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New research on curcumin’s health benefits

The big question about turmeric and curcumin asks how long its explosive growth will last. Will this superstar spice ingredient sustain its popularity and reach omega-3 status or fade into the background as a once-hot natural product trend? Thanks to the wide body of data generated in recent years, curcumin’s benefits categories have broadened substantially.

Sports nutrition is an up-and-coming benefit sector for curcumin, especially in light of its potential to reduce inflammation and soreness caused by strenuous exercise. The antioxidant benefits of curcumin and its ability to modulate inflammatory pathways underscores its potential as an adjunct to recovery.1

In a recent randomized, double-blind, placebo-controlled study, curcumin was shown to be an effective supplement for recovery after strenuous exercise.2 An additional study also reported a reduction in 24-hour pain scores as well as increased muscle performance after a muscle-damaging exercise.3

Curcumin is also finding potential in heart health, where the effects of its anti-inflammatory properties are being researched. Recently, a highly bioavailable form of curcumin was studied in a healthy population to examine its role in endothelial function, which plays a critical role in cardiovascular health.4 Curcumin’s direct impact on healthy circulation was measured using flow mediated dilation (FMD).

The randomized, double-blind, placebo-controlled study showed supplementing with 200 mg of curcumin had a clinically meaningful impact on potentially reducing cardiovascular disease by up to 50 percent in healthy individuals.

As the buzz around turmeric and its active component, curcumin, continues to spread, market opportunities for these popular ingredients are expanding.

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IP trends in sports nutrition

Patent filings directed to sports nutrition continue to generally grow year over year. The trend is particularly pronounced on a global scale.

The increase in patent filings (through 2016) of sports nutrition products has been occurring outside the United States, with a large portion of filings in China. Brazil and Russia, which are not usually on the top filer lists, have weighed in with a significant amount of patent filings specifically associated with sports nutrition.

Sports nutrition ingredients may be formulated into food products, such as modified foods or complete food formulations. Alternatively, specialized ingredients may be incorporated into single or multi-ingredient nutritional supplements. To be patentable, these types of formulations must include a unique non-naturally occurring single ingredient or a previously unknown combination of ingredients, among other innovative features.

Trademarks for sports performance products include some expected terms like “sport,” “perform,” “strong” and “fast.” Since these terms are common, they cannot be registered in trademarks on their own. Common terms and variations thereof must be coupled with more distinctive terms to obtain trademark registration.

Careful consideration is required to determine if a particular combination is available. Trademark availability searches from trademark counsel can help find a potential trademark that does not encroach upon the rights of a third party’s trademark.

Finally, a steady increase in the term “performance” may indicate the sports nutrition performance field is still growing. Opportunities still exist for innovative products and brands to carve out their exclusive rights in an exciting area of nutritional products.

This is an excerpt from the article, “Intellectual property trends in sports nutrition.” To read the complete article, download the Sports nutrition: Performance digital magazine.

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FDA still finding same cGMP deficiencies at dietary supplement facilities

FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted.

In fiscal year 2018 (FY18), 75 inspections—or about 24 percent of firms that received a Form 483 inspection report for “observations,” or alleged cGMP violations—were cited for failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplement, FDA data revealed. This was the most common cGMP observation in FY18 year as well as in FY17 when 24 percent of firms (89 inspections) were cited for the same infraction, according to FDA data INSIDER obtained through the Freedom of Information Act (FOIA).

Over the years, FDA has repeatedly emphasized the importance of setting and following specifications for the identity and other key attributes of a dietary supplement. Without doing so, FDA and outside cGMP consultants have said, manufacturers have no reliable way to know and verify what is in their products.

Nearly half (274 inspections, or 46 percent) of the 591 inspections in FY18 didn’t receive a Form 483, which suggests those dietary supplement manufacturing facilities are fully compliant with the cGMPs.

Warning Letters

There may be another silver lining. Data analyzed by the Natural Products Association(NPA) suggested an increasing number of firms cited in Form 483s for failing to establish product specs make the necessary corrections without requiring an admonishment from FDA in a subsequent warning letter.

NPA, a trade association founded in 1936 and led by former FDA officials, reviewed FDA warning letters to analyze alleged infractions of the cGMPs.

In reviewing the data dating back to 2010, NPA identified a change in the most cited cGMP violation. Through the first nine months of 2018, FDA most commonly cited dietary supplement firms in warning letters for failing to establish and follow written procedures for the responsibilities of quality control operations. In FY18 Form 483s, the latter cGMP infraction was the second most cited cGMP observation (52 inspections, representing around 16 percent of all Form 483s).

