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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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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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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

10_17 Body Boosting Ingredients

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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Nitric oxide for sports performance

10_11 choline

Nitric oxide (NO) is a critically beneficial molecule for sports nutrition due to its role in cardiovascular function. Previously viewed as a noxious atmospheric gas, research in the 1980s began to illuminate the role NO plays as an important chemical messenger. Named “molecule of the year” in 1992 by the journal Science (1992;258(5090):1861), NO received mainstream recognition in 1998 when three scientists were awarded the Nobel Prize for their discovery of the molecule’s benefits to cardiovascular health.

The principal benefits of NO are related to its function as a vasodilator. The production and release of NO in cells along the interior vascular wall triggers a complex set of metabolic reactions that result in vasodilation—the relaxation of smooth muscles, allowing for improved blood flow and delivery of oxygen and nutrients to the muscles. Vasodilation contributes to health by reducing platelet aggregation, inhibiting molecules that promote vascular inflammation and reducing blood pressure(Current Vascular Pharmacology. 2012;(10):4-18)

The vascular endothelium is made up of a layer of cells along the interior of our blood vessels, directly above the smooth muscle layer. Agonists such as acetylcholine can activate receptors in this vessel layer to prompt synthesis of NO from arginine.

Choline helps to optimize NO in several important ways, the first being in triggering localized production in the vascular membrane. As free circulating acetylcholine in the blood, it stimulates eNOS production by activating the receptors on the endothelial wall (J Appl Physiol. 2005 Feb;98(2):629-32), thus contributing to higher NO levels(Clin Hemorheol Microcirc. 2003;29(1):41-51). Additional studies have suggested a novel role for cholinergic signaling mechanisms and acetylcholine release in regulating vascular function and endothelial cell migration and proliferation (J Physiol. 2016 Dec 15;594(24):7267-7307).

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Natural products industry eyes exclusions, new sources for China tariff relief

made in china tariff stamp

The Trump Administration has approved the latest round of superimposed tariffs on $200 billion worth of Chinese imports, including many dietary ingredients. The move places an immediate burden on the supply-side of the natural products industry, as companies scramble to figure out pricing and availability, while hoping for relief via an exclusion process. The effects, including any price increases, are not expected to impact retailers and consumers until a later date, possibly in mid- to late-2019.

President Trump announced the move Sept. 17 and set Sept. 24 as the effective date for this round of tariffs, known as “List 3.” Two previous rounds of tariffs were levied on a total of $50 billion worth of imports, primarily steel, aluminum and equipment.

After much speculation, Trump kept the List 3 tariffs at 10 percent, but this figure will rise to 25 percent on Jan. 1, 2019, if the trade war with China persists.

“We are taking this action today as a result of the Section 301 process that the USTR [U.S. Trade Representative] has been leading for more than 12 months,” Trump wrote in a statement published on the White House website. “After a thorough study, the USTR concluded that China is engaged in numerous unfair policies and practices relating to United States technology and intellectual property – such as forcing United States companies to transfer technology to Chinese counterparts.”

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