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

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While IU seemed to be an innovative idea during the time it was introduced, many would agree that this IU system is now outdated.

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

Vitamin A

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

(1)         retinols from animal sources and dairy products;

(2)         pro-vitamin A carotenoid from plant.

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

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

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

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Probiotics provide a competitive edge in sports nutrition

The gut flora performs a variety of functions that are important for health. In fact, 70 percent of the body’s immune cells are located in the digestive tract, making gut health critical to overall health. A healthy and well-balanced gut flora facilitates digestion, protects against pathogens, provides vitamins and nutrients, and helps form the immune system. For athletes and fitness enthusiasts, optimizing digestion and immunity are major factors as they strive to improve performance. As research advances, probiotics will play a leading role in shaping the sports nutrition supplements of tomorrow.

Athletes and active individuals have high nutrient needs, which are best met when digestion is well-functioning. Healthy bacteria in the gut aid in the digestion of macronutrients, allowing for optimized nutrient uptake from an athlete’s diet. They also aid in the digestion of macronutrients, allowing for optimized nutrient uptake from the diet. Some probiotic strains can play a role in the use of protein for muscle growth and human recovery by promoting the absorption of key amino acids. Being able to absorb more of the amino acids from protein can help increase muscle growth. In addition, probiotics can support immune health by adhering to the gut epithelium, thereby enhancing the “gut barrier” function of those cells by preventing the adhesion of pathogens.

Working out is all about breaking down and rebuilding muscles to become stronger and faster. With such activity, inflammation and free radical production are normal, expected and necessary—but the body’s response to these reactions will determine how quickly an athlete can recover and get back to his or her regimen. The two main areas of focus while doing strenuous activity are providing the right nutrients to build muscle (protein) and recovery (reduced inflammation). Probiotics can help in both of those areas; for example, the strain Bacillus subtilis DE111® (from Deerland) produces many enzymes to help break down protein, and recent research supported its role in reducing markers of inflammatory compounds that arise during exercise (Sports. 2018;6[3]:70).

According to the National Collegiate Athletic Association (NCAA), there are more than 480,000 NCAA student athletes who compete in 24 sports every year. And of course, this is only a slice of the physical-competition pie. Add professional sports, athletic trainers and serious fitness enthusiasts like marathoners and cyclists, and the number of individuals who could benefit from probiotic supplementation is significantly higher.

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Sports nutrition performance ingredients

Performance in sports goes beyond competition to include training or regular exercise. By definition, performance is the execution of an action or the ability or manner used in completing a task. Sports nutrition researchers define performance in terms of strength, power and endurance, as well as sport skills including speed, agility and reaction time. Recently, cognitive function—focus, processing and memory—has drawn rising interest in the market for its impact on overall sports performance.

It could be confidently said that all sports nutrition ingredients have an ultimate effect on performance, even if their primary benefit is in weight management or recovery.  However, many ingredients are researched for an influence on specific performance metrics used by sports nutrition researchers and, thus, have a more direct impact on performance.

Strength and power metrics are tied to the muscles, which are built and driven by protein/amino acids and energy. Each protein source, from dairy to plants and algae, has a unique profile of essential amino acids (EAAs) and specific rates of action. Whey is fast acting, while casein is slower. Each protein can play a role in muscle development and function, and blending different protein types is sometimes advantageous. The branched chain amino acids (BCAAs), specifically leucine, are EAAs singled out for muscle building. Leucine is considered a limiting factor in muscle protein synthesis (MPS), the process of building new muscle mass.

Also involved in muscle building is mTOR (mammalian target of rapamycin), a regulatory pathway for MPS. Leucine and ingredients such as HMB (beta-hydroxy-beta-methylbutyrate) may signal mTOR-activated muscle growth.

Protein boosters, which help increase MPS, and testosterone boosters are other popular categories of ingredients for strength and power.

On the energy side, which also plays into endurance, ingredients that support production of adenosine triphosphate (ATP), the cellular energy molecule, can support performance gains. Creatine helps energize short bursts of activity, such as resistance training and sprinting, while carnitine helps shuttle fatty acids into the mitochondria for use in later stage energy production.

