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GMP and FSMA rules compel close supply chain supervision

Supply chain management involves the careful oversight and organized handling of a product’s development flow, from purchase and receipt of the raw materials to its manufacturing, testing, label development, labeling, packaging and distribution processes with the various service providers in each segment of the supply chain.

Supply chain management is crucial for contract manufacturer selection because of FDA’s recent focus on the requirements under the Food Safety Modernization Act (FSMA), signed into law in 2011—rules that require firms to register their food facility in response to the Bioterrorism Act of 2002. The Act additionally gives FDA the ability to provide critical attention to “improved information management” to help protect the food supply. Under FSMA requirements, firms are required to have a written supply chain program. Not only “food firms,” but dietary supplement firms (i.e., own label distributors and contract manufacturers) as well, must comply per 21 Code of Federal Regulations (C.F.R.) 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food – Subpart G – Supply Chain Program.

In brief, Subpart G is comprised of eight sections:

  1. §117.405—Listing the requirements to establish a supply chain program;
  2. §117.410—General requirements applicable to the program;
  3. §117.415—Responsibilities of facilities that manufacture/process a raw material or other ingredient that it receives from a supplier (known as a “receiving facility”);
  4. §117.420—Use of approved suppliers;
  5. §117.425—Determination of appropriate supplier verification activities (including determining the frequency of conducting the activity);
  6. §117.430—Conducting supplier verification activities for raw materials and other ingredients;
  7. §11435—Performing onsite audits;
  8. §117.475—Records documenting the supply-chain program.

In addition to these regulations, FDA issued a guidance document [link “guidance document” to https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM583490.pdf] in November 2017 to assist the industry in understanding the necessary roles and responsibilities and areas of enforcement.

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Brain health supplements market drivers

Cognition is top of mind for consumers. Tom Druke, director of VitaCholine brand development, Balchem Human Nutrition and Pharma, pointed to data from Natural Marketing Institute’s (NMI) 2015 Healthy Aging Study showing loss of cognitive function is the top age-related apprehension reported by respondents.

Their concerns aren’t without merit. “As we age, changes in brain structure and function lead to declines in several cognitive abilities,” explained Gary Small, M.D., aging and longevity expert, Brain Health Network member. “Brain cells do not communicate as effectively, and abnormal protein deposits—known as amyloid and tau—accumulate in brain areas that control memory and thinking. Most people notice memory decline by the time they reach middle age.”

Add to that a growing senior population, and the need for solutions to combat the cognitive challenges associated with aging become undeniably urgent. U.S. Census Bureau’s 2017 National Population Projections reported that, by 2030, all Baby Boomers will be older than age 65, while the United Nations World Population Ageing report stated the global population ages 60 and above doubled from 1980 to 2017. That number is expected to double again by 2050 to reach nearly 2.1 billion.

Though medical interventions for cognitive decline remain “elusive,” as Sally Aaron, senior vice president, health ingredients and marketing, Evolva, put it, consumers have options to manage or prevent issues related to cognitive decline.

Small concurred: “Considerable research on the impact of healthy lifestyle (physical exercise, diet, social engagement, mental stimulation, etc.) has shown that people do have some control over their cognitive health as they age, and many are searching for novel and effective ingestible products for bolstering brain health.”

According to Global Data’s Q3 2016 global consumer survey, 93 percent of U.S. seniors (ages 65 and up) have used a supplement within the last 12 months, compared to 85 percent for all groups.According to FMCG Gurus, nearly 60 percent of individuals surveyed are interested in cognitive health products, even when not suffering from specific health problems. FMCG also reported over 20 percent of those surveyed are taking supplements, visited a doctor or made changes to their diet to improve cognitive health.

“These trends indicate that healthy adults are looking for ways to slow down cognitive decline and boost brain performance, even before noticeable changes occur,” Aaron said.

Further supporting consumer interest in cognitive health is a growing market; according to data from Nutrition Business Journal (NBJ), the market for brain health supplements achieved an estimated US$912 million in 2018 with growth of 4.6 percent compared to the previous year. The market is projected to reach $1.04 billion by 2021.

