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Eight years ago, Nutritional Outlook honored industry achievements by bestowing the magazine’s first award: Manufacturer of the Year. While it was relatively easy to select 1998’s award winner, Twinlab, it has become more difficult since then to choose just one industry leader.
Eight years ago, Nutritional Outlook honored industry achievements by bestowing the magazine’s first award: Manufacturer of the Year. While it was relatively easy to select 1998’s award winner, Twinlab, it has become more difficult since then to choose just one industry leader. In 2002, Nutritional Outlook gave two Manufacturer of the Year awards, and in 2004, the magazine replaced the Manufacturer of the Year honor with a new accolade, the Natural Product Awards, which went to six recipients.
This year, it was even more difficult to narrow down the winners. The past 12 months have been an exciting period for the industry-a period filled with innovative new products as companies bounced back from leaner times. This year, Nutritional Outlook is proud to announce 16 winners for its 2005 Natural Product Awards:
Research and Testing:
There’s more than one way to skin a cat, or in the case of omega-3 fatty acids, a fish. Most North American diets lack omega-3s. The American Heart Association (Dallas) recommends a combined daily intake of 500–1000 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Most diets average less than 100 mg.
Closing the gap has been difficult, particularly in the United States, where the average person eats only about 16 pounds of fish annually. More foods rich in EPA and DHA would help. The problem is that EPA and DHA are not the easiest materials to incorporate into food matrices. Enter Ocean Nutrition Canada (Dartmouth, NS, Canada). Using microencapsulation, Ocean has had remarkable success formulating with EPA and DHA. Ocean’s MEG-3 brand is on shelves in dietary supplements and in foods like bread, yogurt, and milk.
Breads were first. Early in 2005, Wegmans Food Markets (Rochester, NY) rolled out 100% whole-wheat, 12-grain, and very-low-sodium breads with 80–90 mg of omega-3s in each two-slice serving. The launch was the supermarket chain’s second foray into omega-3s, having successfully debuted eggs enriched with omega-3s in 2001. In February 2005, another company, The Baker (Milford, NJ), launched whole-grain bread containing MEG-3 as a featured ingredient. And in April of this year, Arnold Foods Co. (Bayshore, NY) rolled out Arnold Smart & Healthy 100% whole-wheat bread containing the same MEG-3.
Yogurts were next. In August, Danone Canada (Boucherville, QC, Canada) introduced Cardivia yogurt across Canada. Available in four flavors, the yogurt provides 62 mg of EPA and DHA per serving. Then, in October, the first American yogurt with omega-3s was created by the Woodstock Water Buffalo Co. (South Woodstock, VT). The yogurt contains a high 100 mg of EPA and DHA per 170-g serving.
The latest product is milk: Lark Dairies, based in Hong Kong, introduced its Trappist-brand milk with MEG-3 earlier in 2005. The milk soon outsold Lark’s regular milk by a 2:1 ratio. In North America, Farmers Dairy (Dartmouth, NS, Canada) recently became the first Canadian dairy to sell partly skimmed milk with MEG-3. “We believe our customers will love the taste of milk, the added heart health benefits of MEG-3, and the fact that this is a 100% locally made product,” says Andrea Hickey, marketing and communications manager at Farmers Dairy.
The wave of new product launches signifies that consumers and nutritionists finally agree on the merits of a natural ingredient. “I believe we are at a tipping point for improving American health,” says Ian Lucas, Ocean’s executive vice president of global marketing. “Science and data show that diet deficiencies exist. Microencapsulation technology enables formulations without the taste and smell of fish.”
With sugar and high-fructose corn syrup under fire from health experts, formulators are searching high and low for good-tasting yet functional alternatives. Their choices can be controversial, however. For instance, McNeil Nutritionals (Fort Washington, PA), the maker of the sucralose ingredient Splenda, became embroiled in legal battles last year with the Sugar Association (Washington, DC), which represents the sugar industry, over Splenda’s “Made with sugar so it tastes like sugar” marketing campaign.
