NUTRACEUTICALS NOW OCTOBER 2020 - ANTI-INFLAMMATORY SOLUTIONS - FI GLOBAL
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nutraceuticals | Available by subscription only | NOW October 2020 New – Energy & Alertness Support An Exceptional Approach to Andropause Anti- Inflammatory Solutions st technology • latest technology • latest technolo
HER ALLY FOR A HEALTHY INTIMATE FLORA foreword Editor’s note By Charles Faulkner W ith Covid-19, the Nutraceutical supply chain and Vitamins, with an increased interest in safety equipment, has experienced uncertainty. However, packaging & clothing to protect against corona virus infection. opportunities continue to arise for sourcing and We will maintain communications with leading companies and purchasing new products & services, hearing personnel from Dietary / Health supplements manufacturers, about the latest R&D, talking with existing suppliers, keeping Contract manufacturers, Food / Beverage manufacturers, up-to-date with industry trends, learning about the benefits and Pharmaceutical product manufacturers from leading of specific products & ingredients, and concluding deals. In companies in Europe and north America. 2021, healthy ageing & immunity will lead current topics of interest with a focus on Probiotics, Plant extracts, Botanicals Wishing everyone a prosperous and safe 2021. 6 Issues, titled by months. August/September:Sports Nutrition, Nutricosmetics, Skin Health, Woman’s February/MARCH:Omegas, Botanicals, Health, Asia-Pacific Events. Post Covid 19, News. Copy date: 6th August 2021 Copy date: 14th February 2021 October:Dietary Supplements, Immunity, Supplements, April/MAY: Vitamins, Fruit Extracts, Anti-Aging, Probiotics, Encapsulation, Vitafoods SSW Preview. Europe Preview. Copy date: 2nd October 2021 Copy date: 6th April 2021 November/December: Cognitive Health, Flavours, Plant Proteins, June/July: Bone Health, Collagen, Cocoa, Dietary L. plantarum ROSELLA is Sugar Reduction. IFT Preview. Fibres. Fi/Hi Europe Preview. L. plantarum P17630 (Proge P17630®), Copy date: 17th June 2021 Copy date: 5th November 2021 licensed from PROGE FARM®, Italy. QUALITY PROBIOTICS. COMPLETE SOLUTIONS. 2 | Nutraceuticals Now October Edition 2020 | 3
contents articles Editor Charles Faulkner The Smart Ingredient! Foreward: Editor’s Note...........................................................................................................3 Operations Manager Company News..........................................................................................................................6-9 Daniel Peacock What You Don’t Know About Label Claims Is As Important As What You Do................10-11 Consultant Rosella: Her Ally For A Healthy Intimate Flora.....................................................................12-15 Christopher McIntyre An Exceptional Approach To Andropause............................................................................16-17 Accounts Steve Clark Consumers Seek Better Ways To Increase Alertness, Energy, And Focus.......................18, 20 Meeting The Demand For Effective, Sustainable Anti-Inflammatory Solutions............22, 24 Designer Barnaby Attwell Indena Quercefittm: Effective Support For Respiratory Health, When Allergies Are Rife............................................................................................................26-27 Published by Finding The Perfect Ingredient Combination For Optimal Mobility ...............................28-29 Johnson-Johnsen Publishing 6 Victoria Terrace, Inverness, Q&A With Dupont......................................................................................................................30-31 IV2 3QA Scotland T: +44(0) 1463 718993 Stressed Out? Natural Astaxanthin Offers Relief ................................................................32-33 F: +44(0) 1463 229976 Menaq7® Vitamin K2: The Key To Securing General Health..............................................34-35 Email Pycnogenol® helps to Omega-3S Across The Generations.......................................................................................36-37 info@nutraceuticalsnow.com improve cardiovascular Confidence Over Immune Health On The Decline.............................................................38-39 Website health and blood glucose Ins Farms Launches Farm To Finish Elderberry Ingredients.............................................40-41 www.nutraceuticalsnow.com levels; supports male vascular functions; Printed by alleviates symptoms of an Immune Health: Opportunities Abound For Natural Solutions........................................42-43 Harrisons A Sustainable, Cost-Effective Alternative To Overcome The Challenges Of Pepper Extracts.......................................................................................44, 46 enlarged prostate; naturally supports muscular function Available by subscription only and endurance as well as Nutraceuticals Now is a technical review providing 16 the latest information on functional products and ingredients which are defined as having a disease preventing and/or health promoting bene t in ad- other health benefits.