Considering the strong bone health and joint health needs of the aging population, it’s surprising that a large number of food and drink products promoted for bone and joint health target other populations instead. The baby food market is the biggest user of bone-health and “added calcium” claims. As for joint-health food and drinks, the greatest number of products point to our furry friends over in the pet food market.

The good news is that more consumers in the mainstream seem to understand the link between calcium and bone health. This has sparked more product development with mainstream positioning. Bone-health claims are more prevalent today, but the numbers indicate there is still a lot of room to grow. Just over 0.6% of global food and drink launches recorded by Innova Market Insights in 2013 featured bone-health claims. This figure goes up to 1% if we include “added calcium” claims. By contrast, food and drinks featuring joint-health claims are still few: just 0.1% of global food and drink launches.

While baby food was the leader in bone-health and “added calcium” claims in 2013, accounting for 32% of total global bone-health food and drink launches, dairy products were not far behind. In 2013, dairy foods accounted for just under 30% of global bone-health food and drink launches. These two categories dominated, followed by pet food and cereal products, which came in at 13% and 6%, respectively.

Looking at the dairy sector in terms of product type, milk and dairy drinks led bone-health and “added calcium” claims. Milk and dairy drinks represented 40% of total bone-health dairy launches in 2013. Next up were alternative dairy drinks (20%) and yogurt (20%). (Note: If you look at the percentage of bone-health launches in each product’s specific market, however, the leader changes. Nearly 14% of total alternative dairy drink launches featured a bone-health claim. But a smaller 9% of the-admittedly larger-milk and dairy drinks market used bone-health claims, and just 3% of the yogurt and drinking yogurt/fermented market touted bone-health claims.)

Of the bone-health specialty brands targeting the dairy market, perhaps most notable is Calin from Yoplait, which has been on the French market for a number of years as a high-calcium, fresh cheese product. In France, the brand extended in 2011 with a Calin+ range of bone-health yogurts for women over the age of 55 and again in 2013 with the addition of two active-health drinks.

The Calin+ range also launched in the UK in summer 2012. In the UK, the brand is positioned squarely on a bone-health platform with the tagline “Calcium + Vitamin D for Strong Bones” prominent on packaging. The marketing, however, does not target older women as strongly as it does in France. Rival dairy brand Danone also has an offering: its Densia bone-health yogurt and drink brand in a number of countries, including Spain, Japan, and Brazil.

Other active-health drink makers are leveraging bone health to add value to their existing lines. Benecol, the cholesterol-lowering dairy drink brand with plant sterols, extended its product range in the UK in late 2013 with two dairy drinks, one of which is Benecol Plus Bone Health with added calcium and vitamin D.

Beyond dairy, bone-health claims are popping up in spreads. In the United States, the Smart Balance healthy spread range launched a Buttery Spread with Calcium. And in the UK in 2013, Dairy Crest added three functional-food lines to its Clover spreads range, under the brand name Clover Additions. Products include Clover Additions Strong Bones, marketed as rich in vitamin D and a source of calcium.

The joint-health food and drinks market is much less developed than the bone-health food and drinks market. While interest is growing in joint-health 

this excitement has yet to move into the mainstream food and drinks market in any significant way.

In 2013, pet food accounted for 80% of global product launches with a joint-health positioning. Once we exclude pet food, however, product activity looks highly fragmented. The next clear user of joint-health product claims would be soft drinks, accounting for just under half of total joint-health food and drink launches. Some of these soft drinks, however, may be positioned as supplement-style products. Joint Juice is one of the earliest examples. The brand launched the first ready-to-drink glucosamine supplement in the United States in 2001. Since then, it has added an Easy Shot variant, including Extra Strength Easy Shot in 2013 containing 1500 mg of glucosamine, 1200 mg of chondroitin, and the Hyal-Joint proprietary protein and collagen ingredient blend.

Some other soft drinks make multibenefit promises, including Michelle’s Miracle Original Tart Montmorency Cherry Concentrate, which is marketed as promoting healthy joints and supporting sleep patterns and anti-inflammatory response. Frieda’s Moab Rejuvenate AÃ§ai Juice Superfruit Blend touts omega-3 fatty acid DHA for heart and brain health, as well as natural, plant-derived glucosamine for joint health. The Xango juice drink, meanwhile, focuses on the superfruit properties of mangosteen to support respiratory health, immune health, heart health, and intestinal health, as well as joint health.

While food and drinks for bone and joint health continue to launch, it’s clear that the market, particularly for joint-health products, remains largely confined to supplements. Otherwise, products target specialty markets such as baby food for bone health and athletes for joint health.

Considering the aging population and interest in maintaining active lifestyles, there is a greater opportunity for these kinds of products in the mainstream market. Developing convenient products with a good taste profile is key to tempting consumers, particularly in the United States, away from dietary supplements and toward specifically formulated food and drinks. 

Articles

Food and Drinks for Bone and Joint Health

	It almost sounds like a form of torture, but renal denervation-a treatment in which a clinician steers an electrode-tipped catheter into the arteries of the kidney to kill the nerve endings with two-minute zaps of radiofrequency energy-looked, until recently, like a promising treatment for patients with resistant hypertension. But then came a study (Bhatt DL et al.) published this April in 

showing no significant difference in blood pressure outcomes between patients who received the treatment and those who underwent a “sham” procedure.

	The news likely disappointed physicians desperate for a new arrow to add to their antihypertensive quiver. But in sending them and the medical community back to the drawing board, it may have done us all a favor-for when it comes to dealing with hypertension, the drawing board isn’t such a bad place to be. Because a multitude of variables-from heredity to obesity-contributes to hypertension, any approach to battling hypertension needs to be just as multivariate.

	In a time of rising healthcare costs and rising hypertension rates, it’s worth remembering that good old-fashioned “lifestyle” factors, including the use of supplements, can take the pressure off our healthcare spending and our vascular systems.

	Simply put, hypertension, or high blood pressure, is a measure of how much blood the heart pumps and the resistance the arteries exert against its flow. “The more blood your heart pumps and the narrower your arteries, the higher your blood pressure,” explains Harry B. Rice, PhD, vice president, regulatory and scientific affairs, Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City).

	We express blood pressure as a ratio of the systolic pressure (measured in mmHg) generated when the heart beats to the diastolic pressure generated as it rests between beats. Roughly speaking, a “safe” blood pressure might be somewhere around 115/75 mmHg, whereas the generally accepted cutoff for “high” blood pressure is 140/90 mmHg or above.

	As Sanni Raju, PhD, RPh, CEO and chairman, Natreon Inc. (New Brunswick, NJ), points out, “Many doctors do not prescribe any medications until they see blood pressure readings of 140/90 mmHg.” Alas, doctors are seeing more of those readings these days. In fact, current blood pressure statistics, as reported by the Centers for Disease Control and Prevention (CDC), are what Rice calls “eye opening.”

