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Omega-3 sources for supplement differentiation

At one time, cold water fish was the predominant source for omega-3 fatty acids, but “fish burp” pushbacks, and calls for more sustainable and vegetarian alternatives have given rise to a marketplace flourishing with choice—which can be simultaneously as wonderful as it is confusing to consumers. For omega-3 brands, playing up a product’s unique ingredient origin can help unlock elusive on-shelf differentiation, regardless of whether the product hails from fish, krill, algae, ahiflower, calamari or flax.

To be clear, consumers have a healthy interest in fish-origin docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).Chris Gearheart, director, member communications and engagement, the Global Organization for EPA and DHA Omega-3 (GOED), said the market for those ingredients has grown at least 2% in volume and value for each of the last three years, according to the 2016-17 edition of GOED’s EPA and DHA Omega-3 Ingredient Market Report. However, the overall market is being shaped by two forces: mass market activity and interest from new users.

Eric Meppem, co-founder, Pharmako Biotechnologies Pty Ltd., said the mass market has been commoditized. “Pundits state the market is flat or shrinking, but due to lower retail prices and larger pack size, actual omega-3 use is rising,” he said, adding that the factors are causing margin pressure throughout the supply chain.

New, emergent users typically embrace new omega-3 sources or delivery systems. “In most markets, these are more specialized, but mass-market brands are now considering these, wanting to broaden their offerings and combat margin squeeze,” he explained.

Top drivers behind interest in newer omega-3 sources include bioavailability and absorption, as well as ecological concerns like sustainability from sea-origin ingredients.

Organic Technologies, producer of AlaskOmega omega-rich fish oil products, begins with wild-caught Alaska pollock oil from Alaska’s Bering Sea. Steve Dillingham, vice president of sales and marketing, said the expansive U.S. Alaska pollock fishery is responsibly managed, with less than 1% bycatch and certified 100% sustainable and traceable by the Marine Stewardship Council. AlaskOmega oils are also certified sustainable through the Marine Stewardship Council chain-of-custody program, considered the gold standard by the industry.

Kate Pastor, senior vice president, Superba North America, Aker BioMarine Antarctic US LLC, said she believes ongoing investments in science and innovation are contributing to the vibrancy of the krill oil market. Aker BioMarine recently announced that it would be exploring krill oil’s potential benefit in new areas of study, including sports nutrition, skin health and Lupus.

“More novel sources of EPA and DHA omega-3s like greenshell mussel, hoki and calanus have seen double-digit growth in volume and value recently, but they are starting from a much smaller base,” explained GOED’s Gearheart, based on the 2016-17 edition of GOED’s EPA and DHA Omega-3 Ingredient Market Report. “Some of these unique ingredients appeal to Chinese consumers, for example, because they are especially interested in products from certain geographic regions—mussel oils come largely from New Zealand, [and] calanus saw most of its growth in the U.S. and Europe, where consumers may be drawn to the chance to revisit omega-3 consumption in a novel way.

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FDA’s limited view of inflammatory claims

Sports and other physical activities involve strenuous use of muscles, tendons, ligaments and such, leading to inflammation of the tissues and joints. Our own physiology gives us the ability to address this inflammation. We possess a system that deals with inflammation, known as the cholinergic anti-inflammatory metabolic pathway. It carries signals to and from cells in response to inflammation.

Keeping this system in good health is a good idea, but it can be challenging for natural product brands to communicate how products or ingredients can aid in this effort due to the regulatory realities of structure/function claims.

In the initial years after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the requirement to notify FDA of intended structure/function claims meant brands sent claims to Center for Drug Evaluation and Research (CDER) for evaluation. This drug branch of FDA was not an appropriate place for review of this newly formed class of claims, but that was the reality. Claims involving inflammation were submitted, and the general concept of addressing inflammation with supplementation was allowed (by virtue of no written objections to such claims). In the rulemaking discussion, inflammation claims in joints was noted as off limits, but not anti-inflammatory actions of the body generally.

