Bars have long been an ideal vehicle for protein, combining convenience and functionality. The protein space continues to diversify with more plant-based options and innovations that optimize bar taste and texture.

“The nutritional bar market is dominated by protein-rich bars and is expected to see continued growth with the use of both animal- and plant-based proteins,” says Dina Fernandez, plant protein R&D manager, ADM Nutrition, Archer Daniels Midland Co. (ADM; Chicago, IL).

Plant proteins have received a great share of the attention. “The use of plant-based proteins has increased in the last decade, opening innovative opportunities for all types of food applications, especially in the vegan, vegetarian, and flexitarian markets,” says Fernandez. “Plant-based proteins are often preferred for their nutritional benefits, sustainability considerations, and dietary diversity.”

While plant proteins have been trending, dairy proteins and isolates remain competitive within the protein bar space, specifically within sports nutrition. “Although the plant-based protein market continues to thrive, recent figures show that food and beverage launches featuring dairy proteins are seeing steady growth, with a compound annual growth rate of 7% (globally, 2014-2018),” says Sarah O’Neil of Carbery (Wauconda, IL), citing Innova Market Insights data. She continues: “Sports nutrition is the leading market category featuring dairy proteins. With innovative launches seen in the seniors and infant categories, it is clear that dairy proteins hold strong potential for targeting different consumer groups.”

Sports nutrition has become an interesting space in and of itself, no longer just catering to athletes. “The traditional, single, core protein bar still has its place targeting athletes and fitness enthusiasts; however, we have seen a move toward multilayer bars that incorporate other textures such as protein crisps, and layers,” says O’Neil. “Additionally, there has been an increase in the number of bites and snack sizes being launched, along with products targeted at the paleo, vegan, and ketogenic diets.”

Refrigerated bars are very popular at the moment, points out Leda Strand, manager of snacks, bakery, and confections, applications science and technology, for ADM. Consumers perceive refrigerated bars as healthier because, by virtue of them being in the refrigerated section, they seem fresher, more natural, and less processed.

“These bars are often formulated with a high amount of nut butter and rice syrup, maple syrup, or honey to differentiate them from shelf-stable bars,” explains Strand. “Typically, they are found in the refrigerated section at retail but can be held at room temperature for up to a week. The bars soften once removed from refrigeration and are ideal for athletes, kids, and the whole family.”

A theme that emerges when talking about bars is texture, which is key to the success of a bar. Consumer preference varies when it comes to texture, with some preferring crunch and others preferring softness. Suppliers and protein bar manufacturers are constantly innovating to improve the taste and texture of bar formulations. One common challenge with bars is maintaining a consistent texture during shelf life.

“As a plant-based protein bar ages, the texture typically becomes harder, with a dry mouthfeel. ADM offers a full line of soy proteins that provide functionality to maintain a soft and moist bar texture. These proteins have low-water-binding and -holding capacity and delay moisture absorption, therefore delaying bar hardening,” explains Strand. “In many cases, we also recommend that our customers combine the use of protein isolates or concentrates with soy crisps or textured soy protein such as [ADM’s soy protein concentrate] Arcon T, to reach the targeted protein level. In addition, we use soy protein isolates to differentiate the texture of a bar to achieve varying sensory attributes, from a short, cookie-like texture to a chewy, brownie-like texture. This allows for increased flexibility in the finished bar characteristics.”

The same goes for dairy-protein bars. After surveying manufacturers from Europe, North America, and Australia, Carbery learned that 50% of those surveyed experience hardening as early as three months into a product’s shelf life. Carbery is trying to solve this with its Optipep 4Bars whey protein ingredients, sourced from milk from grass-fed cows, which also offers something for vegetarians and is said to maintain a soft texture.

“Many bar manufacturers are faced with using non-vegetarian protein sources to deliver a soft texture in their bars over shelf life. Increasingly, this can be unappealing to many consumers who are looking for vegetarian and natural claims,” says O’Neil. “Our studies have revealed that using Optipep 4Bars in your bar formulation delivers a 53% reduction in hardness at 12 months versus a protein bar that does not contain Optipep 4Bars.”

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While plant proteins have been trending, dairy proteins and isolates remain competitive within the protein bar space, specifically within sports nutrition.

Protein bar evolution: The latest in protein and dairy advancements

In a market segment as old and enduring as grains, one might wonder if further innovation is possible. In fact, an exploration of grains reveals that not only has the definition of “grains” loosened and expanded in recent years to include some non-cereal-grass seeds and other plants, such as quinoa and chia, but commercial applications for grains have evolved and changed as well.

Traditional domesticated cereal grains, so-called “ancient grains,” and non-cereal-grass seeds are now all gathered under the “grains” umbrella and are puffed into snacks, blended into other foods, formulated into beverages, and milled into concentrates. Grains are nearly as old as humanity itself, yet their dynamism in the commercial market remains strong.

Conventional grains are the seeds or fruits of various grass crops, particularly the cereal grasses, harvested for human or animal consumption. These include wheat, maize, rice, barley, millet, oats, rye, and triticale, and their history is long, having served as staple foods for humankind for upwards of tens of thousands of years.

Some so-called “ancient grains” are conventional cereal grains as well, such as spelt and khorasan wheat (Kamut). Others, such as amaranth, buckwheat, and quinoa, are the seeds of broadleaf plants, sometimes referred to as “pseudograins.”

What’s important, however, is that grains are now regarded and marketed as such based more on their nutritional profile and food application than their botanical classifications. With this newer, more-fluid definition of grains, suppliers and marketers can tailor their grain offerings to consumers seeking lower-gluten or gluten-free choices, higher-protein choices, “cleaner” choices, and convenience.

