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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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Liver health supplement market not meeting consumer demand

Non-alcoholic fatty liver disease (NAFLD) is a growing medical issue. Intake of processed food and medication, together with occurrence of diabetes and obesity are all rising, according to the American Liver Foundation. Liver health is set to become a great concern of the modern age, presenting opportunities for nutraceutical development.

Most products on the market are still commodity herbals with little or no clinical or bioavailability data. This is problematic since most solutions addressing liver issues use milk thistle extract: its major active component, silybin, has poor bioavailability. Some manufacturers settle for a mix of different herbals renowned for their traditional use against liver issues, ignoring which parts of the plant should be used and possible cross-interactions between the substances.

Solutions are commonly positioned as “liver detox,” however, no randomized controlled trials have been conducted to assess the effectiveness of commercial detox diets in humans.1

Hepatic health is one of the categories where the gap between demand and availability of innovative solutions is surprising. Despite increasing consumer attention, the market has a lack of high-quality nutraceutical solutions. Importantly, almost no solutions address children directly. This could be due to the less known fact that NAFLD affects children just as frequently as adults.

NAFLD is a common disorder referring to a group of conditions where abnormal hepatic metabolism of fatty acids leads to accumulation of excess fat in the liver, without significant alcohol intake, viral infection or any other specific aetiology susceptible to cause liver disease.

Its development begins with lipid deposition and progresses to involve oxidative stress, inflammation and fibrosis. Non-alcoholic steatohepatitis (NASH) is a more severe form of NAFLD, for which fat accumulation is accompanied by inflammation, fibrosis, scarring of the liver and subsequent loss of function. If left untreated, this can lead to irreversible cirrhosis and ultimately liver failure, or develop into hepatocellular carcinoma, the most common type of liver cancer.

Between 30 and 40 percent of adults in the United States have NAFLD, and 3 to 12 percent of adults in the United States have NASH.2 Researchers estimate that close to 10 percent of U.S. children ages 2 to 19 have NAFLD.3

NAFLD patients rarely show symptoms. No medicines have been approved to treat NAFLD and NASH; patients are typically recommended to follow a strict diet, lose weight and are prescribed diabetes drugs or statins, intended to treat the accompanying effects on insulin metabolism or cardiovascular system.

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Unravelling the gut-brain axis

Undoubtedly, one of the greatest scientific advancements in our lifetime, along with the sequencing of the human genome, is the profiling of the microbiome. Most people have heard the estimate that we are only “10% human” or that foreign bacterial cells outnumber human cells 10 to 1. New data shows that number is closer to a 50:50 ratio. More accurately, we are 50% human.1 The microbiota exhibits all the characteristics and metabolic activity to be officially categorized as its own “organ.”2   

However, our foreign bacteria have 100 times the genetic diversity and potential of our own DNA. This means they have 100 times the genes that can be flipped on and off through various stimuli, like interaction with each other, metabolites, toxins, exercise and diet.3 The genetic output of our microbial population includes the production of proteins that may signal our own genes to act, either turning them on or off.4,5 

In fact, our microbiota produce nearly 30 different kinds of neurotransmitters, identical to the ones we make in our brain; plus, they manufacture and mediate thousands of immune- or inflammation-modulating molecules.6,7,8,9 The far-reaching impact of our symbiotic relationship with our microbiota influences brain, heart and liver health; the development and etiology of allergic and skin diseases; metabolic efficiency; drug pharmacokinetics; and immune and digestive function.10,11 The ability to manipulate this population for our good is a major constituent of epigenetics and personized nutrition.12,13 

The gut is increasingly referred to as the “second brain.” The gut contains more than 100 to 500 million neurons, exceeding the number of neurons found in the spine.8,14,15

The brain is the manager and sorter of all the stimuli we receive from the outside world. We mainly think of this as what we hear, see and touch, but we forget about the vast amount of data processed via the gut.16 It is no wonder that we have long noticed gastrointestinal (GI) complaints associated with depression, anxiety, insomnia and many other diseases we previously thought of as solely “mental” illnesses.17,18,19 Conversely, for nearly a century, many gut diseases, like irritable bowel disease, were described as “nervous disorders.”

The two-way communication between the gut and the brain via the enteral nervous system (ENS) and the vagal nerve is called the “gut-brain” axis.20,21 Science is still elucidating the complex pathways of communication between the brain and the gut that include hormone signaling, microbial metabolite production and immune system activation.22,23 We already know that enteric nervous system hormones and peptides can make their way into circulation, and more importantly, cross the blood–brain barrier acting synergistically to regulate mood, cognitive function, stress, appetite and sleep.24,25

The communication via the gut-brain axis goes both ways. This is especially evident when stress is introduced. Even short-term exposure to stress can impact the microbiota community profile and lead to dysbiosis by altering the relative proportions of the main microbiota families. This dysbiosis in turn influences stress responsiveness, anxiety-like behavior and the set point for activation of the HPA stress axis.