Cerestar (Cedar Rapids, IA), a company owned by Cargill (Minneapolis), expects erythritol to make a difference. A white, odorless, crystalline, nonhygroscopic powder, erythritol is about 70% as sweet as sucrose but has no calories. European and Japanese studies have shown that more than 90% of ingested erythritol is absorbed and excreted unchanged in urine within a 24-hour period. Erythritol was affirmed generally recognized as safe (GRAS) in 1997.
One of the first companies to introduce erythritol into foods was Stonyfield Farms (Londonderry, NH), which added it to its MOOve Over Sugar snack. The product, which is made with organic milk and enriched with six live active cultures, is marketed as a snack choice for those who like yogurt but want less sugar and fewer calories.
At this year’s IFT Food Expo, which was held in July in New Orleans, Cargill introduced an organic erythritol for manufacturers who are searching for an even cleaner label. According to the company, the organic erythritol is crystallized to 99.5% purity from filtered and concentrated fermentation broth. The ingredient has a clean taste and can be used in dairy products, beverages, baked goods, and confections.
In 2005, DSM Nutritional Products (Parsippany, NJ) launched a nationwide consumer education campaign to support its branded green tea extract, Teavigo. DSM’s marketing campaign includes print advertisements in publications such as Cooking Light, Prevention, and Ladies Home Journal. The company is also running ad spots during “Leeza at Night,” a radio show hosted by media personality Leeza Gibbons. DSM’s promotional campaign, which includes consumer product launches under the Teavigo brand name at retail stores like GNC (Pittsburgh) and the Vitamin Shoppe (North Bergen, NJ), also features a sweepstakes drawing for a weeklong vacation at the Taneque Verde Ranch in Tucson, AZ.
One reason DSM decided to embark on the massive campaign was its market research, which showed that consumers understand the benefits of both green tea extract and epigallocatechin gallate (EGCG), the primary antioxidant compound in green tea. According to DSM, 87% of consumers are familiar with green tea extract, and 18% are aware of EGCG. Similarly, 82% can identify the health benefits of green tea extract, and 53% know some of EGCG’s positive effects. DSM hopes that this consumer knowledge will translate into action: Nearly two-thirds of consumers say they plan to make some effort to consume green tea extract or EGCG in the next six months, according to DSM.
DSM uses a patented process to isolate the EGCG from green tea, resulting in a high-potency extract. First, the company uses water extraction to concentrate green tea leaves into an aqueous extract, which is then purified and spray dried. DSM then uses chromatography to further concentrate the EGCG.
“Teavigo has exceptional purity, with a high EGCG content at a minimum of 94% on a dry-weight basis,” says Lynda Doyle, business development manager at DSM. Doyle adds that Teavigo’s EGCG content is considerably higher than that of some other green tea extracts, which only contain about 30% EGCG. Furthermore, Teavigo has a neutral taste and off-white color, while other green tea extracts can be bitter and dark.
In July, DSM announced that Teavigo, which has already been used as a food and beverage ingredient in South Africa and Japan, is GRAS in the United States. “The maximized purity of Teavigo enables more EGCG to be formulated into applications, optimizing the healthful benefits to consumers,” Doyle says.
To showcase Teavigo’s potential applications, DSM unveiled a prototype beverage at this year’s IFT Food Expo. The beverage, part of DSM’s One Solution concept, uses flavors developed by Givaudan (Vernier, Switzerland), and packaging by Tetra Pak (Lausanne, Switzerland).
One of the most popular ingredients for cardiovascular health, coenzyme Q10, is also one of the most scarce. In the past few years, CoQ10 demand has risen dramatically. Fueled in part by new research into the potential applications of CoQ10 and also by Japan’s decision to grant CoQ10 Foods for Specified Health Use (FOSHU) status, the CoQ10 shortage has even prompted some opportunistic companies to supply fake ingredients. Recognizing the problem, SoftGel Technologies (Los Angeles) recently reformulated its CoQ10 ingredient, CoQsol, into a more bioavailable form that prevents crystallization, CoQsol-CF.