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Flavor and function considerations when pumping up protein volume

Consumers increasingly are hitting the road to wellness and seeking out products high in protein to fuel their bodies before, during and after workout. Fortunately, today’s array of protein-rich sports nutrition products is in sharp contrast to yesteryear’s ready-to-mix (RTM), ready-to-drink (RTD) powders and energy bars that often fell short on flavor and taste.

Brands looking to enter the mainstream sports nutrition space must remember taste is always No. 1 in consumers’ minds, which means food developers must balance the beneficial effects of increasing protein content with the final product’s texture, appearance, taste and stability.

Plant proteins are available in isolates—including powders used for fortification—fractionated concentrates, and whole-food ingredients that are naturally high in protein and lend texture, color and flavor to foods and beverages. In addition to vitamins and minerals, phytonutrients and dietary fiber are other inherent benefits naturally packaged into wholefood sources of plant proteins. Furthermore, plant proteins meet several dietary needs.

“Consumer choices are driven by their quest to increase the repertoire of plant-based foods and protein in their diet as they directly link consumption to a healthier lifestyle,” said Melissa Sheridan, strategic marketing director, functional ingredients and additives, Kerry. “It is also linked to many consumers reducing their meat consumption, adopting a ‘flexitarian approach’ and an interest in a more sustainable food production system.”

While dairy proteins such as whey and casein traditionally have been the go-to proteins for building muscle, plant proteins are taking center stage as consumers look for ways to reduce their intake of animal-derived foods. However, the rapid advancement of plant-based proteins has created two key issues facing developers: mouthfeel and lingering off-flavors.

Consider pea protein, which can impart an earthy, grassy or beany aftertaste and gritty texture. Product developers typically will add other ingredients such as prebiotic fibers to change the texture of the protein and make it more palatable, noted longtime sports nutrition formulator Bruce Kneller, currently a partner with HiQ Financial Holdings Inc.

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Seeing suppliers as true partners is key to successful business continuity planning

A business continuity plan is essential for every company, but this is especially important for contract manufacturers that depend on outside sources for ingredients and packaging components. With the globalization of the industry, and the way the nutraceuticals industry’s supply chain works across international boundaries, and with late delivery potentially causing a halt in the manufacturing process, contract manufacturers must have plans in place to ensure smooth operation. Contract manufacturers rely on raw material vendors and packaging suppliers to make products, so it is imperative that the finished brands know that their contract manufacturers have a plan to deal with out-of-stock situations. Addressing any issue, whether it is from a distribution error or logistical delay, manufacturers must continue to provide brands with consistent on-time delivery.

The industry must adhere to GMPs (good manufacturing practices) and proactively mitigate risk. This means not only making primary suppliers accountable to very high standards (i.e., strict incoming raw material requirements), but also pre-qualifying secondary and tertiary suppliers.

Working with suppliers closely to verify that raw material requirements are being met is a key factor, but the relationship also has other benefits. A well-researched and reliable supply chain should lead to excellent two-way communication. For example, being warned promptly of any likely delays or issues gives more visibility and extra time to make other arrangements, which means contract manufacturers can continue to supply products on time.

Both consumers and brand owners have an understandable increased interest in the integrity of the supply chain for nutraceuticals. The types of ingredients that go into the product and the fillers or additives used are increasingly drawing consumer attention. For example, consumers want to know if supplements are vegetarian, non-genetically modified organism (GMO) and/or natural. These issues are more acute for brand owners, and they need assurances about the ingredient’s purity and identity as well as heavy metals and microbial content to ensure the highest quality finished product.

Building a true partnership with suppliers means they look after contract manufacturers’ interests and communicate information about new, trending ingredients so that manufacturers can continue to innovate for brand owners. In fact, through these partnerships on many occasions, contract manufacturers are among the first to hear of new ingredients coming to market.

Moreover, it is always good practice for brands to ask their contract manufacturers about their relationships with suppliers. Brands should ask questions about the strength and length of their relationships, and inquire about the systems they have to check beyond the certificate of analysis (CoA) that is normally provided by the vendor. Another important question to ask is if contract manufacturers use a trust and verify policy with ingredient suppliers; i.e., do contract manufacturers test incoming batches and undertake onsite audits at least once every two years?