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Nutraceuticals for immune support: Growing standards, room for improvement

From traditional herbal infusions to today’s sophisticated formulations, nutraceuticals for immune support have come a long way. Owing to the pull of scientific progress and push of demanding consumers, we are entering an era where certain products are delivering the promised value with guaranteed safety and clinical proof. But this is far from the standard. 

Astragalus, elderberry and Echinacea infusions are among the earliest immunity-boosting additions to diet. With their successful track record and word-of-mouth popularization, it is understandable they are still regularly used, yet in most cases, they have not advanced in decades or have even dropped in quality. A large portion of immunity nutraceuticals are still simple herbal extracts, commodities that rely solely on historic use and bibliographical data for proof of efficacy. Additionally, ingredients included in a product don’t necessarily have a connection to assumed benefits apart from the name. Questionable origin, interchangeableuse of different plant parts and adulterants are producing ineffective, unsafe supplements that contribute to consumers’ decreasing trust. For a credible product, herbal extract inclusions need to be traceable, have direct research and an established safe dosage, especially when formulating for children.

With increased understanding of biochemical processes in the human body came the next big players of the immunity market: vitamins and minerals. Starting as simple chemical compounds such as ascorbic acid, vitamins and minerals have made an immense leap to what we see today. Branded, patented, clinically supported ingredients with advanced delivery technology are widely available and boast increased stability, controlled release, enhanced absorption or bioavailable chemical states. More importantly, consumer awareness of the range of quality and consequence of lower price is most present for these ingredients. We see partners on markets worldwide increasingly interested in formulations containing vitamins with improved characteristics, seeking to satisfy the growing demand of educated users and to differentiate in a noisy category.

Differentiation can also be achieved by more biologically complex ingredients that later entered the global spotlight. Colostrum, propolis and fungal extracts have brought a new dimension to the industry, correlating with the natural alternatives trend and sparking substantial investment into clinical research. The relatively new concept of immunostimulation is showing undeniable results (Diets, Immunity and Inflammation. 2013;416-434), but keeping the immune system in an excited state should be approached with caution. The benefit of long-term use of activating ingredients such as beta-glucans is questionable. Harmful over-boosting is a new topic, not yet widespread in the industry, and will likely be an influence in future product development trends.

The realization of the complexity of the immune system and its connection to the gut has sparked an exciting new era of research and a completely different angle. Investments into consumer education have made a remarkable shift in gut health. Probiotic product launches with immunity positioning are steadily rising yet may come with some drawbacks: the discrepancy between claim and effect due to personal microbiome differences, and stability issues. The latter are solved with convenient and booming prebiotics.

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Sports nutrition for active consumers

The weekend warrior, the person cramming most of their exercise into two days off from work, is not new. Yoga is not new, but its huge bloom of devotees in western countries like the United States is newish. CrossFitters and Tough Mudderers also are newer. Add to these high-profile exercisers a cornucopia of active consumers at gyms, parks, beaches, trails and all manner of courts, tracks and fields, and you get a big mass of amateur athletes ripe for sports nutrition product use.

We are talking many millions of active people. CrossFit has more than 15,000 official affiliates, with around 4 million participants, according to CrossFit. More than 3 million people have competed in one of the many races annually, and the organization said participation is growing thanks to shorter race options. According to the Outdoor Association, almost half of Americans (49 percent, or 146 million people) engaged in outdoor recreation in 2017, and running, including jogging and trail running, was the mostpopular activity in terms of both participants and total annual outings.

Anthony Almada, a co-founder and fellow of the International Society for Sports Nutrition (ISSN) and consultant to and spokesperson for Indena, highlighted “some inspiring findings from the ongoing USA National Health and Nutrition Examination Survey (NHANES), published in February,” such as: about 8 percent of Americans are performing 2.5 to <5 hours of vigorous, or 5 to <10 hours of moderate exercise per week, and  about 41 percent are engaged in ≥ 5 hours of vigorous, or ≥ 10 hours of moderate exercise, per week.

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Supplement delivery systems

While pills and capsules remain the most popular format for delivering nutrients in dietary supplements, brands are continuing to innovate around delivery systems, and consumers continue to shift to alternative delivery when the products meet expectations around efficacy, ingredient quality and convenience.”

It all started about two decades ago when two innovations hit the scene that began shifting dietary supplement delivery formats.

