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FDA Expands List of Ingredients Approved as Dietary Fiber

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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)

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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

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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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CRN Voluntary Guidelines Reinforce Industry Commitment to Consumer Safety

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The Council for Responsible Nutrition (CRN) has unveiled two developments in its collection of proactive, science-based voluntary guidelines and best practices: new recommended guidelines for products containing SARMs and updates to its recommended guidelines for caffeine-containing dietary supplements.These updates coincide with recent FDA action to protect consumers from the potentially harmful effects of selective androgen receptor modulators (SARMs) and highly-concentrated caffeine.

“CRN’s membership is committed to consumer safety and understands the gravity of going above and beyond what is required by law to ensure their products are high-quality, consistent, and supported by sound science,” said Steve Mister, president & CEO, CRN. “Consumer access to bulk amounts of highly-concentrated powder or liquid caffeine and performance enhancing products containing SARMs are current subjects of sharp industry scrutiny. CRN is grateful for FDA’s recent consumer advisories on these ingredients, as well as for guidance providing clarity to companies attempting to navigate the industry’s strict regulatory framework. CRN’s voluntary guidelines align with FDA’s enforcement actions and help the dietary supplement industry stay on the right side of the law.”

The newly developed guidelines for products containing SARMs stem from increasing concerns raised by FDA, the U.S. Anti-Doping Agency, and the legitimate dietary supplement industry about the dangers of SARMs found in products mismarketed as dietary supplements. Among the many challenges the responsible industry faces with respect to SARMs is the introduction of substances that do not appear to meet the definition of a dietary ingredient as outlined by the United States Federal Food, Drug, and Cosmetic Act; fail to provide proper notification to FDA as new dietary ingredients (NDI); and appear to lack scientific evidence supporting safety. Coinciding with FDA’s position that products containing SARMs do not meet the definition of a dietary supplement, CRN’s guidelines recommend that responsible firms should not distribute or market products containing these ingredients.

CRN’s guidelines for caffeine-containing dietary supplements, originally created in 2013, recommend that companies disclose the amount of caffeine in a dietary supplement, provide label advisories about safe use of such products, and refrain from sale under certain conditions. The guidelines were updated in 2015 to institute restraints against the sale and marketing of bulk amounts of pure or highly-concentrated caffeine in powder form, and the 2018 revisions expand these restraints to also include concentrated liquid forms, as outlined by an FDA guidance released earlier this year.

“CRN trusts that the dietary supplement industry will adopt these two sets of crucial guidelines into its standard operating procedures,” surmised Mr. Mister. “As the marketplace continues to grow and innovate, we lend our full support to FDA’s proactive enforcement efforts to improve consumer safety and industry accountability.”

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LION’S MANE MUSHROOM EXTRACT

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Lion’s Mane History
Lion’s Mane is a choice edible that grows wild on deciduous trees and is now extensively cultivated on sawdust substrates.

Lion’s Mane Uses
Hericium is an immunomodulator that is useful for many conditions where immunity is compromised. It has also been used for gastritis. Current research suggests that Hericium may have some effect on nerve growth.

Proudly Made in China
In 1996, CEO and Founder of Nammex, Jeff Chilton organized organic mushroom production in China. That initiative paid off and today all Nammex mushrooms are grown or wildcrafted deep in the mountains of China by our Certified Organic production partners. Learn more about our growers in China.

Not All Medicinal Mushrooms Products are Created Equal
US lab-grown Lion’s Mane is mycelium grown on grain. Analysis has shown that US Lion’s Mane mycelium on grain has low levels of beta-glucan and very high levels of starch. Nammex only uses 100% organic fruiting bodies which are rigorously tested and guaranteed for active compounds. Learn more about the mycelia myth and the 10 Questions to Ask about Your Mushroom Supplement.

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Organic By The Numbers — Infographic

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In 2016, sales of U.S. organic food and beverages hit a record-breaking $43 billion, accounting for 5.3 percent of total food sales in United States. Sales of nonfood organic products increased by almost 9 percent to $3.9 billion, with organic fiber, supplements and personal care products accounting for most of those sales.

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Report Forecasts Supplement Market to Reach $278 Billion by 2024

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The global dietary supplements market is expected to reach $278.02 billion by 2024, according to a new report by Grand View Research, Inc. Favorable outlook toward the medical nutrition market in light of increasing applications for the treatment of malnutrition and cardiovascular disorders is likely to spur the market, the report said.

Rising sales of sports nutrition products in the U.S. and China on account of increasing prevalence of fitness and sports at a domestic level along with new product launches is likely to have a significant impact on the industry over the projected period. The market is expected to generate revenues worth $37.16 billion by 2024, Grand View Research predicted.

Rising consumption of clinical nutrition products as a prevention medium for reducing malnutrition is expected to have a substantial impact. Furthermore, increasing prevalence of premature births on a global level is expected to promote the use of medicinal supplements over the forecast period. The market was worth $19.17 billion in 2015 and is projected to witness growth at a CAGR of 9.5% from 2016 to 2024.