However, about five years ago, FDA alerted the industry that it determined inflammation claims in nearly all instances constitute a drug claim. The agency reasoned the anti-inflammatory system of the human being is not always active. This contrasts the immune system, which is always active. Thus, claims involving support of a “system” that is always turned on are allowed but supporting a “system” that turns on in response to dysfunction and/or damage involves a pharmaceutical action. FDA made an exception where inflammation and discomfort are occasional and the result of strenuous exercise. Exercise apparently does not cause damage or render any part of the body dysfunctional regardless of how strenuous the exercise, though I have some personal stories to the contrary.

Ingredients used in dietary supplements are substantiated to benefit or reduce inflammatory processes. That is a truth. The basic standard for claims is that they be “truthful and not misleading” per the Federal Food, Drug, and Cosmetic Act (FD&C). Substantiation is the legal and regulatory requirement to meet this standard. When this is in place for inflammation claims, however, other standards come into view. This narrower finding by FDA is simply that: a finding. It is not a regulation. It is not guidance on the topic nor is it published as official. However, FDA has emphasized statements such as “supports healthy inflammation response” are unauthorized. This is owed to inflammation being considered a dysfunctional state. When it is the result of something not vector-driven (disease) or injury-caused (damage), the inflammatory response is a result of something other than normal, which is the standard for which dietary supplements are intended to benefit. Where these boundaries are drawn is blurred and not adjudicated. Regardless, without continual challenge to these soft boundaries, the interpretation of the law by the agency about claims remains an ever-shifting and narrowing landscape as shown by the anti-inflammation issue.

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Optimizing the precision blending of supplements

Nutraceutical ingredients can be formulated into a wide variety of health-related products, including vitamins, supplements, mineral blends and foods like energy bars. Many of these formulations involve the fine blending of as many as 40 to 50 components, including powders and trace elements.

While nutraceuticals are not regulated like pharmaceuticals, the products still must substantiate label claims, and a number are tested in clinical studies like medicines.

Whenever a nutraceutical makes a label claim, like a specific recommended dietary allowance (RDA) or FDA allowances, vitamin percentages or active components, it must meet those criteria. Further, nutraceutical products must not only avoid doing harm, but also increasingly substantiate any claims or benefits.

One industry challenge is that the blending of solid ingredients is easier and more uniform if the ingredients are approximately the same size. However, it is difficult to create precise blends with trace ingredients (less than 1%) that are dissimilar in size and density. In some cases, this might require multiple key blends in a time-consuming and costly process.

Fortunately, with tumble blending equipment that is engineered to meet the requirements of the application, the process can be simplified to produce a precise, homogenous blend containing necessary components and trace elements in the specified amounts. Such blending can eliminate the need for key blends and produce a better distribution of active ingredients.

Limitations of Traditional Mixing Equipment

Traditional equipment such as plow, ribbon and paddle mixers, which use blades or paddles to push material, are limited to moving the material within the confines of their active area. The mechanics force the material bed outward, leaving dead spots inside the vessel where material moves more slowly or remains stationary. A stationary port at the bottom of such machines further isolates the material.

Another issue lies in the positioning of the intensifier bars, which should ideally be in the mixing zone, where every particle passes through. Many times, however, traditional mixers position intensifier bars in dead zones, resulting in material not being fluidized properly and active ingredients getting incorporated throughout the batch.

Traditional mixers can also waste expensive additives. Because additives initially contact only a small portion of material in the vessel, they get absorbed into the material bed, so more additives are usually needed to achieve the desired mix concentration, which increases cost.

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Nootropics for healthy cognitive function

People in many countries, including the U.S., are experiencing an increased life span.1 However, the aging population aims not just for increased, but optimized, years of life. Paramount to this are strategies to improve cognition or delay age-related cognitive decline. Supporting cognitive function is something that can, and should, be considered, even before the earliest signs of dementia are noticed.

Nootropic, a term coined in 1972 by Corneliu E. Giurgea, Ph.D, refers to a nontoxic substance that enhances learning and memory, facilitates communication between the brain hemispheres and enhances neurological resilience.2 Nootropics are commonly utilized to prevent or support early states of cognitive decline; they are also utilized by those who simply wish to optimize their cognitive function.

