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Herbs for muscle building

The sports nutrition marketplace is on the climb, and it’s not just for the trained athletes anymore. In 2018, trends toward high-calorie-burning exercise among Americans had 4.8 million more people participating when compared to five years prior, according to the Physical Activity Council. People in this category reported doing high-calorie burning activities at least three times a week for a minimum of 20 minutes. And although this still doesn’t meet the recommended rate of daily activity, people are more active than before.

In addition to more exercise, consumers are taking preventative and holistic measures for their health care. The 2018 Council for Responsible Nutrition (CRN) Consumer Survey on Dietary Supplements showed 75 percent of U.S. adults now take supplements, up 10 percent from the year before. And they’re spending more money; Americans spent US$43.2 billion on supplements in 2017,  increasing by $8 billion from 2012.

Consumers purchasing supplements also have healthier habits than those of non-supplement users. Adults taking supplements are more likely to exercise, visit a doctor regularly, try to eat a balanced diet, get a good night’s sleep and maintain a healthy weight, and are less likely to use tobacco.

However, with all this growth within the industry and the increase in physically active consumers, the sports nutrition sector grew just 4.4 percent in 2017, a significant drop from 2016, when growth was marked at 5.9 percent, according to Nutrition Business Journal. This could be due to a lack of innovation within the category.

Getting an edge on the competition

Protein products have flooded the muscle-building marketplace for years. In fact, they accounted for more than 80 percent of global sports nutrition sales in 2017, according to Euromonitor International. Despite this, the market for nonprotein options is still relatively small ($2.5 billion in 2017), leaving room for major growth.

Consumers incorporating natural supplementation into their everyday healthcare routines opens a door of possibilities for finished product brands. Specifically, brands may need to promote advancements within the nonprotein sports marketplace.

Take, for example, curcumin. This ingredient is well-known to the consumer for its ability to help manage oxidative stress and inflammation,1 and several studies showed branded curcumin (as Meriva®, from Indena2 and as Theracurmin, from Theravalues Corp.3,4) and commodity curcumin5,6 had the potential to prevent delayed onset muscle soreness (DOMS). DOMS occurs after unaccustomed exercise in both novice and experienced athletes. It is associated with muscle pain, decreased range of motion (ROM), muscle fiber disruption, altered joint kinematics, decreased strength and acute tissue damage, each of which contributes to an impairment in future athletic performance and/or predisposes individuals to injury.

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Measuring curcumin absorption

In Natural Product INSIDER‘s article, “Curcumin’s popularity ups and downs,” Chase Shryoc noted that the supplement industry can better market the bioavailability of enhanced absorption curcumin products. He observed that comparing “X” times bioavailability of one product as opposed to “X + 1” times for other products is “confusing and meaningless to consumers.” He further noted that a better way of comparing products would be to show how much of an active ingredient is absorbed by stating the number of curcuminoids per ml of plasma. This simple statement raises several issues.

Free bioactive curcumin in the blood (plasma) is the best indicator of absorption and bioavailability. When curcumin is absorbed, much of it is converted to the biologically inactive forms curcumin sulfate and curcumin glucuronide. Most curcumin pharmacokinetic studies in humans designed to assess curcumin absorption measure total (free plus conjugated) curcumin, and not free, bioactive curcumin in the blood becauseenzymatic hydrolysis of plasma samples is employed prior to extraction and analysis. Enzymatic hydrolysis frees curcumin from its inactive forms. Therefore, the amount of free bioactive curcumin is unknown and cannot be determined. Therefore, products that use enzymatic hydrolysis to determine blood levels greatly inflate the results of their studies regarding curcumin absorption, and their reports of enhanced curcumin absorption can be misleading. What is important is the amount of free, un-metabolized and biologically active curcumin in the blood, and not the amount of biologically inactive conjugates of curcumin [Biomed J Sci Tech Res. 2019; DOI: 10.26717/BJSTR.201912.002289].

The dietary supplement industry must adhere to the highest standards of appropriate pharmacokinetic practice, utilizing the same techniques and methods for assessing blood levels of bioactive constituents as are used in the pharmaceutical industry. Hydrolysis of plasma samples prior to extraction and analysis is not an accepted technique in the pharmaceutical industry, nor should it be in the dietary supplement industry. Only then will consumers have a clear understanding of the efficacy of any given curcumin product.

