A trend is persistently growing among consumer advocates to know more about food and dietary supplements, the ingredients added to them, and even the packaging in which the finished product is sold. This call for manufacturer transparency includes a demand for simple to read, “clean” labels, with fewer multi-syllabic chemical names and, most specifically, a decrease in the use of preservatives and processing aids.

The U.S. Food and Drug Administration (FDA) feels the heat from consumers as well and has declared its interest in more transparency in all phases of U.S. food production, as described in the recent release (September 17, 2015) of the Food Safety Modernization Act (FSMA) final rule. In the agency’s words, FSMA’s goal is “to better protect human and animal health by helping to ensure the safety and security of the food and feed supply.”

Especially now under FMSA, it is crucial that firms know the basics of ingredient identification. Ahead, we outline some key points.

In order to make a uniform, consistent, and safe product, a manufacturer must have specifications that define each ingredient. Specifications should state characterizing information critical to the identity of the ingredient, such as data on chemical and physical properties. These can be used as a metaphorical “fingerprint” for identification and also provide the appropriate analyses that help ensure the safety of an ingredient by defining the tests to be conducted to analyze for contaminants. A specification sheet should include information on the detection method, along with the acceptance criteria for each test.

 In the regulations for the manufacture of dietary supplements, FDA states that individual components of a product should have specifications established to: (1) confirm the identity of each component; (2) ensure that the purity, strength, and composition of any produced final product are met; and (3) place limits on the types of contamination that may adulterate or may lead to adulteration of the finished product.

 The guidance for the specifications of ingredients added to dietary supplements is consistent with regulations for establishing the safety of food additives under the food additive petition (FAP) process and, by extension, generally recognized as safe (GRAS) substances, which state that “specifications for identity and purity of the petitioned food additive should be proposed.” The FDA guidance

 for food additives indicates that the following criteria are necessary to identify, characterize, and define purity of a new ingredient. In FDA’s words:

1. A description of the food additive (e.g., physical form, odor, color, and solubility). For food additives derived from natural sources, the sources themselves should be clearly identified.

2. Identification tests for the food additive, including the method(s) used or reference(s) for a suitable method(s)

3. An assay of purity for the additive, including the method used or reference for a suitable method

4. Physico-chemical characteristics of the food additive (e.g., ash content, moisture content, melting point, density, refractive index, pH)

5. Parameters related to the particle size, shape, and surface properties of the food additive, as appropriate, if particle size is important for the identity and functionality of the additive

6. Limits for impurities and contaminants

a. A limit for lead should be proposed. In addition, limits for arsenic and heavy metals, such as cadmium and mercury, should be considered when their presence needs to be controlled.

b. Limits for any known natural toxicants or for microbial contaminants in or on a food additive derived from a natural source should be proposed.

c. Limits for residual reactants, reaction by-products, and residual solvents should be proposed.

The acceptance criteria for specifications are typically numerical ranges for the described tests, and each batch of the ingredient must fall within these ranges to be considered acceptable for use in production of the final product. Occasionally, specifications comprise qualitative criteria, such as for color or physical form or appearance such as granule or powder and in the case of the latter two, particle size and distribution, etc.

The determination of food additive or GRAS status is based on the safety of the product, which is determined by toxicity testing conducted on an ingredient with certain specifications. If an ingredient is used in the product that does not meet specifications, there is a chance that it could have toxic contaminants from an alteration in the production process that led to the out-of-spec product. Further, if a substance does not meet specifications of the original GRAS or FAP, it is not considered to be the ingredient that was approved and, thus, FDA considers the ingredient an adulterant.

Examples of specifications for ingredients may be found in the 

 a compendium of nationally recognized standards for the purity and identity of food ingredients. Specifications may be submitted to FCC, but this is only on a voluntary basis. Specifications must be focused enough such that they define and describe the ingredient, but not so unreasonably strict that a significant number of individual batches would need to be discarded for reasons that are not of a safety concern. An example of a hypothetical specification sheet for a novel food oil is provided in Table 1 on page 70. For food additives, FDA requests that five batches be evaluated (three of which are nonconsecutive) and meet the specifications. These “batches” do not need to be commercial-size production batches, but can be a smaller, “pilot plant” size; however, “bench-top”-type batches may not be truly scalable and may not represent commercial production run. The request for the batch analysis is to determine if the company can consistently produce an ingredient that meets the specifications the company has set for itself. 

Articles

What firms must know in terms of specifications, verification, and validation

Ingredient Identification in the Time of FSMA

Clean-label ingredients are all the rage, but determining what 

 actually means is often challenging. With no comprehensive federal definition to rely on, ingredient suppliers frequently turn to their customers and end-users for a better idea of clean-label priorities.

“Following guidelines of FDA and USDA is important, but listening and responding to customer needs is equally, if not more, important to the success of a natural or clean-label product,” says Stacy Reed, product development manager, cocoa and chocolate, Cargill (Amsterdam, the Netherlands).

But for an ingredient like cocoa, there may be more than one path to a clean-label solution. Which is the best? It depends.

One strategy to boost cocoa’s clean-label appeal is removing the alkalizing agent, or alkali, that cocoa processors have historically used to mitigate cocoa’s bitterness and improve its solubility. Potassium carbonate, or potash, is one common alkalizing agent.

In August, the DeZaan cocoa brand from Olam Cocoa (London) launched TrueDark, a dark cocoa powder made completely without an alkalizing agent. The company says TrueDark is the first dark, non-alkalized cocoa powder, which is especially noteworthy since darker cocoa powders typically require a more intense alkalization process than lighter powders.

Potential alkalizing agents aside, cocoa is otherwise free of additives. “Thus, removing the alkali gives the cocoa a full clean-label status,” suggests Rinus Heemskerk, global innovations director, DeZaan.

