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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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Protein powder products: Differentiating in a crowded market

Protein is booming, and powders have played a huge role in delivering efficacious amounts of protein to sports nutrition consumers looking to build and maintain muscle mass. Tubs of ready-to-mix (RTM) protein powders have long been a visual mainstay of many sports nutrition stores, aisles and sections, and powdered ingredients are also used to fill sports supplement capsules and provide muscle to bars and beverages. However, the protein powder market is crowded, and the consumer shift to wanting higher protein intake via foods and beverages instead of supplements only adds to the challenges of making a protein powder-based product stand out and be successful.

For companies playing in the RTM protein powder space, differentiation requires innovative flavors and ingredient combinations, as well as enhanced bioavailability and responsible sourcing. The protein ready-to-drink (RTD) market is seeing increasing numbers of clear or water beverages with high protein content, in addition to new hot protein RTD products. The food segment has exploded with high-protein offerings as companies have found ways to infuse protein into an array of everyday foods and snacks. In every corner of the protein powder market, new technologies are supporting innovation.

The size and future of the protein supplement market varies depending on which market expert you ask, but Allied Market Research and Marqual IT Solutions Pvt. Ltd (KBV Research) both predicted around 7.5% compound annual growth rate (CAGR) over the next five or six years and a resultant market of US$8.7 billion. Zion Market Research calculated the CAGR at 5.7% and a size of $3.6 billion heading into 2024. Either way, the segment is expected to enjoy solid growth worldwide.

On the animal side, whey protein is set to grow 7.6% to $12.5 billion by 2024, according to Statista. On the plant side, the global pea protein market was about $101.7 million (all uses) in 2018 and should grow at a 17.4% CAGR through 2025, reported Grand View Research. Persistence Market Research reported organic pea protein should grow at an even more robust 7.2% CAGR through 2027.

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Amarin asks Supreme Court to hear dispute involving omega-3 supplements

Amarin Pharma Inc. wants the nation’s highest court to hear a long-running dispute with several dietary supplement companies that the U.S. International Trade Commission (ITC) declined to investigate in 2017.

Amarin, the maker of the pharmaceutical drug Vascepa, filed a July 30 petition for a writ of certiorari with the U.S. Supreme Court after an appeals court affirmed ITC’s decision.

It’s Amarin’s last chance in the judiciary to compel ITC to investigate its complaint over the legality of certain “synthetically produced omega-3 products” promoted as dietary supplements, a category of products principally regulated by FDA.

A ruling by the Supreme Court could provide clarity over ITC’s authority to hear complaints involving unsettled issues within FDA’s expertise. A quasi-judicial federal agency, ITC has broad powers over matters of trade, including enforcement of the Tariff Act of 1930.

Representatives for FDA and ITC declined to comment on the petition.

“This case offers the Court an opportunity to restore the private rights of action that Congress granted parties under the Tariff Act of 1930 in order to protect domestic industry from unfair trade practices,” Amarin wrote in its 38-page petition through its outside counsel, Ashley C. Parrish of King & Spalding LLP.

Amarin’s grievances are with several prominent dietary supplement firms, including Nordic Naturals Inc., Nordic Pharma Inc., Pharmavite LLC, DSM Nutritional Products LLC and related DSM entities.

“We are disappointed that Amarin continues to pursue this issue, and we are confident that the U.S. Supreme Court will rule consistent with the ITC and the Federal Circuit Court rulings on this matter,” said Hugh Welsh, president of DSM North America, in an email.

Nordic Naturals, Nordic Pharma and Pharmavite did not immediately respond to requests for comment.

In its 2017 complaint, Amarin alleged the companies’ products above are unapproved new drugs under the Federal Food, Drug & Cosmetic Act (FDCA). Therefore, the false labeling of the products, Amarin argued, constituted an unfair act or method of competition under Section 337 of the Tariff Act of 1930 because the acts violate the Lanham Act and standards the FDCA established.

FDA asked ITC to refrain from an investigation because the agency hadn’t determined whether the products subject to the complaint were drugs or dietary supplements. And in June 2018, a U.S. Department of Justice (DOJ) attorney noted a guidance from FDA on the regulatory classification of these articles would not be forthcoming.

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GMP and FSMA rules compel close supply chain supervision

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

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

In brief, Subpart G is comprised of eight sections:

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

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

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Brain health supplements market drivers

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

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

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

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

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

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

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

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

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Flavor and function considerations when pumping up protein volume

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

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

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

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

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

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

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

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

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

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

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

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

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

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