A second issue in comparing various curcumin products formulations is the wide disparity in the amount of curcumin administered, which can range from 65 mg to as high as 1,000 mg. Plasma levels of free curcumin, and its inactive conjugates and metabolites are not only impacted by the relative ability of a given product to be absorbed, but also the relative dose of curcumin administered. Two common pharmacokinetic terms are used to express absorption. The Cmax is the maximum (peak) concentration of a substance such as curcumin, and the area under the curve (AUC) over a finite period of time provides information on the amount (extent) of curcumin absorbed.

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FDA commissioner highlights ‘unanswered questions’ regarding safety of CBD

FDA has many “unanswered questions” when it comes to the safety of cannabidiol (CBD), a cannabis-derived compound, the agency’s top official said last week.

FDA Acting Commissioner Norman “Ned” Sharpless, M.D., cited “real risks” and “critical questions” that remain regarding the safety of CBD and tetrahydrocannabinol (THC) in FDA-regulated products, including food and dietary supplements.

During a May 31 public hearing at FDA’s campus in Silver Spring, Maryland, more than 100 speakers representing myriad interests addressed CBD and THC issues, including FDA’s prospective regulation of cannabis-derived compounds.

The hearing was intended to obtain scientific data and information about the labeling, manufacturing, marketing, product quality, safety and sale of products containing cannabis or cannabis-derived compounds.

Sharpless underscored FDA has many questions about CBD that remain unanswered.

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” he said.

Sharpless suggested population-based research focused on CBD was scant prior to the passage of the Agricultural Improvement Act of 2018, otherwise known as the Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act (CSA).

The “lack of evidence to support CBD’s broad use in FDA regulated products—including in food and dietary supplements—has resulted in unique complexities for its regulation,” he said, “including many unanswered questions related to … safety.”

For instance, Sharpless asked a fundamental question about CBD: How much of the compound is safe to consume in a day?

“What if someone applies a topical CBD lotion, consumes a CBD beverage or candy and also consumes some CBD oil?” Sharpless asked. “How much is too much?”

Sharpless also asked how CBD would interact with other drugs taken by a person, and he left unanswered the question of how the compound would impact the health of a pregnant women.

“What if children access CBD products like gummy edibles?” the commissioner asked. “What happens when someone chronically uses CBD for prolonged periods?”

FDA has concluded CBD and THC—the psychoactive compound responsible for the “high” from consuming marijuana—cannot be added to conventional food or marketed in a dietary supplement because the compounds were first studied as drugs. But FDA has authority to create an exception by issuing regulations, a process that could take several years.

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Building a better brand-supplier relationship

Part of the problem is rooted in misconception. For instance, some brand holders may think a supply partner doesn’t provide much value beyond a given product or service. Andrew Rice, director of product and brand strategy at Stratum Nutrition®, was quick to counter. “We absolutely want to ensure our customers find success with the products they masterfully create with our ingredients so that our brand partners and their customers both benefit.” Stratum’s value-add comes from internal resources it offers at no extra cost, such as brand, marketing, science and formulation consulting. “This is our way of ensuring they aren’t just getting an ingredient, but something that will help them find product launch success, build a stronger relationship with our company, and above all else, benefit their customers’ health and wellness.”

Shaheen Majeed, president worldwide at Sabinsa, said raw materials sourcing is an additional area brands may misunderstand. “Brand holders often worry that suppliers will fall short of supply, but in fact, good suppliers anticipate and take action to address potential shortfalls well in advance; that knowledge alone is worth its weight in gold,” he stated. “In the world of botanical extracts, if there is too much rain or not enough rain during the growing season, we can predict the outcomes fairly accurately; this can help the brand owners make adjustments. Supply chain risk mitigation is something that both suppliers and brand holders can, and should, work on together.”

Brand holders looking to formulate with USDA Organic ingredients should work closely with trusted suppliers. Saumil Maheshvari, senior vice president of business development, Orgenetics Inc., said a significant lag in organic supply can occur when trying to meet demand. “It often takes years for farms to become Certified Organic, and it also is sometimes not easy cultivating crops as USDA Organic,” he pointed out. Close partnership with an organic supplier allows a “forward mapping of supply/demand … to build out a supply chain of the future, for the future consumers.”