Olam believes formulators will be able to offer finished products with enhanced clean-label appeal thanks to its TrueDark powder. But are there any limitations to formulating with non-alkalized cocoa?

Cargill’s Reed chimes in. One challenge could be “being limited to the type of beans used to make the powder or [having to] potentially manipulate the product during the remainder of the process to enable changes in color, flavor, and pH, as alkalizing is a strong contributor to certain aspects of the cocoa product.” Reed says Cargill cannot comment on whether it has plans to create its own non-alkalized cocoa.

The low pH of a non-alkalized cocoa powder may also be an obstacle for food applications like dairy and pudding, suggests Leanne de Muijnck, R&D cocoa director for cocoa manufacturer Barry Callebaut (Zurich, Switzerland). Barry Callebaut has been offering domestically-produced, organic-certified, non-alkalized cocoa powder June.

However, DeZaan’s Heemskerk says Olam's non-alkalized TrueDark actually requires less formulation adjustment than alkalized cocoa because of its low pH of 5.5.

“Getting the same color and flavor intensity, but without the alkali, can actually prove to be a cure, rather than a cause, of problems,” says Heemskerk.

Looking beyond the topic of alkalization, other ingredients may also play a role in consumers’ perception of cocoa’s clean-label appeal.

Cargill’s Reed suggests cocoa manufacturers consider looking at other ingredients that, while allowed in cocoa processing under the 

consumers might frown upon. For example, lowering sodium levels might be a possibility to clean up the Nutrition Facts panel of cocoa products.

Barry Callebaut’s de Muijnck says the key is for manufacturers to provide a range of natural cocoa powders to meet whatever definition of 

 is necessary for a given formulation. Barry Callebaut offers both alkalized and non-alkalized organic cocoa powders, as well as high-fat and low-fat options.

The search for a cleaner cocoa is on. And with an ingredient as popular as cocoa, this is likely just the beginning.  

Cacao Pulp: It's Not Just a Waste Product of Cocoa Anymore

Industry-First Natural Dark-Cocoa Powder Skips Alkali Processing Altogether

Michael Crane
Associate Editor
Nutritional Outlook Magazine


Cocoa suppliers are removing alkalizing agents and adopting other strategies to improve cocoa's clean-label appeal.

Different Paths to Clean-Label Cocoa

Slideshows

New flavors, “healthy” energy, and clean labels help sports drinks keep up with the times.

Six Trends Driving the Sports Drinks Market

Discussions of heart disease can make anyone feel paranoid, what with the risks lurking around every apparent corner. Case in point: If you consider just three common cardiovascular risk factors alone-dyslipidemia, hypertension, and tobacco use-research

 shows that as many as 47% of Americans exhibit at least one of them. 

And there are more risk factors where those came from, including overweight, obesity, hyperglycemia-even the inevitable passage of time. Given that each predisposes a person as much to endothelial disease specifically as to cardiovascular disease more generally, it should come as no surprise that “a large percentage of the population is thus at risk of developing endothelial dysfunction and the subsequent development of atherosclerosis,” says Jimmy Salas Rushford, MD, a San Juan, PR–based internal-medicine specialist and an advisor to Maypro Industries (Purchase, NY).

For those in the supplement industry, the question, then, becomes, “How can we prevent endothelial dysfunction, and if such dysfunction occurs, what can we do to help the body heal?” Salas Rushford concludes. The most obvious answer, he says, is to attack the risk factors most within our control-excess weight, inactivity, smoking-while warding off others like high levels of blood pressure, blood sugar, and blood cholesterol.

Most relevant to industry: “All this should be accompanied by proper nutrition and supplementation with ingredients that help with the pro-inflammatory state that characterizes endothelial damage,” he says.

To be sure, one attribute that characterizes cardiovascular risk factors is their tendency to promote inflammation, Salas Rushford says. That inflammation, in turn, causes endothelial dysfunction that “may lead to a loss of vasodilator and prothrombotic products,” and it also involves an increased presence of reactive oxygen species, or pro-oxidative free radicals. So it’s promising to note that antioxidants “have been shown to help modulate the capacity of the endothelium to deal with oxidative stress,” Salas Rushford says.

One such antioxidant is a patented, flavanol-rich blend of lychee fruit extract and green tea that’s been processed to convert its native high-molecular-weight proanthocyanidins to more bioavailable, lower-molecular-weight forms. It’s in part thanks to this depolymerization, Salas Rushford says, that the ingredient-trade-named Oligonol and marketed by Maypro-“can provide superior antioxidant activity with higher bioavailability.”

“Studies have shown increases in circulation following Oligonol ingestion, and this is thought to be through the enhancement of nitric oxide production,” he explains. This matters because nitric oxide (NO) is an intracellular signaling molecule that modulates vasorelaxation, endothelial regeneration, and platelet adhesion along the endothelium, among its other functions. Damage to endothelial cells impairs their ability to produce, liberate, and use NO to such an extent that diminished NO bioavailability is a recognized sign of endothelial dysfunction. The upshot, Salas Rushford says, is that compromised NO bioavailability or effectiveness “translates into a more rigid blood vessel and a decreased ability of the endothelium to handle oxidative stress, such as that induced by diabetes or tobacco use.”

Another antioxidant that improves the endothelium’s NO profile is Pycnogenol, a natural plant extract harvested from the bark of the French maritime pine tree. The ingredient appears to activate an enzyme known as endothelial nitric oxide synthase (eNOS), allowing for a more efficient generation of NO from the precursor amino acid L-arginine.