On the flip side, compounds that inhibit fatigue can also improve performance. Beta alanine and carnosine help buffer fatigue-causing ions in the muscles, whereas caffeine disrupts fatigue signaling in the brain and stimulates the central nervous system.

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Sugar reduction in sports nutrition applications

The sports nutrition market continues to see steady growth. Athletes and mainstream users, including exercisers and those leading active lifestyles, are looking for products that support their recreational and lifestyle-driven performance. Both men and women seek sports nutrition products to help improve their nutritional intake, general health, well-being, performance, and muscle growth and recovery from exercise. The success of sports nutrition products requires meeting consumer demand with formulations they can trust and rely on, while also delivering on taste. Whether protein powders or bars, gummies, chews, ready-to-drink (RTD) beverages, pre-workout enhancers or post-workout enhancers, flavor and sweetness must meet consumer expectations.

Clean label and free-from claims

Many active consumers are looking for clean label products, including those with no artificial colors, flavors or sweeteners, and other “free-from” claims. There is a clear shift toward plant-based, natural, sugar-free and less-added-sugar products. Sugar reduction innovation is at an all-time high, and there is tremendous demand for sweeteners that allow for 100 percent sugar replacement—and are also natural and taste good. However, consumer preference for sweetness is still strong, too. Sports nutrition product manufacturers are actively seeking ways to successfully achieve low sugar content while delivering on good taste, texture and overall appeal.

Natural, plant-based sweeteners

The demand for sugar reduction and product purity has brought much attention to natural and plant-based sweeteners such as stevia and monk fruit. Stevia has led the natural high-intensity sweetener market, and demand has grown exponentially since its approval and introduction. Monk fruit, also known as luo han guo, is quickly rising in popularity. Many sports nutrition brands are recognizing the benefits of incorporating monk fruit into products and formulations, and it is garnering attention as a sugar alternative. The sweetness of monk fruit comes from components called mogrosides found in the flesh of the fruit. Monk fruit is a no-calorie, natural sweetener with a glycemic index of zero that provides a well-rounded, fruity taste profile, and allows for an added “fruit-based” claim.

Finding the sweet spot

Formulating sports nutrition products that meet these needs may require manufacturers to address significant technical challenges. Reducing sugar content can impact not only sweetness, but also texture, color and the overall taste experience. While athletes and other sports nutrition consumers are looking for healthier alternatives and less sugar, they are also not willing to give up taste. Mintel reported taste is the most important product attribute to consumers. For this reason, reducing sugar in sports nutrition products cannot be done at the expense of flavor and familiarity.

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Dietary ingredients ensnared in U.S.-China trade war

President Trump’s trade war with China is set to impact many dietary ingredients, with additional 10 to 25 percent import duties on a range of products from minerals to proteins and sweeteners sourced from China.

IngredientsOnline.com, which connects U.S. and other manufacturers and vendors to ingredient suppliers from around the world, including China, has compiled a list of more than 180 potentially affected ingredients in the company’s supply chain, including choline, creatine, xylitol, animal and plant proteins, ribose, phytosterols, hemp seeds and various forms of minerals and amino acids.

“With boots on the ground in China, our teams in Shanghai have identified this list of ingredients that are on the HTS [U.S. Harmonized Tariff Schedule] Code as ‘potentials’ for the additional duty fees that will start at 10 percent,” said Peggy Jackson, vice president of sales and marketing for ingredientsonline.com. “Keep in mind this is just the beginning; we’re hearing the tariffs can range from 10 percent to 25 percent. It’s obvious this will have a tremendous effect on not only the industry but on consumers as well.”

The Council for Responsible Nutrition (CRN) has been working on this issue since Trump released the first tariffs in May and has received lists from its members, sometimes including 30 to 40 or more ingredients potentially affected by the tariffs.