Maheshvari suggested, “This sort of ‘vertical collaboration’ can be the brand owner’s relevant teams reaching out to their specified supplier, and working with them through the entire product development’s stages—from inception/formulation to the marketing and timing of launch, etc. Having clear launch timings and expectations alleviates strains on USDA Organic supply chains (upstream to the farmer even), and it helps the supplier better manage investing in growth. It also secures new organic supply for the brand’s new products/projects.”

Beyond supply chain, Majeed suggested brands ask detailed questions of suppliers regarding testing protocols and standard operating procedures (SOPs). “A common misconception is that suppliers only test the first shipment and nothing after—this may be true of some suppliers, but should not be assumed,” he said.

Audits are another area where trust can be built. “Suppliers should expect to be routinely audited,” Majeed noted. “Any supplier that cannot or will not accommodate an audit by a customer should be suspect. It’s a basic GMP (good manufacturing practice) requirement.”

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Bridging the fiber gap with better-for-you ingredients

The role of proper nutrition on overall health and well-being is well documented, leading more consumers to seek functional food and beverage products made with recognizable, functional ingredients that address specific dietary needs. Data from the International Food Information Council’s (IFIC) 2018 Food & Health Survey found at least 80 percent of consumers rank vitamin D, fiber and whole grains as the top healthiest nutrients they look for when shopping for food.1

However, good intentions often fall by the wayside. Case in point: fiber. Americans consistently fall far below the recommended daily intake of 25 g of fiber, which is why the 2015-2020 Dietary Guidelines for Americans (DGAs) labeled it as a shortfall nutrient that poses a public health risk (along with vitamin D, calcium, potassium and iron for premenopausal women). 2

In the United States, the recommended dietary fiber intake is 14 g/1,000 kcal. For an average adult, this means a daily intake of 25 g for women or 38 g for men; however, most Americans only consume about half of the recommended intake (13.5 g and 18 g, respectively), according to the Calorie Control Council.

This “fiber gap” also was addressed in May 2016 when FDA released its updated Nutrition Facts label for packaged food and beverages sold in the United States to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The sweeping overhaul was the first in 20 years, and included FDA’s first evidence-based definition of “dietary fiber” and an increase of its daily reference value (DRV) from 25 g to 28 g. Food manufacturers must comply with the new labeling rules no later than Jan. 1, 2022.

Defining (and Redefining) Dietary Fiber

Prior to 2016, food and beverage manufacturers could declare synthetic or isolated fibers as dietary fiber on the label, even if they did not have a physiological effect beneficial to human health. The 2016 evidence-based definition allows naturally occurring fibers in fruit, vegetables and whole grains to be considered fiber, as well as seven other isolated (i.e., extracted from plant sources) or synthetic non-digestible carbohydrates (NDCs) or synthetic fibers—beta-glucan soluble fiber, psyllium husk, cellulose, guar gum, pectin, locust bean gum and hydroxypropylmethylcellulose—that are well-recognized by the scientific community for their physiological benefits.

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Nootropics and sports nutrition for the weekend warrior

Nootropics are compounds that improve cognitive function, and in some cases, brain health. They have been gaining buzz lately, which is not surprising since we are all striving to work harder and achieve more, and sustained focus is required to maintain that high watermark. One group that exemplifies the “work hard, play hard” lifestyle is “weekend warriors.” These individuals—who are tough competitors both at work and at play—are familiar with sports nutrition to optimize their bodies, but now it is time to “focus” on their brains.

When considering how sports nutrition can affect the brain, it is important to start with the basics of hydration and fueling, which can affect a wide range of cognitive domains. These topics have been addressed in research1,2,3 while two other important cognitive areas stand out for weekend warriors: focus and reaction time.

For people who compete in all aspects of their life, laser-like focus is paramount. For example, many weekend warriors engage in CrossFit or other types of high-intensity interval training, which demand pushing past physical and mental limits. Not only do they want to finish those workouts, they want to achieve new PRs (personal records) and feel the rush from knowing they just crushed that workout. In those situations, fatigue can dramatically reduce focus, and branched-chain amino acids (BCAAs) are one nutrition solution. It has been suggested BCAAs may delay fatigue by reducing transport of tryptophan, a precursor to the neurotransmitter serotonin that contributes to feeling tired.4 In a study of cyclists, the rate of perceived exertion and mental fatigue while cycling was significantly lower when they drank BCAAs vs. placebo.5 In soccer players, psychomotor performance was improved with BCAA consumption during intense interval training.6

Delaying exercise-induced fatigue is awesome, but weekend warriors do more than just exercise. They need optimal focus while at work and at play, which is where botanicals can play a role. Consumers who want to “hit a PR” at work, at home, at the gym or on the field (whatever “field” they choose to play on) must stay locked-in and on task wherever they are. Researchers demonstrate this by testing “sustained attention,” a cognitive domain we are all familiar with: sit down and do your work (or play with your kids) and don’t get distracted by your phone, calendar, Facebook or getting another cup of coffee. Studies have shown sustained attention can be improved by ingesting certain botanicals,7 allowing focus to be improved and maintained throughout a hectic day.