	To wit, one in every three adults-fully 67 million Americans-has high blood pressure, while roughly the same percentage has pre-hypertension: not quite high enough to qualify as “high,” but still high enough to merit attention. Of those Americans with high blood pressure, less than half (47%) have their condition under control. No wonder hypertension costs the country some $47.5 billion annually in healthcare services, medications, and lost productivity.

	Perhaps more costly, though, are the more serious implications. As Raju notes, “Hypertension can lead to heart disease, coronary artery disease, stroke, aneurysms of the arteries, and peripheral arterial disease and is a cause of chronic kidney disease, ultimately reducing life expectancy.”

	With potential consequences that dire, the medical community has tried to learn more about how hypertension arises, and how best to treat it when it does. And as far as Kelley Fitzpatrick, director of health and nutrition, Flax Council of Canada (Winnipeg, MB), is concerned, it’s about time. Hypertension, she believes, “is a disease that we haven’t paid as much attention to from either the pharma or non-pharma side.”

	What we do know is that hypertension can be either primary or secondary. Secondary hypertension “is caused by certain conditions affecting the kidneys, heart, endocrine system, arteries, et cetera,” Raju says. It can be associated with adrenal gland tumors, for example, and unlike primary hypertension tends to appear abruptly. The condition “needs medical intervention,” he continues, “and there are many effective pharmaceuticals for its treatment.”

	Primary hypertension, also known as essential hypertension, is more common and derives from lack of exercise, a “modern” diet poor in fresh fruits and vegetables, obesity, smoking, excess alcohol consumption, stress, genetics, and an imbalanced intake of minerals like sodium, potassium, magnesium, and calcium. The condition tends to creep up gradually, usually over many years. Considering the number of Americans who don’t exercise or eat healthily, it’s not surprising that this type of hypertension is on the rise.

	Hypertension pharmaceuticals may often provide only symptomatic relief and require lifelong use. “In addition,” Raju says, “most of them have side effects.” Indeed, the true cost of pharmaceutical treatment includes far more than just the drugs’ sticker price-although, with the population aging, those costs are only going to rise, Fitzpatrick says.

	While it’s largely secondary hypertensive patients that may spiral into what Fitzpatrick calls “this unending cycle of drugs,” even primary hypertensives often, on doctors’ advice, turn to pharmaceuticals. It’s a judicious decision, as “high blood pressure is a serious condition for which a physician should be consulted,” Rice notes.

	But pharmaceutical intervention might not be the answer alone. “Lifestyle modifications,” Rice says, “may allow an individual to delay, indefinitely, the use of prescription blood pressure–lowering medication.”

	Indeed, by reversing behaviors that lead to primary hypertension in the first place-by exercising more, losing weight, quitting cigarettes, reducing alcohol intake-primary hypertensives may also reverse the upward trend in their blood pressure measures.

	Perhaps no other lifestyle change is more effective at this than diet. “An excess of sodium, carbohydrates, saturated fats, trans fats, and sugars are dietary culprits in hypertension,” Raju says. Avoiding these triggers while increasing consumption of fruits, vegetables, beans, fish, whole grains, and other “whole” foods “is essential to preventing or mitigating” the condition.

	Yet even diet has its limits. Consider, for example, the issue of sodium. A 2013 Institute of Medicine (IOM) report (Strom BL et al.) concluded that no rational reason exists to reduce sodium consumption below 2,300 mg/day-much higher than the 1,500 mg/day that national dietary guidelines recommend for the prevention of heart attacks and stroke. Further, Raju notes, “A low-sodium diet is important to reducing the risk of hypertension, but the body needs a balanced intake of sodium, potassium, magnesium, and calcium. Thus, one cannot eliminate sodium completely.”

	Even setting aside our evolving thinking on sodium, maintaining the sort of gold-star diet that experts recommend as optimal for vascular health takes more work than many of us can afford. “In today’s fast-paced society,” Raju notes, “unfortunately, not many people have time to eat nutritionally balanced fresh foods or exercise regularly.”

	And that’s where supplements come in. As Anil Shrikhande, president, Polyphenolics (Madera, CA), says, “Supplements fill the gap of inadequate dietary habits and help maintain normal blood pressure.” Offering the advantages of lower cost compared to pharma, prescription-free access, and consumer appeal, supplements may also produce fewer, if any, side effects and have a general record of safety.

	Among the supplements already identified as having a positive effect on blood pressure are resveratrol, vitamin D, anthocyanins, magnesium, Pycnogenol, coQ10, omega-3 fatty acids, acetyl-L-carnitine, and melatonin, Raju says. “Many of these work by blocking the angiotension-converting enzyme-ACE-and improving endothelial function,” he notes. And while we still have a lot to learn about how these nutrients effect their beneficial changes, here’s some of what we do know.

	These days, it’s hard to find a condition that 

respond positively to the long-chain omega-3 fatty acids DHA and EPA. Hypertension is no exception. In fact, a 

(Miller PE et al.), looked at 70 randomized controlled trials (RCTs) involving adults given DHA and EPA via seafood, fortified foods, or dietary supplements. The results indicated that omega-3s equal, and in some cases exceed, the effect of recommended lifestyle changes like increased exercise and reduced alcohol and sodium in lowering blood pressure.

	The study, which GOED funded, showed the most significant effects among subjects with existing high blood pressure. In these subjects, DHA and EPA produced an average decrease in systolic and diastolic blood pressure of 4.51 and 3.05 mmHg, respectively.

	In addition, Rice points out that though nonselective beta-blockers have long been the “first-line treatment” for primary hypertension, “this is changing due to the associated side effects, as well as limited benefits.”

	In fact, he notes that a recent Cochrane Review (Wong GWK, Wright JM) on the blood pressure–lowering efficacy of nonselective beta-blockers for primary hypertension reported that these reduce blood pressure by an average of 8 mmHg systolic and 5 mmHg diastolic. “While these results are slightly better than those associated with omega-3s”-4.51 mmHg systolic and 3.05 mmHg diastolic-“omega-3s don’t increase the risk of mortality. [And] while newer blood pressure–lowering drugs decrease blood pressure much better than nonselective beta-blockers, side effects are still an issue,” he says.

	Long-chain DHA and EPA aren’t the only omega-3 fatty acids with blood pressure–lowering potential. A prospective, double-blinded, placebo-controlled randomized trial, the results of which appearance last year in 

(Rodriguez-Leyva et al.), found that whole flaxseed-naturally rich in the short-chain omega-3 alpha-linolenic acid (ALA)-produced “dramatic blood–pressure lowering, both systolic and diastolic, equivalent to, and for some patients better than, some hypertensive drugs,” Fitzpatrick says.