“The cost of sourcing raw material is going to go up in all these cases,” said Steve Mister, president and CEO of CRN. “Sometimes it’s the finished ingredient; in other cases, it’s the excipients or fillers and similar compounds. Each one incrementally increases the cost of goods, the cost to make the products.”

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AKA says it can see signs that government position on kratom is evolving

Kratom advocates say they can see cracks developing in the wall the federal government has tried to build around access to this botanical.

The American Kratom Association sent out a communication in which it claimed that the National Institute of Drug Abuse had changed its tune on the safety of the botanical. According to AKA, a NIDA webpage associated with the botanical has recently changed its wording to “Kratom by itself is not associated with fatal overdose”.

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FDA Expands List of Ingredients Approved as Dietary Fiber

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, released decisions made on citizen petitions to expand and better define what ingredients fall under the legal definition of “dietary fiber.”

When in 2016 FDA unveiled a new definition for dietary fiber as part of updating the final rule for the Nutrition Facts label, the agency specified this term referred to “naturally occurring fibers like those found in fruits, vegetables, and whole grains, and seven isolated (i.e., extracted from plant sources) or synthetic non-digestible carbohydrates (NDCs), each having a physiological health benefit.”

FDA solicited citizen petitions for isolated or synthetic NDCs outside of this initial list of ingredients, if scientific evidence demonstrated a beneficial physiological effect on human health.

Notably, several common non-digestible carbohydrates, such as the popular ingredient inulin, were omitted from the initial definition, leaving suppliers left to wonder whether these ingredients would be included as a dietary fiber on the Nutrition Facts label.

With the announcement of the new rulings from Commissioner Scott Gottlieb, eight new fibers were added to the list, including:
mixed plant cell wall fibers (a broad category that includes fibers like sugar cane fiber and apple fiber, among many others);

-arabinoxylan;
-alginate;
-inulin and inulin-type fructans;
-high amylose starch (resistant starch 2);
-galactooligosaccharide;
-polydextrose;
-resistant maltodextrin/dextrin.

“Consumers can be assured that non-digestible carbohydrates counted as fiber on the new Nutrition Facts label have health benefits grounded in scientific evidence,” commented Commissioner Gottlieb. “Eating foods rich in dietary fiber, as recommended by the Dietary Guidelines for Americans, can help cholesterol levels, increase feelings of fullness (satiety) resulting in reduced calorie intake, and increase the frequency of bowel movements.”

He also noted the list of dietary fibers could expand, looking ahead. “We are taking a flexible approach to dietary fiber, allowing for the possibility of additional fibers to be added to the list of those meeting our dietary fiber definition if the scientific evidence shows they are physiologically beneficial,” he said.

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Health Benefits Of Palmitoylethanolamide (PEA)

 

1) PEA Reduces Pain and Inflammation

In humans, PEA reduced the pain intensity in patients given a PEA supplement than those without a PEA supplement (R).

PEA reduced pain levels in patients with back pain better than in patients not given PEA (R).

In women with pelvic pain, PEA improved the pain and sexual function symptoms in 6 months (R).

PEA decreased pain intensities in patients with fibromyalgia syndrome (R).

In chemotherapy-caused pain, PEA can help treat nerve pain in cancer patients (R).

In animals, adelmidrol, a PEA equivalent, reduced acute and chronic inflammation (R).

PEA-treated mice had less inflammation and lung damage than those treated without PEA (R).

PEA has an anti-inflammatory effect on mice with collagen-induced arthritis (R).

In mice, PEA helped reduced spinal cord injury-induced inflammation (R).

 

2) PEA Protects the Brain

 

In stroke patients given PEA, recovery outcomes, such as cognitive skills and brain status, improved compared to stroke patients not given PEA (R).

PEA improved cognitive and social behaviors in autistic children (R).

In mice, PEA helps preserve brain cells and reduces the expression of pro-inflammatory enzymes. PEA may reduce brain inflammation and brain cell death (R).

Mice given PEA had improved results in neuron regeneration after spinal cord injury (R).

In rats, a pre-treatment of PEA reduced seizure duration, indicating PEA may also have anti-epileptic properties (R).