The first shift in the way manufacturers delivered nutrients happened with vegetarian encapsulation systems, which gave consumers choice in putting their vegetarian values into the capsules they popped.

The second was gummi bears—once just another cute candy for kids—which became a format by which to deliver not just sugar and fun but also nutrients.

Gummies saw a 109 percent growth in preference over a seven-year period, according to a 2018 Natural Marketing Institute (NMI) report. Growth in this and other alternatives-to-pills formats are coming from younger generations the iGen, Millennials and Gen Xers.

While remaining in the pill format, softgels can improve the bioavailability of nutrients compared to other dosage forms.

Softgels also better protect ingredients, allowing nutrients to make it further down the digestive system.

In an attempt to boost bioavailability of nutrients, other technologies are coming to the fore to supercharge supplements.

One is liposomes, which are made of phospholipids—the basic building blocks of cell membranes—and encapsulate nutritional compounds. These tiny molecular spheres bond with cell membranes to deliver nutrients into cells. Liposomes also bypass the digestive process that normally degrade or limit the body’s ability to fully absorb and utilize nutrients.

One new bioavailability booster is a proprietary microtablet technology that is about the size of a BB and dissolves and disperses nutrients in seconds.

All of these shifts in the supplement market helps meet consumers where they are—whether they have difficulty swallowing, or are weary of taking pills, or are just looking for something new and novel in their quest for optimal nutrition.

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Alpha lipoic acid for healthy aging

Alpha lipoic acid for healthy aging

In a time where antioxidants are essential, consumers are looking for the right ingredient to combat free radicals. Known as thioctic acid, alpha lipoic acid is generated through small amounts in the mitochondria—otherwise known as “the powerhouse of the cell.” One study found that “As an antioxidant, [alpha lipoic acid] directly terminates free radicals, chelates transition metal ions (e.g., iron and copper), increases cytosolic glutathione and vitamin C levels, and prevents toxicities associated with their loss.”1 Also known to help with the aging process, another study found ALA helps lower oxidative stress associated with aging.2

In addition, according to Clinical Nutrition, ALA plays a key part in boosting energy production, as it helps the physiological responses to stress.3 As aging occurs, the body is not capable of maintaining the same level of cellular energy production. The Clinical Nutrition study evaluated the efficacy of carnitine, a mitochondrial metabolite, and lipoic acid. The research indicated that an age-dependent decrement in the levels of the TCA cycle enzymes and electron transport chain complexes, in which supplementation of carnitine (300 mg/kg bw/d) and lipoic acid (100 mg/kg bw/d) for 30 days brought the activities close to normal levels. This suggested that alpha lipoic acid helped reverse the age-related decline.

An additional study found that added with L-carnitine, alpha lipoic acid reduced oxidative stress and improved mitochondrial function.4 In the double blind, crossover study, researchers examined the effects of alpha lipoic acid with acetyle L-carnitine treatment on vasodilator function and blood pressure in 36 subjects for eight weeks compared to placebo. The results indicated that active treatment increased brachial artery diameter by 2.3 percent and reduced systolic blood pressure for the entire group. Moreover, there was a dramatic effect in the subgroup with blood pressure above the median, and in the subgroup with the metabolic syndrome. This strongly indicated alpha lipoic acid’s effect on blood pressure and endothelia function in the brachial artery.

As an important part of cellular production, alpha lipoic acid plays a profound impact on oxidative stress. Indeed, the right ingredient to combat free radicals could be Alpha lipoic acid—and helpful ingredient to provide consumers a long and healthy life.

Read The Full Article HERE

Probiotics for improving mental health

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The microbes in the gut produce neuroactive compounds that connect to the brain, affecting behavior and mood. There are more than 100 million neurons in the gut—nerve cells, which are normally perceived as brain cells. In fact, the gut is sometimes called the little brain because it is the largest area of nerves outside the brain.

An increasing number of studies link gut health to mood and mental health. In a four-week probiotics study, compared with participants who received a placebo intervention, participants who received probiotics showed a significantly reduced overall cognitive reaction to sad mood, which was largely accounted for by reduced rumination and aggressive thoughts, resulting in evidence that probiotics may help reduce negative thoughts associated with sad mood (Brain Behav Immun. 2015 Aug;48:258-64).

Research involving 15 human studies discovered patients who supplemented with Bifidobacterium and Lactobacillus strains for one to two months experienced improvements in anxiety, depression, autism, obsessive-compulsive disorder and memory, including spatial and non-spatial memory, showing the efficacy of probiotics on central nervous system function (J Neurogastroenterol Motil. 2016 Oct 30;22(4):589-605).