	Specifically, 110 patients consumed foods fortified with 30 g of milled flaxseed or placebo daily for six months, at the end of which time systolic blood pressure fell by about 10 mmHg and diastolic by about 7 mmHg in the experimental group compared to placebo. Further, those patients whose systolic blood pressure exceeded 140 mmHg at baseline experienced a significant reduction of 15 mmHg over the trial period.

	We don’t really know how the flaxseed exerts these effects, Fitzpatrick says, as the research hasn’t revealed the mechanism of action. It’s likely that flax’s ALA played a part, as may have its fiber and lignan content. But bioactive peptides in flax present another “very interesting area of ongoing inquiry,” she says, as these peptides serve as ACE inhibitors, helping to dilate blood vessels. Whatever the reason, “Researchers agree that it’s probably a synergistic effect of all of the above” that makes flax effective, Fitzpatrick says. Stay tuned.

	A very different seed-that of the grape-could contain the ingredients for yet another supplement with antihypertensive capabilities.

	According to Shrikhande, Polyphenolics’s unique grape seed extract, which goes by the name MegaNatural-BP, “opens the door for reducing blood pressure before it gets to the hypertension range.”

	How? The product “improves vascular health through an increase in the activity of eNOS”-that is, endothelial nitric oxide synthase, an enzyme that catalyzes the production of nitric oxide, a vasodilator, in the arterial endothelium.

	Two double-blinded, placebo-controlled clinical trials, as well as a third study, support the benefits of grape seed extract for blood pressure. The clinical trials were conducted by UC Davis and the Illinois Institute of Technology’s Institute of Food Safety and Health and involved 300-mg daily doses delivered in capsule form over a six-week course (Sivaprakasapillai B et al.; Robinson M et al.). The third study involved a fortified fruit-juice beverage containing 150 mg of the grape seed extract, consumed twice daily for six weeks (Burton-Freeman B et al.). Blood pressure fell to a normal range of 120/80 mmHg and then rose only slightly to 130/89 mmHg-pre-hypertensive-after cessation of active grape seed extract administration. All three studies’ results were significant to p<.005, Shrikhande notes.

	The grape seed extract seems to trigger endothelium-dependent relaxation, Shrikhande says. “It is a strong antioxidant and maintains its action in keeping the major blood vessels supple, as in a healthy person.” In very high hypertensives, the ingredient even “acts as a synergizer to maintain normal blood pressure,” he says. Also of note: it may be safer than some pharmaceuticals, with “no complications, side effects, or interactions” reported as adverse events.

	Two other nitric oxide inhibitors attracting attention also come from the plant world: 

 also known as Indian gooseberry or amla, and 

or ashwagandha. In multiple randomized, double-blind, placebo-controlled clinical studies, Raju says, extracts of both botanicals have improved endothelial function in type 2 diabetics currently on conventional treatments, as well as in subjects with symptoms of metabolic syndrome-in both cases by increasing production of nitric oxide.

	Also promising is their ability to decrease levels of C-reactive protein, a biomarker for inflammation, by upwards of 50%. This is “a highly significant reduction that may also contribute to reduced blood pressure, as inflammation is believed to be involved in causing many diseases,” Raju says. The botanicals appear to increase the body’s production of glutathione, a natural antioxidant, and reduce total cholesterol, LDL, and triglyceride levels while increasing levels of HDL, too, “all of which reduces plaque formation in the blood vessels, thus helping reduce blood pressure,” Raju says.

	His company sells extracts of Indian gooseberry and ashwagandha under the respective names of Capros and Sensoril, and has put them to the test in multiple double-blind, placebo-controlled crossover clinical trials. In studies of healthy subjects subjected to cold-pressor and mental stress, Raju says, both products have shown an ability to lower radial and aortic systolic and diastolic blood pressure, as well as the augmentation index (AIx), an indirect measure of arterial stiffness. Conversely, they significantly increase the subendocardial viability ratio (SEVR), a measure of the inflow and outflow of oxygen to the heart muscle-something we’d all like to see occur with ease.

	Alas, for those with hypertension, it may not be so easy. But they and their medical professionals have lots of tools to improve the situation. As Raju says, “Lifestyle and dietary changes have to be the mainstay for hypertension management, but the more we learn, the more we learn that supplements can help.”

Hypertension during pregnany may relate to magnesium deficiency

New studies point to vitamin D for blood pressure

Blood Pressure and Dietary Supplements

	Omega-3 fatty acids derived from oily fish and other sources are essential structural components of human cell membranes and play significant roles in moderating inflammation. Among the family of omega-3 fatty acids, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) have been well-researched for their ability to support heart health, including helping to prevent heart disease, helping to normalize blood fats such as triglycerides, and maintaining healthy blood pressure levels, as a 

	But, the potential benefits of omega-3 fatty acids extend beyond heart health. Recent strong evidence points to their beneficial impact on patients with critical illnesses, an area of omega-3 research that hasn’t garnered much mainstream attention but is significant nonetheless. Furthermore, evidence from recently published investigations highlights emerging indications, including unique, cognitive benefits of omega-3s, especially on memory function, as well as potential in addressing sleep-related issues.

	A fair amount of evidence points to the benefit of omega-3 fats from fish oil in patients with critical illness. Among other actions, omega-3 fatty acids have potent anti-inflammatory effects that are believed to be of primary usefulness in these cases. Researchers have found that the administration of fish oil as continuous infusions as a component of a post-surgical enteral nutrition protocol has the potential to improve patient outcomes and reduce morbidity and mortality.

	Jacquelyn Glenn and Paul Wischmeyer conducted a review of clinical trials encompassing the use of fish oils in critically ill patients with lung injury, including those with acute respiratory distress syndrome (ARDS).

 Their examination of trials published between 1999 and 2012 found that the continuous administration of an enteral nutrition formula containing fish oil was associated with significant reductions in 28-day mortality, intensive care unit (ICU) length of stay, and time on a ventilator, compared to standard formula administration.

	In infants, intestinal failure is a condition that sometimes occurs as a result of certain gastrointestinal infections, which then leads to a significant portion of the small intestine being surgically removed. It is a condition associated with severe nutrient malabsorption. During the interim period after surgery, patients generally receive most of their nutrition through a combination of enteral feeding and parenteral intravenous nutrition. Current standard protocols often involve the intravenous infusion of soy-based lipid formulas; however, this often leads to complications, including cholestasis (disrupted or blocked flow of bile from the liver to the intestines), which is associated with high morbidity and mortality in infants. Recent trials have investigated the use of fish oil–containing formulas as alternatives to traditional soy-based lipids in these cases.

	Qing Yang and colleagues from Wake Forest University in Winston-Salem, NC, assessed the benefits of early enteral feeding of fat and fish oil in premature infants who had undergone surgical bowel resection and found that this led to a decreased need for intravenous lipid therapy, increased uptake of nutrients through enteral nutrition, lower risk of cholestasis, and greater gains in weight and length compared to the control group receiving standard care.