Another cognitive area to consider for weekend warriors is reaction time, or quick reflexes. Reaction time becomes important in a variety of popular, athletic contexts, such as mountain biking (to avoid major spills), HIIT (high-intensity interval) training or obstacle course racing (such as American Ninja Warrior)—just to name a few. Reaction time testing is generally done on a computer, which means full-body reflexes are not being captured, but only the contribution of the brain (and maybe a finger or two for keyboard tapping). Active choice reaction performance (ACRP) is more applicable to sports since it involves reaction time while moving the whole body. Certain botanicals have been shown to improve ACRP by testing people’s reflexes while moving their whole body.

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FDA urged to act swiftly to settle confusion in CBD market

“Time is of the essence.”

The statement, made by Andrew Kline of the National Cannabis Industry Association (NCIA), encapsulates the views of many people who attended a recent public hearing hosted by FDA on cannabidiol (CBD) products.

During the May 31 hearing in Silver Spring, Maryland, several speakers urged FDA to provide clarity to a confused marketplace and do so swiftly.

“We strongly recommend that FDA act quickly to clarify the regulatory environment because there is significant confusion in the market,” Kline said.

FDA is mulling whether to issue regulations that would permit CBD in conventional food and dietary supplements, but its search to answer questions over safety, effectiveness and other issues could lead to a years-long proceeding.

Based on its current interpretation of federal law, FDA has opined CBD cannot be added to conventional food or marketed as a dietary supplement because, in large part, it was first studied as a drug.

“Three to five years, at a minimum for rulemaking, is too long,” Megan Olsen, assistant general counsel of the Council for Responsible Nutrition (CRN), told FDA officials during the public hearing.

The debate over safety, she added, should not hamper FDA from promulgating regulations to allow for the use of CBD in supplements.

“There is already a regulatory framework in place that is proven to ensure the safety of dietary supplements and food—one that will automatically be implemented should FDA develop a regulation permitting CBD use in food and supplements,” Olsen said.

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Collagen: An ingredient for the ages

To be “beautiful inside and out” is the ultimate compliment. Imagine a supplement that performs its healthy aging functions internally as effectively it does externally, supporting both fluid movement and glowing, resilient skin. These flexible feats are among the boasts of collagen, a word derived from kolla, or “glue” in Greek.

The collagen movement began across Asia, China and Japan, according to Lauren Clardy, vice president of branded ingredients, AIDP Inc. Specifically, she noted, type I and the beauty-from-within market started to gain traction in the 1980s. “At Expo West recently, collagen launches were still front and center in food, beverages, supplements and personal care,” she reported. “We will see more incorporated into functional foods and beverages as the market matures. Compare this to 2012 when there was little to no collagen at Supply Side West. Today, it is one of the hottest ingredients trending alongside turmeric, CBD [cannabidiol] and others.”

When cartilage supplements—specifically shark cartilage—were all the rage in the late 1990s and early 2000s, it soon came to light that its power mostly came from naturally occurring collagen. Of the 28 different kinds of collagen, the primary and “most medicinal” is collagen type II. Collagen in general comes from skin, bones and cartilage from fish and common livestock (bovine, porcine and chicken).

Collagen product innovation is in full force to satisfy an excited consumer base. Oliver Wolf, head of B2B global marketing at GELITA, said sports nutrition, beauty-from-within concepts and products that support healthy aging are the most promising application fields for collagen peptides. In their natural form, he explained, collagen peptides are odorless and taste-neutral, and do not react with other ingredients, making them suitable for a wide range of different applications—from dietary supplements to functional foods and beverages. They are soluble in cold water and have “perfect” flow properties for dust-free pouring and dosing, he said. And in powder form, the peptides can be mixed with other ingredients, as “they have excellent wetting and dissolution properties when stirred into liquids, even in high concentrations.”

