E and matched selenium placebo, selenium + vitamin E, or placebo + placebo for a planned minimum follow-up of seven years.
After five years, results showed these nutrients not only failed to prevent prostate cancer, but also indicated a "statistically non-significant" increased risk of prostate cancer in the vitamin E group and the same for type 2 diabetes mellitus in the selenium group.
SELECT was initiated after secondary analyses of two randomized controlled trials and supportive epidemiologic and preclinical data indicated the potential of selenium and vitamin E to prevent prostate cancer. Critics of SELECT say previous evidence remains valid, often citing the form of selenium used as the root cause for outcome discrepancies.
"With the benefit of hindsight, it's easy to second-guess the investigators," said Gameil Fouad, PhD, president, Biotron Laboratories, Centerville, UT. "Still, one is tempted to ask why selenium yeast wasn't used in the SELECT trial as opposed to a single isolated form of selenium, given that SELECT was designed to be a more rigorous and truly hypothesis-driven project. The SELECT experience highlights another difficulty with these kinds of studies. The action of any given nutrient is susceptible to so many confounding factors that it is notoriously difficult to draw firm conclusions even in the most well executed trials."
Dr. Coates, of ODS, said he believes the SELECT trial was well conceived, but agreed that its conclusion does not close the book on the issue at hand. "The question is still out there to be answered. Would the combination of these nutrients prevent prostate cancer?"
According to Paul Willis, CEO of Fresno, CA-based Cypress Systems, which makes SelenoExcell high selenium yeast, the results from SELECT highlight an important issue regarding vitamin and mineral compounds: specific chemical composition is critical. "For the first time [SELECT] brought clarity to the position that form absolutely does matter," he said.
For example, in 1996, researchers at the University of Arizona and Cornell University reported in the Journal of the American Medical Association (JAMA) that regular use of 200 micrograms per day of selenium in the form of SelenoExcell (high selenium yeast) reduced the incidence of lung, colon and prostate cancers by 50-63%.
Following this NCI-funded Nutritional Prevention of Cancer (NPC) trial, conducted by Larry Clark along with Gerald Combs and others, oncology groups began submitting grant applications to NCI. In 1997, Cypress began an extensive standardization process with NCI, which resulted in the signing of a clinical trial agreement on SelenoExcell. As a result, it will be used as the sole intervention agent in a series of future cancer (colon, lung and prostate) prevention trials.
Cypress Systems has also initiated a consumer awareness campaign, looking to capitalize on media attention surrounding COO Mark Whitacre-the famed whistleblower in the Archer Daniels Midland (ADM) price-fixing scheme of the 1990s. The upcoming feature film, "The Informant," is based on his experiences.
"Cypress Systems has dedicated many years and resources into pharmaceutical grade research for selenium, which is almost unheard of for a supplement," said Mr. Whitacre. "I am passionate about the prevention of cancer, and we at Cypress will use this once-in-a-lifetime media platform that the upcoming movie creates in order to raise consumer awareness as to the prevention of cancer and the role that a simple ingredient like selenium plays in the prevention of this dreadful disease."
Faced with conflicting results, the jury may still be deliberating on selenium. But there is sure to be more evidence unveiled in the future. For instance, Kelatron Corporation, Ogden, UT, has been working with researchers at Brigham Young University by providing selenium for trials currently testing the hypothesis that selenium combined with soy-derived isoflavones could reduce prostate cancer risk.
Design in Mind
CRN's Dr. Shao noted that many randomized controlled trials (RCTs) on vitamins and minerals have been undertaken because of strong positive evidence from epidemiological studies. And with observational data supporting the use of these supplements as part of a healthy lifestyle, "the reasons for the different results in clinical trials remain to be clarified," he said.
While the sources of such discrepancies remains a hot topic, experts often point to trial design as a critical issue worthy of discussion. "In our view, the negative findings from recent studies do more to inform trial design than speak directly to the benefits (or lack thereof) of a particular nutrient," said Biotron's Dr. Fouad. "Often, the headline-grabbing publications are meta-analyses or retrospective studies that are engaged in linking a certain nutrient and the presence or absence of a perceived benefit. Such examinations are not truly hypothesis-driven and often rely on data sets gathered for other purposes. This is not to say the studies themselves aren't valuable, but it is important to draw clear distinctions between the original endpoints a given study was designed to address, the populations that were involved and the conclusions."