As evidence of the compound’s efficacy, a study

 evaluated the level of oxidative stress in 32 hypertensives, 31 hyperlipidemics, and 30 hyperglycemics, half of each group of whom supplemented with 150 mg/day of Pycnogenol and the other half of whom didn’t. (A group of 31 normal subjects participated as a control.) At eight and 12 weeks into the treatment, measures of oxidative stress were significantly decreased in the Pycnogenol subjects, while only minor differences emerged in the controls, indicating that daily supplementation with the ingredient may help improve endothelial function among those with borderline hypertension, hyperglycemia, and hyperlipidemia.

According to Carolina Burki-Sozzi, director of product development, Horphag Research (Hoboken, NJ), the worldwide exclusive supplier of Pycnogenol, the ingredient’s cardiovascular benefits represent its “strongest area of research, as it helps normalize blood pressure and platelet function and improve blood lipids, as well as blood sugar values,” she says. “It does so by increasing the blood vessels’ ability to enlarge when needed, which improves blood flow overall, and helps to reduce blood clots.” Further studies show that it enhances the body’s innate ability to counteract vascular constriction, which “naturally helps maintain blood pressure that is already in the normal range,” Burki-Sozzi says.
 

Vitamin K2, Pycnogenol,  omega-3s, and other ingredients show potential for endothelial health in new research.

Key Ingredients for Endothelial Function

As we go through life, we run up against some numbers we just can’t forget: a key anniversary, a child’s birth weight, the final score of our home team’s Super Bowl win, our trusty SSN. Increasingly, though, we’re adding a few more figures to these memorable-digits lists, and our cholesterol levels and blood-pressure readings are chief among them. 

For good reason: With heart disease accounting for one in every four deaths in the United States each year, per Centers for Disease Control and Prevention (CDC) data, such numbers serve as revealing barometers of cardiovascular health. Yet the high-profile test results only tell part of the heart-health story, for absent amidst the triglyceride counts and HDL/LDL ratios is any quantitative reflection of vascular function.

And that’s a pity. Because the more we learn about what makes a heart healthy, the clearer it becomes that healthy vessels with a healthy endothelium are fundamental to it. True, you may have heard this claim before, as endothelial health seems perpetually poised to go mainstream. But stick with us here, for experts say it’s only a matter of time until endothelial health achieves the breakout velocity it needs to make a difference both to consumers and to the supplement marketers who pursue them.

As far as SÃ©bastien Bornet, vice president, global sales and marketing, Horphag Research (Hoboken, NJ), is concerned, “Endothelial health is an emerging area of research and innovation, and one to which manufacturers and marketers should devote the same attention as they do to other areas of cardiovascular health.” Yet it remains relegated to a back seat in an increasingly crowded cardiovascular bus. After all, Bornet admits, “not everyone is familiar with endothelial terminology or even knows what endothelial function is.”

If that includes you, here’s the gist: The endothelium is the thin layer of cells lining the inner surface of blood vessels. In addition to acting as a semipermeable barrier between vascular tissues and the contents of its lumen, endothelial cells are also “in charge of managing an intricate and complex mechanism of cell signaling that aids in maintaining homeostasis, helping to repair and assure proper functioning of the blood vessel,” says Jimmy Salas Rushford, MD, a San Juan, PR–based internal-medicine specialist and an advisor to Maypro Industries (Purchase, NY).

If that’s what a properly functioning endothelium does, what happens when endothelial health goes south-as can happen under conditions of oxidation, or when vascular walls become calcified? “Studies have shown,” Salas Rushford continues, “that endothelial dysfunction correlates with the development of cardiovascular events and disorders,” ranging from coronary artery disease, cerebrovascular disease, and rheumatological heart disease to congenital heart disease and venous and arterial disease.

In light of such dire outcomes, it’s astounding that the promotion and preservation of a healthy endothelium doesn’t get more attention from media, consumers, or marketers than it does. “My personal opinion is that no one has figured out how to effectively communicate the appeal of maintaining or improving endothelial health and function,” posits Harry B. Rice, PhD, vice president of regulatory and scientific affairs, the Global Organization for EPA and DHA (GOED; Salt Lake City).

Another impediment to wider endothelial awareness is the lack of a “rapid, relatively inexpensive test” to measure endothelial function, he adds. “You can go to your family doctor and ask about your blood cholesterol or triglycerides level or blood pressure,” he notes, “but you’d likely get a weird look if you asked about your endothelial health.” This “shows how much we have to learn about endothelial health and function in general.”

Eric Anderson, global vice president, sales and marketing, NattoPharma USA Inc. (Metuchen, NJ), agrees. In addition to blaming “ever-changing diet fads and their effect on cholesterol” for keeping lipid levels in the spotlight, he, like Rice, cites the echo chamber that common medical tests create, noting that although “a simple test to measure one’s cholesterol currently exists and is part of nearly every regular physical, the only current way to measure how calcified one’s arteries are is with a coronary calcium scan.”

But endothelial health’s prospects for breakout are hardly doomed. Even though “cholesterol has been a centerpiece of heart-health discussions for as long as anyone can remember,” Anderson says, “that’s beginning to shift.”

Some momentum appears to come from a paper

 that paints oft-prescribed cholesterol-lowering statin drugs as “mitochondrial toxins” liable to harm the heart and vessels by depleting them of coenzyme Q10 (CoQ10) and inhibiting the synthesis of vitamin K2, a cofactor essential to removing calcium from arteries.

“So the conversation,” Anderson says, “is, in fact, changing. But more education is needed to teach Americans about what vascular health means and that addressing optimum vascular function is critical. It’s still not an aspect of cardiovascular wellness that’s top of mind among consumers.”

For his part, Bornet is bullish on endothelial health’s future. “As consumers become more educated about their health, proactively checking whether or not the products they buy contain evidence-based, safe, and efficacious ingredients, they better understand why endothelial health is so important,” he says. “This is why the segment is definitely gaining more attention in the natural-ingredients and supplement market.” 