“The growing consumer interest in clean-label ingredients has put ancient grains at the top of all healthy grains,” says Olga Garcia, milling marketing manager for Bunge North America (White Plains, NY). “This demand has shown steady growth over the years.” Bunge’s Whole Harvest Ancients brand adds such grains as quinoa, sorghum, and millet to masa products for wraps, tortillas, and taco shells, thereby conferring the cachet of ancient grains to more conventional food products. Garcia adds that these ancient-grain-enhanced products “can help customers meet growing demand for higher nutritional value, including higher fiber and protein, as well as their demand for gluten-free, non-GMO products.”

In the beverage space, which is a relatively new and interesting market for grains (more on this ahead), Andrew Wheeler at FutureCeuticals Inc. (Momence, IL) says that the company’s ancient grains are among the “major movers.” He adds that “organic and gluten-free have become almost a given expectation.”

At GoodMills Innovation (Hamburg, Germany), Svenja Frank, head of social business and communications, points to ancient grains’ “authenticity” and “naturalness, but with added functional benefits, such as improved intestinal health.” Ancient grains emmer and einkorn, she says, are currently experiencing increased demand at GoodMills Innovation from customers using them as ingredients in bread, rolls, cakes, and muesli. The company is also marketing its 2ab Wheat, which is an ancient grain “consisting only of the genomes A and B-which contain few fermentable oligo-, di-, and monosaccharides and polyols,” Franks adds. “It is free of the D-gluten found in modern wheat varieties that can be difficult to digest.”

She also points to GoodMills Innovation’s research into and work with ancient-grain variety tartary buckwheat, processed by the company into its RutinX ingredient. “This buckwheat variety is a prehistoric plant, rich in fiber and trace elements such as zinc and rutin,” Frank explains. “Rutin is a naturally occurring phytochemical. We succeeded in reducing the strong, bitter taste of rutin and now deliver it as a versatile ingredient for different application areas.”

“Beverage-ready grains,” such as those offered by FutureCeuticals, are a nutritious, “clean label” way to improve taste and texture of functional beverages, says the company’s Wheeler. Stable across a range of applications and easily incorporated into existing formulations, he explains, beverage-ready grains work well for formulating into protein and green drinks as well as dairy and dairy alternatives. “The USDA-patented TRIM process we deploy takes the normally ‘gritty’ grains and transforms them into a hydrocolloid-like material that masks off notes and delivers a smooth and creamy mouthfeel to beverages,” without the need for artificial gums or fats and oils, Wheeler says.

When asked how the gluten-free trend has affected FutureCeuticals’ grain-powder offerings, Wheeler replies frankly and bluntly: “We don’t sell much barley any more, if that tells a story on how gluten-free has become the expectation.” He elaborates, “BarleyTrim used to be a top global product for us five to seven years ago, but now we see ModCarb (a blend), QuinoaTrim, AncienTrim (ancient grains), and Nutrim (oats)- all organic and gluten-free-as our top products in the beverage-ready-grains space.”

GoodMills Innovation’s Frank speaks along similar lines. “The gluten-free trend definitely plays an important role in our innovative work,” she explains. “The issue of tolerability has formed part of our research for more than 20 years.” The company offers its reduced-gluten 2ab Wheat in addition to gluten-free masa flours and YePea (a European, GMO-free alternative to soybean grist). “Nowadays,” Frank adds, “the hype has led to those who can tolerate wheat or rye well continuing to seek gluten-free alternatives anyway.”

“Making wheat cool again” is the edgy slogan Arcadia Biosciences is using to promote its to-be-launched GoodWheat Reduced-Gluten wheat-flour products. The company’s reduced-gluten wheat, developed through research funded in part by a grant from the National Institutes of Health’s Diabetes and Digestive and Kidney Disorders Institute, is the second product to be added to its recently announced GoodWheat-branded ingredients platform, along with its high-fiber resistant-starch wheat lines. The goal of the GoodWheat brand, according to Arcadia’s press materials, is “to add value to the entire wheat supply chain, from seed to table, by enabling a wider range of choices to meet evolving consumer demands”-less gluten being one of them.

Bunge’s Garcia cites research-firm Mintel’s placement of “gluten-free” third among consumers’ trending claims. “This demand has clearly affected all food segments,” she states, “and the grains market has not been an exception.”

In a market segment as old and enduring as grains, one might wonder if further innovation is possible.

Grains: What’s old is new again

FDA’s refusal to consider certain synthetic ingredients as dietary ingredients remains one of the big struggles the dietary supplement industry faces today.

In 2016, FDA wrote in its revised new dietary ingredient (NDI) draft guidance that a synthetic copy of a botanical or herb does not, in the agency’s eyes, qualify as a dietary ingredient. This opinion relates specifically to synthetic botanical ingredients; FDA recognizes synthetic vitamins, minerals, and amino acids as legal dietary ingredients under the Federal Food, Drug, and Cosmetic Act.

FDA’s stance on synthetic botanicals is as problematic and unresolved today as it was for the industry 

 in the NDI draft guidance. As recently as last week, the topic was top of mind when industry associations submitted public comments to FDA in response to FDA’s invitation to the public to 

 about how the agency should improve the way it regulates dietary supplements. The topic of synthetic botanicals was addressed by the Council for Responsible Nutrition (CRN; Washington, DC), 

 that if a resulting synthetic ingredient is equivalent to a naturally occurring botanical or herb, “there are no scientifically justifiable grounds for treating synthetic copies of botanical constituents differently…”

Then there are those, such as omega-3 drug firm Amarin Pharma, who argue that certain synthetic ingredients should not be considered dietary ingredients. Amarin’s FDA-approved prescription drug, Vascepa, contains a purified, highly concentrated source of omega-3 fatty acid eicosapentaenoic acid (EPA) in ethyl ester form. In its 

 to FDA, Amarin declared, “Oils with a concentration of EPA and DHA that is greater than approximately 30% must be chemically synthesized in a laboratory.”