In mice injected with neurotoxins, PEA reduced some of the neurotoxic and neuroinflammatory effects (R).

 

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Marketing Advantages for Branded Ingredients

Dietary supplement marketing today requires transparency. After years of mainstream media raising all kinds of questions about the safety and efficacy of products this industry produces, people are skeptical, even as the number of users continues to grow. The supply chain for commodities remains problematic, but branded ingredients engender trust, which is worth examining in some detail. How have branded ingredient suppliers stepped up their game, and how can that be conveyed to customers?

Pulling the Curtain Back
Consumers have access to more information—at any time or location—than ever before. Consequently, more supplement brands are pulling back the curtain to reveal their testing practices, manufacturing facilities, company policies, and especially what their ingredients are and how they choose them. Suppliers with heavy investment in branded ingredients are making it easier for their customers to provide that information to consumers, and some of their stories will resonate deeply with supplement users. I predict in the near future we’ll see an increasing number of brands putting the stories their suppliers have to tell front and center in more of their marketing efforts. Some branded ingredient companies are even reaching out directly to educate retailers in the health food channel about their products.

Ingredients are complicated. Which ingredients are selected for product formulations influence, and are influenced by, all aspects of a company. Managing supply chain challenges, short-term profits vs. the long-term view, healthcare professional acceptance, regulatory compliance, and consumer expectations all coalesce in this one decision.

What do branded ingredients bring to the table? Generally, but not always, branded ingredients are backed by intellectual property in the form of research and patents. The ingredients and the company often have other virtues that help establish trust and credibility as well. Let’s look at examples of those and some of the most effective ways to convey the advantages to brands, consumers, and the medical community, all of which are crucial to an ingredient’s success.

Research & IP
Ingredient suppliers have stepped up their research game exponentially in the nearly 30 years I’ve been in the industry. Years ago, there were a few suppliers involved in solid research on their own branded ingredients, but it was more common for ingredient marketing to be built around science “borrowed” from competitors. It was an unsustainable practice, subject to much criticism within the industry, and a source of both amusement and frustration to trade media. Slowly that changed as more branded ingredients were researched to establish safety data for New Dietary Ingredient (NDI) and Generally Recognized As Safe (GRAS) status applications. Patent applications required data as well. R&D departments developed novel extracts, which had to be studied for regulatory purposes. The benefits were also researched, sometimes discovering health supporting mechanisms not previously known.

Early on, most of the research was in vitro, with some in vivo mostly in animal models. Sometimes it was published, sometimes not. Over time, human clinical trials became more common, and were increasingly published in peer-reviewed journals. Today, the quality of research is far more respectable, and paying off, as evidenced by the medical community’s endorsement of ingredients such as curcumin and choline, which has been a significant factor in sales growth for those ingredients.

Leading suppliers are also being more proactive about self-policing when they see problems, particularly with adulteration. Advocating for fit-for-purpose testing has moved beyond labs and forward-thinking trade associations, with some ingredient suppliers notifying colleagues and competitors about adulterants they have uncovered and how to test to find them. We’ve even seen one supplier in particular develop extensive cultivation programs, giving it adequate supply of raw material and more control over quality, while at the same time materially improving quality of life for small farming communities. The company recently pioneered a first of its kind reforestation program.

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Ashwagandha: Leading the Adaptogenic Revolution

One of the most well-known botanical plants in traditional Ayurvedic medicine, ashwagandha (Withania somnifera) has gained attention in the health and wellness industry for its restorative and rejuvenating benefits. Offering a variety of applications, including as a general tonic, the root can be used as an adaptogen, meaning it helps the body cope with stress.

Ashwagandha is frequently referred to as “Indian ginseng” because of its rejuvenating properties, even though botanically, ginseng and ashwagandha are unrelated. Belonging to the same nightshade family as tomato, eggplant, and potato, ashwagandha is a shrub with oval leaves and yellow flowers. It bears red fruit about the size of a raisin. The herb is native to arid regions of India, northern Africa, and the Middle East, and is also grown today in more moderate climates.

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