 Taken together with previous studies in patients with intestinal failure showing benefits using lipids from fish oil, this research indicates favorable outcomes from this simple and cost-effective intervention and significant reductions in both morbidity and mortality.

	The relationship between dietary fat intake and cognitive development has been examined previously in several research studies. While the essential omega-3 fatty acids have been linked to various cognitive benefits, the research remains somewhat ambiguous regarding clinical results.

	Carol Baym and colleagues from the University of Illinois in Urbana, IL, suggest that a potential reason for these mixed research findings is that studies have tended to use assessment techniques that are often not well suited to delineating the specific interactions of essential fatty acids with brain structures.

 Looking at the interactions of nutrients and specific brain areas, and assessing the cognitive processes influenced by those areas, should yield better outcomes in reaching conclusions about the effects of different dietary fats on cognitive development.

	In this light, the research team conducted a study to assess the impact of dietary fat intake on hippocampus function in 52 healthy children aged 7–9 residing in the East-Central Illinois area.

 Specifically, the researchers assessed the impact of dietary fat intake on relational memory function, which is significantly influenced by the hippocampus, and contrasted this with item memory retention ability, known to be largely hippocampus-independent. Item memory encompasses functions like remembering simple facts. Relational memory, on the other hand, plays a role in scholastic achievement and learning and involves the formation of memories surrounding complex situations that require interpretation and organization.

	In the study, children completed a memory task that was designed to assess both hippocampal-dependent as well as hippocampal-independent memory function. A standardized food-frequency questionnaire was used to assess dietary intake. The results of the study indicated significant positive associations between the intake of omega-3 fatty acids and accuracy regarding the relational memory indicators. In contrast, saturated fatty acid intake was negatively correlated with both relational and item memory task performance. No clear correlation was observed (positive or negative) for omega-3 fat intake on item memory abilities, indicating the preferential influence of omega-3 fatty acids on hippocampus function.

	Ultimately, the results of the study indicated that children who consumed more omega-3 fats as a part of their diet had superior relational memory compared to those children consuming lower amounts.

	While the study mentioned above showed that omega-3 fatty acids support hippocampus function and development in children, at the other end of the age spectrum the loss of total brain volume and atrophy of the hippocampus are indicators of dementia, including Alzheimer’s disease. Studies indicate the importance of DHA and EPA in maintaining brain structure and function. DHA makes up approximately 40% of the fatty acid profile in grey matter of the human cortex, and Alzheimer’s patients have been reported to have decreased serum, brain, and neuronal levels of DHA and EPA compared to individuals without dementia.

	James Pottala and colleagues set out to assess the relationship between red blood cell concentrations of DHA and EPA and brain volumes.

The researchers analyzed MRI scan data from 1,111 postmenopausal women that were included in the Women’s Health Initiative Memory Study. The Women’s Health Initiative was a randomized placebo-controlled trial designed to test the effects of hormone replacement therapy in women. The Memory Study included a subset of these women who were free of dementia at the time of enrollment and between the ages of 65 and 80. Red blood cell fatty acid levels and MRI scans were taken as a part of the Memory Study. There was a mean time differential of eight years between the fatty acid analysis and the MRI scans.

	James Pottala’s group analyzed this data and concluded that higher omega-3 concentrations (omega-3 index; a measure of total red blood cell EPA + DHA) were associated with larger total brain and hippocampus volumes, as assessed by MRI. While additional research is needed, these results suggest that higher omega-3 fatty acid tissue levels that are achievable through diet and supplements may be a promising approach for delaying brain aging and the onset of dementia.

	An additional area of emerging research is the potential role that fatty acids play in sleep problems in children. Adequate sleep is essential for cognitive function and emotional wellness, while contributing broadly to health overall. Poor sleep is linked to aspects of Attention Deficit Hyperactivity Disorder (ADHD) and other behavioral and learning difficulties. Along the same lines, adequate essential fatty acid intake is associated with healthy cognitive function and overall health. Essential fatty acids are critical for the optimal performance of cells throughout the body because of the crucial structural and functional role they play. Deficits especially in the intake of omega-3 fatty acids DHA and EPA have been implicated in ADHD and other learning and behavioral issues.

	Given the similar associations and outcomes common to poor sleep and fatty acid deficiencies, Paul Montgomery and colleagues at the University of Oxford in the UK investigated the association between blood concentration of fatty acids and subjective measures of sleep in 395 healthy children aged 7–9. In a 16-week randomized trial, they further explored supplementation with DHA (600 mg/day) versus placebo in 362 of these children who were underperforming in reading.

 Analysis of blood fatty acid levels and subjective sleep measures found that higher blood DHA status was significantly associated with better sleep. In the 16-week study including DHA supplementation, no significant effects were evident across the whole sample; however, in a subgroup analysis in individuals with clinically significant sleep issues, DHA supplementation was found to improve total sleep disturbance scores.

	Furthermore, a subsample of 43 individuals underwent a pilot study in which actigraphy was used to measure sleep patterns. After 16 weeks of DHA supplementation (600 mg/day), significant improvements were noted in sleep duration (average increase of 58 minutes in the DHA group versus placebo), with improvements seen in sleep efficiency as well as less night waking.

	Although more studies are needed, the evidence from these investigations indicate that DHA supplementation plays a positive role in enhancing sleep parameters in children with sleep issues.

	Emerging research clearly suggests that science is just scratching the surface with regard to the benefits of omega-3s for human health. With well-established indications for supporting the heart and brain, and reducing inflammation, these essential fats occupy a crucial place in any diet and supplement regimen. However, as newer studies continue to explore the unique mechanisms of these critically essential molecules, it is inevitable that their useful potential will extend to even more broad and diverse areas.  

 thanks editorial advisory board member Harry Rice, PhD,  for his help in culling research studies for this article. Rice is the vice president of regulatory and scientific affairs for the Global Organization for EPA and DHA Omega-3s (GOED).

Miller PE et al., “Long-chain omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid and blood pressure: A meta-analysis of randomized controlled trials,” 

. Published online ahead of print March 6, 2014	

Glenn JO et al., “Enteral fish oil in critical illness: perspectives and systematic review,” 

Current Opinion in Clinical Nutrition and Metabolic Care,

 vol. 17, no. 2 (March 2014): 116–123.	

Yang Q et al., “Randomized controlled trial of early enteral fat supplement and fish oil to promote intestinal adaptation in premature infants with an enterostomy,” 

 Published online ahead of print March 12, 2014.

Baym C et al., “Dietary lipids are differentially associated with hippocampal-dependent relational memory in prepubescent children,” 

The American Journal of Clinical Nutrition. 

Published online ahead of print February 12, 2014.	