Any high-concentration EPA ethyl ester ingredients being sold as dietary supplements are synthetically produced, Amarin wrote. The company argued that these ingredients do not meet the legal definition of a dietary ingredient and that they “are unlawful synthetic copies or slightly altered versions of branded and generic drugs, and they have evaded the ‘new drug’ approval process.” It went as far as to say that FDA should “exclude synthetic substances related to natural products from the definition of ‘dietary ingredient,’ unless those substances have been commonly/customarily, and lawfully used in conventional food…”

Amarin argued that FDA should remove these “unapproved new drugs” from the market because they “distract patients from seeking medical attention, and if appropriate, obtaining treatment with proven drug therapies…” Another concern, it said, is that these synthetic supplement products may not carry the same side-effect warnings and precautions for use that FDA requires on drugs, and they may be sold “without the safety and effectiveness data required for FDA drug approval,” the company wrote.

If an omega-3 dietary supplement were equivalent in nature to a drug product that has been shown to be safe, would that supplement inherently present a risk to human health? What is clearer is the concern that high-concentration omega-3 supplements stand to undercut omega-3 drugs. Amarin was frank about this, noting in its comments that these supplement ingredients “undermine incentives for legitimate drug manufacturers to invest in drug development” and that “purported dietary supplement companies that unlawfully bypass the ‘new drug’ approval process are…able [to] avoid the costs and risks associated with drug development…”

Amarin warned, in its FDA comments, that it plans to file a 

 to argue against “chemically concentrated forms of EPA that are not found in natural substances” being allowed in dietary supplements. This is just Amarin’s most recent battle against the supplement industry. In May, the company 

 to have the International Trade Commission (ITC) investigate supplement companies making concentrated omega-3 EPA products. The company was more successful in 

 this year with dietary supplement companies that Amarin said piggybacked off of its positive clinical trial results.

Amarin shows no sign of scaling back its fight to keep synthetic omega-3 supplements off the market. And while it’s uncertain today where FDA’s decision on synthetic 

 ingredients will ultimately land, does Amarin’s argument against synthetic omega-3 supplements stand to influence the agency’s opinion on synthetic botanical supplements?

There are no answers yet, but what we know is that the supplement industry will continue keeping a watchful eye on Amarin’s actions, even as industry leaders continue to communicate with FDA on how supplement regulations, and definitions, should be changed.

Amarin Pharma did not offer further comments for this story.

Amarin Pharma’s recent comments advising FDA not to allow synthetic omega-3 supplements to be dietary supplements is just one more case in which synthetic supplement ingredients are under fire.

Synthetic ingredients’ regulatory uncertainty still a huge problem for dietary supplements, whether in Amarin’s omega-3 drug battle or in NDI guidance

“Of all five senses,” observes Karen Hecht, PhD, scientific affairs manager, AstaReal USA Inc. (Burlington, NJ), “vision is the prime one most of us rely on for information.” A Research!America poll even found that 88% of respondents consider vision to be vital, with 47% agreeing that losing sight would have the most impact on their lives, precipitating lost independence and a dramatic disruption of daily activities.

So it’s surprising-and a little ironic-that vision is also the sense that’s easiest to take for granted, 

 And with screen time, blue light, environmental assaults, and the process of aging all exacting a toll on our eyesight, that time of waning is arriving sooner than before.

But it doesn’t have to, for researchers are finding that dietary supplementation can go a long way toward shoring up ocular health and protecting eyes against the battery of threats they face. The science-and the possibilities for nutritional interventions it suggests-are worth looking at.

Given vision’s primacy in our lives, it’s remarkable how sensitive and vulnerable the organs responsible for it are. But they’re hardly defenseless.

As Brian Appell, marketing manager, OmniActive Health Technologies (Morristown, NJ), explains, “We’re constantly bombarded by different wavelengths of light, including UV and high-energy blue light. The good news is that eyes are incredibly effective at blocking UV radiation from the sun, only allowing about 1% to reach the retina, which is at the very front of the eye.”

The bad news is that eyes are less adept at filtering the high-energy blue light emitted not only by the sun, but from digital device screens and even energy-efficient lighting. “In fact,” Appell says, “almost all blue light reaches the retina and travels all the way to the macula, which is located at the very back of the eye.”

High-energy blue light is a concern on a number of counts. For one, it generates considerable oxidative stress within the eye. It also reduces contrast, which keeps eyes in a continual state of having to re-accommodate focus. This overworks the ciliary muscles that help our eyes adjust to viewing at different distances, and it produces the eye strain and fatigue that go by the very 21

-century name of computer vision syndrome, or CVS.

While this news won’t likely convince us to abandon our digital devices, it may further complicate our love/hate relationship with them. For Hecht notes that the average American spends 7.5 hours daily focusing on screens at an average distance of 14 inches away, bathing their eyes in the blue light and ciliary stress that cause 65% of American computer users and approximately 60 million people worldwide to suffer from eye strain.

Even kids get hit. While 66% of U.S. adults cop to spending too much time on digital devices, research by Kemin (Des Moines) reveals that fully 69%of parents of 6- to 12-year-olds report not only that their child uses digital devices, but that their use won’t likely diminish, as it’s part of both leisure and school routines.