The effects of nutrients in the human body are complex and influenced by many variables, said Dr. Shao. "RCTs may be inherently limited in their capacity to address the unique challenges presented by nutrients and dietary interventions. Nutrients appear to work best in combination with other nutrients, yet RCTs tend to examine effects of single compounds in isolation-which is more how pharmaceuticals work."
Moreover, establishing a true control or placebo group has become a unique challenge for researchers. "The problem is we don't have good metrics or measures to establish a baseline from which to draw comparisons," said Daniel Fabricant, vice president, Scientific & Regulatory Affairs, Natural Products Association, Washington, D.C. "It's a complicated issue and there's got to be some thinking about more adaptive trial designs."
Dr. Coates said he believes the RCT design has great value in determining the impact nutrients impart, as it eliminates confounding effects. "Information from observational studies and other pre-intervention trials can be very valuable in providing clues, determining endpoints and discerning populations. I'd be really interested in finding ways to enhance or look at alternatives to existing strategies. But I'm always cautious about building a case for health effects based simply on observational studies."
Most agree that vitamins and minerals aren't intended to be magic bullets. "I wouldn't necessarily want to see a dramatic, homerun effect," said Dr. Coates. "I'd be very worried to see a profound biological effect. Risk almost invariably follows the benefit. I'm comfortable with relatively small effect seen over a long period of time."
Alongside its role in SELECT, vitamin E was involved in another major, long-term trial that failed to indicate a positive effect on chronic illness prevention-this time paired with vitamin C. The Physicians' Health Study-II, a 10-year, randomized, double-blind, placebo-controlled factorial trial concluded that vitamins E and C failed to reduce risk of CVD in middle-aged and older men after evaluating 14,641 U.S. male physicians, who were aged 50 or older at the time of enrollment (including 754 men-5% with prevalent CVD at randomization).
Participants received 400 IU of vitamin E every other day and 500 mg of vitamin C daily. During a mean follow-up of eight years, there were 1245 confirmed major cardiovascular events. Findings were published in JAMA.
Despite these unflattering study results, Sharrann Simmons, senior marketing manager, Cognis Nutrition & Health, La Grange, IL, said traditional vitamins such as A, C and E could be making a resurgence.
"I think the average consumer today is getting numb," she said. "One day they hear about a study with good results, and the next day another with bad. They don't really know what to trust. People are reverting back to nutrition models they learned early in life-things they've been taught from their early days." Vitamins and minerals offer "affordable insurance," she added. "It's a good maintenance plan."
Vitamin E in particular could find new comfort in the beauty market, according to Ms. Simmons. "The whole idea of vitamin E as an antioxidant with anti-aging and skin health benefits has vastly overshadowed negative results," she said. "Cosmeceuticals has been and is growing in terms of a category. Vitamin E is finding a new position in the 'beauty from within' market. But consumers need to see good value. People need to understand the value before they pay a premium price."
For example, she said natural forms of vitamin E will continue to grow in popularity and overtake synthetic forms, as consumers revert to more trusted natural sources.
Vitamin D: A Big Bright Spot
There are two major forms of vitamin D: D3 (cholecalciferol) and D2 (ergocalciferol). Both appear to be absorbed with equal efficiency, but vitamin D3 may be more potent and is significantly more efficient in raising serum levels of 25-hydroxyvitamin D.
Generating significant attention lately, vitamin D-also known as the "sunshine vitamin"-has shown great potential for various health conditions, as medical studies have raised awareness about deficiencies and associated risks.
The American Public Health Association (APHA) recently cited vitamin D deficiency and insufficiency as a leading concern among public health issues. In the past year, the American Medical Association, the American Academy of Pediatrics and the American Academy of Dermatology have also stressed the need for increased intake.
DSM's Dr. McBurney noted that mean serum (OH)D levels in the U.S. were lower in the period between 2000 and 2004 than between 1988 and 1994. "These negative changes are primarily attributable to increasing body mass index (BMI), declining milk intake and increasing sun protection. This means that more Americans are at increasing risk of adverse health outcomes and the nation faces increasing economic burdens related to vitamin D status."
While various health conditions have been associated with this rising star of the vitamin market, evidence has been strongest in the area of bone health. FDA even amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health. The revision authorizes the following health claim: "Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis."