The Migraine-Stroke-Endothelium Controversy

Updated: “Breakthrough” Vitamin K2 MK-7 Study Confirms Heart Benefits

Okuyama H et al., “Statins stimulate atherosclerosis and heart failure: pharmacological mechanisms,” 

Experts say it’s only a matter of time until endothelial health achieves the breakout velocity it needs to make a difference to consumers and supplement marketers.

Is Endothelial Health Headed Mainstream?

Arthritis can take credit for a significant portion of healthcare costs in the United States. By 2030, as many as 67 million U.S. adults over the age of 18 will be diagnosed with some form of arthritis, according to Centers for Disease Control (CDC) estimates

; back in 2013, nearly a quarter of U.S. adults had already been diagnosed with the disease.

Osteoarthritis (OA) is by far the most prevalent form of arthritis. Nearly 27 million adults were diagnosed with osteoarthritis in 2005.

 OA symptoms develop over time, the most common among them joint pain and tenderness, stiffness, and loss of flexibility. Studies suggest that frequent knee pain (resulting from arthritis and other causes) affects approximately 25% of adults

, leading to significantly limited function and mobility and adversely impacting quality of life. Risk factors for OA include increasing age, obesity, and the presence of other chronic conditions, such as diabetes, gout, or rheumatoid arthritis.

The cost of dealing with these symptoms is great. Even as far back as 2003, the CDC estimated that medical care and lost earnings resulting from arthritic conditions totaled $128 billion. And, of course, no dollar figure can quantify the impact of lost quality of life those with arthritis face.

While inflammation plays a big role in autoimmune joint conditions such as rheumatoid arthritis, OA has historically not been considered an inflammatory condition. However, the paradigm through which OA is viewed has shifted dramatically over the years.

Researchers now suggest that inflammatory processes localized within joint tissue play a significant part in the progression of OA.

 Similarly, research is also showing that inflammatory processes play a role in knee pain that occurs as a result of strenuous activity, even when the criteria for OA are not met.

 Thus, inflammation is an important factor in rheumatoid arthritis, OA, and frequent knee pain and discomfort.

Conventional medicine currently offers no known cure for OA; instead, treatment is aimed at relieving symptoms with acetaminophen and non-steroidal anti-inflammatory drugs.

 These drugs, however, are not without their risks; worse, they may even accelerate the degradation of cartilage within joint tissue with longer-term use.

 Thus, natural alternatives that are effective and that don’t come with these downsides are attractive to consumers looking for joint support.

The popularity of glucosamine and chondroitin as natural therapeutics for joint health is well documented; however, these compounds aren’t effective for everyone with OA or non-OA related joint pain. Recent research has illuminated the benefits of several unique and potentially effective brand-name nutraceutical compounds derived from natural sources that may be used in conjunction with glucosamine and chondroitin supplements or as alternatives to these popular choices. These include NEM eggshell membrane, UC-II undenatured type II collagen, and AppleActiv dried apple peel powder.

Eggshell membranes are the soft membranes that line and peel away from the inner wall of an eggshell. These membranes are a natural source of compounds including chondroitin sulfate, hyaluronic acid, and glycosaminoglycans. Extracts from the membrane have been studied for their ability to support joint health.

A recent multicenter, open-label clinical study led by Ulrich Danesch and colleagues from Germany was conducted to assess the effectiveness of NEM eggshell membrane from ESM Technologies (Carthage, MO) in individuals with knee and hip OA.

 Forty-four individuals aged 18 and over with moderate, persistent knee or hip pain due to OA were included in the trial and were asked to consume 500 mg of NEM daily. The primary outcome measures included changes in pain and stiffness based on a questionnaire derived from the Western Ontario and McMasters University Osteoarthritis Index questionnaire (WOMAC). Individuals were assessed at baseline and then again at 10, 30, and 60 days after initiation of supplementation with eggshell membrane.

Significant reductions in pain were noted with eggshell membrane supplementation at 10 days, and a greater magnitude of pain relief was found at 30 and 60 days. Measures of joint stiffness were also improved at 30 and 60 days, with high physician and patient ratings of treatment effectiveness. More than 75% of individuals showed moderate or significant improvement from baseline by the end of the study period. In addition, the use of acetaminophen as rescue medication (assessed for the 30 days prior to study initiation) dropped substantially after 30 and 60 days in individuals supplementing with NEM. The results of the study indicate that NEM is effective for rapid as well as sustained pain relief in individuals with hip and knee OA.

The study by Danesch and colleagues highlighted above followed earlier human studies conducted in the United States showing efficacy of NEM eggshell membrane for individuals with OA. These studies showed that NEM was also effective in a European population.

One of the earlier clinical trials was a randomized, double-blind, placebo-controlled study in which 60 participants with moderate OA of the knee (the intent-to-treat population) received either NEM (500 mg daily) or placebo for eight weeks.

 The primary endpoint of this trial was the change in overall WOMAC scores as well as changes in the pain, stiffness, and function subscales of the same questionnaire. Individuals were assessed at baseline and again at 10, 30 and 60 days after supplementation commenced.

There was a trend towards improvement. The overall dropout rate of the participant group in this study was relatively high and may have contributed to the lack of statistically significant improvements in overall WOMAC and functional improvement scores; however, the pain and stiffness subscales of the WOMAC questionnaire showed significant improvement, resulting in reduced joint pain and stiffness compared to placebo at 10, 30, and 60 days.

This placebo-controlled study came on the heels of two pilot open-label trials in which individuals over the age of 18 with joint and connective tissue disorders consuming 500 mg of eggshell membrane daily for four weeks had significantly improved joint flexibility and reduced overall pain as well as reductions in range-of-motion associated pain

, suggesting substantial benefits of NEM eggshell membrane for joint health and pain reduction.