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Astaxanthin for muscle endurance and recovery

Post-workout recovery supplements replenish energy stores, promote muscle repair and reduce muscle breakdown after a demanding workout. Intense physical exercise is energy-dependent. When the muscles burn calories by oxidation, free radicals and other reactive oxygen species (ROS) are formed as a byproduct.1 Free radicals can damage muscle fibers and reduce their ability to contract.2

Moderate exercise has health-promoting effects, while strenuous exercise, especially in unfit individuals, may have the opposite effect. Physical activity enhances metabolism that leads to increased production of free radicals and other ROS.

Astaxanthin sourced from the microalgae Haematococcus pluvialis is a powerful natural antioxidant. Comparison studies have shown astaxanthin is 6,000 times more powerful than vitamin C, 100 times more powerful than vitamin E, and five times more powerful than beta-carotene in trapping energy from singlet oxygen, one of the most common ROS in biological systems.3 Astaxanthin can trap several types of ROS/free radicals. In addition, the way astaxanthin neutralizes harmful ROS/free radicals is gentle to the body’s cells. Other antioxidants can be harmful, since they may turn into highly reactive molecules.4

As a bioavailable antioxidant, astaxanthin is transported throughout the body to organs and muscle tissues, combating excessive free radical production. Natural astaxanthin improves muscle endurance and strength by helping to reduce oxidative stress. Clinical studies have found natural astaxanthin neutralizes exercise-induced free radicals, protects the activity of antioxidant enzymes, reduces muscle fatigue and inhibits the formation of lactic acid.5-9

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The relationship between sleep aids and stress management

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Sleep aids are rapidly growing in popularity across the globe, posting a compound annual growth rate (CAGR) of 6.5 percent between 2012 and 2017 to reach retail sales of US$2.3 billion in 2017, according to market research firm Euromonitor International. Driven by an increasingly stressed and sleepless consumer base, particularly in the developed world, sleep aids are expected to continue growing through 2022.

Stress and sleep management are essentially one in the same when looking at consumer response: lack of sleep leads to increased stress, which results in an increase in reported sleeplessness. As a stressed consumer base turns to over-the-counter (OTC) sleep aids for relief, products positioned to address both conditions will continue to grow in popularity.

Sleep Aids Among Fastest-Growing OTC Categories

Though retail sales of sleep aids amounted to just $2.3 billion in 2017—far below cough, cold and allergy remedies, which is the largest OTC category—sleep aids experienced strong growth over 2012-2017, second to emergency contraception, which posted a CAGR of 9.4 percent over the same period. Looking forward, sales of sleep aids are expected to post a CAGR of 2.6 percent globally through 2022, according to Euromonitor.

Sales of sleep aids are heavily affected by demographic and epidemiological factors, particularly in the developed world as consumers increasingly report higher levels of work- and family-related stressors as well as a decline in number of hours slept each night. As stress levels continue to increase, consumers will likely continue to turn to OTC sleep aids for relief.

Increasing Stress Levels

The most common sources for consumers’ increasing stress levels are their jobs, familial obligations and, often, pressure from peers or society to work harder and accomplish more to achieve perceived success. Surveys of consumers’ attitudes toward work/life balance and stress management activities indicate across global markets (though largely excluding the developing world), consumers report being more stressed and under more perceived pressure in 2016 than in previous years, and there is every reason to believe these attitudes will persist and strengthen in the coming years as well.

Since the market for sleep aids is tied so closely to stress management, any discussion of retail sales of products to promote sleep must necessarily include a discussion about the psychological health of the consumer base and their motivations for buying sleep aid products in the first place.

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Body boosting ingredients for the serious athlete

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Branched chain amino acids (BCAAs) are incredibly popular with hardcore athletes and body builders. BCAAs include leucine, isoleucine and valine, which are essential amino acids that humans only get from food and beverage because the body doesn’t make them on its own. Among the benefits of BCAA products  are stimulation of muscle protein synthesis (MPS), prevention of muscle breakdown and delaying of muscle fatigue.1

There are hundreds of BCAA products on the market, and some of the most popular brands include Cellucor, BPI Sports and Dymatize. BCAA supplements are most often sold as powders with sweet and citrus flavors, but brands such as Optimum Nutrition and Scivation have developed ready-to-drink (RTD) beverages, as well.