Vitamin D promotes calcium absorption in the gut and maintains adequate serum calcium and phosphate concentrations to enable normal mineralization of bones. Health effects associated with a lack of vitamin D can often remain dormant, according to Vladimir Badmaev, MD, PhD, vice president, Medical & Scientific Affairs, Sabinsa Corporation, Piscataway, NJ. "Vitamin D osteopathy, a collection of vitamin D deficiency symptoms, is a condition occurring when there isn't enough vitamin D to make the hormones that maintain healthy calcium balance," he noted. "This condition takes place over a very long time. For a period of up to five years, there may be a shortage of calcium going into the bones, but there are no symptoms."
FDA's amended rule also suggests that all populations may benefit from consuming calcium and vitamin D, not just women and children. Overall, researchers have estimated that nearly half (40-50%) of adults and more than 30% of children in the U.S. are at risk of vitamin D deficiency. Risk is especially high in dark-skinned people who live far from the equator, said Dr. Badmaev. "In the U.S., 42% of African American women between 15 and 49 years of age were vitamin D deficient compared to 4% of white women."
A recent study also found that one in seven American adolescents is deficient in vitamin D, a potential risk factor for high blood pressure, high blood sugar and metabolic syndrome. Low vitamin D status in children has also led to the reemergence of rickets, a bone-weakening disease.
In response to new information, the American Academy of Pediatrics has doubled the amount of vitamin D recommended for infants, children and adolescents, from 200 IU to 400 IU, starting in the first few days of life. Clinical data suggest that 400 IU of vitamin D a day will prevent and treat rickets.
Science indicates the sunshine vitamin plays other roles in human health too, including modulation of neuromuscular and immune function and reduction of inflammation. For example, a secondary analysis of the Third National Health and Nutrition Examination Survey (NHANES) found that individuals with low blood levels of the vitamin D marker 25-hydroxyvitamin D were more likely to have an upper respiratory tract infection (URTI). Specifically, the analysis found that compared to those with levels greater than 30 nanograms/milliliter (ng/ml), individuals with less than 10 ng/ml had a 36% higher risk of having a recent URTI; those with 10 ng/ml to less than 30 ng/ml had 24% higher odds.
Dr. Badmaev also noted a possible association between vitamin D deficiency and occurrence of depression, bipolar disorder and schizophrenia. "Vitamin D activates receptors on neurons in regions implicated in the regulation of behavior, stimulates neurotrophin release, and protects the brain by buffering antioxidant and anti-inflammatory defenses against vascular injury."
In addition, optimum vitamin D levels have been linked to maintaining cardiovascular, colon, breast, prostate and ovarian health. "I'm pleased there have been some interesting results obtained about the possible role of vitamin D in cancer prevention," said Dr. Coates, of ODS. "It also appears to play a role in metabolic and immunologic pathways."
Still, Dr. Coates urged caution in "over-interpreting" study findings. "[These] results need to be verified and validated in other populations. We are trying to aggressively pursue information and health gaps associated with vitamin D."
In August last year, for example, experts convened by NIH reviewed data to find such gaps in clinical evidence and published its proceedings in a supplement to the American Journal of Clinical Nutrition.
CRN's Dr. Shao said the Daily Recommended Intake (DRI) for vitamin D, last published in 1997, is "woefully outdated" and requires prompt revision. "New recommendations currently being considered by the Institute of Medicine's Food and Nutrition Board (FNB) must go beyond avoidance of diseases of overt deficiency affecting only bone related outcomes, and must address avoidance of long-term inadequacy or insufficiency, a consequence of which may be increased risk for several chronic diseases." CRN has also called for reassessment of calcium DRIs.
Dr. Coates said all the available evidence must be weighed carefully before any revisions are formalized and disseminated to the public. "At the end of the day, dietary reference intakes are intended to be recommendations for all Americans," he noted.
Calcium & Vitamin K
Representing more than half of the overall U.S. market for minerals, calcium sales reached $1.1 billion in 2007-a 5% increase from the prior year, according to NBJ.
"Calcium is essential in helping premenopausal women achieve peak bone density early in life," said Biotron's Dr. Fouad. "Maximizing bone density is the best protection against osteoporosis down the road and it seems this principle is understood by consumers. Because calcium is required in relatively large amounts, getting adequate calcium from the diet alone remains difficult for many."
Micah Osborne, president, ESM Technologies, Carthage, MO, said calcium carbonate has higher elemental calcium levels (35%) compared to other forms, such as calcium citrate (24%). ESM offers its ESC ingredient, a highly bioavailable form of calcium carbonate derived from a natural, renewable source: the shell of chicken eggs. "The chicken adds protein to the egg membrane, which allows for better calcium absorption through the epithelial wall," he said. As a result, this bone health ingredient can be taken in a relatively small dose while still offering high potency.