Pottala JV et al., “Higher RBC EPA + DHA corresponds with larger total brain and hippocampal volumes: WHIMS-MRI study,” 

vol. 82, no. 5 (February 4, 2014): 435–442.

Montgomery P et al., “Fatty acids and sleep in UK children: subjective and pilot objective sleep results from the DOLAB study - a randomized controlled trial,” 

Published online ahead of print March 8, 2014.

Exploring omega-3 benefits beyond heart health

Omega-3 for Brain Health, Sleep, and Critically Ill Patients

Here in 2014, there is little doubt that functional foods represent a market segment with continued growth potential and staying power-that is, if the ingredient and food industries can do it right. In fact, functional foods and beverages are poised to be “the hottest growth area of the next decade”-and, in the United States specifically, “a significant growth category”-according to Jeff Hilton, chief marketing officer and cofounder of BrandHive, a marketing firm representing health and wellness brands.

Indeed, supplementation through food and beverages (termed 

) keeps gaining traction, particularly in the current key wellness areas of energy and performance, healthy aging, immunity, digestion, cardiovascular function, joint support, weight loss, and diabetes. A quick tour of one’s local large supermarket reveals such functional ingredients as calcium, fiber, vitamins, minerals, omega-3 fatty acids, hemp, probiotics, proteins, and more, in foods and beverages ranging from snack foods and frozen desserts to juices and beverage shots.

Convergence seems to be an area worthy of ingredient suppliers’ attention and investment, as well as the attention and investment of premixers and firms providing technologies for incorporating ingredients into foods and beverages. However, functional foods do present challenges along with great opportunity, so suppliers who are ready to channel time, R&D, and resources into this market segment are advised to do their homework and learn from those already competing successfully in the convergence game.

Having a valuable, sought-after ingredient is one thing; getting it into a food or beverage matrix successfully is another. The latter can be complicated, but challenges are overcome through inventiveness, creativity, and the rigorous application of science.

Russ Hazen, PhD, premix innovation manager at Fortitech Premixes by DSM (Schenectady, NY), admits that there are technical issues involved in the formulation of any product, but the primary factors for functional foods are nutrient stability and organoleptics. For instance, he describes the high heat, humidity, and pressure sometimes involved in extruding food products or processing them with steam. “Many nutrients do not tolerate these conditions well, particularly some of the B vitamins and vitamin C. Even the fat-soluble vitamins like A, D, and E are susceptible to oxidation during processing,” he says. These sensitive nutrients can still be added to products, but the conditions of processing must be considered when selecting the amount of nutrients to add.

One solution to this problem is to add overage, Hazen explains, to account for expected losses. “By conducting stability tests in the finished product, these overages can be optimized to account for the specific losses seen in the manufacturing of a specific product.”

Thomas Douglass, category director, food and beverage, Corbion Caravan (a premixer based in Lenexa, KS), agrees with Hazen on this point. He advises that the anticipated loss of each nutrient caused by such processing stresses as heating, pasteurizing, baking, or shearing, in addition to shelf-life stresses, must be part of the formula from the beginning. And Bob Green, president, Nutratech Inc. (West Caldwell, NJ), concurs: “Many functional foods and beverages require miscibility and water solubility to properly mix in the ingredient. With Advantra Z-our thermogenic bitter orange extract for diet, fitness, and energy-we continue to address and refine these qualities.”

Michael Crabtree, sales manager, sports nutrition and supplements, Bioenergy Life Science (Minneapolis), says that for his company, it is the susceptibility of D-ribose to react with amino acids, particularly those amino acids with high-charge functional groups, which can prove tricky. This hurdle can be negotiated, he says, by “avoiding mixing ingredients that have conjugate electrostatic natures.” Or, Crabtree offers, “Elimination chelation agents, such as copper, zinc, and others, can be added to attenuate the electrical attraction of the target ingredients.”

Even a time-tested ingredient like insoluble fiber can prove difficult to incorporate into functional foods. Jit Ang, executive vice president, research and development for International Fiber Corp. (North Tonawanda, NY), says that working insoluble fiber into food products requiring a smooth mouthfeel or a small serving size can be very challenging. This is because most insoluble fibers contribute some chalkiness or grittiness to end products, and a serving of food must contain at least 2.5 g of fiber to make a fiber claim. “This limits the scope of food products that can be targeted for insoluble-fiber fortification,” Ang says. But, he adds, to overcome this limitation, his company is “currently developing a new class of insoluble fibers that is ‘smoother’ and therefore less gritty.”

Probiotics have been in the market for a while but present some challenges to certain foods. “Traditional probiotics like Lactobacillus acidophilus are very, very difficult to keep alive during processing,” says Michael Bush, senior vice president, Ganeden Biotech Inc. (Cleveland). His company’s star ingredient, the probiotic strain GanedenBC30, forms spores and is therefore hardier during processing. “We have been able to overcome most of the usual probiotic challenges by the sheer physical makeup of the organism itself, and we’ve also become good at knowing where in a particular food application we should integrate the probiotic to get the best from it, especially through processing,” Bush explains. “For example, say we’re talking about a [nutrition] bar. There are a few places you can add the probiotic. If the bar is enrobed in chocolate, you can add the probiotic to the chocolate. If it’s bound with honey, you can work it in there. But you’ll need to determine how long the probiotic will be in there, how hot it’s going to be. You want to be sure you’re not forcing the germination of the bacteria.”

In the case of the bar, Bush says, Ganeden would normally blend the probiotic in with the mix of dry ingredients, then the manufacturer would roll out the bar and pack it. Ganeden would shelf-life test the finished product in its own microbiology lab to ensure the probiotic count is above spec at the end of shelf life.

For drinks, solubility is the key. Agglomeration can come to the rescue and increase the solubility of an ingredient when that ingredient is mixed with liquids, says Walt Zackowitz, director of specialty ingredients for Innovative Food Processors (IFP; Faribault, MN). Agglomeration can also enhance “flowability” and assist with ingredient dosing and dispersion when working with a formula requiring expensive ingredients, he says.

As for ensuring desirable organoleptics, the appropriate product form is crucial, Fortitech’s Hazen says. Encapsulating ingredients and changing processing procedures may be required to retain desirable sensory qualities.

Flavor masking is one option, of course, adds Bob Verdi, PhD, business director, health and wellness, for flavors supplier Virginia Dare (Brooklyn, NY). “Most functional ingredients will contribute ‘off’ flavors to foods and beverages and present challenges to the product developer,” Verdi says. “Two areas where there is a lot of [flavor masking] activity are vegetable-protein enhancement and natural, high-intensity sweeteners, such as stevia.” The proteins can contribute beany, musty ‘off’ flavors that require masking, he explains, and the sweetness profile of stevia can be made to more closely resemble that of sucrose via masking as well.

