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Considerations for success in the women’s health market

As with any other population, women have unique nutritional needs, life challenges and preferences that influence their purchasing decisions. Clinical studies have indicated a plethora of promising women’s health ingredients to help address nutrient shortfalls and enhance well-being at all life stages. In fact, Cornell University research identified a correlation between increased choline intake in pregnant women and higher information processing speeds in their infants (FASEB J. 2018;32:2172-2180). Additional studies are examining the potential brain health benefits of maternal choline intake as the children reach older ages, from 7 to 15. The importance of maternal health and proper fetal nutrition is well established, but research supporting the long-term effects gleaned secondhand, so to speak, is a game-changer.

A few key considerations can assist product developers looking to reach female consumers.

Identify the target audience

Although a given when creating any product, the women’s health category isn’t always clear-cut. Women from their teens to their 40s may be taking prenatal supplements. Market trends indicate some consumers are looking for proactive nutritional support decades earlier than women of the past, so Millennials may be seeking joint health products with different motivation than their parents, and likewise, their grandparents. The same goes for beauty-from-within products and more.

Create the right formulation

Dozens of ingredients are popular in women’s health products, including omega-3 fatty acids, vitamins, minerals, protein/collagen, botanicals, carotenoids, probiotics, enzymes, yeasts, collagen and other nutrients. Drawing from the Ayurvedic practice of addressing various aspects of well-being, combination formulas are increasingly popular. Some women may follow a plant-based diet, and therefore require a vegetarian or vegan product. For others, organic positioning is a selling point.

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Recent research on brain-boosting nutrients

Everyone wants the best brain they can have. The U.S. Centers for Disease Control and Prevention (CDC) defined a healthy brain as “one that can perform all the mental processes that are collectively known as cognition, including the ability to learn new things, intuition, judgment, language and remembering.” Several dietary ingredients have recently shown promise for safely improving human cognition.

In these studies, “significantly improved” indicates superior benefit, with a probability (“P value”) of at least 95 percent that the finding is real. Animal studies are not covered because they do not consistently predict human benefit.

The brain makes and consumes huge amounts of energy, for which it needs supplies of nutrients out of proportion to its small size (Frontiers Mol Neurosci 2018 Jun 22;11:216. DOI: 10.3389/fnmol.2018.00216.) But the current food supply falls far short of being sufficient for brain (or body) health. Based on ongoing findings from large CDC surveys, the 2015-2020 Dietary Guidelines for Americans listed magnesium; vitamins C, D and E; and choline among “underconsumed nutrients.” All are vital to cognitive performance.

This gives consumers a good reason to take a good multivitamin. Analyses of the national U.S. population survey data established taking a daily multi vitamin-mineral helps offset the nutrient gap in the U.S. food supply (Nutrients. 2017 Dec 22;10(1). pii: E4. DOI: 10.3390/nu10010004 and Nutrients. 2017 Aug 9;9(8). pii: E849. DOI: 10.3390/nu9080849).

Taking a multivitamin formulated with the most proven ingredients provides a steady supply of the nutrient “nuts and bolts” needed by the enzymes that make cognition possible.

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All natural products imports from China face higher tariffs

An already tariff-weary natural products industry will face elevated tariffs on nearly all ingredients and materials sourced from China, if a fresh 10% increase on the remaining US$300 billion in imports from China goes into effect Sept. 1, as promised by President Trump in his ongoing trade war.

The Trump Administration proposed the tariffs earlier this summer and held public hearings in June. However, the tariffs were put on hold after Trump and China President Xi Jinping met at the G20 Economic Summit in Japan in late June.

The tariffs would include the remaining imports from China not on the earlier three lists of punitive tariffs, some of which have elevated from an initial supplemental 10% to 25%.

The challenges for industry include how to deal with the elevated costs and possibly find non-Chinese sources of ingredients, whether another country or creating domestic supply. However, finding new sources can be nearly impossible for some ingredients, especially agricultural items that grow in certain climates and conditions. Further, it can take years to develop domestic sources of materials and ingredients that were almost exclusively imported for years and decades.

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Astaxanthin and healthy aging

The aging process is accompanied by numerous health challenges, which will vary from individual to individual due to several factors, including genetics, lifestyle choices, environmental factors and life events. Premature aging is also closely linked to oxidative stress.1

Reactive oxygen species (ROS), otherwise known as pro-oxidants, are formed as by-products of normal metabolism in our body when food is converted into energy. Immune cells fighting bacterial infections also release ROS. High levels of ROS can initiate harmful alterations in key biomolecules, such as lipids, proteins and DNA in a condition called oxidative stress.2

Aging is typically accompanied by a reduction in cellular energy production and increased free radical production. This leads to an overloading of defense systems and oxidative damage. From a biological point of view, aging involves the accumulation of oxidative damage in cells and tissues. Younger people are naturally better protected from free radicals and other ROS through balanced activity of the mitochondria, efficient antioxidant and DNA repair systems, and active protein degradation machinery. Aging, on the other hand, is generally accompanied by mitochondrial dysfunction leading to increased free radical production that, in turn, leads to an overloading of the defense systems and oxidative damage of cellular components.1

The study of oxygen-free radicals has been going on for many years, but within the last two decades, the research into their effects on human health has really taken off. The evidence shows that oxidative stress plays a significant role in the aging process, as well as the development of chronic and degenerative illness. This, in turn, has spurred tremendous interest in finding out more about the effects of antioxidants in neutralizing free radicals, and the health support benefits they provide in the human body.

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

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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

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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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Product offerings grow for the anxiety, stress, mood and sleep category

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Qualifying and quantifying the market for products that address anxiety, stress, mood and sleep is a little like trying to nail jelly to the wall or define “obscenity.” Regarding the latter, U.S. Supreme Court Justice Potter Stewart famously remarked in 1964 that “I know it when I see it” to describe his threshold test in Jacobellis v. Ohio. To some extent, this also applies to the market for products that address anxiety, stress, mood and sleep.

Products addressing anxiety, stress, mood and sleep are scattered all over the marketplace. No longer are innovation opportunities limited to over-the-counter (OTC) medications and dietary supplements.

GlobalData identified product innovation oriented around anxiety, stress, mood and sleep that spans nearly 30 different product categories. Product manufacturers are addressing these needs in categories as diverse as fruit, chocolate, yogurt and beer, to air fresheners, fabric conditioners, facial-care products and more.

Companies far and wide want a piece of the pie because the pie is big—and growing. GlobalData puts the global market for sleeping aids (classified as OTC health care products) at $US1.36 billion as of 2016. GlobalData expects this market will grow at a compound annual growth rate (CAGR) of just over 4.1 percent for the period from 2015 to 2020. GlobalData puts the U.S. market for sleeping aids at just under $375 million as of 2016, and projects that this market will expand at a CAGR of 3.5 percent for the period from 2015 to 2020.

But trying to measure a market like sleeping aids is not as easy as it used to be, as a growing amount of sleep-related product innovation is taking place outside of OTC health care products and supplements. It is not unusual today to see functional drinks, milk, tea, food products and even facial-care products promote enhanced sleep. Even within OTC medications, sleep aids have become a moving target as companies attempt to monetize interest in more natural and holistic formulations.

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