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Fiber Revisited: Closing the Gap

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On May 27, 2016, the U.S. Food and Drug Administration (FDA) published a definition of “dietary fiber” and created a pre-approval system for various isolated and synthetic non-digestible carbohydrates (NDCs). For all food labeled on or after Jan. 1, 2020, the isolated or synthetic NDCs must be determined by FDA to have a physiological effect that is beneficial to human health before they can be counted as dietary fiber for nutrition labeling purposes.

Dietary fiber is now defined by FDA as “non-digestible soluble and insoluble carbohydrates (with three or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with three or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.”

This change has impacted product development in some significant ways.

According to Aouatef Bellamine, PhD, senior science manager, Lonza Consumer Health & Nutrition, Morristown, NJ, the new fiber definition means dietary supplement formulators and manufacturers will need to either adhere to this list of ingredients if they want to make a fiber claim, or petition for their fiber source to be added to the definition.

One company doing just that is Somerville, NJ-based Nexira, which along with representatives of the gum acacia industry, is conducting additional studies to strengthen the evidence supporting the beneficial effects of gum acacia on blood glucose attenuation and energy intake, noted Julie Impérato, marketing manager. After completion of the studies, Nexira is expected to submit a Citizen Petition to FDA in the spring of 2019 to request that gum acacia be recognized as a dietary fiber for nutrition labeling and claims on foods and beverages. “We are hopeful to receive a positive response from FDA by the summer of 2019,” said Ms. Impérato.

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Takeaways: Power for powder innovation

Takeaways Power for powder innovation

Powdered supplements are projected to experience a 10.8 percent compound annual growth rate (CAGR) from 2016 to 2024, according to a 2018 report from Grand View Research. Succeeding in a thriving market with anticipated double-digit growth requires fine-tuned product development and formulation to ensure powdered supplements not only meet consumer expectations for quality, but also stand out on the shelf (or on a web page).

To achieve success in the powdered supplements category, consider these market dynamics:

Telling trends: As the category for powders grows, innovative products will steal the sought-after spotlight. Understanding consumer and category trends is critical to creating products that meet the needs of the market. Some trends impacting the powder category include clean labels, flavor innovation and packaging. Contract manufacturers with global presence can help to identify global and ingredient trends.

Quality considerations: Quality is essential in every category of dietary supplements. But powdered supplements have unique considerations such as taste, texture and solubility. If consumer expectations around quality aren’t met, consumers won’t repurchase the product, regardless how innovative the product is.

Partnership power: Whether a brand wants to test the waters of a trending market with a seasonal flavor or to see what a concept product may look, feel or taste like, a contract manufacturer may be the best resource. This is especially true when a brand is in a growing category like powders. Contract manufacturers can help brand owners to identify market trends, navigate quality considerations and improve time to market, among other benefits.

In the coming year, innovation will drive interest in the powders category. Longtime staples such as collagen and protein powders will remain strong players. Within these key product segments, innovation will take place in the form of packaging, flavor concepts and improved quality in areas such as taste. For example, sports nutrition brand BSN launched in March, in collaboration with Cold Stone Creamery, three new flavors—birthday cake remix, germanchokolatekake and mint mint chocolate chocolate chip—while Sparta Nutrition announced in January the launch of five new protein flavors, including loopy fruits (a take on Kellogg’s Froot Loops cereal) and blueberry muffin. Newcomers to the category will offer trending ingredients as a way to approach innovation. One example is the growth and interest in medium-chain triglyceride (MCT) oil powders to support ketogenic diet trends.

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FDA’s willingness to explore reform of DSHEA draws mixed reactions

dietary supplements 2019

Consumer advocates, some Democratic lawmakers and industry trade organizations reacted differently to FDA’s willingness to examine possible reform of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

The divergent reactions reflect stark differences of opinion over the reputation of the dietary supplement industry and its 25-year-old regulatory regime.

Peter Lurie, M.D., a former FDA associate commissioner who leads the nonprofit Center for Science in the Public Interest (CSPI), described DSHEA in a statement as a “deeply flawed law that has long handcuffed the FDA’s regulatory efforts and has produced the sprawling, largely unregulated and often reckless industry we have today.”

Industry trade groups weighed in with a radically different perspective. DSHEA offered consumers wide access to supplements while protecting the safety of the public, according to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

“We are intrigued and enthusiastic to hear what FDA has in mind, but we will be very careful to protect that balance between access and safety,” Mister said in an interview.

FDA’s top official supported the notion that most companies in the industry are responsible. The remarks by FDA Commissioner Scott Gottlieb, M.D., also underscored the need for FDA to rigorously enforce its authority to target “bad actors” who spike products with undeclared prescription drugs or otherwise endanger the public health.

“We know that most of players in this industry act responsibly,” Gottlieb said in a statement, revealing his plans to strengthen regulation of dietary supplements. “But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”

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Inside the plant-based protein market

The plant-based protein market

Consumer demand for sustainable products and knowledge of the health benefits of protein has driven the need for protein from plants, such as pea, hemp, rice, oats and beyond. A decade ago, soy-based veggie burgers were the primary plant protein-rich food found in a typical grocery store. Fast forward to 2019, and products made with plant proteins have evolved to include a wide variety of flavors, textures and formats for every eating occasion.