Collagen is the most abundant protein found in the human body and is the basis of connective tissues that help give structure to tendons, ligaments, skin, bones and teeth. It is also sold as a supplement in products that are rapidly growing in popularity. The ingredientworks with endogenous hyaluronic acid (HA) to improve joint health,2 enhance hair,3 skin4 and nails.5 As a bonus, it may also help repair muscle tissue, although whey and casein are generally regarded as more effective for that purpose.6

The source of the collagen isn’t quite so sexy. It comes from animals such as cattle, fish, turkeys and chickens, which means it is not vegan and can cause issues with a product’s kosher status. Allergenic concerns also need to be taken into consideration for sensitive consumers. Formulating with collagen can be challenging because it can have solubility issues, but brands such as Eviva Collagen Elixir, Beauty & Go and Pure Gold Collagen have successfully developed RTD collagen supplements. Many collagen protein powders are on the market, as well, including in  brands such as NeoCell, Ancient Nutrition, Vital Proteins and Sports Research.

Micellar casein is an up-and-coming ingredient for active consumers and is generally regarded as the most effective form of casein compared to similar ingredients like calcium caseinate. It is the slowest digested caseinate protein and is a source of high-quality BCAAs and glutamine.

“The mechanism of action is a stark contrast to hydrolyzed whey, which is known for fast-acting, quick absorption into the body,” explained Jason Dompeling, beverage scientist at Imbibe. “Micellar casein is known for very slow absorption. The casein micelles form a sort of ‘clot’ in the gastrointestinal (GI) tract that slow down the protein breakdown and amino acid absorption.”

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Probiotics provide a competitive edge in sports nutrition

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The gut flora performs a variety of functions that are important for health. In fact, 70 percent of the body’s immune cells are located in the digestive tract, making gut health critical to overall health. A healthy and well-balanced gut flora facilitates digestion, protects against pathogens, provides vitamins and nutrients, and helps form the immune system. For athletes and fitness enthusiasts, optimizing digestion and immunity are major factors as they strive to improve performance. As research advances, probiotics will play a leading role in shaping the sports nutrition supplements of tomorrow.

Athletes and active individuals have high nutrient needs, which are best met when digestion is well-functioning. Healthy bacteria in the gut aid in the digestion of macronutrients, allowing for optimized nutrient uptake from an athlete’s diet. They also aid in the digestion of macronutrients, allowing for optimized nutrient uptake from the diet. Some probiotic strains can play a role in the use of protein for muscle growth and human recovery by promoting the absorption of key amino acids. Being able to absorb more of the amino acids from protein can help increase muscle growth. In addition, probiotics can support immune health by adhering to the gut epithelium, thereby enhancing the “gut barrier” function of those cells by preventing the adhesion of pathogens.

Working out is all about breaking down and rebuilding muscles to become stronger and faster. With such activity, inflammation and free radical production are normal, expected and necessary—but the body’s response to these reactions will determine how quickly an athlete can recover and get back to his or her regimen. The two main areas of focus while doing strenuous activity are providing the right nutrients to build muscle (protein) and recovery (reduced inflammation). Probiotics can help in both of those areas; for example, the strain Bacillus subtilis DE111® (from Deerland) produces many enzymes to help break down protein, and recent research supported its role in reducing markers of inflammatory compounds that arise during exercise (Sports. 2018;6[3]:70).

According to the National Collegiate Athletic Association (NCAA), there are more than 480,000 NCAA student athletes who compete in 24 sports every year. And of course, this is only a slice of the physical-competition pie. Add professional sports, athletic trainers and serious fitness enthusiasts like marathoners and cyclists, and the number of individuals who could benefit from probiotic supplementation is significantly higher.