* 28 dition to their nutritional value. 42 It is targeted at manufacturers of food and drink, who are producing finished products aimed at the ever For Men increasingly health conscious consumer. The opinions expressed in our published works are those of the author(s) and do not reflect the opin- advertisers ions of Johnson-Johnsen Publishing or its Editors. Information contained in our published works have been obtained by Johnson-Johnsen from Lallemand .................................................Inside front cover sources believed to be reliable. However, neither GLUCOSE CARDIOVASCULAR PROSTATE VITALITY COGNITION MUSCLES Horphag Research............................................................... 5 Johnson-Johnsen nor its authors guarantees the accuracy or completeness of any information NSF........................................................................................11 published herein and neither Johnson-Johnsen Tischon................................................................................ 18 nor its authors shall be responsible for any errors, omissions, or claims for damages, including exem- Sabinsa................................................................................. 21 plary damages, arising out of the use of or inability Tishcon................................................................................ 23 to use information, or with regard to the accuracy Vidya.................................................................................... 25 or sufficiency of the information contained in this publication. 40+ years research, 160+ clinical trials with 12,000 subjects and 1000+ finished products worldwide* Gelita....................................................................................39 All rights reserved. No part of any Johnson-John- INS Farms............................................................................ 41 sen published work may be reproduced, stored in a retrieval system, or transmitted in any form or by follow us on… Quimdis...............................................................................45 Catalent............................................................................... 47 any means, electronic, mechanical, photocopy- For more information, visit www.pycnogenol.com ing, recording, or otherwise, without written per- Indena................................................................... Back cover ISSN - 1478-6605 mission from the publisher. *For a complete list of scientific research and further information visit our website at www.pycnogenol.com. Pycnogenol®, French maritime pine bark extract, is a registered trademark of Horphag Research, Ltd and its applications are protected by U.S. patents and other international patents. ©2020 Horphag Research USA, Inc. 4 | Nutraceuticals Now These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
BUSINESS NEWS • BUSINESS NEWS • BUSINESS NEWS • BUSINESS NEWS Gnosis by Lesaffre Fully Merges Human Health I’m very pleased to welcome you to our previous expectations, although the and events sector has slowed dramatically. company news, which reports on recent level of activity remains well below the The strength of the recovery remains Capabilities developments in the Global Nutraceutical levels prevailing before the coronavirus surrounded by significant uncertainty, as it supply chain. (COVID-19) pandemic. While activity in continues to be highly dependent on the Recent data suggest a strong the manufacturing sector has continued future evolution of the pandemic and the rebound in activity generally in line with to improve, momentum in the services success of containment policies. Gnosis by Lesaffre is striving to create a world that compliance, and extensive clinical validation procedures moves better, digests better, ages better, feels better, to develop effective solutions for its key markets: Wellness and, ultimately, lives better thanks to microorganisms & Immune Health, Digestion & Gut Health, Mobility & GELITA also supports major sporting event in and biotransformation. Earlier this month, Gnosis by Joint Health, Reproduction & Women’s Health, and Mood Lesaffre unveiled its new, fully integrated brand and busi- & Cognitive Health. Corona year ness strategy to help make this vision a reality. “In the past, we have focused solely on build- Gnosis by Lesaffre, a business unit of the Lesaffre ing awareness for