“If supply is diminished and demand is increased, the solution lies in improving the performance of the material we have available,” says Kenn Israel, director of marketing at Soft Gel. According to Israel, the principal idea behind the reformulated ingredient is that CoQ10’s bioavailability is limited by its large particle size, crystalline form, and lipophilic nature. The new ingredient, whose “CF” suffix stands for “crystal free,” uses a natural citrus-peel extract, D-limonene, and vitamin E to completely dissolve the CoQ10 crystals. “Previous technologies to solubilize CoQ10 have relied on harsh synthetic detergent surfactants, or the formulations created suspensions of fine particles,” Israel explains. “CoQsol-CF is superior in that it is a truly solubilized material, maintains its solubility in normal storage and use conditions, does not recrystallize, and features enhanced absorption.”
According to Ron Udell, Soft Gel president, CoQsol-CF has become a valuable addition to the company’s portfolio of ingredients. “We know that the market is demanding both cost-effective and research-backed solutions,” Udell says. “This new product strengthens our position as the leading supplier of enhanced-performance softgels while upholding our commitment to using only safe and natural ingredients.”
Health officials have sounded the obesity alarm, and for once, America is listening. A July 2005 opinion poll from the Harvard School of Public Health (Boston) reported that 75% of Americans rate obesity as an extremely or very serious public health problem. A majority also believe that scientific experts have accurately portrayed obesity’s health risks, and 22% think those risks may actually be underestimated.
Childhood obesity also is high on the list of concerns. School boards across the country are rewriting menus and banning soda in response to studies that show that 15% of children and adolescents are overweight.
Fortitech (Schenectady, NY) reacted by formulating nutrient-rich foods and drinks for kids. At this year’s IFT Food Expo, the company unveiled vitamin and mineral premixes aimed specifically at parents and kids.
“According to the statistics we captured, the most highly researched market for product development is children,” says Maria Battista, director of marketing at Fortitech. “Coupled with the high obesity rates in children, the demonstration proved to be very successful and offered progressive ideas for taking products that appeal to kids and making them nutrient rich.”
One idea was individually wrapped vitamin C– and calcium-fortified apples for lunches or snacks. The added ascorbic acid inhibits the typical browning effects that keep kids away from peeled apples. Freeze pops fortified with vitamins A, C, and E were another. A third intriguing concept, donuts that were enriched with vitamins and calcium, also had a good amino acid profile. And knowing that chocolate is a child’s best friend, Fortitech also added vitamins A, B, and D to chocolate pudding. The vitamins transformed the dessert from an empty-calorie meal into a chocolate-flavored treat with heart-friendly antioxidants.
For adults, Fortitech offered calcium chelate in a cappuccino-flavored shake. The shake provides half of the recommended daily allowance of calcium, but the calcium chelate is specially formulated to disperse in neutral-pH liquids without needing stabilizers-eliminating settling, chalky taste, and precipitation.
All herbs arrive from the farm contaminated with microorganisms. Steam, ethylene oxide, and gamma irradiation reduce bacterial counts, but not without side effects. In 2004, PureWorld Botanicals (South Hackensack, NJ) filed a U.S. patent for a gentler, residue-free sterilization method called PurePowder. In 2005, PureWorld began using the process to bring extracts to market.
PurePowder relies upon heterogenous biphase sterilization technology to decontaminate botanical ingredients. The process eliminates microbial contamination without changing the raw material’s chemical or physical properties. In addition, the process does not leave a chemical residue. The process takes place in a fluid-bed mixer. PureWorld mixes the raw materials with filtered heated air and hydrogen peroxide or another nascent oxygen source. As the hydrogen peroxide comes in contact with heat, it releases nascent or atomic oxygen, which functions as a germicide by oxidizing microorganisms. Mixing continues for up to an hour, depending on batch size.
According to tests conducted by PureWorld for its patent application, the process is highly effective. A solution of 3–10 kg of 35% hydrogen peroxide, for example, sterilized 1000 kg of botanical powder. There were no residues because hydrogen peroxide quickly breaks down into water and oxygen, and the chemical and physical properties of the botanical powder remained intact.
One of the most useful developments for manufacturers has been the advent of encapsulation technology for nutraceutical ingredients. NutraLease (Ashkelon, Israel) has invented a delivery system that significantly widens the field of applications for nanoencapsulated ingredients. According to P.L. Thomas (Morristown, NJ), NutraLease’s exclusive distributor in the United States, the delivery system has several benefits. First, it improves solubility for ingredients. Second, it enhances bioavailability. Third, it protects ingredients from forces such as oxidation and enzymatic reactions.