That means exposure to blue light starts early and worsens with time. But the eye’s macula-a pigmented region specialized for high-acuity vision

a victim of blue light-may contain the secret to countering the high-energy wavelength’s menace.

That’s because it’s where the three main macular carotenoids congregate: lutein in the peripheral macula, RR-zeaxanthin in the mid-peripheral macula, and RS-zeaxanthin in the center. “The macular carotenoids are imperative to healthy vision for a lifetime,” Appell explains, “and as more science comes out, it seems their ‘magic’ comes from the combination of all three.”

However, the body doesn’t produce lutein and the zeaxanthin isomers de novo, and we know dietary intake to be low.

 As a result, “The average individual isn’t getting enough from dietary sources to increase their macular pigment optical density-or MPOD-to a level that provides significant protection from blue light,” says Ceci Snyder, MS, RD, global vision product manager, human nutrition and health, Kemin (Des Moines).

That’s where supplementation comes in. “Solid scientific evidence supports the benefits of supplementation with lutein and zeaxanthin for eye health,” Snyder continues, pointing to the largest study to examine its effects on age-related macular degeneration (AMD) thus far: the Age-Related Eye Disease Study 2 (AREDS2), conducted by the U.S. National Eye Institute.

Appell agrees, adding that while no defined requirement for the major dietary carotenoids yet exists, the data suffices to consider lutein and zeaxanthin’s isomers “conditionally essential,” he says. “Their importance to eye health should not be understated, especially considering the growing prevalence of AMD, one of the leading causes of vision impairment globally.”

The evidence supporting macular carotenoids’ protective effects is undeniable, and imperative, given the threats to basic ocular health we face. But, Appell notes, emerging research is affirming how these nutrients not only help us see, period, but help us see 

Endpoints like contrast sensitivity, photo-stress recovery, and glare performance are all quantifiable measures of how well we see under different circumstances, Appell says, and as such, they offer “a huge opportunity in the eye-health market.”

Consider that “how we react within our environments starts with how rapidly visual information travels from our eyes to our brain-visual processing speed,” Appell says. “Improving visual processing speed through supplementation provides new opportunities in categories like sports nutrition, where reaction time is key.”

So a time will come when the eye-health category will be about more than just prevention; it’ll offer optimization, “providing ‘immediate’ benefits that are important and relevant to consumers,” Appell says. “That, in turn, requires new science to elucidate and support these benefits.”

Check out the following pages to see what some of that science is revealing.

1. Research!America press release. “New Public Opinion Poll Reveals a Significant Number of Americans Rate Losing Eyesight as Having Greatest Impact on Their Lives Compared to Other Conditions.” September 18, 2014. Accessed at: 

http://eyeresearch.org/pdf/Poll_press_release.pdf

Journal of the American Dietetic Association, 

As potent antioxidants and filters of blue light, lutein and the zeaxanthin isomers are gaining greater recognition for protecting against digital-device dangers. And while “the protective qualities of the macular carotenoids are well established,” Appell says, “the mechanisms by which they protect haven’t been well-explored.”

 published last year showed for the first time that blue light damages retinal tissue not only by promoting oxidative stress, but by increasing stress in the endoplasmic reticulum (ER), a cellular organelle that participates in protein synthesis.

The study also found that lutein and zeaxanthin-in the form of OmniActive’s Lutemax 2020 ingredient-downregulated genes involved in ER stress and thus protected the macula’s sensitive photoreceptors against blue-light exposure.

The study, Appell says, “further demonstrates the importance of consistent and adequate intake of these important nutrients for healthy vision.”

4. Minzhong Y et al. “Lutein and zeaxanthin isomers protect against light-induced retinopathy via decreasing oxidative and endoplasmic reticulum stress in BALB/cJ mice.” 

As Appell notes, “Improving visual processing speed and other key performance markers like disability glare and photo-stress recovery through supplementation provides new opportunities in different categories-like sports nutrition-where reaction time is key.”

 drew upon the LAMA II study-a year-long double-blind, placebo-controlled trial involving 59 healthy young subjects randomly assigned to 1) a placebo, 2) 10 mg of lutein plus 2 mg of zeaxanthin, or 3) 20 mg lutein plus 4 mg zeaxanthin (both as Lutemax 2020)-to demonstrate that MPOD, visual performance in glare, and photo-stress recovery improved significantly in both supplement groups relative to the placebo after six months, with further improvement emerging at 12 months.

The results of LAMA II also showed that supplementation with all three macular carotenoids improved processing and reaction speed. “The study suggests that the positive findings may be, in part, due to the unique composition of Lutemax 2020, which contains all three macular carotenoids-lutein, RR-zeaxanthin, and RS (meso)-zeaxanthin.”

5. Stringham JM et al. “Macular carotenoid supplementation improves disability glare performance and dynamics of photostress recovery.” 

“An exciting new area of research is the connection between eye and brain health,” says Snyder. A study

 published in 2017 was the first randomized, double-blind, placebo-controlled trial to test the combination of 10 mg lutein (as Kemin’s FloraGLO brand) and 2 mg zeaxanthin in healthy, well-nourished young adults, and it revealed increased visual memory and MPOD, and improved complex attention and reasoning ability.

 showed lutein’s benefits in enhancing connectivity between brain networks. The findings make sense, Snyder says, as lutein is the brain’s predominant carotenoid, and the mechanism behind its benefits may involve how the pigment “integrates into cellular membranes in specific directions, likely influencing the functional properties of synaptic membranes and the speed at which messages are transmitted across neurons.

The upshot: “For supplement brands, the opportunity to connect eye and brain health is an opportunity readily supported by science,” Snyder says.