Recent investigations have focused on determining the potential mechanisms behind eggshell membrane’s joint-health benefits. The clinical effects seen in human studies as well as preliminary 

 studies indicate that a potential mechanism of NEM is an anti-inflammatory one.

Kevin Ruff and Dale Devore of ESM Technologies and Membrell LLC (Carthage, MO) undertook an exploratory study in rats in which the animals consumed NEM for seven days, and effects on inflammatory cytokines were evaluated.

 The results of the study showed that two major cytokines identified as primary mediators of arthritic inflammation in the early phase, IL-1β and TNF-α, demonstrated trends towards reduction in rats after seven days, while nearly all of the cytokines known to play crucial roles in the pathogenesis of late-phase inflammation in arthritis-including those known to impact cartilage degradation and disrupt chondrocyte activity (cells involved in cartilage synthesis and repair)-were significantly reduced by NEM.

A further rat study conducted at Daejon University in Daejon, South Korea, by Boo Yong Sim and colleagues seems to provide the first evidence of a direct cartilage-protective or -preserving effect of eggshell membrane.

 Rats in which arthritis was chemically induced received NEM at three different concentrations. The results of this study showed that several inflammatory cytokines and cartilage-degrading enzymes were reduced in serum, while the production of nitric oxide and high-sensitivity CRP-markers of inflammation-was also decreased in comparison with controls. In addition, patellar cartilage volume increased significantly in rats given NEM, indicating its benefits for cartilage preservation.

In other research, investigators from Missouri State University in Springfield, MO, found that eggshell membrane actually activates the signaling protein NF-ÎºB 

While this may initially seem to be a counterproductive benefit-that NEM activated this protein involved in promoting pro-inflammatory effects-the authors suggest that this preliminary finding may indicate that NEM functions by inducing oral tolerance via activation of NF-ÎºB in the gastrointestinal tract. (Oral tolerance may be induced by repeated exposure of the immune system to an antigen that is taken in from the diet, leading to the body becoming “tolerant” to the substance, preventing the immune system from mounting an unnecessary or inappropriate immune response.) If this mechanism is born out in future research on NEM, it gives greater importance to the comprehensive joint-supportive benefits this natural substance confers.

Joint discomfort will impact a good portion of the aging population in the coming years, but research shows three natural ingredients may help.

Natural Options for Osteoarthritis

There’s no disputing it: protein is one of the most successful categories on the functional food and beverage market today.

According to Innova Market Insights, product claims of being “high in protein” or a “source of protein” appeared on nearly 4% of global food and drink launches in the 12 months prior to July 2015. The power of protein appears to be even greater in the United States, and in the dairy market specifically, where more than 17% of U.S. dairy launches were “positioned on their protein content” in the same 12-month period, says Innova.

One of protein’s biggest players, whey protein, has made a name for itself on the sports nutrition market thanks to its potential benefits in muscle protein synthesis (MPS) and maintaining muscle during weight loss.

But new research and marketing campaigns may be taking whey beyond sports nutrition.

“Developing further from its traditional role as an excellent source of protein for muscle building and recovery for elite athletes, the muscle-related benefits of whey protein are now being transferred to the healthy-aging market,” says Noel Corcoran, sales and marketing director for whey supplier Carbery (Cork, Ireland). “Whey protein ingestion is an effective nutritional strategy to combat the age-related loss of muscle mass, strength, and function known as sarcopenia.”

Early research into whey’s potential to fight against sarcopenia has marketers and consumers looking at whey protein in a new light. Will this be the latest ingredient to expand into the healthy-aging market?

Among the older adult population, sarcopenia is a widespread, progressive, and potentially debilitating condition. An estimated 15% of people over the age of 65 and 50% of people over the age of 80 may experience some degree of sarcopenia.

 Beyond just causing a decline in muscle mass (reported at rates as high as a 2% loss each year after the age of 50), sarcopenia is often associated with physical inactivity, decreased mobility, poor physical endurance, and overall frailty.

Making the situation even more pressing is the fact that sarcopenia affects a slice of the population that is growing, and fast. By the year 2050, the world’s population of people aged 60 years and over is expected to triple.

Here’s where protein comes in. The current recommended dietary allowance (RDA) of protein is 0.8 g per kg of body weight, and studies as far back as 2008 have suggested that almost 40% of people over the age of 70 fail to meet this level of protein intake.

High-protein diets have also been found to be associated with reduced instances of sarcopenia in older adults, although research into a causal link is still in the early stages.

But given the prevalence of sarcopenia, the growing elderly population, and the indications that protein intake may be linked to preserving muscle mass and strength, it’s easy to see how there could be a place for protein in the healthy-aging market. And what better candidate than whey, protein’s superstar, to stand up to sarcopenia?

“The problem of sarcopenia is only likely to worsen as a result of the world’s aging population,” says Anne Poulsen, business development manager of health and performance nutrition for dairy cooperative Arla Foods Ingredients (Viby J, Denmark). “This creates a significant opportunity to develop convenient, tasty, and healthy food and drink products that help seniors get more high-quality protein into their diet and prevent or even slow down the development of sarcopenia.”

Though the association between general protein intake and sarcopenia has been relatively well-researched, research into a causal link between sarcopenia and protein-and whey protein specifically-is still in the early stages. However, two studies published in 2015 do explore the relationship between a diet high in whey protein and sarcopenia in older adults.

Researchers in the Netherlands recently studied the effect of a supplement high in whey protein, leucine, and vitamin D on muscle mass preservation in obese older adults who were trying to lose weight.