our renowned ingredients, such as Numerous running events have been cancelled this Group, harnesses the power of microorganisms and Quatrefolic® and Lynside® nutritional yeasts,” Global year due to the Corona pandemic. GELITA, one of the biotransformation processes like fermentation to cultivate Marketing Director Philippe Caillat said. “At the same leading manufacturers of collagen proteins, has decided nutritional actives, probiotics, and nutritional and func- time, we have been building our expertise and market to continue its involvement in sports, particularly in this tional yeasts that benefit human health and wellbeing. leadership for our key market segments, so we are proud situation. The business unit collaborates with dietary supplement, to bring those to the forefront of our brand strategy.” “As a supplier of collagen peptides, which among functional food and beverage, and pharmaceutical brands Within its market segments, Gnosis by Lesaffre has other things help to keep bones and joints mobile to develop game-changing products for their customers. developed a portfolio of solutions that improve health and and healthy, we have a strong affinity to the topic of “The term ‘biotransformation’ may be unfamiliar to wellbeing throughout the entire body: sport,” explains Michael Teppner, Global Vice President some in the industry, but it refers to fermentation and • Wellness & Immune Health: Immunity, Daily Marketing and Communication at GELITA. Within the other natural processing methods that involve transform- Nutrition, Cardiovascular Health, Beauty, and General scope of its corporate social responsibility activities, the ing compounds within a living system,” General Manager Wellbeing company has been supporting the GELITA Trail Marathon Marc Philouze said. “It describes exactly what we do. We • Digestion & Gut Health: Microbiome Balance, in Heidelberg, near the company’s headquarters in use living microorganisms to transform compounds into Digestive Comfort, Liver Health Support Eberbach, since 2016. The track is particularly popular usable nutritional actives.” • Mobility & Joint Health: Bone Health, Joint Health, Urinary Health, Fertility, Pregnancy, and Menopause with both professional and amateur athletes because of Happily crossing the finish line after 42 kilometers: The winner of the Trail Marathon course Merle Brunnée The business unit draws on its focused research and Muscle Health, and Sports Nutrition • Mood & Cognitive Health: Mood Health, Cognition, its demanding and attractive route. (Engelhorn sports team). Source: PIX-Sportfotos applications capabilities, rigorous quality and regulatory • Reproduction & Women’s Health: Vaginal Care, and Stress & Anxiety Thanks to GELITA’s support, it was possible to hold the running event successfully at the beginning of October sporting challenges,” says Teppner. After so many line with our principle ‘Improving Quality of Life’, we - even under this year’s exceptional circumstances. “We sporting events had to be cancelled in recent months, the evidently hit the bull’s eye and managed to delight Quimdis GmbH distributes the range DHA are delighted that our commitment has once again rush for a starting place in the Trail Marathon showed numerous sports enthusiasts in these difficult times,” played a role in inspiring people to take up special how important the competition is for many people. “In Teppner explains. ORIGINS® of Fermentalg in Germany, a premium plant-based DHA New Cognitive Human Clinical Trial on Fermentalg has decided to entrust Quimdis GmbH with (ISO certification and GOED Monograph). ocotrienol + Astaxanthin Synergistic Formula the distribution of its range of Omega 3, with a naturally Its expertise includes fully traceable supply chain combined highly concentrated DHA from microalgae as of Septem- with controlled, sustainable and gentle process thereby offer- study was done on 44 subjects over 12 weeks using a synergistic antioxidant performance of a Tocotrienol + ber 1, 2020 in German market. ing global clients a high purity and quality Omega-3. combination of 50mg of TheraPrimE® Palm Tocotrienols Astaxanthin blend, and it would be of great interest to This collaboration completes the range of products Mr. Jean-Francois Quarre, President & Chairman of and 9mg of AstaZine® Natural Astaxanthin. Statistically investigate in future studies if this outcome is due to offered by the Quimdis dietary sector, whose commercial, Quimdis said “Adding Fermentalg to our list of approved significant results versus placebo were found using the an ameliorated absorption of Astaxanthin or perhaps technical and regulatory teams remain at your entire principles is another important value addition to the Cognitrax cognitive test to measure composite memory to increased