6.  Renzi-Hammond et al. “Effects of a lutein and zeaxanthin intervention on cognitive function: a randomized, double-masked, placebo-controlled trial of younger healthy adults.” 

7. Lindbergh et al. “The effects of lutein and zeaxanthin on resting state functional connectivity in older Caucasian adults: a randomized controlled trial.” 

Published online ahead of print January 24, 2019.

Astaxanthin belongs to the same xanthophyll carotenoid family as lutein and zeaxanthin, but boasts two to three times the antioxidant capacity. Even better, Hecht says. “Astaxanthin works in the muscles at the front of the eye that help support dynamic focus.”

Hecht points to earlier clinical work showing that astaxanthin supplementation improves eye fatigue by quenching free radicals that trigger the inflammation associated with persistent visual stress and tension of the ciliary muscle. A preclinical study showed that as much as half of all astaxanthin in cellular membranes localizes in mitochondrial membranes, too. “This is important because mitochondria form free radicals as a byproduct of their metabolism,” Hecht says. “With astaxanthin positioned at their source, it can protect mitochondria and energy production in the eye.”

In a 2010 double-blind, randomized placebo-controlled study

, computer workers supplemented with 9 mg of her AstaReal’s astaxanthin or a placebo for four weeks. At treatment’s end, 62% of those in the astaxanthin group who reported moderate to severe eye strain before the study experienced improvement, while only 15% of those taking a placebo did. “Increased accommodation amplitude in all treated subjects, for example, indicated improved reaction on near and far objects,” Hecht says.

8. Nagaki Y et al. “Effect of astaxanthin on accommodation and asthenopia.” 

We usually think of vitamin K2-particularly the menaquinone 7 (MK-7) form-as a nutrient for heart and bone health. But “new research has come to light identifying vitamin K2’s mechanism as benefiting vision health,” says Kate Quackenbush, director of communications, NattoPharma (Oslo, Norway).

 examined calcification-induced aortic stiffness as a factor in retinal arteriolar health, finding that circulating inactive matrix Gla protein (MGP) is a long-term predictor of smaller retinal arteriolar diameter in the general population.

Active MGP is a well-known inhibitor of vascular calcification, Quackenbush notes, and “vitamin K2 as MK-7 is the only compound to date shown to impact arterial calcification through its activation of MGP.” Because obtaining an adequate vitamin K2 intake from diet alone is a tall order, the researchers note that their “observations highlight the possibility that vitamin K supplementation might promote retinal health.”

“This new study is an exciting development for vitamin K2’s potential,” Quackenbush says. “We already know that K2 supplementation can help the population support bone and cardiovascular health simultaneously; just imagine if one nutrient could support vision health at the same time.”

9. Wei FF et al. “Inactive matrix Gla protein is a novel circulating biomarker predicting retinal arteriolar narrowing in humans.” 

Photo © Shutterstock.com/photographyfirm

Researchers are finding that dietary supplementation can go a long way toward shoring up ocular health and protecting eyes against the battery of threats they face.

Eye health science and supplements: The long view

Three out of every four Americans take a dietary supplement-and that number is growing. Yet, current regulations governing this massive market do not ensure that those supplements consumers are purchasing do what they say they do or even include the ingredients they claim to include. And that must change in order to protect consumer health and to ensure that honest companies operating in this space have a level and fair playing field.

To establish rules to guide the health supplements market, Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994. But, while well intentioned, DSHEA’s rules are not strong enough, and, more importantly, they are not enforced to their fullest. And that opens the door for unscrupulous players in this market to introduce products that are not effective and not based on science, to make baseless and false claims about the efficacy of their products-or even to steal the intellectual property of other companies and claim it as their own.

A few bad actors diminish the reputation of the entire industry, erode consumer confidence in the products they are buying, and even threaten the health of consumers who are taking these products. Although it is uncommon, perhaps, for a company CEO to request stronger regulations and regulatory enforcement for his or her industry, that is precisely what I am doing. Poor enforcement and lax regulation are a problem for my company and for every other company in our market following the rules, investing in science and health discovery, and rigorously testing the efficacy of its products. According to the research firm Euromonitor, the dietary supplements market will surpass $17 billion by 2023. We need everyone in this dynamic and fast-growing market to understand and follow clear rules and regulations-and to be penalized or removed from the market if they refuse to do so.

U.S. Food and Drug Administration recognizes

 that current regulations are not keeping pace with this vibrant market. That is why the agency recently hosted a 

 of industry leaders, academics, legal experts, and other key stakeholders to discuss the issues of regulation and enforcement and how to balance promoting innovation, scientific rigor, and consumer safety.

In my view, the process toward stronger market enforcement should focus on three simple steps.

The first step is enforcement. FDA requires notification any time a dietary supplement is introduced with a new ingredient, and proof that the supplement is safe for consumers. This is a good process that, when followed, leads to better products, champions the integrity of our industry, and, most importantly, protects consumer safety.

Unfortunately, it is not enforced, and bad actors are able to ignore the rules, bring products to market with limited substantiation or consumer safety protections, and steal the intellectual property of responsible companies who have made their science public through the notification process. Better enforcement and improvements to the process are desperately needed.

The second step is to introduce new incentives for compliance and investment in good science. For example, the same approach FDA used with drug companies to provide exclusivity rights could be applied to the dietary supplements industry. This approach would not only provide intellectual property protections, but it would also incentivize investment in science which would, in turn, elevate the integrity of the entire industry and weed out companies lacking scientific substantiation for their products.

The third step is to establish rules that require companies to provide consumers with accurate information on the health benefits of their products, and to support those claims with sound, well-documented science. This would allow consumers to be better educated about the steps they can take today to improve their quality of life and to have confidence in the products they are buying.