In addition to seeking innovative and scientific methods for overcoming chemical and technical formulation challenges, ingredient suppliers are also advised not to underestimate the importance of open, detailed, two-way communication with the marketer. “Too often purchasing departments will come to us and ask for a product with few to no specifics on what they actually need,” says Stacy Peterson, president and owner, ConnOils LLC (Big Bend, WI). “We can provide a lot of customization so that formulations work or can be tweaked to work with minimal time and expense. When we have all the specifics we need from the customer, it is uncommon for the initial material to fail.”

Learning from customers what didn’t go well in their trial process, if anything, Peterson adds, is critical. “More and more, food and beverage customers are coming to us for new ideas, especially sports nutrition folks. We love when they share their trial findings with us so that we can lend additional support to help them meet their needs. Usually the outcome is very successful.”

Ingredient suppliers will find the greatest success, Peterson concludes, “when open communication occurs that allows everyone involved to make the right decisions.”

Ingredient suppliers understand that their respective ingredients provide the maximum health benefit only when the dose-in the case of functional foods and drinks, the amount present in the end product-is sufficient. Suppliers themselves must remain ever-vigilant about educating marketers on this matter-and on the price point involved.

“Efficacious doses can be characterized as being typically on the higher end of the ingredient’s dosing spectrum,” says Bioenergy’s Crabtree. “This poses inherent challenges to formulating ingredients at levels that can be successfully marketed.”

He adds that food companies generally operate on thinner profit margins than liquid-system companies do. The reasons for this discrepancy, Crabtree explains, include food companies’ navigation of more stringent regulatory oversight as well as food production’s significantly higher cost and greater financial risks associated with a failed product launch. “These things all contribute to a higher price point,” Crabtree says. “And this higher price point exacerbates the likelihood of the price playing an important role in the dose.” However, he warns, “A fairy dusting of this and that does nothing for the consumer, directly impacts the morale of the target customer, and does not stimulate the desire to repurchase.”

Ganeden’s Michael Bush agrees that pixie dusting is still a problem in today’s functional foods market. “Pixie dusting is an issue across the board when you’re looking at functional foods. In some cases, people just don’t want to pay the money to put an efficacious dose of any functional ingredient into a food product. We actually have standards for our customers that require them to use what is our tested minimum [dose]. They have to put an efficacious dose in, or we won’t work with them.”

After all, if a supplier’s ingredient-due to a low dose-appears not to work, it reflects as poorly on the ingredient supplier as it does on the marketer. Bush encourages the industry to self-police on this issue.

Ingredient supplier and encapsulator Balchem Corp. (New Hampton, NY) is frequently asked by formulators what constitutes a meaningful or efficacious dose of choline, which the company provides. Kristine Lukasik, director, applications, scientific, and regulatory affairs for food and nutritional ingredients, has a thoughtful and research-based answer at the ready: “Choline intake in the United States is around 75% of what is recommended. Our typical suggestion, then, is addition of choline at 10% to 20% of the adequate intake-55 to 100 mg-which neatly addresses that intake gap and entitles the manufacturer to leverage the nutrient-content claims available for choline.” This advice, she says, may go some way toward minimizing marketers’ temptation to fairy dust.

Innovate, Learn, Document, and Communicate

Ingredient suppliers, premixers, and firms with the most advantage in the functional foods space are those that provide the following: ingredient-protecting technologies, an in-depth scientific knowledge of the ingredient at hand (and documentation of that knowledge), a willingness to innovate and invest in R&D, a high regard for open communication with and education of marketers, and an awareness of the food industry’s constraints. To that end, International Fiber Corp.’s Ang advises, “It is always best if the project is not rushed but goes through all the required product development stages. This will result in the development of a final product that is superior in eating qualities and will have a higher degree of acceptability and sustainability in the retail marketplace.”

Balchem’s Lukasik states, “There is no substitute for solid science, particularly in the form of clinical studies and formulation stability data.”

Additionally, Ganeden’s Bush reiterates the importance of documenting the ingredient’s safety and efficacy. “We believe that the only way for a company to have a legitimate ingredient is to make sure it is documented as safe and effective,” he says. “FDA GRAS designation is becoming more and more important. Our advice is to either invest in your ingredient or don’t participate in the market.”

BrandHive’s Hilton advises suppliers to proactively “bridge the gap” between their ingredient and product applications. Bring in the food scientists, he urges, and meet the food and beverage people halfway in terms of R&D. “Participate more actively in this discussion to establish credibility for your ingredient with the food and beverage companies, and instill confidence.”

And, finally, Bioenergy’s Crabtree offers the following counsel for the food manufacturers themselves: “My advice to them is to exercise simplicity when developing their products. Take a qualitative approach to development by using only the ingredients for which the regulatory bodies have the highest regard. Functional-ingredient overkill by adding as many functional additives as possible typically has a negative impact on the ingredient sourcing and cost.”

Functional food manufacturers talk specific formulating challenges-and solutions.

Insider Tips on Formulating Functional Foods

	Genetic modification involves gene-splicing biotechnology (genetic engineering) to merge DNA from different species of plants or animals to create combinations that cannot occur naturally or in traditional cross-breeding. The technology required to genetically modify food and animals in a lab was commercialized in the 1970s. The first commercial sale of a genetically modified food is typically attributed to Calgene in 1994, with its Flavr Savr delayed-ripening tomato. Unlike genetic modification, traditional cross-breeding-such as hybridization and selection-has been popular in agriculture for centuries.

	GMO corn, canola, cotton seed oil, and soybeans are cash crops for today’s farmers. According to the USDA, 85% of soy, 40% of corn, and 75% of canola produced in the United States are GMOs. Today’s GMO foods are largely bred for tolerance of the herbicide glyphosate (branded Roundup). GMOs bred with glyphosate tolerance allow farmers’ cash crops to grow, while the competing weeds that try to grow around the crops are killed.
	 

	Although many GMO crops are classified as “safe,” there are no long-term studies available to prove the safety of their extended human consumption. Some shorter-term studies have found traces of toxins from GMO crops in humans post-consumption. For instance, in a 2011 study published in the journal 

 (BT), the toxin in GMO corn, in the blood of pregnant women and their babies.

	Another argument against GMO is genetic contamination, if GMO crops cross-breed with natural varieties of the same crop. A 2013 paper published in the journal 

 details how BT corn has contaminated the indigenous corn of Oaxaca, Mexico.

 Critics of GMO foods also often claim that genetic engineering can disrupt the functions of neighboring genes in plants, giving rise to toxic or allergenic molecules and thus lowering the value of the food.

	At the retail level, some consumers say that companies such as Monsanto and Syngenta have oversold the benefits of GMO crops. Some object to having GMO-patented seeds concentrated in the hands of a few corporations, marginalizing smaller farms.

	While there is currently no federal labeling law to indicate foods containing GMOs, many manufacturers today still choose to label non-GMO foods specifically as such.