In contrast to some reports, recent evidence suggests calcium may play a role outside its traditional position in supporting bone health. Previous observational studies have shown an inconsistent relationship between calcium intake and cancer. But data published in the Archives of Internal Medicine suggest that women with higher intakes of calcium from both food and supplements-up to 1300 mg/day-appear to have a lower risk of cancer overall, and both men and women with high calcium intakes have lower risks of colorectal cancer and other cancers of the digestive system.
This large prospective study, part of the NIH AARP Diet and Health Study, followed 293,907 men and 198,903 women, ages 50 to 71. After seven years of follow-up, the study also found that women who were in the top one-fifth of calcium consumption (1881 mg/day from a combination of conventional food and supplements) had a 23% lower risk of digestive types of cancer, particularly colorectal cancer, than those in the bottom one-fifth (494 mg/day). Men who consumed the most calcium from conventional foods and supplements (about 1530 mg/day) also had a 16% lower risk of digestive types of cancer than those who consumed the least calcium.
In addition to calcium and vitamin D, several studies published over the past few years suggest that higher intake of vitamin K may increase bone mineral density and reduce the risk of fracture.
Vitamin K denotes a group of fat-soluble vitamins (K1 and K2) primarily responsible for the carboxylation (activation) of certain proteins that block precipitation of calcium in the arteries, allowing it to bind to the mineral structure of bone.
"The risk of death after major bone fractures increases by 65% for women and 70% for men," according to Cecilia McCollum, executive vice president, Blue California, Rancho Santa Margarita, CA, which produces Natural Vitamin K2 1% (menaquinone-4). "As a matter of fact, any bone fracture increases the risk of death for patients over 75 years old. We believe supplementation with vitamin K2 provides men and women with the opportunity to build stronger bone structure, and possibly prevent fractures and reduce the risk of injury and death from falls."
Research also indicates that vitamin K has clear benefits for children. In a recent study published in Clinical and Experimental Rheumatology, high vitamin K status in healthy children and those with juvenile idiopathic arthritis correlated with better bone properties, whereas low blood concentrations of active osteocalcin-indicative of poor vitamin K status-were associated with a significant impairment in bone quality.
There are several forms of vitamin K2-designated as menaquinones-1 through -10. Vitamin K2 in the form of menaquinone-7 is believed to have a longer half-life than vitamin K1 or the menaquinone-4 form of vitamin K2, resulting in more stable serum levels. But according to Ms. McCollum, a product standardized to 1% menaquinone-4 delivers more vitamin K than a product with .1% menaquinone-7. Blue California has started a review to attain GRAS (Generally Recognized as Safe) self-affirmation for use of its product in foods.
While data indicates typical Western diets are deficient in vitamin K, the traditional Japanese food natto, made from fermented soybeans, has been one of the best sources of menoquinone-7. PL Thomas, Morristown, NJ, and Norway-based NattoPharma have teamed up to offer MenaQ7 natural vitamin K2 extracted from natto, which is available for use in food and supplements. MenaQ7 provides optimal vitamin K status with a recommended daily dose of 45-90 micrograms.
B Vitamins
Different chemical compositions of specific vitamin or mineral compounds affect the human body in unique ways. This is perhaps best seen in the B vitamin category, which constitutes a market worth more than $1 billion in the U.S.
"The B vitamin group receives steady attention as nutritional supplements, especially for its role in metabolism of carbohydrates, and support of the cardiovascular system and the digestive tract," said Sabinsa's Dr. Badmaev.
One of the most versatile nutrients involved in physical and mental well-being, vitamin B6 is fundamental to a properly functioning central nervous system. It participates in the formation of red blood cells and plays an important role in cancer immunity and cardiovascular health by inhibiting the formation of homocysteine, Dr. Badmaev said. It also helps maintain a healthy immune system and may help prevent allergies and asthma, he added.
Vitamin B6 comprises three chemically, metabolically and functionally related forms: pyridoxine, pyridoxal and pyridoxamine. After a Citizen's Petition was filed in 2005, FDA effectively banned pyridoxamine from use in dietary supplements in January, saying it has been authorized for investigation as a new drug for which substantial clinical investigations have been conducted and that there is no independent, verifiable evidence of prior marketing as a food or dietary supplement. The issue has raised concern among trade associations, which fear the decision could establish precedent for challenges to the status of other dietary ingredients.