The net result of these three important steps would be enhanced consumer safety protections, greater industry compliance, more pervasive and robust science, and increased consumer clarity and education. Not a bad return on smart regulation end enforcement.

At the end of the day, consumers who are looking for products that promote their health and wellness should be able to trust the safety of what they are consuming and the companies behind those products.

I am so proud to be part of an industry that each day strives to improve the lives of people worldwide and does so with state-of-the-art science from some the world’s greatest minds. But so great a mission makes the shortcomings that much worse. That is why I am asking everyone in our market to join me in calling for more rigorous rules and better enforcement, and to provide support for the FDA as they take on this challenge. Working together, we can promote a thriving marketplace in which good science is rewarded, compliance is attractive, and public safety is protected.

Rob Fried is the CEO of ChromaDex (Irvine, CA; 

), an integrated, global nutraceutical company devoted to cellular health and improving the way people age. A seasoned chief executive officer, successful entrepreneur, and enterprise builder, Mr. Fried has a track record for driving transformational growth across a variety of industries. He is an Academy Award-winning motion picture producer and Emmy Award-winning television producer. He holds a B.S. from Cornell University and a M.B.A. from the Columbia University Graduate School of Business.

ChromaDex CEO Rob Fried: “Although it is uncommon, perhaps, for a company CEO to request stronger regulations and regulatory enforcement for his or her industry, that is precisely what I am doing.”

The dietary supplement industry needs stronger enforcement, writes ChromaDex CEO (Op-ed)

Astaxanthin has long been known for its clinically validated uses for eye health, skin health, joint and tendon support, and its benefits for athletes. But it does a whole lot more. In fact, there are over 100 human clinical trials showing that astaxanthin-and, specifically, natural astaxanthin-has ten distinct health benefits in humans.

Did you know that natural astaxanthin can enhance male fertility? Or that Washington State University did a series of trials showing that natural astaxanthin can modulate the immune system of several different mammal species, including humans? Or that there are nine different human studies showing that natural astaxanthin can support brain health? In this article, we take a brief look at these three lesser-known health benefits of natural astaxanthin.

Washington State University Professors Boon Chew and Jean Soon Park performed a progressive series of studies on astaxanthin’s effects on immunity starting in the late 1990s. They were not the first academics to do research in this area, however. Harumi Jyonouchi, MD, of the University of Minnesota’s School of Medicine was the initiator of immunity research on astaxanthin. She published eight different studies starting in the 1980s-

studies and in rodents-each demonstrating that natural astaxanthin can enhance the immune response.

Drs. Chew and Park picked up where Dr. Jyonouchi left off. They did a few mouse studies before moving on to a study in cats

, both with very positive and similar results showing that astaxanthin increased several immune markers. The dog study went even further, finding that astaxanthin decreased DNA damage and also reduced C-reactive protein, the chief marker of systemic inflammation.

Then they moved to humans and did a landmark clinical study

 in young women. They randomly separated the women into three groups: 1) placebo, 2) 2 mg of astaxanthin per day, and 3) 8 mg of astaxanthin per day. The diverse results showed that, at both the 2-mg and 8-mg doses, natural astaxanthin:

Increased the total number of antibody-producing B cells

Amplified natural killer cell cytotoxic activity

Significantly increased delayed-type hypersensitivity response

There have been almost 100 studies demonstrating that astaxanthin supports the brain in a variety of ways. However, only nine of these studies have been in humans, and five of them have taken place over the last few years. But in the future, we believe that studies exploring astaxanthin’s effects on the brain will continue to grow, leading to increased potential of the ingredient in cognitive health. After all, the supplement industry has long embraced natural astaxanthin for its eye-health benefits for two reasons: 1) because the human research in that area started earlier, and 2) there has been more of it. The same could be true for astaxanthin in the area of brain health as more research accumulates.

The very first trials in the brain-health area were done in rodents way back in the 1940s and 1950s in France. Two doctoral candidates did pioneering work to show that astaxanthin can cross the blood-brain barrier and bring its antioxidant and anti-inflammatory protection to the brain.

 They showed that once astaxanthin reaches the brain, it can then cross the blood-retinal barrier and help protect the eyes as well.

In the interest of brevity, let’s look at some of the most important human clinical trials on brain health to understand natural astaxanthin’s protection of our bodies’ control center:

In the first human brain-health study, astaxanthin at 12 mg/day over 12 weeks showed efficacy for age-related decline in cognitive and psychomotor functions in subjects with age-related forgetfulness

In another study on older subjects (who were also suffering from age-related forgetfulness), astaxanthin showed potential to improve cognitive function. The participants were asked to perform two cognitive tests after supplementing with placebo, 6 mg of astaxanthin/day, or 12 mg of astaxanthin/day. Improvements were found in both treatment groups, with the 12 mg/day group showing better results

There have been a few different studies showing that astaxanthin can help people prevent neurodegeneration as they get older. But how does this occur? There is a substance that accumulates in the erythrocytes of dementia patients called phospholipid hydroperoxide (PLOOH). In a randomized, double-blind, placebo-controlled study on older adults, Japanese researchers found that natural astaxanthin reduced PLOOH levels and increased antioxidant activity in erythrocytes at both dosage levels tested (6 mg/day and 12 mg/day). They concluded that astaxanthin supplementation may contribute to the prevention of dementia

A new benefit for brain health emerged in a study published this year. (Disclosure: This study was sponsored by our company, Algae Health Sciences/BGG.) Healthy individuals who were exercising were given either placebo or 12 mg/day of natural astaxanthin. After eight weeks of supplementation, significant improvement in psychological state was found in the astaxanthin group. Results included reduction in feelings of depression by 57%, decrease in mental fatigue by 36%, and improvement in overall mood state by 11%. (A patent is pending for this novel finding.)