Several of the first ingredients to be nanoencapsulated under the NutraLease system, including CoQ10, lutein, and lycopene, are known for not being very bioavailable or soluble under normal conditions. Through nanoencapsulation, these ingredients can be added to a variety of oil- or water-based beverages. Similarly, the fat-soluble vitamins D and E, which are also part of the NutraLease portfolio, normally require special handling because they are not soluble in water. NutraLease enables manufacturers to add these ingredients into a wide range of beverages, including clear and high-pH liquid systems, without causing sedimentation.
Best Formulations (City of Industry, CA) has expanded several times since chemist Charlie Ung founded the company in 1984. First came a 50,000-sq-ft manufacturing complex in 1998. Then, in November, the company opened a new 75,000-sq-ft facility that more than quadruples the company’s softgel production capacity from 400 million softgels per year to 2.5 billion.
The new facility now boasts 10 softgel lines. “We have a strong and talented technical team that has allowed our softgel sales to grow tremendously,” says Robin Koon, vice president of sales and marketing at Best Formulations. “This new facility will help us cater to our customers’ needs as the appetite for softgels has been increasing in the marketplace, and ensure that we can provide the highest-quality products at competitive prices.”
On December 15, 2004, federal marshals accompanied a Food and Drug Administration (FDA; Rockville, MD) investigator to a facility used by a supplement manufacturer. There, they seized bulk and blended ginseng supplements on the grounds that the material contained residues of two pesticides, procymidone and quintozene. The agency also issued a nationwide consumer warning about the products.
Pesticides are a major sourcing issue for ginseng. Farmers use pesticides to protect ginseng from rot. FDA, however, has not established tolerance levels for procymidone or quintozene. Manufacturers using contaminated materials risk a most unpleasant visit from FDA.
One solution is GinsenPure quintozene-free ginseng from Blue California (Rancho Santa Margarita, CA). The highly purified extract can help manufacturers conform to FDA’s zero-tolerance policy for quintozene.
“There is an increasing need in our industry for pure ingredients that will meet the most stringent quality requirements domestically, as well as in the Japanese and European markets,” says Cecilia McCollum, vice president of sales and marketing.
Family Pak ODT
Locating reliable child-resistant, senior-friendly (CR-SF) packaging is a major concern for many supplement manufacturers, particularly those that produce items containing iron or other nutrients that can cause an accidental overdose. CR-SF options exist for many products, but some supplements pose special challenges for packaging designers.
In July, TestPak (Whippany, NJ) expanded its Family Pak line of CR-SF products to include a new packaging system designed for orally disintegrating tablets. Family Pak ODT, which uses a carded blister with dual peeling tabs, enables manufacturers to safely package fragile tablets that could break if packaged in standard, push-through foil blisters.
According to Bill Eveleth, vice president of sales and marketing at TestPak, the company designed the Family Pak ODT to be used with a range of unlaminated and paper-laminated foil structures. TestPak can also configure the packaging to comply with U.S. Consumer Product Safety Commission (Bethesda, MD) regulations. “It offers an excellent balance of child protection and accessibility, while still protecting the physical integrity of the product,” Eveleth says.
Marketers and manufacturers are always looking for new ways to present their products. When it came time to develop a new family of containers for large quantities of foods and supplements, Alpha Packaging (St. Louis), a leader in packaging material design, thought big. The result was its Get-A-Grip series of canisters, which feature a built-in handle for easy transport.
Alpha Packaging came up with the designs to satisfy a request from one of its clients, Bear Creek Country Kitchens (Heber, UT), which wanted a new container for its popular line of soup mixes. Bear Creek previously packaged its soups in metal cans.
Alpha’s in-house design team created a high-density polyethylene (HDPE) canister that comes in three different sizes: 2000, 2500, and 3000 ml. The dust-free canisters, which are available in six styles, have built-in gripper panels for easier handling, and wide mouths to facilitate pouring. Aside from being stackable and easy to carry, the canisters also provide extra barrier resistance to oxygen and carbon dioxide.