The double-blind, randomized, controlled trial followed 80 obese older adults who either took the whey protein/leucine/vitamin D supplement or an isocaloric control supplement 10 times per week for 13 weeks. All participants also followed a hypocaloric diet of -600 kcal/day and performed resistance training three times per week. The experimental supplement contained 21 g of protein, and the mean age of study participants was 63.

Both the experimental and control groups showed similar reductions in body weight and fat mass over the course of the 13-week period. However, while the experimental group experienced an average increase in appendicular muscle mass of 0.4 g, the control group’s average appendicular muscle mass actually decreased by 0.5 g.

The researchers concluded that “a high whey protein-, leucine-, and vitamin D–enriched supplement, compared with isocaloric control, preserves appendicular muscle mass in obese older adults during a hypocaloric diet and resistance-exercise program, and might therefore reduce the risk of sarcopenia.”

It is difficult to draw conclusions about whey protein alone from this study since its effect on sarcopenia symptoms was only studied in combination with vitamin D and leucine, but it’s certainly a promising sign for whey protein as a healthy-aging ingredient.

Also published this year, a new research review examines the breadth of research that has previously linked protein consumption with diminished muscle mass resulting from aging.

 Again, there is still not enough evidence to establish a strict causal link between whey protein intake and protection against sarcopenia symptoms. The review does, however, provide some compelling circumstantial evidence in favor of whey protein for healthy aging.

“Whey protein has been shown to stimulate MPS to a greater extent than casein and soy protein at rest and following exercise in young and older individuals,” according to the review. Later, the study also notes that higher protein intakes have been found to be protective against weight and lean-mass loss in older adults, and “are positively associated with muscle mass” in older adults. 

So if general protein intake is associated with a reduction of sarcopenia symptoms, and whey is the best protein for stimulating muscle protein synthesis, then it certainly seems possible that whey protein may have beneficial effects on sarcopenia.

Future research may establish a more concrete, causal connection between consuming whey protein and staving off the effects of sarcopenia, but in the meantime several companies, as well as the National Dairy Council (NDC; Rosemont, IL), are already getting excited about the potential healthy-aging benefits of whey protein.

“If the growing elderly population doesn’t put more emphasis on muscle mass, strength, and functionality, they run the risk of increased falling, loss of autonomy, and greater dependency,” says Moises Torres-Gonzalez, PhD, director of nutrition research, NDC. “Powering up diets with more high-quality proteins, such as whey protein, spreading that protein intake throughout the day, and exercising more regularly are three simple steps for maintaining, and even increasing, muscle mass in older adults.”

Early research into whey’s potential to fight against sarcopenia has marketers and consumers looking at whey protein in a new light.

Whey Protein’s Role in the Healthy-Aging Market

As it becomes clear to consumers that physical fitness is an instrumental component of overall wellness and lasting vitality, everyone, from power walkers to CrossFit aficionados, is heading to the sports nutrition aisle in search of the right supplements.

According to Euromonitor International, the U.S. sports nutrition market reached $5.95 billion by the end of last year, with U.S. sales accounting for over half of the global $10 billion market. With numbers like that, it’s obvious that the category’s shoppers are diverse-and, in response, so too are the offerings. In other words, the high-protein bars and powders valued by bodybuilder types are no longer the only offerings on the table.

“While we all know that protein is the leader in the sports nutrition market, not every consumer is looking for the same functional solution,” says Michael Bush, senior vice president at Ganeden (Cleveland, OH). “Consumers who eat a high-protein diet aren’t looking for more protein; they are looking for non-protein offerings that will support digestive and immune health, bone health, amino acid levels, energy, endurance, and recovery.”

Though still a smaller segment of the sports nutrition market, sales of non-protein offerings are growing. Euromonitor valued the non-protein segment at just $248.6 million in 2000; by 2014, it had grown to $667.9 million; this year, it jumped over 7% to $715.9 million.

According to Richard G. Mueller, president of Biothera Health Inc. (Eagan, MN), this upward trend is indicative of a shifting mentality among shoppers that started 20 years ago with eliminating “bad” ingredients like sugar, sodium, and artificial sweeteners. Today, while shoppers have clearly embraced adding in “good” ingredients like protein, the mentality has shifted yet again-and this time, it goes beyond adding and subtracting singular ingredients to focusing on broader benefits like heart health, joint health, energy, digestion, and immunity through a multipronged approach.

“With goals of the user expanding from just fat loss, muscle-mass gain, or improved sports performance to improvements in overall energy, better mental focus, and decreased pain, the types of products people are looking for to optimize their performance is expanding beyond items like protein powders,” agrees Amanda Carlson-Phillips, MS, RD, CSSD, vice president of nutrition and research at human performance company EXOS (Phoenix, AZ). “More and more, people are starting to understand that our body is a complex system and not a series of linear actions. Creating holistic game plans around nutrition and supplementation supports benefit attainment, versus trying to solve one problem at a time.”

Though protein remains the category leader-clocking in at $5.3 billion in sales in the United States alone in 2014, says Euromonitor-non-protein offerings represent an opportunity for growth if formulators can make the case that their ingredient or product makes sense alongside an existing protein regimen or as a part of a holistic health plan in support of general physical fitness.

At Biothera, immune health is starting to creep into the sports nutrition category and remains an area of untapped potential. “What is often not correlated is that high-intensity exercise can temporarily weaken the immune system. This is commonly known as the ‘open window’ where the immune system is impaired, causing an increased risk of infection,” says Mueller. This can pose a problem for athletes who can’t be derailed from their training programs.