Indeed, consumers have a seemingly insatiable appetite for protein. Consumers associate protein with a healthy diet, helping maintain muscle during aging, recovery from exercise and greater feelings of fullness.

The 2014 Food & Health Survey from the International Food Information Council (IFIC) found 58 percent of consumers are influenced to purchase a product based on its protein content. By 2015, interest in protein had grown to the point where IFIC’s online Food & Health Survey found more than half of Americans surveyed were trying to consume acertain amount of protein per day or eat as much protein as they could. Food manufacturers can capitalize on this trend by giving consumers what they want: front-of-pack labeling that calls out “good source of protein” or “high in protein” versus listing the amount of protein in grams per serving on the front of the pack.

Interestingly, consumers are not focusing solely on typical sources of protein such as meat, fish, poultry and dairy. In 2014, research by the NPD Group found almost half of primary grocery shoppers bought protein-enriched foods including cereal, bread, protein bars and pasta. The same survey revealed consumers were clamoring for more options including bagels and frozen foods. The door is wide open for plant proteins as roughly 66 percent of U.S. consumers believe meat alternatives are healthier than meat, according to a 2017while Mintel protein report, while 20 percent of shoppers are willing to pay more for these foods.Need proof? Data by Persistence Market Research reported the plant protein market is rapidly growing and expected to reach roughly US$16.3 billion by 2025.

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Bill to limit certain dietary supplement sales to minors resurfaces in Massachusetts

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Massachusetts Rep. Kay Kahn, a Democrat from the Boston suburb of Newton, refiled a bill in January that would restrict sales of certain weight loss and muscle building dietary supplements to minors, requiring retailers to post dire warnings of potential injuries and even death, as well as placing these supplements behind the counter.

Introduced in the Democrat-controlled House last week, the new bill (H.D. 2883) is unchanged from bill H.1195, which Kahn introduced in the 2017-2018 legislative session.

It would require retailers to limit access of weight loss and muscle building supplements to any consumer under the age of 18, essentially putting the products under lock and key and permitting access by store manager only.

The bill also proposes a requirement that retailers of such supplements post a warning on the counter “that certain over-the-counter diet pills, or dietary supplements for weight loss or muscle building are known to cause gastrointestinal impairment tachycardia, hypertension, myocardial infarction, stroke, severe liver injury sometimes requiring transplant or leading to death, organ failure, other serious injury, and death.”

The state’s Department of Public health would determine the exact warning language and partner with FDA and key stakeholders, including the eating disorder community, to determine which weight and muscle products would be restricted for sale.

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Joint Health Supplements: Steadily, flexibly forward

Joint Health Steadily flexibly forward

As the global joint health market grows a steady 7 percent over the next three years, the category’s staple dietary ingredients and products are giving way to a fresh wave of botanicals and specialty compounds, bringing researched joint and inflammation management to a wider, active audience than those with aging bodies.

Beyond Relief. “Consumers want products that improve their health, not products that mask their symptoms,” explained Tim Hammond, vice president of sales and marketing, Bergstrom Nutrition. In fact, as joint health and function is something consumers want to preserve over a lifetime, they are looking for customized joint health solutions that are safe for long-term use. For many, this means a small, daily supplement dose—but for others, including the younger generations, alternative delivery formats are the way to joint regimen compliance in busy lives.

Herbs on the Rise. Persistent local inflammation is a recognized key driver of wear and tear joint problems, including osteoarthritis (OA). Inflammation is typically a short-term consequence of activities, but chronic or persistent inflammation can have a lasting damaging effect on joints. Turmeric has reached superfood status and is on the rise in joint health, owing largely to its primary anti-inflammatory constituent curcumin. Additional botanical ingredients offering anti-inflammatory and other joint-related researched benefits include ashwagandha, ginger, Boswellia serrataTerminalia chebulaBacopa monnieri and Kaempferia galangal, which has the cool nickname of “resurrection lily.”

Animals to the Rescue. Despite the growing use of botanicals for inflammation and oxidative stress control, joint health still relies heavily on supplying naturally occurring compounds found in cartilage and synovial fluid, which are commonly derived from animal sources. A popular trademark in this category involves collagen, a critical cartilage component. Research has shown undenatured collagen from chicken and collagen peptide ingredients derived from animal skin and bones deliver key amino acids crucial to improving the structure and function of cartilage and connective tissues, including inflammation management. Also, glucosaminoglycans (GAGs) and other compounds found in healthy cartilage are commonly supplemented through popular ingredients like glucosamine and chondroitin from shellfish, but eggshell membrane has emerged as an alternative animal source that also delivers keratin and collagen, as well as anti-inflammatory compounds.

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FDA commissioner announces plan to modernize regulation of dietary supplements

FDA commissioner

The head of FDA on Monday announced a goal to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”

A quarter century after Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA), the industry has thrived with tens of billions of dollars in annual sales, the majority of U.S. adults taking supplements and an estimated 80,000 products on the U.S. market.