However, B vitamins as a family remain very functional. For example, previous observational studies have suggested an association between lower homocysteine concentrations in the blood and lower risk of age-related macular degeneration (AMD). In a recent randomized, double-blind, placebo-controlled trial, 5442 female healthcare professionals age 40 years or older received a placebo or a combination of vitamin B9 (folic acid) (2.5 mg/day), vitamin B6 (50 mg/day) and vitamin B12 (1 mg/day). After more than 7 years of follow-up, women taking the supplements had a 41% lower risk of visually significant AMD.
This trial was part of the Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS), which failed to show any association between the use of these vitamins and reduced risk of major vascular events among women who either had a history of CVD or were considered at high risk. Moreover, the larger Women's Antioxidant Cardiovascular Study (WACS), which involved 8171 females, also failed to show correlation between CVD risk and use of antioxidant vitamins A, C or E after a mean follow-up of nine years.
Still, according to the U.S. Public Health Service Act, all women of childbearing age should consume 400 micrograms of folic acid a day. Studies have shown that if taken before and during early pregnancy, folic acid can significantly reduce the number of birth defects of the brain and spine, also known as neural tube defects, by up to 70%.
Minerals & Formulations
The minerals segment grew 5% to nearly $2 billion in 2007. Alongside calcium, magnesium has held a strong market share, growing 13% to reach $271 million in sales. Likewise, iron is up about 7% to $253 million and potassium has grown 4% to $78 million. However, chromium has declined 6% to $108 million and zinc dipped a modest 2% to $72 million.
Dave Johnson, vice president of business development, Kelatron Corporation, Ogden, UT, said the mineral market continues to attract consumers based on years of efficacy studies.
"Magnesium, iron, potassium, calcium and zinc all play vital roles in cellular function and continue to be needed as supplements, as the foods we eat become more processed and less nutritious," he said. In the meantime, Kelatron continues to invest in chelated minerals, increasing bioavailability, reduced gut intolerance and solubility.
Patrick Stano, vice president, Sales and Marketing, North America, with Dr. Paul Lohmann Inc., Islandia, NY, said he is seeing the most interest for magnesium, calcium, potassium and iron. "There are several recent studies that might explain the interest in these particular minerals," he said. "One is a recent study by the North Central Cancer Research Group, which showed that magnesium may help reduce the risk of cerebral palsy. Another recent study shows that potassium may actually lower blood pressure."In an effort to continue attracting consumers, manufacturers-focused on convenience-are utilizing new delivery systems such as powdered stick packs that can be added to bottles of water, liquid supplements, quick dissolving strips and chewable tablets, said Mr. Stano.
"The number of liquid supplements has increased and as a result, so has demand for mineral salts with better solubility," he said. "One of the ways to achieve better solubility is through minerals with finer particle size and we have seen an increase in the sales of our micronized grades. We have also seen an increased interest in our microencapsulated minerals for taste masking, as well as our premixed mineral blends where we combine minerals and other functional ingredients together to provide a synergistic effect, such as our calcium-inulin product, which is available in a granular form."
In general, traditional pill formats for vitamins and minerals have given some ground to functional food and beverages.
"Starting with the enrichment of bread, the fortification of everything ranging from a ready-to-drink (RTD) replacement shake to a simple jar of peanut butter, numerous products have had value added ingredients incorporated into them," said Vanessa Teter, food technologist, Watson Incorporated, West Haven, CT. "While the same obstacles exist (i.e., off flavors and odors), vitamin and mineral sources have improved and can now be included in a simple water beverage without detection, which has always appealed to consumers."
The use of spray drying to encapsulate oil-soluble vitamins into a starch matrix has improved the solubility of these vitamins in many RTD products, regardless of the product base, she added. "Vitamins A, D, E and K can now be used in thick shake-like products along with juices with little to no detection in the final product. Lipid encapsulation has helped the bar industry with meal replacement bars containing high levels of vitamins and minerals with a much improved flavor profile."
While the fortification of foods and beverages will certainly continue to advance, according to Cognis' Ms. Simmons, "People are relying on both supplements and functional foods, not at the exclusion of one over the other."
Ultimately, technological and scientific innovation will drive the broad, still profitable market for vitamins and minerals forward-past any rocky terrain it encounters.