	Of course, with so much emphasis today on non-GMO products, demand for non-GMO ingredients is higher than ever.

	But there are challenges in the non-GMO supply chain. First and foremost, the limited availability of verified non-GMO feed makes sourcing non-GMO ingredients somewhat difficult. Other challenges include supply shortages and poor crops due to bad weather or drought.

	What’s more, non-GMO food is often more expensive than its GMO counterparts. Labor costs are higher because not using conventional chemicals requires hiring more workers for tasks like weeding and cleaning up polluted water. Other costs include higher fertilizer costs, the price of crop rotation-as opposed to conventional farms that can use every square inch-and certification costs.

	Still, if you’re going to market a non-GMO food, you need to know how to source non-GMO ingredients, and you should know exactly what to look for in potential suppliers. Finding the right non-GMO supplier takes effort. Also, remember that GMO issues start early on. For instance, limited availability of non-GMO feed means limited availability of non-GMO ingredients.

	There are a number of ways to vet a supplier’s non-GMO capabilities. To start, ask the supplier for documentation or certification.

	Third-party non-GMO verification, such as certifications from the Non-GMO Project or Identify Preservation (IP), is the first thing to look for in a potential supplier. Thankfully, this sort of certification is increasingly in demand, and more suppliers will likely work to become certified. “With Whole Foods’ recent commitment to GMO labeling by 2018, the demand for non-GMO and organic grains and ingredients is likely to increase,” wrote Ken Roseboro in a recent article for 

	Third-party verifications are increasingly important in terms of the downstream market, as they allow you to market and label your foods as GMO-free with absolute certainty. On top of a certificate, you could also require that your potential supplier provide proof, such as GMO test results, should you require it.

	You should also check if potential suppliers have any documented system that aids in proper segregation of non-GMO and GMO goods, to avoid cross-contamination. Traceability is also important; seeing an entire timeline of a supplier’s products can help confirm the supplier’s claims. Where have the ingredients been during different parts of the supply chain? Where are they sourced from, and what have they been exposed to?

	In the same vein, approaching the sourcing of non-GMO ingredients with an international perspective can help. Knowing where ingredients and products come from, as well as the non-GMO laws of other countries, all help to ensure that you’re getting what you paid for-non-GMO ingredients from your suppliers.

	Lastly, the sign of a reliable non-GMO supplier is experience and a successful track record in supplying non-GMO goods. “You want essentially the same qualities you are seeking from your other valued suppliers,” Roseboro wrote.

 “It would be beneficial if the supplier had a history in handling organic products inasmuch as most of the protocols will be similar.” In other words, when you choose a supplier, you want to be sure it can deliver. Ask for demonstration of its track record. What other companies does it work with? Who can vouch for the supplier’s reliability in avoiding GMOs?

	Going completely non-GMO requires dedication, considering the various challenges and high costs associated with the process at this time. But with controversy surging through the market over GMO labeling and GMO-related health concerns, companies may want to consider a move to non-GMO ingredients when forecasting the future of their business.
	 

Aris A et al., “Maternal and fetal exposure to pesticides associated to genetically modified foods in Eastern Townships of Quebec, Canada.” 

Gilbert N, “Case studies: A hard look at GM crops,” 

 vol. 497, no. 7447 (May 2, 2013): 24-6. doi: 10.1038/497024a.	

www.non-gmoreport.com/articles/april2013/tips-for-sourcing-non-gmo-grains-ingredients.php

The limited availability of verified non-GMO feed makes sourcing non-GMO ingredients somewhat difficult.

How to Source Non-GMO Ingredients and Suppliers

	Not a moment too soon, gummies are enjoying life beyond the confectionery aisle. SPINS market data indicate that for the year ending March 23, 2014, vitamin and mineral gummies alone saw a 24% jump in sales. From fiber to fish oil, manufacturers are increasingly marketing health products as these confectionery treats, but the decision to make health products as gummies can bring manufacturers to a crossroads: should they use gelatin or pectin? Despite the many methods for formulating gummies today, these two gelling agents remain the most popular, and a case can be made for using either.

	Gelatin is a processed protein from collagen, extracted from the hides and bones of pigs, cattle, and, to a lesser extent, fish. The ingredient is a byproduct of the meat industry, and it would not be widely available if not for this larger industry supporting it.

	Gelatin has the essential gelling characteristic that is necessary for making gummies, but gelatin is often regarded not just for this sole function, but for a collection of functional benefits that can support everything from the ability to swallow dietary supplement capsules to the plush springiness of marshmallows. Gelatin is an aerating agent. It’s also an emulsifier, a stabilizer, a protective colloid, film-forming, water-binding, and an adhesive. Gelatin is versatile. Its most signature effect in gummies, though, is its melt-in-mouth quality.

	Gelatin has what is technically referred to as “thermal reversibility.” This means that gelatin can transition from a solid state as candy to a melting condition at body temperature and ingestion. “For orally ingested foods and supplements, this allows for a more intense, rapid release of flavor,” says Lara Niemann, marketing director for gelatin supplier Gelita USA (Sergeant Bluff, IA). “With other hydrocolloids, you don’t get the same flavor sensation, because that hydrocolloid is not 

, so to speak, when it’s in your mouth.”

	Another potential advantage of gelatin formulations is the ingredient’s inherent sheen, capable of producing gummies with brilliant, almost transparent color. With or without gelatin, manufacturers often coat gummies in powdered sugar, so there are other ways of achieving visual brilliance; still, researchers say gelatin’s combination of sheen and melt-in-mouth texture has yet to be duplicated by any polysaccharide.

	For all of gelatin’s versatility, gelatin’s animal source can create obstacles. Pig gelatin is, by and large, the most popular source of today’s commercial gelatin, but the porcine source represents a problem for both halal and kosher diets, as these cultural doctrines forbid the consumption of any part of the pig.

	In response, two gelatin suppliers, Gelita and Geliko LLC (New York City), have partnered to secure what is likely the only cattle-derived, certified kosher gelatin on today’s market. And it wasn’t easy to achieve it.

	“The certification process is very cumbersome and complex, because it all starts with the sourcing of raw material (the hide), which has to be obtained not only from kosher slaughter, but kosher-certified animals,” says Geliko president Zach Rubin. “This means you need, from slaughter, to be able to identify and trace every single hide that goes into your production. Furthermore, all of the hides must be kosher salted, and processed and transported in a certain way.”

	Thanks to gelatin’s long history of use- and because of the conundrum surrounding what exactly organic livestock is-gelatin is on USDA’s National List of Allowed and Prohibited Substances, meaning it can be used up to 5% in certified organic food and
	beverage products.

	The plant-based nature of pectin is likely a relief for some manufacturers, who would otherwise be without a very large vegetarian and vegan consumer base. While this gelling agent can be found in numerous plants, a great majority of production comes from just a few of them.