Infertility is an increasing occurrence among couples worldwide, and in approximately half the cases, the cause is poor semen quality or performance. Due to changes in our environment, food consumption, and lifestyle, sperm just aren’t swimming as well as they used to. Fortunately, research in a few different mammal species (including humans) shows that supplementing with natural astaxanthin may help. Research in this area started back in the 1990s, and a patent (now expired) was taken out on the use of astaxanthin to improve breeding in mammals.

 was done in couples who had been trying to conceive unsuccessfully for over 12 months and where the male had been diagnosed with poor semen quality. The men were randomized into two groups: a placebo group and a group taking 16 mg/day of astaxanthin. There were no significant differences between the two groups in any fertility-related parameters. This study lasted for three months. At the end of the study, some major differences were found between the placebo and treatment groups:

Sperm linear velocity increased in the astaxanthin group

Reactive oxygen species decreased in the astaxanthin group

10.5% of the placebo couples got pregnant

54.5% of the astaxanthin-treated couples got pregnant

In simple terms, astaxanthin appears to have made the men’s sperm swim faster. This is most likely due to astaxanthin’s ability to eliminate a lot of the oxidation that occurs in sperm. This is a fantastic result, considering that the average time that the couples were trying to conceive was 20 months, yet in this three-month study, over half of the treatment couples got pregnant. The researchers theorized that this quick result could mean that astaxanthin helps improve the functional capacity of the sperm, as compared to changing the sperm themselves. Another study

 showing similar results had been published previously. This study concluded that astaxanthin helped improve the quality of sperm.

 was done by a group of researchers sponsored by the government of Italy. Unlike the previous two human studies, this study was done on men with no fertility issues. Their fertility was evaluated using a “spermiogram” (a series of biochemical, physical, and morphological tests on a man’s semen, including on sperm count, motility, morphology, volume, fructose level, and pH).

The analysis of the subjects in this study determined that their sperm fell into the normal range on all parameters tested. In addition, the men all had at least one child and were within a normal age group for new fathers (24 to 37 years). Results for the treatment group showed a net increase in different motility parameters and sperm functioning, leading to the conclusion: “Astaxanthin, by ameliorating the patient group’s sperm functioning, may be utilized to decrease male idiopathic infertility.” Thus, we see that astaxanthin can help improve the functionality and motility of sperm in both fertile and infertile men.

Most people in the dietary supplement industry are already familiar with astaxanthin’s benefits for eyes, joints, skin, and for athletes. But a review of the literature shows that it does a lot more. It can help protect our brains as we age and may also be effective for reducing depression and mental fatigue. It’s been shown to improve immune markers in many different mammal species, including humans. And one of its most unique benefits is that it can improve male fertility. More research in these areas is needed, but already, it’s remarkable how many ways this one molecule may be capable of keeping us healthy and happy.

Bob Capelli is executive vice president, global marketing, Algae Health Sciences (Irvine, CA), a subsidiary of BGG North America (Irvine, CA). Reach him at 

. Lixin Ding, PhD, is chief scientist for BGG North America. Reach him at 

Natural Astaxanthin: The Supplement You Can Feel,

 a 300-page consumer-friendly book on astaxanthin available at no cost by e-mailing 

Natural Astaxanthin: The Supplement You Can Feel.

Park JS et al. “Astaxanthin stimulates cell-mediated and humoral immune responses in cats.” 

Veterinary Immunology and Immunopathology, 

vol. 144, no. 3-4 (December 15, 2011): 455-461

Chew BP et al. “Dietary astaxanthin enhances immune response in dogs.” 

Veterinary Immunology and Immunopathology,

 vol. 140, no. 3-4 (April 15, 2011): 199-206

Park J et al. “Astaxanthin decreased oxidative stress and inflammation and enhanced immune response in humans.” 

Grangaud R. “Research on Astaxanthin, a New Vitamin A Factor.” Doctoral Thesis at University of Lyon, France. (1951)	

Massonet R. “Research on Astaxanthin’s Biochemistry.” Doctoral Thesis at University of Lyon, France. (1958)	

Satoh A et al. “Preliminary clinical evaluation of toxicity and efficacy of a new astaxanthin-rich 

Journal of Clinical Biochemistry and Nutrition, 

Katagiri M et al. “Effects of astaxanthin-rich 

extract on cognitive function: a randomized, double-blind, placebo-controlled study.” 

Journal of Clinical Biochemistry and Nutrition,

 vol. 51, no. 2 (September 2012): 102-107	

Nakagawa K et al. “Antioxidant effect of astaxanthin on phospholipid peroxidation in human erythrocytes.” 

Talbott S et al. “Astaxanthin supplementation reduces depression and fatigue in healthy subjects.” 

U.S. Patent #6054491. Lignell A et al. “Agent for increasing the production of/in breeding and production mammals.” (2000)	

Comhaire FH et al. “Combined conventional/antioxidant ‘astaxanthin’ treatment for male infertility: a double blind randomized trial.” 

Garem Y et al. “Natural Astaxanthin Improves Semen Quality in Infertile Men.” XIII International Carotenoid Symposium Hawaii, January 2002. Patent Cooperation Treaty Application WO99/29313. AstaCarotene AB, Sweden.	

Andrisani A et al. “Astaxanthin improves human sperm capacitation by inducing lyn displacement and activation.” 

 vol. 13, no. 9 (August 25, 2015): 5533-5551

A brief look at three of the lesser-known health benefits of natural astaxanthin.