Cognitive function can be enhanced in a variety of ways. Studies show high levels of free radicals in the brains of those with cognitive decline.3 Antioxidants that can cross the blood-brain barrier tend to support cognitive function and protect the brain from the expected effects of aging. Vasodilators increase blood perfusion to the brain, enhancing oxygen levels and aiding glucose utilization.4 Substances that support neurotransmitter levels, particularly acetylcholine (ACh), can treat dementia.5 Finally, substances that support neurogenesis and increased neurological plasticity via modulation of brain-derived neurotrophic factor (BDNF) show great promise in enhancing cognitive function.6

Ginkgo bilboa (ginkgo) leaf is a well-known nootropic herb. Ginkgo trees belong to the Ginkgoaceae family, an ancient family cultivated for thousands of years for medicinal use in China. Much of the ginkgo used in research studies is a standardized product (EGb 761) of 22 to 27% flavonol glycosides, 5-7% terpene lactones, and less than 5 ppm ginkgolic acids. Ginkgo increases circulation to the brain, supporting glucose levels and adenosine triphosphate (ATP) utilization, and decreasing free-radical damage. Nootropic effects may also be due to increased levels of BDNF.6 Ginkgo is most effective when used for at least six weeks; long-term dosing is safe if the patient doesn’t have a clotting disorder or using anticoagulants (ginkgo thins the blood and should also be discontinued prior to surgery). Adulteration/contamination of ginkgo can be a concern,7 so analysis should be done on ginkgo sources to ensure a high-quality product.

Bacopa monnieri (water hyssop) is an Ayurvedic herb traditionally used as a medhya rasayana (memory/intellectual enhancer). Water hyssop grows in swampy or marshy areas; the arial portion of the plant is used, making it a very sustainable product. Sometimes referred to as brahmi, water hyssop is often contaminated with Centella asiatica.8 Water hyssop is a potent antioxidant that can cross the blood-brain barrier. Administration is protective against toxic exposure, including tobacco and common environmental contaminants with neurotoxic side effects.9,10 Water hyssop also increases cerebral blood flow and supports ACh levels.9 Additionally, early research seems to indicate enhancement of BDNF.6 Multiple studies have shown water hyssop improves memory acquisition and retention, as well as attention and memory processing. Results are most pronounced after three months of administration; short-term memory improvements are not seen in research studies, although many patients feel subjectively better even with short-term administration.

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Product formulation with plant-based proteins

The increasing popularity of, and consumer demand for, plant-based foods has created a whole new set of challenges for product developers. Whether creating plant-based foods that eat like their animal protein counterparts or developing great tasting standalone plant-based products, the obstacles can be significant.

Formulating with plant proteins requires a juggling act when it comes to balancing the functionality, sensory impact, nutrition profile, regulatory status and cost impact of the various ingredients. Two main challenges unique to plant proteins include perfecting functional and sensory attributes.

Functional

Animal and plant proteins are very different in their structure and functionality. While animal proteins are fibrillar and fibrous and play primarily a structural role, plant proteins are less organized and are globular and play more of a functional role. This results in differences in analytical measures such as oil- and water-holding capacity, emulsion capacity/stability, and foaming capacity/stability along with corresponding functional differences in gelation, emulsification, water/fat retention, matrix formation, viscosity, etc.

Protein content and quality also differ significantly between animal and plant proteins. Animal-sourced proteins are complete—containing an adequate proportion of each of the nine essential amino acids. Plant-sourced proteins—with the exception of soy—typically are not complete proteins and must therefore be strategically blended with other complimentary proteins to achieve the desired amino acid composition.

Sensory

In addition to structural differences, plant proteins each have their own unique flavor volatiles that often require masking or manipulation. These volatiles can include earthy, grassy, beany, “green,” hay, cardboard and “dirty,” just to name a few. Texturally, plant proteins can differ significantly, with some being dry and chalky, and others being described as gritty or sandy.

