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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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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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Astaxanthin for muscle endurance and recovery

Post-workout recovery supplements replenish energy stores, promote muscle repair and reduce muscle breakdown after a demanding workout. Intense physical exercise is energy-dependent. When the muscles burn calories by oxidation, free radicals and other reactive oxygen species (ROS) are formed as a byproduct.1 Free radicals can damage muscle fibers and reduce their ability to contract.2

Moderate exercise has health-promoting effects, while strenuous exercise, especially in unfit individuals, may have the opposite effect. Physical activity enhances metabolism that leads to increased production of free radicals and other ROS.

Astaxanthin sourced from the microalgae Haematococcus pluvialis is a powerful natural antioxidant. Comparison studies have shown astaxanthin is 6,000 times more powerful than vitamin C, 100 times more powerful than vitamin E, and five times more powerful than beta-carotene in trapping energy from singlet oxygen, one of the most common ROS in biological systems.3 Astaxanthin can trap several types of ROS/free radicals. In addition, the way astaxanthin neutralizes harmful ROS/free radicals is gentle to the body’s cells. Other antioxidants can be harmful, since they may turn into highly reactive molecules.4

As a bioavailable antioxidant, astaxanthin is transported throughout the body to organs and muscle tissues, combating excessive free radical production. Natural astaxanthin improves muscle endurance and strength by helping to reduce oxidative stress. Clinical studies have found natural astaxanthin neutralizes exercise-induced free radicals, protects the activity of antioxidant enzymes, reduces muscle fatigue and inhibits the formation of lactic acid.5-9

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The next generation of disruption in dairy alternatives

The large, complex U.S. dairy market faces several forces that are influencing growth and challenging the status quo. One trend impacting the industry across cheese, milk and yogurt, among other categories, is the competition from plant-based alternatives.

Once a nascent, niche trend driven by a narrow subset of consumers, plant-based formulations are now surging in popularity with more products entering the mainstream market. Growing concerns about the environment, animal welfare and personal health are attracting consumers to plant-based products, poaching sales from traditional dairy sectors in the process.

The rise and disruption of plant-based dairy alternatives has been steadily building for many years. Most notable is the category’s recent evolution from a rapidly growing upstart sector to one with widespread availability and mainstream appeal. In a way, this signals the onset of a second generation of plant-based alternatives, beyond merely acquainting Americans with the idea of consuming plant-based products and focused on expanding the sector to new frontiers and diversifying its offerings.

In the minds of many, dairy alternatives remain associated with traditional cow’s milk. For generations, cow’s milk has been as much of a staple commodity for U.S. consumers as any food item can be. Understandably, soy-based milk alternatives were the face of this sector for many years. More recently, the most sector expansion has been a result of developing other popular milk alternatives from ingredients such as almonds and cashews. In fact, sales of milk alternatives other than soy-based varieties skyrocketed in the U.S. from less than US$100 million in 2008 to just under US$2 billion in 2018, according to Euromonitor International.

Competition has increased significantly as more players enter the market, and, much like other fast-growing industries, concerns have grown over the potential of an impending stagnation as a ceiling is approached. Considering these concerns, manufacturers of dairy alternatives have sought new growth frontiers, a pursuit that has influenced the evolution of new formats that are quickly gaining popularity. Free-from-dairy ice cream and yogurt products have rapidly proliferated. According to Euromonitor International, both categories achieved double-digit retail sales growth in each of the last five years behind strong consumer enthusiasm for products, surpassing taste expectations and carving out notable portions of the market as a result. Though much smaller sales, free-from-dairy cheese products and even coffee creamers have also seen promising recent developments, demonstrating the potential for plant-based products to thrive well beyond serving as a contrast to milks and instead functioning as a class of viable alternatives to dairy more broadly.

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Where is innovation in sports supplements?

Food and beverage delivery have grabbed much of the cool factor attention in the sports nutrition market. However, the most bang for the buck is still in supplement form, which can deliver higher amounts of beneficial ingredients for building muscle and improving recovery/adaptations, among other body goals. Where supplement brands have a tougher task in innovating delivery—will gummies infiltrate the sports supplement space?—they can create unique products in areas such as formulation and flavor.

How is your brand innovating in the sports supplements market? NEXTY Awards at SupplySide West 2019 is a chance for such brands and products to win recognition for quality innovation.

Flavor licensing is one area where some brands are winning consumers. While pre-workouts that break free from the usual common citrus flavors to bring candy or mocktail flavors, for example. Protein powders that go beyond the Neopolitan ice cream flavors to bring a wider array of dessert (think pie) and indulgent flavors (e.g. crème brulee and hazelnut latte).  

Industry market specialist Josh Schall, J. Schall Consulting, explained Man Sports first introduced flavors based on famous candy brands like Sour Patch Kids and Starburst, but the company had to use similar sounding names. Then Ghost Nutrition licensed actual consumer brands such Warheads, Swedish Fish and Chips Ahoy. Licensing flavors is part of what Schall calls creating an exclusive experience for consumers.

Schall and Ghost CEO Dan Lourenço will present during SupplySide West’s sports summit, Finding New Pathways in Sports Nutrition, on Wed. Oct. 16 in Las Vegas.

Novel and emerging ingredients may also help sports supplement brands standout. This is a bit harder to do on the protein side, even with the slight whey protein tweaks like native and grass-fed whey. New Hope’s NEXT data analysis (based on Expo West exhibitors) has shown a big dip in innovation in the whey, casein and milk protein categories, with more opportunity for these ingredients in food and beverage. Egg protein was the only animal protein showing positive innovation numbers in supplements. Most protein innovation activity in supplements was on the plant side, with pea and rice dominating and hemp lagging—a real opportunity area, NEXT said.