Astaxanthin for immune health, brain health, and male fertility?

Interest in medium-chain triglyceride (MCT) oil and MCT-enriched products has grown significantly in recent years, particularly among consumers and brands in the natural products industry. Data provided to 

 by SPINS (Chicago, IL) indicates that MCT product sales grew by 2% in the 52 weeks leading up to November 2018, and Grand View Research predicts that the global MCT market will be worth $2.46 billion per year by 2025.

MCTs, fatty acids commonly sourced from coconut and palm kernel oils, have come to prominence for their reputation as weight-loss supplements. Consumers are adopting MCT products for all manner of applications, using it to promote weight loss, brain health, ketosis, and more.

Why are consumers so drawn to MCTs these days? “Let’s just say, ‘Fat is back!’-and we think it is here to stay,” says Amanda Coulter, marketing manager for Abitec Corp. (Columbus, OH), a supplier who has manufactured MCTs for more than 25 years.

Coulter continues: “Numerous scientific studies have shown that consuming the right kinds of fats can not only help you lose weight and feel more energetic but also help you live a longer and healthier life…Saturated fats like MCTs have been shown to support a variety of benefits, including supporting normal cognitive requirements, sports performance, energy, satiety, and nutrient absorption. MCTs are naturally found in coconuts and palm, and the body can easily digest saturated fats for fuel to energize the brain and body.” The medical establishment has also used MCTs in cases of malnutrition and nutrition malabsorption, as MCTs are high-energy compounds that are relatively easy to metabolize.

Health benefits like these are driving renewed interest in MCTs, Coulter says. “MCTs have been around for decades, and in the last five years, there has been a lot more focus around them as a beneficial addition to your daily diet. With the comeback of the Keto Diet, which originated back in the 1920s, more companies are focusing on the ‘high-fat’ component of their nutritional products. Many manufacturers have turned to MCTs for a multitude of reasons, including the scientific evidence, proven health benefits, ease of use, and the improved functionality it brings to their products and formulations.”

MCTs also offer a relatively flat and neutral taste profile, making them ideal for use in a variety of food and supplement products. Coulter says they can be used in everything from pills, powders, and liquids to baked goods, snacks, candy, and beverages.

More companies are definitely taking advantage of the market opportunities that MCTs afford. “The MCT market is definitely growing and doesn’t appear to be slowing down anytime soon,” Coulter says. “As an MCT manufacturer, we have noticed a vast spike over the last year of nutritional companies adding MCT oil as a dietary supplement to their portfolio. The number of companies offering a bottled MCT oil on the market today is close to triple the number 18 months ago.” She also cautions formulators to select their MCT supplier carefully. Remember, she says, that “not all MCT oils are alike, and certainly the variety of sources and purity are widespread, so it’s important to know what you are getting before you make that purchase.”

With that in mind, here are just some of the trends behind the rise of the MCT market.

1. “Medium-chain triglycerides market size worth $2.46 billion by 2025.” Grand View Research. Published online July 2017. 

https://www.grandviewresearch.com/press-release/global-medium-chain-triglycerides-mct-market

MCT products have a wide variety of applications, from brain health to sports performance and beyond. Most notably, MCT oil has a long history as a weight-loss supplement due to its ability to induce a higher rate of fat oxidation during exercise.

One randomized, controlled-feeding crossover trial followed 19 overweight men in their 40s, with a BMI range of 27.3 to 28.3, for a period of four weeks. Participants were fed a diet rich in either MCT oil or long-chain triglyceride (LCT) oil throughout the trial. Researchers measured energy expenditure and body composition through calorimetry and MRI technology at baseline and at the end of each feeding period. The researchers found that relative to LCT oil, MCT oil supplementation resulted in a greater decrease in body weight and a greater increase in fat oxidation. MCT oil consumption also resulted in a reduction in concentrations of subcutaneous adipose tissue.

Beyond fat loss, though, MCT oil is incorporated into sports nutrition regimens in other ways. It is often used as an endurance enhancer and immune booster, particularly during high-intensity interval training. MCT-enriched products have also long been popular in the ketogenic diet community thanks to their high-fat, high-energy composition and the fact that consuming MCT oils increases ketone concentrations.	 

2. St-Onge MP et al. “Greater rise in fat oxidation with medium-chain triglyceride consumption relative to long-chain triglyceride is associated with lower initial body weight and greater loss of subcutaneous adipose tissue.” 

International Journal of Obesity and Related Metabolic Disorders: Journal of the International Association for the Study of Obesity,

 vol. 27 no. 12 (December 2003): 1565-1571

MCTs are seeing incorporation in a variety of finished product formats. Bioriginal (Saskatoon, Saskatchewan, Canada) launched a coconut-based ketogenic MCT powder enriched with collagen and whey in November 2018 at SupplySide West.

MCTs are increasingly popular among consumers and product makers, in part due to their ease of use as well as their health benefits.

Nutritional Outlook Vol. 22 No. 6

Protein bar evolution: The latest in protein and dairy advancements

Grains: What’s old is new again

Synthetic ingredients’ regulatory uncertainty still a huge problem for dietary supplements, whether in Amarin’s omega-3 drug battle or in NDI guidance

Eye health science and supplements: The long view

The dietary supplement industry needs stronger enforcement, writes ChromaDex CEO (Op-ed)

Astaxanthin for immune health, brain health, and male fertility?

Medium-chain triglycerides are in high demand. Here's why.

Beyond CBD: Other cannabinoids in hemp and their exciting potential as ingredients

Can blockchain save dietary supplement industry transparency?