In terms of adding flavors to plant proteins, one faces not only the challenges of masking the undesirable flavors mentioned above, but also is challenged with the flavor “dampening” (binding) effect that plant proteins have. Plant proteins will require bolder and more impactful flavors (and possibly a higher usage rate for seasonings and flavors) to compensate for this dampening effect.

While the increasing popularity of food products made with plant proteins does present some new and unique challenges to the product developer, there are flavors, functional raw materials and processing methods that are available to successfully work through these challenges. Given the rapidly increasing consumer demand for new plant-based food products, flavor and functional ingredient suppliers are responding, and are constantly developing new solutions for food and beverage manufacturers.

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Trade groups to Congress: Authorize CBD in supplements

Four dietary supplement trade groups on Tuesday urged Congress to pass legislation clarifying hemp-derived CBD is a lawful dietary ingredient if the supplement meets established product safety and quality criteria.

Lawmakers also were asked to devote sufficient resources to shield consumers from unsafe CBD products.

While FDA has been examining the potential for a rulemaking that would authorize CBD to be added to food and marketed as a dietary supplement, agency officials have stressed such a process could take several years to complete.

Industry representatives have expressed fears that a lack of federal oversight could endanger the health of the public and continue to foster an environment of uncertainty, stymieing investments and innovation.

The U.S. market is already inundated with CBD products and a patchwork of state testing and labeling laws governing them.

Since at least 2015, FDA has asserted CBD can’t be marketed in a dietary supplement under federal law because, in short, the compound was first studied as a pharmaceutical drug. Last year, the agency approved the first CBD medicine, Epidiolex, to treat seizures associated with two severe forms of epilepsy.

Despite the drug-related exclusion above, the Federal Food, Drug & Cosmetic Act (FD&C Act) grants the head of the U.S. Department of Health and Human Services (HHS) discretion to authorize CBD to be marketed in supplements.

In the Oct. 8 letter to Congress, the trade associations noted any CBD products subject to such a “limited waiver” would need to meet the definition of hemp in the 2018 Farm Bill and comply with applicable requirements of the FD&C Act and FDA’s regulations related to dietary supplements, including requirements for new dietary ingredients.

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Applying the ‘E’ for joint health

Whether it’s an aging Boomer, an overworked Gen X weekend warrior or an active Millennial, maintenance joint health is increasingly a top daily concern. It’s a concern that spans generations and is driving consumers to seek out great information on natural solutions. Which raises the specter of the “E” in DSHEA.

That “E” stands for education. The concept behind the Dietary Supplement Health and Education Act of 1994 (DSHEA) was not only that dietary supplements were safe, but they are beneficial. That “E” stands for the opportunity to educate the consumer, and the law allows education to be available. Consider the critical discussion regarding claims for dietary supplements. That special allowance is present so that meaningful—as well as truthful and not misleading—educational information could be delivered to consumers.

Of course, there is a challenge with that when it comes to the topic of joint health. Even looking at this challenge from two widely different angles, the challenge is simple: Claims about joint health are tough to make. Add to this the desire to discuss the substantiated potential of some nutrients to affect minor pain and inflammation, but also the cost of such substantiation, and what we see in the market is more borrowed science that still doesn’t comply with the law.

FDA several years ago determined that inflammation claims were generally equivalent to disease claims, with few exceptions. When considering the limited potential for presenting acceptable pain relief claims and the preclusion of discussion of joint health, we have a claims quagmire. Substantiation alone for joint health support is challenging since most clinical endpoints would be either too long to measure realistically (populations with dietary components and statistically significant effect on joint health) and/or require evaluation of who would be considered “diseased” individuals. That substantiation, in FDA’s current thinking, is not appropriate.

However, I believe we can educate the consumer in those areas with the relative regulatory impunity; the emphasis in the approach lies in the “E” portion of the acronym and other allowances within the law.