antioxidant activity due to the addition of disposal for any project. of microalgae. Fermentalg is specialized in R&D, strong list of suppliers and also increases our product domain as well as by subjective user evaluation. tocotrienols.” Fermentalg SA, an industrial biotechnology firm, aims to industrialization and exploitation of microalgae, through portfolio with high quality branded products. With the Lead author Takahiro Sekikawa, PhD, commented, “We meet high expectations from consumers, laboratories and fermentation, for the bio-production of molecules or technical expertise and an outstanding knowledge of previously demonstrated that AstaZine® Natural Astax- 1. Sekikawa, T., Kizawa, Y., Li, Y., Takara, T. “Cognitive function dietary supplement manufacturers, meets the nutritional biomasses with nutritional benefits and the potential for the German market, Dr. Ajax Mohamed who is heading anthin alone was able to markedly ameliorate how well improvement with astaxanthin and tocotrienol intake: a randomized, requirements in the agri-food industry, by supplying natural a positive impact on health. The technology developed the German office shall be able to promote Fermentalg subjects can recognize, remember, and retrieve words double-blind, placebo-controlled study.” Journal of Clinical Biochemistry microalgae health products. The company was founded in together with the wealth of its bank of strains allows it to products very well “ BGG World (BGG) announces that a new clinical trial1 was and geometric figures.2 In this study we decided to add and Nutrition 19 June 2020 1-10. 2009 and is headquartered in Libourne, France. Fermentalg target highly varied markets with high value for human Mr. Jean-Louis Caradec Sales Director of Fermentalg successfully completed and published on a synergistic 50mg of tocotrienols to the same dosage of Astaxanthin 2. Sekikawa, T., Kizawa, Y., Li, Y., Takara., T. “Cognitive Function manufactures high quality vegan DHA oils based on their nutrition, animal feed as well as health industry. said, “We are convinced that Quimidis, thanks to its combination of TheraPrimE® Palm Tocotrienols and previously tested and we were able to show a statistically Improvement with Astaxanthin Intake: A Randomized, Double-Blind, expertise in bio-industrial production of microalgae. DHA ORIGINS® range will be perfectly suited your range strong distribution network, infrastructure and technical AstaZine® Natural Astaxanthin showing cognitive significant amelioration versus the placebo group on Placebo-Controlled Study.” Pharmacometrics 97 (1/2) 1-13 (2019). Fermentalg’s mission is to provide health and nutri- developments of dietary supplements, beverages and health capabilities, will be able to promote our DHA ORIGINS® improvements in subjects with age-related memory de- Cognitrax in addition to improvement in all subjective tion industry leaders with new sources of oils, natural foods. All products are compliant with US & EU regulations range on the German territory and offer its customers a cline. The randomized, double-blind, placebo-controlled symptoms measured. Previous research has established Further Information on BGG: www.bggworld.com pigments and proteins by harnessing the vast potential and have trusted process according to quality standards superior satisfaction”. 6 | Nutraceuticals Now October Edition 2020 | 7
BUSINESS NEWS • BUSINESS NEWS • BUSINESS NEWS • BUSINESS NEWS The FDA’s new qualified health claim for New study suggests vitamin K deficiency as whole fruit cranberry supplements causes the missing link in COVID-19 pathogenesis tremendous excitement than in extra-hepatic proteins. Yet, these extrahepatic for COVID-19, may induce short-term hypercalcemia, proteins play a decisive role during COVID-19 infection. resulting in an accelerated elastic fiber calcification, and our level of expertise,” acknowledges Jean Leclerc, director fied health claim without demonstrating efficacy. “We Insufficient activation of protein S in blood vessel walls degradation. “Vitamin D administration in a state of of Sales and Business Development for Fruit d’Or, which is still have to fight that battle. Clearly, those who want and matrix Gla protein (MGP) in the lungs may lead vitamin K deficiency may thereby endanger pulmonary the world’s largest grower of certified organic cranberries. to differentiate themselves will also want to promote to an increased risk for thrombosis, and lung damage, and vascular health”, notes Janssen. “With this ruling, the FDA is raising the bar by their cranberries’ anti-adhesion activity, standardization, The review, published in the British Journal of Nutrition, respectively. “There is a need for further experimental evidence to recognizing whole fruit powder for both