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Probiotics proving beneficial to microbiome, overall well-being

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As Woody Allen said, bacteria—those microscopic organisms only visualized with a microscope’s help—were the first inhabitants of the Earth and will probably be the last to abandon it. They are also the most abundant living beings on the planet. Experts in microbial ecology calculate there exist about 50 nonillion bacteria (5X1030); this means for every human being on Earth, there are almost seven hundreds of quintillions of bacteria (7X1020). Interestingly, an important part of this microbial biomass lives inside the human body. All this was unknown 10 years ago. Thanks to the application of massive genomic sequencing techniques, in recent years, scientists have determined there are as many human cells in the body as bacteria inside. They are particularly numerous on the skin and in the digestive tract. If a person weighs approximately 155 pounds, 2.2 pounds consists of the bacteria that populate his/her digestive system. In fact, scientific experts have spoken about a neglected organ not described to date that has a transcendental relationship with one’s diet. The reason is clear: a person’s bacterial ecosystem is responsible for extracting energy from the diet and modifying or destroying ingested substances that may be healthy or deleterious to a person’s health.

This set of bacterial species that populate the human digestive tract is known as the gut microbiome. Each human being has their own particular gut microbiome, and no two are the same—it is like a fingerprint. However, there are similarities, so the gut microbiomes of healthy individuals can be classified into three groups, known as enterotypes. The gut microbiome can vary depending on age, diet, the use of drugs (mainly antibiotics) or state of health (e.g., disease, sickness). These changes are usually reversible and open the door to the development of new foods and dietary supplements that contain bacteria and/or metabolites (e.g., prebiotics) capable of returning the microbiome to its original condition or modifying it.

Consider the situation of individuals with celiac disease. Children with celiac disease have a different gut microbiome than healthy children. They have a high proportion of Enterobacteria species and less Bifidobacteria or Lactobacilli counts. This alteration is called dysbiosis and is, to some extent, responsible for the intestinal inflammation these patients exhibit. In a double-blind, randomized, placebo-controlled clinical study, children with celiac disease were given B. longum CECT 7347 or placebo daily for three months, together with a gluten-free diet (Br J Nutr. 2014;112:30-40). Results suggested Bifidobacteria and Lactobacilli were increased and Enterobacteria were decreased in the CECT 7347 group, as compared to placebo.

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Sports nutrition performance ingredients

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Performance in sports goes beyond competition to include training or regular exercise. By definition, performance is the execution of an action or the ability or manner used in completing a task. Sports nutrition researchers define performance in terms of strength, power and endurance, as well as sport skills including speed, agility and reaction time. Recently, cognitive function—focus, processing and memory—has drawn rising interest in the market for its impact on overall sports performance.

It could be confidently said that all sports nutrition ingredients have an ultimate effect on performance, even if their primary benefit is in weight management or recovery.  However, many ingredients are researched for an influence on specific performance metrics used by sports nutrition researchers and, thus, have a more direct impact on performance.

Strength and power metrics are tied to the muscles, which are built and driven by protein/amino acids and energy. Each protein source, from dairy to plants and algae, has a unique profile of essential amino acids (EAAs) and specific rates of action. Whey is fast acting, while casein is slower. Each protein can play a role in muscle development and function, and blending different protein types is sometimes advantageous. The branched chain amino acids (BCAAs), specifically leucine, are EAAs singled out for muscle building. Leucine is considered a limiting factor in muscle protein synthesis (MPS), the process of building new muscle mass.

Also involved in muscle building is mTOR (mammalian target of rapamycin), a regulatory pathway for MPS. Leucine and ingredients such as HMB (beta-hydroxy-beta-methylbutyrate) may signal mTOR-activated muscle growth.

Protein boosters, which help increase MPS, and testosterone boosters are other popular categories of ingredients for strength and power.

On the energy side, which also plays into endurance, ingredients that support production of adenosine triphosphate (ATP), the cellular energy molecule, can support performance gains. Creatine helps energize short bursts of activity, such as resistance training and sprinting, while carnitine helps shuttle fatty acids into the mitochondria for use in later stage energy production.

On the flip side, compounds that inhibit fatigue can also improve performance. Beta alanine and carnosine help buffer fatigue-causing ions in the muscles, whereas caffeine disrupts fatigue signaling in the brain and stimulates the central nervous system.

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