To this end, the company’s Wellmune beta-glucan was found to reduce upper respiratory tract infection symptoms by 40% in marathon runners, says Mueller, and can make sense combined with protein or probiotics in a sports nutrition product. More recently, University of North Texas researchers found that Wellmune may also benefit more-casual exercisers. At the National Strength and Conditioning Association’s annual conference this July, the researchers presented the results of a study performed on 109 adults who were not regular exercisers. They found that after subjects supplemented with Wellmune and performed brisk treadmill walking or light jogging, they experienced a significant increase in salivary IgA-an antibody critical to mucosal immunity-an indicator that Wellmune alleviated the mucosal immune suppression that may come as a result of strenuous exercise.

“These new results suggest that even a small amount of exercise stress can trigger a drop in immune responses and that Wellmune can help enhance key immune functions to keep individuals healthy,” said Brian McFarlin, PhD, the study’s lead researcher.

Within herbal supplements, immune-health booster 

 may also support athlete health. A new study

may protect athletes from viral infections.

Researchers in North Carolina examined blood samples from 48 marathon runners to compare the effects of 600 mg/day of 

 versus a placebo on the body’s response to viral infections after heavy exercise. Although initial studies found 

 had no impact on inflammation or oxidative stress, additional testing of an 

assay found that polyphenolic compounds in 

 may have protected the runner’s cells against vesicular stomatitis virus (VSV) by delaying the infection for up to 12 hours after the marathon.

“Basically, after heavy exertion, bacteria and viruses can multiply at a higher rate than normal due to factors in the serum like stress hormones and inflammatory cytokines,” said David Nieman, PhD, lead author of the 

study. “This is why runners are six times more likely to get sick after a marathon.”

Also of interest, researchers from the University of Aberdeen (Aberdeen, Scotland) report that krill oil may increase markers of immune function after a bout of acute exercise. The findings come from a new study

The study followed 19 men and 18 women who were randomly assigned to consume either 2 g per day of krill oil or a placebo for six weeks. Aker Biomarine (Oslo, Norway) provided the Superba krill oil capsules used in the study.

At the beginning and end of the supplementation period, all subjects participated in a maximal exercise test and cycling time trial to evaluate exercise performance and illicit an immune response. The cycling time trial included participants cycling at 70 revolutions per minute with workload increasing every minute until volitional exhaustion.

Blood samples were collected before both exercise trials, as well as immediately after, one hour after, and three hours after exercise. Researchers examined the blood for markers of immune function, including erythrocyte fatty acid composition, plasma IL-6 concentration, thiobarbituric acid reactive substances (TBARS) concentration, natural killer (NK) cell cytotoxic activity, and peripheral blood mononuclear cell (PBMC) production.

Krill oil supplementation did not appear to modify exercise performance among study participants, but the experimental group did show increased PBMC IL-2 production and NK cell cytotoxic activity three hours post-exercise compared with the placebo group.

“The current study has demonstrated that NK cell cytotoxic activity and PBMC IL-2, but not other cytokines, are increased after krill oil supplementation,” wrote the researchers. “What remains to be established are the mechanisms through which n-3 PUFA [polyunsaturated fatty acid] supplementation results in these alterations.”

Many other ingredients are helping serious and casual athletes reach holistic health.

Protein Isn’t the Only Game in Town for Sports Nutrition

In a year of regulatory strife, it’s nice to celebrate positive news for a change. The dietary supplements industry is enjoying a moment of triumph following Bayer Corp.’s recent victory over the FTC in a court case over probiotic structure-function claims.

A New Jersey federal district court judge ruled in September that Bayer met its “competent and reliable scientific evidence” burden and affirmed that randomized controlled trials (RCTs) aren’t required for structure-function claims. The bottom line: supplements are not to be regulated as drugs, the judge said. More importantly, he ruled that the FTC cannot, by way of regulatory creep, introduce new substantiation standards for supplements that run counter to the laws governing supplements, to FTC’s own guidance governing supplements, and to language already instated in existing consent decrees. (

Click here to read about the case and the opinion's key points

“This was a great moment for industry in dealing with what has been, as an agency, one of our more rigorous opponents,” said attorney Marc Ullman of Rivkin Radler LLP during a SupplySide West panel in October.

For Jonathan Cohn of Sidley Austin LLP, one of the attorneys who argued the case on behalf of Bayer, the takeaway is simple: Industry should fight more cases when the FTC is trying to sidestep the appropriate route for changing legal statute.

“Try more cases,” he urged, speaking at October’s Council for Responsible Nutrition (CRN) annual conference. “Bottom line, industry can win. We did it before, and we can do it again."

Others are happy, but cautious. "Don’t take this as the end of the issue,” Ullman said. FTC will almost certainly try to flex its muscles again in the future, and it also has 60 days to appeal the Bayer case.

“What’s going to come next? Well, what I think is going to come next is more specific orders,” said attorney John Villafranco of Kelley Drye & Warren LLP, also speaking at the CRN event. He pointed to prior statements made by David Vladeck, former director of FTC's Bureau of Consumer Protection, that FTC believes consent orders are more enforceable and stronger in court if they spell out specific types of tests.

New FTC consent orders will provide hints of what’s to come, industry leaders say. And industry should monitor those orders closely.

Speaking to CRN conference attendees, FTC’s Mary Engle, associate director for advertising practices, Bureau of Consumer Protection, likewise advised companies to examine FTC’s complaints. While consent decrees only bind the companies under order, “they may provide some guidance as to where we’re drawing the line between when you need clinical trials and what broader claims that you may not necessarily need clinical trials [for].”

“Sometimes competent and reliable scientific evidence is randomized controlled trials,” she added. And while the agency has “pretty much stopped putting in our order provisions [a requirement for] at least two RCTs, what you’ll see instead is simply the requirement that the court put in the [consent order for] POM Wonderful [in its FTC case over disease claims] that they have clinical testing, without specifying that number.”