In the previous three years, the most common cGMP violation reported in FDA warning letters was related to specifications to establish when devising a production and process control system, NPA reported this week in a chart within a news release. The above infraction dropped to the third most-cited cGMP violation in 2018 warning letters, while the second most commonly cited infraction related to recordkeeping requirements for production and process control systems.

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FDA’s new nutrition label regulation for fat-soluble vitamins

The international unit (IU) has been used to measure fat-soluble vitamins—vitamin A, D and E—for decades. The IU is an arbitrary amount based on the amount of a given nutrient needed to produce a biological effect. Different than milligram or microgram, the IU measurement describes something that we cannot see; the potency or biological activity of a product. While IU seemed to be an innovative idea during the time it was introduced, many would agree that this IU system is now outdated.

In the new regulation for the nutrition facts label, FDA is replacing the unit “IU” for vitamin A, vitamin D and vitamin E with the metric unit. The unit for vitamin A will be changed to micrograms of retinol activity equivalents (mcg RAE), milligram of alpha-tocopherol (mg) for vitamin E while Vitamin D will be changed to microgram, while the IU reading for Vitamin D could be displayed in parentheses. This regulation will come into effect on Jan. 1, 2020 for companies with US$10 million or more in annual sales; and Jan 1, 2021 for companies with less than $10 million in annual sales. It is expected that other countries will follow this new regulation as well to standardize the labelling system. This new supplement/ nutrition facts label hopefully will help consumers to make a better decision in terms of choosing the right vitamin A and vitamin E for their daily consumption.

Vitamin A

Vitamin A is essential vitamin for healthy vision and cellular communication. There are two main ways to obtain vitamin A in the diet, through:

(1)         retinols from animal sources and dairy products;

(2)         pro-vitamin A carotenoid from plant.

Both retinols and pro-vitamin A carotenoid are metabolized in the body into the active form of vitamin A, retinoic acid. However, retinols and pro-vitamin A carotenoid differ in their bioactivities. As an example, it takes different amount of IU from retinol, beta-carotene from food, beta-carotene from supplement or alpha-carotene to make 1 microgram of retinoic acid.

Therefore, it is vital for consumers to check the source and forms of vitamin A to ensure they get sufficient vitamin A according to the recommended dietary intake (RDI). The RDI of the vitamin A has also changed from 5,000 IU (equivalent to 1,500 mcg RAE) to 900 mcg RAE for males and 700 mcg RAE for females respectively.

The conversion of unit of vitamin A from IU to the metric unit, mcg RAE, will take into account the differences in vitamin A activity between retinols and pro-vitamin A carotenoid. In the new unit, 1 RAE will equal to 1 mcg retinol, 12 mcg beta-carotene, 24 mcg alpha-carotene or 24 mcg beta-cryptoxanthin. Hence, the change of IU to mcg RAE for vitamin A is welcomed as this will reflect the actual or reality of vitamin A activity of its different forms—retinol and pro-vitamin A carotenoid.

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The relationship between sleep aids and stress management

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

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

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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Powders dominate key sports nutrition categories

Powder-based formulas are all over the lists of best-selling sports nutrition products at top retailers including Amazon, Walmart and Bodybuilding.com. Powder products dominate certain categories more than others. For instance, Amazon’s protein, pre-workout and post-workout/recovery categories are mostly owned by powder products, specifically ready-to-mix (RTM) formulas.

Mixable powders more popular in sports nutrition compared to other sports nutrition formats, including capsules, bars and ready-to-drink (RTD) products.

Capsules have the advantage of more easily hiding off flavors and not having to contend with liquid from consumer mixing before use. However, consumers increasingly seek more food- and drink-like experiences rather than a litany of pills, so RTM powders offer a way for consumers to drink their sports supplements in a range of palatable flavors. Further, RTM powders often involve “scoops,” each of which delivers anywhere from 5 g to more than 30 g of ingredients. It would take many capsules to deliver an equivalent amount of product.

For ingredients such as protein, which is typically dosed at 20 to 30 g per serving, powders are the primary delivery format, followed by RTD and bar products. RTD sports nutrition products can deliver the amounts of protein sports nutrition consumers want and offer pleasurable convenience, but they cost more to ship (no water content) and have a shorter shelf life than RTM products, especially with high-protein products.

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Nitric oxide for sports performance

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

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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