But in a lengthy statement revealing plans to strengthen the agency’s regulation of dietary supplements, FDA Commissioner Scott Gottlieb, M.D., expressed concern that changes in the supplement market may have outpaced the evolution of the agency’s policies and capacity to manage emerging risks.

“To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products,” Gottlieb said. “Toward these goals, the FDA is committing to new priorities when it comes to our oversight of dietary supplements at the same time that we carefully evaluate what more we can do to meet the challenge of effectively overseeing the dietary supplement market while still preserving the balance struck by DSHEA.”

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Dietary supplements for mental performance and protection in athletes and soldiers – slideshow

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Athletic and active consumers, including soldiers, are paying increased attention to cognitive health and function, including protection/recovery from brain injury.

Much of sports nutrition focuses on muscles, joints and entire cardiovascular system. However, the brain is the control center, and athletic and active consumers are paying increased attention to cognitive health and function, including focus, attention, memory, reaction time, visual processing, emotions and protection/recovery from brain injury.

This slideshow looks at the potential effects of dietary supplements on the central nervous system (CNS) for improved health and performance. It was developed from the SupplySide West 2018 workshop, “Neurosports: Inside the Brain for Improved Performance.”

Watch The Slideshow HERE

CBD concentration matters

CBD concentration matters

t’s true cannabidiol (CBD) is a drug. GW Pharmaceuticals went to great effort and expense to determine the clinical benefits of CBD. The specific, single-entity chemical is considered a drug because FDA approved it as one, and that is how the U.S. regulatory system operates. The regulatory system also renders items as drugs based exclusively on what is said about them. Cognitive dissonance occurs with different interpretations of the law, and this dissonance, while remaining unresolved, affords opportunity.

Harvesting CBD from hemp raw material (the botanical that was so much the focus of the passage of the Agriculture Improvement Act of 2018, otherwise known as the Farm Bill) is acceptable from a statutory perspective. Hemp products have recently passed through FDA review with a few specific new ingredients (not all) being considered GRAS (generally recognized as safe) for use in foods. The presence of CBD in hemp products additionally renders it consumed in conventional foods. The lack of objection to these hemp product GRAS notifications affirms FDA’s current determination regarding the safety of CBD and tetrahydrocannabinol (THC).

The question of whether this lack of objection extends to use in dietary supplements is a separate, open issue. Proper notification of CBD products as new dietary ingredients (NDIs) for use in dietary supplements is mandatory unless the article of food (hemp) has not been “chemically altered.” The current thinking from FDA is that just about anything is considered chemical alteration. The draft guidance on NDI notifications, issued in August 2016, clarifies this thinking regarding what results in chemical alteration.

Peak cognitive dissonance occurred when FDA Commissioner Scott Gottlieb, M.D., said in a Dec. 20, 2018 statement, “. . . it’s unlawful under the Federal Food, Drug and Cosmetic Act (FD&C) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” While FDA did not recently object to three GRAS notices for hemp products that contain trace amounts of both CBD and THC, it simultaneously stated its conclusions do not affect its position in an FDA Q&A on marijuana: It is a prohibited act under federal law “to introduce into interstate commerce a food to which CBD or THC has been added.” This is reminiscent of the similar agency view on the presence of lovastatin in products marketed as red yeast rice supplements and the related regulatory challenges it posed from years past.

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Takeaways: Sports nutrition for female athletes

Sports Nutrition for Female Athletes

The world is half female. At least half of the sporting world is female; however, most products are formulated for men or based on research conducted mostly on men.

Women are not small men. They are different anatomically, physiologically, biologically and biochemically. The biggest difference, and one of the primary reasons given for lack of female-specific sports nutrition research, is the menstrual cycle. During certain phases of their cycle, women can experience hormone fluctuations that affect muscles, energy and bone health.

There is tremendous opportunity for companies to capture part of this growing category, but it will require an approach that considers and respects the uniqueness of active females.

Research, Research, Research. It is up to brands and manufacturers to request, fund and support increased research on female athletes. Accept and account for challenges from menstrual cycle influences. “The inane idea that women are more difficult or more expensive to study is pure laziness, in my opinion,” said Susan Kleiner, Ph.D., R.D., owner of High Performance Nutrition LLC and nutritionist for many elite female sports teams.

For instance, researchers like Bill Campbell, Ph.D., associate professor of exercise science at the University of South Florida, purposefully does not plan trials around menstrual cycles. “The reason I do not consider the menstrual cycle in my studies is that I like to be able to extrapolate my results by saying that the outcomes were irrespective of the female’s menstrual cycle,” he explained.

More companies, such as sports nutrition brand Dymatize and ingredient supplier Bergstrom Nurition, are funding studies on females. Abbie Smith-Ryan, Ph.D., associate professor of exercise physiology and director of the Applied Physiology Lab at University of North Carolina, Chapel Hill, who also conducts studies on females, reported NIH now requires researchers to justify why they are or are not including women in their research proposals.

Read The Full Article HERE

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