Read The Full Article HERE

Protecting performance, promoting recovery

Athletes are human, too, and vulnerable to chronic inflammation. Repetitive strain injury, post-exercise pain and stiffness, lowered resilience and mood—all which involve inflammatory stress—can affect performance during and out of season. A severe problem will take an athlete out of competition, and even the milder inflammation in delayed muscle soreness (DOMS) will take them out of contention by reducing performance such as running economy by up to 3%.1

A physiological inflammatory response to training is essential to the development of muscle tone, fitness and growth, but the 21st century food universe has become excessively pro-inflammatory, and unless countered, is inimical to performance on the field or track. The reasons for this are well-known, including the progressive removal from modern processed and ultra-processed foods of such key anti-inflammatory nutrients like omega-3 highly unsaturated fatty acids (HUFAs), polyphenols and beta glucans, and prebiotic fibers. This negative configuration is aggravated by the presence in modern foods of high levels of pro-inflammatory factors such as advanced glycation and lipoxidation products (AGEs and ALEs), and an excessive glycemic index.

The overall impact of this inflammatory stress and dysbiosis is responsible at the public health level for the increased frequency and decreased latency of the so-called ‘diseases of civilization.’ Among the sports and athletics communities, this inflammatory nightmare can downgrade stamina, performance and recovery. And after an athlete’s active career is over, the inflammatory cascade can accelerate their decline into illness.

Comprehensive dietary change is indicated, but can be difficult or distasteful; instead, there is a growing interest in nutritional anti-inflammatory ingredients.

The polyphenols in curcumin (Curcuma longa) and the fatty acid amide palmitoylethanolamide (PEA) are generating promising data against inflammation. Given their wide therapeutic indices and different mechanisms of action, these two nutrients make up a very attractive combination in sports and athletics.

Until recently, curcumin’s diverse pharmacology has failed to transfer to clinical results due to its poor bioavailability.2 However, a new curcumin-rich turmeric extract (HydroCurc®, from Gencor Pacific), developed with patented technology (LipiSperse, from Gencor), has been shown to provide the highest bioavailability of curcuminoids into blood plasma (807nm/ml) to date from a single dose, well within the therapeutic range where curcuminoids exert multiple anti-inflammatory effects.

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Standardization of the ‘blessing seed’

Over the past several decades the healing benefits of black seed (Nigella sativa) have become a significant focus in the world of medicine; more specifically, the oil of these seeds has become the primary focus. To sort through the murky environment of black seed oil (BSO), we need to take a closer look at the current research into what makes this BSO effective and what to look for when purchasing a BSO ingredient.

For analogy purposes, the game show “To Tell the Truth” comes to mind. A person of some notoriety and two impostors try to fool celebrity panelists into choosing one of the impostors instead of the real person. Each celebrity has some time to question the three contestants; while the fakes can lie, the real person has “to tell the truth” about themselves. After every celebrity has had time to question them, they guess who the real person is, and each wrong guess earns the trio cash to split among themselves.

The reference of “To Tell the Truth” is used due to the number of BSO ingredients available in the marketplace that do not have the clinical research “to tell the truth” leaving many people guessing what a valid source of BSO is.

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Sustainability challenges in the supply chain

Sustainability from a natural products corporation comes from many operations; however, the department that will be tasked in implement the policy, whatever that form may be, will be supply chain. Therefore, the supply chain professional running the program will have to wear many hats in order to accomplish this task.

From a supply chain standpoint, the initial reaction to implementing a sustainability program would be the impact on cost. Other impacts could be potential changes to the supply bases, quality, availability and continuity of supply. In addition, the company will need a coherent sustainability mission statement to implement the program.

Supply chain professionals have multiple touch points in any organization; they need to be able to engage and influence other departments in an effective manner. It is critical to understand the company mission statement regarding sustainability, and there is alignment across the organization from marketing, finance, production and logistics. In some cases, supply chain may have to help sell the idea.

Sustainability and corporate social responsibility

Sustainability must first be adequately defined before a program can be implemented. The United Nations’ World Commission on Environment and Development in 2008 defined sustainability as “development that meets the needs of the present without compromising the ability of future generations to meet their own needs”.

From here, we can tether sustainability to corporate social responsibility (CSR). CSR is not as universally adopted. It could a different concept for each organization despite the increasing pressure for the need to do so.

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