Tony Federico, vice president of marketing for Natural Force, added, “Consumers are looking to collagen for its anti-aging properties (improves skin moisture and reduces the appearance of fine lines and wrinkles), ability to support gut and joint health, and for its contribution to strong and healthy hair and nails.”

Heather Wilson, director of brand development and licensed esthetician for Insta Natural, agreed, noting more consumers are embracing and understanding collagen’s benefits. Beyond supporting bone and muscle health, she pointed out, consumers also know it holds great potential for beauty and skin health as well. “Other proteins, such as whey and pea protein, used to be the ‘go to’ proteins, but as soon as people realized that collagen has all these amazing benefits for skin, hair and joints, it became very popular,” she stated.

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FDA official highlights noncompliance with dietary ingredient requirement, enforcement challenges

Only a small fraction of the ingredient notifications required under the Dietary Supplement Health and Education Act of 1994 (DSHEA) have been submitted to FDA since the 1990s, an agency official concluded during a May 16 public meeting.

Distributors and manufacturers must notify FDA, providing the agency evidence of safety 75 days before introducing a new dietary ingredient (NDI) into interstate commerce.

Although many companies are suspected of neglecting to comply with the notification requirement, the director of FDA’s Office of Dietary Supplement Programs (ODSP), Steven Tave, suggested his agency doesn’t have a way to accurately measure all the NDIs that should have been submitted to FDA but were not.

Part of FDA’s challenge is the law exempted from the NDI notification (NDIN) requirement dietary ingredients marketed before Oct. 15, 1994, and those that have “been present in the food supply as an article used for food in a form in which the food has not been chemically altered.”

Nonetheless, Tave calculated less than 25 percent of the required NDINs have been submitted to FDA. His conclusion is based, in part, on an estimated 50,000 dietary products on the market today. Tave’s figure is at the low end of FDA’s estimates of the current dietary supplement products on the market, which could number as high as 80,000.

Only 4,000 products were on the market in 1994, according to Congress’ estimates, so at least 46,000 new dietary supplement products have been introduced since 1994.

Responding to criticism that companies have failed to comply with the NDIN requirement, industry sources have pointed out many new products are exempt from the NDIN requirement because they are, for example, combinations of old ingredients grandfathered under DSHEA.

Tave acknowledged such exemptions were not subject to the NDIN requirement.

“Let’s say 90 percent of these products did not require a notification,” he said. “That still leaves 10 percent of the products that did require a notification.”

That means the distributors or manufacturers of 4,600 products were obligated to notify FDA, providing evidence that their NDI is reasonably expected to be safe. However, only about 1,100 NDINs have been submitted to FDA since the law was signed, Tave reported.

Tave noted people could “quibble with the math,” but he suggested the order of magnitude was correct.

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Energy ingredients: The next generation of caffeine

Caffeine remains a wildly popular energizer in both the mainstream world and sports nutrition market. This purine alkaloid is known as an adenosine antagonist because it competes with fatigue-signaling for receptors in the central nervous system. This delays fatigue and triggers a stimulant effect that active consumers and athletes love, providing a perk to daily activities and a boost to exercise performance.

However, many consumers are increasingly concerned about the source of caffeine, especially after FDA warned about the use pure and synthetic caffeine—the agency’s concern was focused on bulk caffeine, for which it is difficult for consumers to accurately measure efficacious but safe dosages. This concern has created opportunity for natural and organic alternatives to caffeine, as well as other energy ingredients.

INSIDER talked to Brian Zapp, creative director, Applied Food Sciences Inc. (AFS), about “clean” energy alternatives, including consumer trends and ingredient innovation.

Brian Zapp: When it comes to clean energy, the full concept of “clean” goes beyond incorporating natural ingredients into a formula. It aligns more with demonstrating the transparency of the product as a whole. One of the basic premises behind the “clean label” trend is that consumers are skeptical about what manufacturers are putting in their products and for a category like energy, this is even more evident.

According to Mintel more than one quarter of energy drink consumers surveyed say that they drink fewer energy drinks because they don’t trust the artificial ingredients inside (Mintel 2015, survey based on 168 internet users aged 18+ who consume fewer energy drinks). By substituting artificial and unrecognizable ingredients with known sources, like coffee and tea, consumers can easily draw a connection of familiarity.

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