Nutritional Outlook isn’t the only observer that noticed the new containers. Alpha Packaging’s Get-A-Grip canisters have already won a bronze Package of the Year award from the National Association of Container Distributors (Naperville, IL) earlier this year.
RESEARCH AND TESTING
Raftilose Synergy 1
The battle against osteoporosis has come down to bone strength. According to the National Institutes of Health (NIH; Bethesda, MD), 10 million Americans already have osteoporosis, and an additional 34 million suffer from low bone mass. The disease costs close to $14 billion annually. The front-line defense against osteoporosis is calcium. Unfortunately, the people who need calcium the most don’t consume enough. Saralyn Mark, MD, senior medical advisor for NIH’s Office of Women’s Health, says that only about 10% of young girls get the calcium they need each day. Recently, Orafti (Malvern, PA) completed a year-long intervention study designed to determine whether prebiotics can increase calcium retention within bones. The results were promising.
According to Anne Franck, vice president of science and technology at Orafti, researchers found that supplementing the diet with Raftilose Synergy 1, Orafti’s blend of oligofructose and inulin, helped increase calcium retention and accretion in bones by 15%. “Until now, only short-term studies had been carried out on the effects that Raftilose Synergy 1 has on calcium absorption and retention in humans,” Franck says. “If effects are not long term, they have little clinical benefit.”
The study used a randomized sample of 100 male and female volunteers aged 9–13. Half consumed 8 g of Raftilose Synergy 1 with breakfast each day for a year, and half took a placebo. The researchers measured calcium absorption and retention along with bone mineral content and density before the study began. The tests were then repeated after two months, and again at the end of the study.
Raftilose’s selective fermentation process appeared to be the force behind the improved calcium absorption. The short oligofructose fraction thoroughly changed the flora in the proximal part of the colon, and the more slowly fermented inulin functioned as a selective fuel for the modified flora. This selective fermentation pattern then produced short-chain fatty acids that decreased the colon’s pH environment. The result: improved calcium solubility and enhanced absorption.
Hi-Maize 5-in-1 Fiber
Resistant starch is an extremely well-researched ingredient that is making inroads as a natural source of dietary fiber. Technically defined as the “sum of starch and products of starch degradation not absorbed in the small intestine of healthy individuals,” resistant starch is indigestible by the human body and rarely alters the taste, texture, or appearance of food. Moreover, recent studies have shown that resistant starch may have beneficial effects on gut health, blood sugar management, and weight control.
Hi-Maize 5-in-1 Fiber, a high-amylose resistant starch from National Starch Food Innovation (Bridgewater, NJ), is now supported by more than 120 studies, including 45 human clinical trials. Earlier this year, National Starch Food Innovation released a monograph of published studies on high-amylose resistant starch that can be used to support meaningful label claims on foods. The company also supplies Novelose resistant starch.
“This monograph offers nutritionists, food scientists, marketers, and anyone involved in health and nutrition with critical information on the health benefits and the substantiation for labeling claims delivered by Hi-Maize 5-in-1 Fiber and Novelose resistant starch.”
According to the company, three published human clinical trials have shown that Hi-Maize has beneficial effects on weight management and metabolism, and seven published studies have shown beneficial effects on glucose and insulin response. In addition, 13 published studies have found that resistant starch has a positive impact on colon health. One of the most recent studies, published in the September issue of the American Journal of Clinical Nutrition, shows that consumption of 30 g of Hi-Maize per day increases insulin sensitivity in healthy adults.
Aside from its health benefits, Hi-Maize also offers some functional advantages to food manufacturers. For instance, resistant starch can improve the texture of baked goods by adding crunchiness and extending shelf life. The ingredient can also maintain an al dente texture in pasta and increase crispiness in crackers and other baked snacks.
Nutrition 21 (Purchase, NY) wins special honors this year for convincing the Food and Drug Administration (FDA; Rockville, MD) to grant a qualified health claim for its Chromax chromium picolinate ingredient. The health claim recognizes chromium picolinate as a safe ingredient that may help reduce the risk of insulin resistance and, by extension, type 2 diabetes.