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Higher intake of linoleic acid may reduce type 2 diabetes risk

Linoleic acid, a polyunsaturated omega-6 fatty acid (PUFA) found in nuts, seeds and most plant oils including soybean, canola and flaxseed, is one of two essential fatty acids (EFAs) humans must obtain through diet. The findings suggest swapping saturated fats, trans fats or carbohydrates for linoleic acid is inversely associated with risk of type 2 diabetes.

For the study, researchers from the Chinese Academy of Sciences in China used data from 83,648 women participating in the Nurses’ Health Study (NHS; 1980-2012), 88,610 women from NHSII (1991-2013), and 41,771 men from the Health Professionals Follow-Up Study (1986-2012) to examine the association between intakes of n-6 polyunsaturated fatty acids (PUFAs) and type 2 diabetes risk. There were 18,442 type 2 diabetes cases during 4.93 million person-years of follow-up.

The researchers found dietary n-6 PUFAs accounted for an average of 4.4 to 6.8% of total energy and consisted primarily of linoleic acid (at least 98%). When extreme n-6 PUFA quintiles (highest versus lowest) were compared in multivariate-adjusted models, the hazard ratio for type 2 diabetes risk was 0.91 for total n-6 PUFAs and 0.92 for linoleic acid. In a model allowing for isocaloric substitution, type 2 diabetes risk was 14% lower when linoleic acid isocalorically replaced saturated fats (5% of energy), 17% lower when substituting for trans fats (2% energy), and 9% lower when substituting for carbohydrates (5% energy). There was no impact on diabetes risk when n-3 PUFAs or monounsaturated fats were replaced with linoleic acid.

Read The Full Article HERE

Supply chain transparency: A practice of trust through legitimacy, from ‘farm to fork’

Supply chain transparency A practice of trust through legitimacy from farm to fork

How important is supply chain transparency to supplement brands? The level of its importance determines the level of the business’ growth and success. Supply chain transparency builds trust through legitimacy across the board–trust with suppliers, employees, customers and oversight agencies. Are you transparent in the chain? Are others transparent with you? More importantly, how high is the trust level within the chain? Have you ever suspected “deceptive documentation?”

Supply chain transparency is the disclosure and transfer of credible, accurate and truthful information from one supplier to another through the chain of products and services down to the end user. Specifically, in the dietary and food supplement industry, this could mean raw material originating from a farm; shipped or delivered to a raw material supplier or processor, then to a manufacturer; then finished product shipped to a distributor or direct to consumers. A commonly used phrase to describe this chain is “from farm to fork.”

Supply chain transparency is embedded in supply chain management that dates to the early 1900s, according to the supply chain management site SupplyChainOpz. As this network of business evolved, so did the need for dependence on each segment or entity to provide truthful and credible information in order to traverse the continuous flow of exchange of materials and goods through both foreign borders and domestic marketplaces.

The need for supply chain transparency is a demand being placed by consumers who want to know exactly what’s in their supplements, their sources or countries of origin, and how all the associated components were handled and distributed.

Over the last decade, increased attention from regulatory and compliance agencies resulted from a spate of food-safety issues and heightened threat of bioterrorism, as evidenced by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), signed into law by President George W. Bush on June 12, 2002.

As a result, conducting an internet search for information on supply chain transparency today, will result in an overwhelming plethora of information, enough to keep one occupied at length. Whether this represents an emerging trend or a growing corporate awareness of consumer desires might be less debated given the climate of business-related human rights concerns also associated with supply-chain activities (e.g., child labor, forced labor, slavery and human trafficking). Consumers are not the only ones concerned about transparency.

Congress is just as concerned about supply chain transparency, traceability and disclosure requirements demonstrated in the Business Supply Chain Transparency on Trafficking and Slavery Act of 2014 (H.R.4842) introduced by New York State Rep. Carolyn Maloney (D-12). Further, FDA’s enforcement measures have caused the industry to pay more attention to supply chain management and transparency.

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FDA launches tool to ‘quickly alert’ consumers of unlawful ingredients marketed as supplements

Various Dietary Supplements 2019

FDA announced today a new tool designed to quickly alert consumers of ingredients unlawfully marketed as supplements.

Dubbed the Dietary Supplement Ingredient Advisory List, the tool is intended to provide rapid notification to consumers of unlawful ingredients in order to better protect them from potentially dangerous ingredients. Included in the list are ingredients FDA deems not permissible for use in dietary supplements based on its “initial assessment” of an ingredient.

The tool is part of the agency’s efforts announced earlier this year to modernize its regulatory framework over supplements to meet the demands of an industry that has grown significantly over the last 25 years.

“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy and the law,” said Frank Yiannas, FDA’s deputy commissioner for food policy and response, in a statement announcing the tool. “In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This list is intended to get information to both consumers and industry more quickly. It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination.”

Yiannas also pointed to “bad actors” who “seemingly ignore the legal requirements for dietary supplements” as an issue threatening the safety of consumers.

“While many dietary supplements meet the FDA’s standards, there are some companies who knowingly distribute and sell dangerous or otherwise illegal products that put consumers at risk,” he said. “As the agency entrusted with the oversight of dietary supplements, we will not stand by and allow these companies to compromise the health of the very people who are seeking out supplements to aid in their well-being.”

FDA cited potential reasons for adding an ingredient to the list, including lack of pre-market notification based on regulatory requirements; exclusion from use in a dietary supplement; and/or not fitting FDA’s definition of a dietary ingredient.

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