	Citrus peel is the most widely used source of pectin, followed by the likes of apple and sugar beet, which bears pectin used for different purposes altogether. Citrus peel and apple are used in classic gelling applications such as jams, jellies, and gummies. Suppliers say these pectins create only slightly different textures, and apple peel is browner in color.

	Beyond the plant-based distinction of pectin, this ingredient differs from gelatin in that the resulting eating experience is, despite being gel-like, markedly different.

	“With pectin, one gets a much cleaner, shorter bite, with no chewiness and no elasticity,” says Neil Gordon, technical support manager for food applications at CP Kelco (Atlanta). “So when you’re comparing the two as gelling agents for [gummies], the final texture is completely different. Of course, both are very good, very effective, and very functional.”

	Gordon says pectin also comes with a very different melting point-one that is higher than gelatin’s. This explains pectin’s shorter bite and lack of melt-in-mouth character, but it also explains a potential advantage to transport. In hot countries or supermarkets that are not air-conditioned, pectin-based gummies may hold up better than gelatin-based gummies, which may risk sticking together (i.e., melting and resolidifying). Formulations of both pectin and gelatin could provide a rather unique solution here.

	At the end of the day, pectin can list as a basic source of dietary fiber, although consumers would need to consume quite a lot of gummies in order to see a real dietary fiber increase.

Of all the gel-forming ingredients available, gelatin and pectin are some of the most prevalent. And a case can be made for each.

Should Gummy Manufacturers Use Gelatin or Pectin?

	FDA’s New Dietary Ingredient (NDI) draft guidance has become a touchstone for all interested parties concerned about re-interpretations of existing law-namely, the Dietary Supplement Health and Education Act (DSHEA) of 1994. As most know, the NDI guidance, which FDA published in the 

 on July 5, 2011, has evoked numerous concerns-and sustained rallying cries for guidance revision-within the dietary supplements industry at large.

	Again, the central concerns with the current version of the draft guidance include:

		The draft guidance indicates that FDA could require the submission of an NDI notification from every manufacturer for every finished product that contains what the FDA considers a NDI.

		It would shift the burden of proof that an ingredient is 

 an NDI from FDA to individual companies.

		The guidance asserts that there are no authoritative lists of “grandfathered” ingredients-dietary ingredients that existed in the dietary supplements market pre-DSHEA (before October 15, 1994)-to establish that a dietary ingredient is an Old Dietary Ingredient (ODI) and therefore doesn’t require NDI notification. This includes any lists of pre-DSHEA ingredients industry trade associations have compiled.

		Many argue with the guidance’s definition-and list of-manufacturing processes that would lead an ingredient to be considered chemically altered and thus require NDI notification. Those who criticize the guidance’s list of what comprises chemical alteration say that the list would significantly expand the category of ingredients that would require NDI notification.

		The guidance states that human-synthesized constituents of botanical ingredients are different from those synthesized by the plant, meaning that synthetic ingredients at large would require NDI notifications.

		The guidance would impose a level of data necessary to demonstrate the safety of a NDI similar to what is required for food additives, a standard that critics argue Congress and the courts already rejected during DSHEA’s implementation.

	Again, here is a detailed discussion on the 

main points of concern with FDA's NDI draft guidance

A Look Back: Initial Industry and Consumer Response

	In response to the guidance, several industry trade associations issued calls for a revised guidance. In addition to the 144,000 pages of comments ultimately submitted to FDA’s public-comment docket on the guidance, consumer groups, such as Citizens for Health and the Alliance for Natural Health, mounted sustained grassroots campaigns that generated thousands of consumer letters also calling for guidance revision.

	At the end of 2011, the American Herbal Products Association (AHPA; Silver Spring, MD) stated that, if implemented as written, “[The guidance] would change the rules that have been in place for the last 17 years and significantly increase the burden on the supplement industry far beyond the intent of Congress, with no concomitant benefit for consumers.”

	AHPA went on to call for the draft to be completely withdrawn, describing the draft guidance as “hugely flawed” and as “seek[ing] to erect extra legal barriers to market entry, impose food additive–type evaluative criteria, [and] require multiple NDI notifications for dietary supplements beyond those required by law.” AHPA also argued that the guidance, as written, would transform the NDI legal requirements for the marketing of dietary supplements from a notification process to one of FDA preapproval.

	On December 2, 2011, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), was quoted as saying, “The draft guidance would essentially undo nearly two decades of agency practice and policy that began with DSHEA’s passage” and would “impose significant and unnecessary burdens on the industry, stifle innovation, and curtail industry growth-without conferring additional safety benefits to consumers.”

	Data from Emory University in Atlanta, GA, predicted that the NDI guidance, if adopted as originally proposed, would force between 22,240 and 41,700 dietary supplements to be removed from the market, resulting in an economic loss of between $5.6 billion and $10.5 billion.

	“I can’t comment on whether the estimates in the Emory University study are too high or too low,” Michael McGuffin, AHPA’s president, tells 

today. “But it is certain that the impact of the guidance as written is far higher than FDA’s own economic analysis that accompanied the promulgation of the actual NDI regulations. At that time, the agency’s financial impact discussion strongly implied that only one NDI notification would need to be submitted for each ingredient that is actually an NDI, presumably by the ingredient supplier. On the other hand, the draft guidance suggests that every finished product marketer that includes the NDI in its product would need to file separate submissions,” a much more consuming burden.

	As to why the current draft guidance seems so off the mark to many, attorney Justin Prochnow of Greenberg Traurig LLP looks at it this way: “I truly believe that FDA believes there has been an overall lack of compliance in [the NDI] area, and it wants to see better compliance. The problem becomes that FDA has let [non-compliance] go on for so long that it is going to be hard to rein in. If every company filed every NDI that would be required under […] FDA’s interpretation of the guidance, there would not be nearly enough personnel to handle the submissions. This is the very reason the GRAS process became voluntary.”

Nutritional Outlook Vol. 17 No. 4

Food and Drinks for Bone and Joint Health

Blood Pressure and Dietary Supplements

Omega-3 for Brain Health, Sleep, and Critically Ill Patients

Insider Tips on Formulating Functional Foods

How to Source Non-GMO Ingredients and Suppliers

Should Gummy Manufacturers Use Gelatin or Pectin?

When will FDA release revised NDI draft guidance?

How to Create Ingredient Monographs

FDA, Social Media, and Health Claims

Tapioca Syrup is a Corn Syrup Replacer

Minerals in Ancient Grains Are Celiac-Friendly

2014 FDA Warning Letters: Key Takeaways

Yes, We Need a Federal GMO-Labeling Law. But Maybe It Should Be a Voluntary One.

Agave Inulin May Aid Digestion

Prop 65 Proposal: Listing Specific Chemicals on Warning Labels?

Stop Craving Sweets? Spinach Could Help