The health claim text reads: “One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain.”
FDA based the qualified health claim on a study that was conducted by William Cefalu, MD, chief of the division of nutrition and chronic diseases at the Pennington BioMedical Research Center (Baton Rouge, LA) at Louisiana State University. “Emerging research suggests that 200–1000 µg of chromium as chromium picolinate may play an important role in carbohydrate metabolism,” Cefalu says.
According to Gail Montgomery, president and CEO of Nutrition 21, the company expects several additional peer-reviewed studies to be published in the near future. The new studies may bolster stronger claims in the future. “FDA’s initial response, while a starting point, is an important milestone in our company’s effort to communicate the health benefits of our products,” Montgomery says. “The FDA ruling confirms our strategic investments in clinical research to differentiate Chromax and Diachrome from other chromium supplements. This qualified health claim should help health professionals and millions of consumers make better-informed choices about reducing the risk of insulin resistance with chromium picolinate supplementation, and possibly reducing the risk for type 2 diabetes.”
Hoodia gordonii rose from relative obscurity after 60 Minutes correspondent Leslie Stahl ate a piece of the rare South African succulent and reported that she “wasn’t hungry all day.”But as more Hoodia supplements began to appear, questions were raised about the purity and authenticity of the Hoodia inside the packages. Recently, Stephen Holt, author of The Supreme Properties of Hoodia Gordonii, decided to settle the issue by engaging Stella Labs (Paramus, NJ) to define Hoodia purity standards.
“Stella Labs and Holt MD Labs are actively researching reported differences in Hoodia testing between laboratories and have already submitted replicate samples to different testing laboratories that dispute each others’ chemical methodology,” Holt says.
Stella Labs will identify a validated reference standard, apply a proven test methodology, and report measurable quantitative results.
As part of the protocol, Stella Labs contracted three independent labs to corroborate the bioactive molecule findings first reported by IBC Labs’ (Tucson, AZ) testing of Stella Labs bulk South African Hoodia gordonii material. All of the labs contracted by Stella Labs will apply the same documented test methodology and provide specific quantitative results.
Meanwhile, Craig Payton, managing director of Stella Labs, cautions that reports of Hoodia mixed with cellulose, sawdust, senna leaves, and Nopal cactus present a major challenge to supplement manufacturers. “There are inferior brands of Hoodia on the market today, but there is a solid group of committed scientists that wish to provide purity, quality, and biological activity in Hoodia material grown and manufactured under strict quality control regulations in South Africa,” he says.
Deborah Vickery, marketing director for Stella Labs, adds that the greatest challenge in marketing Hoodia has been the consumer chaos created by those selling fake, adulterated, and inferior Hoodia into the market. “Retailers, manufacturers, and suppliers share the responsibility and obligation to provide their customers with authentic bioactive Hoodia that is found to be efficacious,” she says.
As test standards are developed, other sources have cautioned against using Hoodia products. The UC Berkeley Wellness Letter pointed out that “Hoodia is now grown from China to Texas, and no one knows if plants outside the Kalahari region have the same effect in the body.” And Andrew Weil, MD, explained on his Web site that until the science is in, consumers should not “waste money on products that haven’t been proven to work and may not contain any Hoodia at all.”
Lastly, Geni Herbs (Noblesville, IN) deserves a special note of recognition for the research behind its standardized pomegranate extract, PomElla. Although pomegranate extract is rapidly becoming one of the most popular supplement ingredients, more clinical research on the beneficial compounds in pomegranate fruit is needed. To learn more about how pomegranate extracts work in the human body, Geni plans a series of new clinical studies on PomElla, which is standardized to contain concentrated amounts of the polyphenol punicalagin, in 2006.
One of the most recent studies on pomegranates was published in the May 2005 issue of the Journal of Nutritional Chemistry by Navindra Seeram, PhD, assistant director of UCLA’s Center for Human Nutrition (Los Angeles). In his paper, Seeram reported that pomegranate concentrate standardized to contain punicalagins displays more-potent in vitro antioxidant effects than any other single pomegranate compound. Let’s hope that this new research is just a harbinger of the good news to come in 2006.