In a study of 40 patients with depression, individuals who took probiotic supplements also reaped benefits. Taking probiotic supplements for eight weeks decreased depression levels and reduced levels of C-reactive protein (a marker of inflammation) and hormones such as insulin, compared to people who did not take a probiotic (Nutrition. 2016 Mar;32(3):315-20). After the eight-week intervention, patients who received probiotic supplements had significantly decreased Beck Depression Inventory total scores.

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Trends in digestive health

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Digestive health has become increasingly important. Yes, it’s on-trend, but why is it really so important? Because it’s all about the “gut.” Martha Carlin, CEO of The Biocollective Research, is one of many people doing important work related to the gut. She became interested in the topic after reading Martin Blazer’s book Missing Microbes. In a recent episode of the Business Leaders Podcast, Carlin said, “For people who don’t know what the human microbiome is, that’s the trillions of bacteria, fungi, viruses and archaea that live in and on our body. We’re actually more microbial than we are human.”

Carlin isn’t alone; even Hippocrates acknowledged: “All disease begins in the gut.” 

As product developers continue to incorporate functional attributes to address consumer need states related to gastrointestinal (GI) health, a good place to start is with a combination of probiotics and prebiotics, a positive synergy referred to as synbiotics. Probiotics gained recognition in recent years with the growing popularity of foods like yogurt, kimchi and sauerkraut. Probiotics add healthy bacteria into the body, while prebiotics feed the healthy organisms in the gut.

Product development trends over the last five to six years have focused on—or even obsessed over—probiotics, with less emphasis on prebiotics. However, both are needed for optimal health. Obtaining effective probiotics strains and adequate prebiotics via diet to improve GI health isn’t easy; in order to have healthy gut, supplementation with both is often advised.

Roughly one-fourth of U.S. adults seek foods and beverages with high amounts of probiotics or prebiotics, according to a 2017 national consumer survey conducted by Packaged Facts. The interest is spurring innovation in the food and beverage industry.

The future mission of product developers is to focus on effectively formulating with both prebiotics and probiotics. It is important for the long-term progression of digestive health to incorporate the synbiotic approach. It will take into account solutions based on the total body, focusing on introducing products that can effectively address areas like immune system, gut health and overall well-being.

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Researched ingredients with anti-inflammatory effects

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• Short-term inflammation is a protective response, but chronic inflammation can have a negative effect on the human body.

• Palmitoylethanolamide (PEA), Terminalia chebula, grape seed extract and magnolia are among the options for formulators.

• The anti-inflammatory market is projected to reach US$130.6 billion by 2026 with a CAGR of 8.5 percent from 2018 to 2026.

Inflammation is one of the body’s natural defense mechanisms, addressing hazardous stimuli such as tissue damage or allergens. On a short-term basis, inflammation can help the body return to a healthy state. However, according to a 2016 review, “Uncontrolled inflammatory response is the main cause of a vast continuum of disorders including allergies, cardiovascular dysfunctions, metabolic syndrome, cancer and autoimmune diseases.”1

While various pharmaceuticals are available to help control and suppress inflammatory crisis, the potential for side effects and the desire for a natural course of action lead many consumers to seek alternative solutions. The review noted several herbs with anti-inflammatory effects that have been evaluated in clinical and experimental studies, including Curcuma longa (curcumin), Zingiber officinale (ginger), Rosmarinus officinalis (rosemary), Borago officinalis (borage), evening primrose and devil’s claw. It also mentioned, “the treatment of inflammation is not a one-dimensional remedy,” and therefore, suggested “a multidimensional therapeutic approach to inflammation with the help of herbal medicine and modification in lifestyle.”

Blake Ebersole, president of NaturPro Scientific, pointed to palmitoylethanolamide (PEA) as an emerging anti-inflammatory ingredient that’s been studied in large trials in Europe. It’s a peroxisome proliferator-activated receptor-alpha (PPAR-α) ligand that exerts anti-inflammatory, analgesic and neuroprotective actions.2 A 2014 review noted PEA was first identified as an anti-inflammatory compound more than half a century ago, but greater exploration didn’t occur until the mid-1990s. PEA was shown to reduce tumor necrosis factor (TNF)-α in lipopolysaccharide (LPS, a pro-inflammatory endotoxin)-induced pulmonary inflammation in mice, as well as mast cell degranulation and edema formation in various inflammatory models.3

The review mentioned more recent investigation of the anti-inflammatory mechanisms. PEA inhibited phosphorylation of kinases involved in activation of pro-inflammatory pathways, and the nuclear translocation of nuclear factor-kappa beta (NF-κβ) and activator protein 1 (AP-1), as well as preventing degradation of the inhibitory IκB-α, which when associated to NF-κβ prevents its nuclear translocation.4,5

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