Companies should not take the Bayer case as a cue to relax; just the opposite. They should be more vigilent of their claims substantiation, said Michael McGuffin, president of the American Herbal Products Association, at the SupplySide West panel. “What the court’s decision did 

 do is tell us that we don’t have to have substantiation. We still need to have substantiation for our claims.”

“FTC is not going to go away,” said panelist Dan Fabricant, PhD, CEO and executive director of the Natural Products Association. “[The Bayer case] is limited to one jurisdiction. Even if the judge’s language is somewhat of an endorsement of Bayer’s procedure, that’s not going to get you real far. They’re going to find another jurisdiction to keep bringing these sorts of cases. They’ve already shown that from the start.”

In terms of RCTs, said Villafranco, FTC’s “thinking is really starting to evolve, and it’s becoming crystallized.” Even if we do not see orders delineating two RCTs in most cases, he said, pay attention to the fact that the FTC does not seem to flinch at requiring two RCTs for highly scrutinized categories like weight-loss supplements.

“Not a lot of companies have the conviction that Bayer had here or the resources or time to really dig in” and take the FTC on in court, Villafranco added. For most companies, the path forward will be vigilance, careful stepping, and the sense not to become complacent when it comes to the FTC.

The top key takeaways from the judge’s decision in Bayer versus the FTC


Editor-in-Chief
Nutritional Outlook magazine


“What’s going to come next? Well, what I think is going to come next is more specific orders,” said attorney John Villafranco of Kelley Drye & Warren LLP.

The Dietary Supplements Industry Won the Bayer Case, but Still Needs to Watch the FTC, Leaders Warn

Cargill (Minneapolis) gave SupplySide West attendees a first taste of its new blend of fermentation-derived steviol glycosides Reb M and Reb D. The company said it would start supplying the new blend, EverSweet, next year.

“Today is really the introduction to the market to gauge interest and give people a chance to taste it, and then we can start sampling customers, because most people’s formulation time is 12-18 months. So we want to give them a head start. And then we plan on being commercial in 2016,” said Andrew Ohmes, global commercial manager, Corn Milling, North America, Cargill.

Key Cargill customers are now sampling EverSweet. Beverages will be a target market out the gate. “Beverage is usually where we start. That’s obviously where the big volume is, and that’s where the biggest challenge is specifically in carbonated soft drinks. But it will easily move into yogurts, dairy beverages, baking, or even supplements,” Ohmes said.

As a fermented sweetener, EverSweet stands apart from Cargill’s other stevia offerings that focus strictly on traditional stevia leaf extraction. The company's Truvia Reb A stevia is derived from the leaf, and its 

 to determine best glycoside ratios, introduced last March, also revolves around leaf glycosides.

Compared to these other stevia sweeteners, EverSweet offers some important formulation advantages, Ohmes said. “Reb M and Reb D and the EverSweet product has a better temporal profile that’s more sugar like than other stevia products-better up-front sweetness, less sweet linger, and virtually no bitterness at all. So you get a much more rounded sweetness.”

What this means is that in a carbonated soft drink, for instance, the company can achieve up to 100%, zero-calorie sweetener substitution with EverSweet, whereas 100% replacement was not possible with the previous technologies. Before, Ohmes said, with “a high-Reb A product, you could probably do a 30% replacement, and it tastes pretty good. ViaTech will easily get you to 70%, and depending on the application might go all the way to 100%. But there might be a gap getting that last little bit, that last 15% or so." But EverSweet can get to the 100% replacement easily, while maintaining a desirable taste profile, he said. Carbonated soft drinks are one of stevia's most desirable markets. Even with its preexisting technologies, Ohmes said, “We couldn’t reach the highest carbonated soft drinks. As you go to higher and higher levels [of stevia], you have the bitterness, the linger, the bad attributes, not as much up front sweetness, and then the overall sweetness was lacking.” Now, with EverSweet, he said, companies may not even need to use-or at least reduce their use of-taste maskers that are otherwise so often required to hide stevia's bitter or licorice notes.

Fermentation-derived steviol glycosides offer numerous advantages. Most notably, they allow a business to produce some of the sweetest glycosides in the stevia leaf that are otherwise generally present in very small amounts in the natural leaf. Cargill says that some of the sweetest glycosides like Reb M are present in the leaf only at a percentage of around 1%; by contrast, Reb A occurs at up to 12% of the leaf. If a company were to extract those glycosides traditionally from the leaf, there would be a lot of unused leaf wastage left over, or, at the very least, a lot of leftover Reb A. But through fermentation, the company can produce just the same target glycoside that exists in the leaf, in scalable amounts, cost-effectively, and it can also sidestep any environmental challenges of traditional leaf agriculture. (When asked whether companies would ever consider using fermentation to produce Reb A, Ohmes said, “I think there are some out there that have looked at that. For us, it doesn’t make a lot of sense to do Reb A in this manner because you can produce Reb A relatively inexpensively from leaf and you still have all the taste issues [associated with Reb A], so why produce something that has taste issues where you have a much better tasting product with this product [EverSweet]?”

Some might call stevia fermentation synthetic because no part of the stevia leaf is involved in the process. In Ohmes’s words, with EverSweet, Cargill is “recreating the sweetness.” Ohmes said that the company is “transparent about how it’s made. We’re using an age-old process to solve a modern problem.”

On its website Q&A, Cargill addresses questions about fermentation and whether EverSweet would be considered a genetically modified organism (GMO). It says, “The sweet parts produced by the yeast-Reb M and Reb D-are identical to the Reb M and Reb D found in a stevia leaf. The baker’s yeast used to 

Beverages, especially carbonated soft drinks, will be the key market out the gate, Cargill says.

Nutritional Outlook Vol. 18 No. 9