Further key findings from the report include:

 

  • The market for dietary supplement capsules was valued at $26.42 billion in 2015. The increasing use of omega-3 fatty acids in the formulation of dietary supplement capsules is expected to have a positive impact over the forecast period.
  • Amino acid-based dietary supplements accounted for 14.3% of the market share in 2015 and is projected to witness significant growth on account of increasing protein intake by bodybuilders and sports athletes
  • Gel caps and soft gels together accounted for 13.2% of the overall market in 2015. These products are expected to witness growth on account of their increasing application in confectionaries including chocolates, candies, and desserts.
  • Asia-Pacific is projected to grow at a CAGR of 11.2% from 2016 to 2024. Rising sales of green juice, royal jelly, blueberries, chlorella, and black vinegar in Japan owing to increasing awareness toward natural products is expected to promote the use of nutritional supplements over the forecast period.
  • North America accounted for 28.5% of the total market in 2015 and is projected to witness growth on account of increasing consumption of products with reduced calorie level and high nutritional content.
  • Key participants include Amway Corporation, Pfizer Pharmaceuticals, Abbott Laboratories, Herbalife International, ADM, DuPont, and Carlyle Group. In April 2016, Amway Inc. launched a new sports nutrition energy drink under the brand name, XS Sports Nutrition line. This type of product innovation is expected to force manufacturers to develop new products over the next eight years.

 

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Supplement Regulation Evolves Gradually: IADSA Executive Director

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IADSA, the International Alliance of Dietary/Food Supplement Associations, has hailed the progress made in developing effective food supplement regulations worldwide over the past two decades and pledged to maintain the same momentum in the coming years.

This year is IADSA’s 20th anniversary, a milestone that was celebrated at its 2018 Annual Meeting in London. Addressing attendees, IADSA Executive Director Simon Pettman said that regulation of the health supplements industry had been a “stepwise process, not a Big Bang.”

He illustrated the gradual evolution of regulation along a similar pattern across the world using examples of regional developments in ASEAN, the EU, Latin America, and the U.S., as well as global developments in Codex Alimentarius. “Codex has played a key role to help guide this process,” he told the meeting.

“All these things take time and we have a long way to go,” he said. “But in broad terms, across the world, over the past 20 years since IADSA was formed, we have always moved forward.”

Mr. Pettman said IADSA would continue to work for better integration of food supplementation in policy, harnessing partnerships with government and the scientific community. He added: “We are now at the point where we need to look more closely at where this category can fit more widely into policy. Policymakers are asking us that question and we are further investing in the information and data we need to respond.”

The meeting was attended by more than 100 representatives from IADSA’s trade association and company members, as well as regulatory bodies. During the course of the event IADSA elected a new management board to support its ongoing global program of work.

Michelle Stout, previously treasurer, was elected as chair of the IADSA board, succeeding Ric Hobby. Ms. Stout has worked in regulatory affairs for over 20 years and is currently regulatory policy director at Amway.

Steve Mister was elected to the position of vice-chair. He is president and CEO of the Council for Responsible Nutrition (CRN). IADSA’s new treasurer is Dr. Gerhard Gans, who is vice president, regulatory affairs/quality management at DSM Nutritional Products.

Ms. Stout commented: “It is an honor and privilege to be elected chair of IADSA and I look forward to continuing the excellent work of my predecessor. These are exciting times, with evidence growing of the positive impact supplements can have on people’s well-being and the well-being of society at large.”

She continued: “IADSA is committed to working with regulators and other stakeholders to ensure the global health supplements sector continues to thrive all over the world. I look forward to working alongside my fellow new board members, and the wider IADSA membership, to build on the progress we have already made in this area.”

Attendees at the annual meeting also saw the IADSA Leadership Award presented to Dr. BH Lim in recognition of his outstanding work over many years to support development of the ASEAN health supplement agreement.

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Versatile Capsules for Sports Nutrition

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The sports nutrition market is generally the supplement industry’s first adopter and first mover of cutting-edge products. This history bodes especially well today for the entire industry.  Sports nutrition, once a smaller niche market of elite athletes and sports teams, is now the fastest growing and leading supplement market due to the entry of active mainstream consumers seeking healthy living and fitness trends driven by Millennials and Gen Xers as well as seniors bent on maintaining mobility and independence.

Now relabeled the “sports nutrition/active nutrition” market—with emphasis on the slash!—the category is embracing a wider array of supplement ingredients that benefit and lengthen physical strength, endurance and dexterity. Dosage delivery forms are now a critical part of chemistry for creating inventive products forward-looking consumers will buy. Innovative delivery forms can meet a unique subset of consumer requirements ranging from convenience to consumption pleasure to preservation and/or enhancement of ingredient effectiveness.

Sports nutrition sales revenue rose from US$7.3 billion in 2011 to $13.6 billion in 2017, and is expected to continue growing at a fast rate (7.9 percent compound annual growth rate [CAGR] from 2016 to 2021), according to Euromonitor International. The United States has represented 60 percent of the value over the past decade.

The market’s new crowd wants supplements that will help them gain more energy and endurance, lose more weight, feel better, perform better, recover better and relieve muscle soreness. They look for products to support joints, bones and the cardiovascular system. They also want to build and maintain muscle.

While sports powders, drinks and bars are the most popular delivery forms for protein—which comprise the bulk of sales in sports nutrition—other delivery forms for a wide range of supplements are continuing to fuel demand.

According to the National Marketing Institute’s (NMI) 2018 Supplements, Over-the-Counter, and RX Database (SORD) study (data collected in 2017), capsules are not only the top delivery form for the population (41 percent), but also for the sports nutrition supplement crowd—beating out tablets (second), softgels (third) and other novelty delivery systems.

Versatility is the core appeal of the capsule as a delivery form. Not only can it meet clean label claims, but it can be neater (no messy packages from sport bars), more convenient (slides right into purses, bags and pockets) and easier to consume (no mixing and stirring of powders).

A variety of innovative hard-capsule technologies also can meet delivery challenges of sports nutrition ingredients. These technologies can bolster stability, bioavailability, and targeted and/or timed release—all beneficial to promoting the effectiveness of a supplement ingredient.  Some can also mask odors and bitter tastes, which can support compliance of a supplement regimen.

 

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Ashwagandha: Leading the Adaptogenic Revolution

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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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