its soluble and in- purity, potency and quantifying the amount of soluble presents vitamin K metabolism as the potential missing link “Because of their structural differences, vitamins K1 link vitamin K deficiency with the pathology of COVID-19 soluble proanthocyanins (PACs). We’ve done all the heavy and insoluble PACs. Fruit d’Or is a pioneer and leader in between lung damage and thromboembolism, two of the and K2 do not have the same biological activities. With and determine whether vitamin K2 supplementation lifting in this area, and companies are eager to learn how each of those areas.” most serious outcomes observed in COVID-19 patients. K2, the role of vitamin K extends beyond blood clotting, has a place in treatment protocols. The potential role of these soluble and insoluble PACs work together.” Anti-adhesion assays by Rutgers University have “Considering that vitamin K is important for regulating as it also regulates other important metabolic processes, vitamin K2 supplementation to prevent development of shown that cranberry PACs may inhibit pathogenic E. lung health and blood clotting, vitamin K deficiency such as calcification and inflammation. K1 is easily severe COVID-19 in subjects who have not yet contracted Some companies will need to revisit their coli’s ability to adhere to epithelial cells in the urinary during COVID-19 may make both those problems worse,” found in a balanced diet, which is not the case for K2. COVID-19, but are at risk for the infection, is also very Fruit d’Or says the FDA’s acknowledgment of the need formulations tract. Additionally, work conducted by Complete explain Dr. Rob Janssen and Jona Walk, Researchers Deficiency might be more common than we think,” says relevant to assess,” Janssen and Walk conclude. for soluble and insoluble PACs could push cranberry “The FDA’s qualified health claim is confirmation that Phytochemical Solutions using Fruit d’Or Cran Naturelle, at the Canisius Wilhelmina Hospital (Nijmegen, The Dr. Trygve Bergeland, VP Science at Kappa Bioscience, Kappa Bioscience, who supported this study, is enter- ingredients over $100 million in sales. not all cranberry is the same. It’s not the components of captured electron microscopic images of that specific Netherlands), and lead authors of the study. who supported the research. ing research agreements with several research centres, The FDA authorized three wording options including, the fruit … it’s not just the juice … it’s the whole fruit. cranberry ingredient’s PACs bound to pathogenic E. coli The “triage theory” implies that, because vitamin The review also highlights the important link between both in Europe and in the US. The company aims to sup- “Limited scientific evidence shows that by consuming 500 And products must have a 500 mg daily dose of actual that showed how the anti-adhesion works. K1 is preferentially transported to the liver, carboxyla- vitamin D3 and vitamin K2. Vitamin D administra- port research to generate a better understanding around mg each day of cranberry dietary supplement, healthy cranberry to make this claim,” explains Leclerc. Fruit d’Or is having its premium branded ingredients, tion grades are higher in hepatic coagulation factors tion, which is part of certain clinical trials protocols vitamin K2 deficiency and COVID-19 pathogenesis. women who have had a urinary tract infection (UTI) may He adds, “A sprinkle of cranberry does not constitute organic Cran Naturelle and conventional Cran d’Or, tested reduce their risk of recurrent UTI.” efficacy. All companies will need to revise their formula- by Amy B. Howell, Ph.D. and her team at Rutgers Uni- This news is expected to trigger even more products tions and decide if they want to participate in this claim. versity for this anti-adhesion activity. This testing is more Lonza Launches First Probiotic Ingredient for and innovations within the already popular cranberry We have always believed in the whole spectrum of the than the current gold standard for confirming efficacy. supplement industry. In 2019, cranberry ranked #5 in cranberry. This is what drove Fruit d’Or to set the industry It will also help further advance cranberry research and Sports Nutrition: TWK10® brand U.S. sales by the American Botanical Council. standards for proper cultivation and handling processes, science by relating structure to function. Demand increases for Fruit d’Or Nutraceuticals’ Cran and to pioneer proper fingerprinting to ensure that Leclerc explains that the FDA qualified health claim Lonza announces the launch of its new TWK10® ingredi- Any athlete, any person, every advantage Naturelle and Cran d’Or “Fruit d’Or, a farm-to-finish formulas contain actual cranberry.” will also open the door for companies that want to create ent, a unique Lactobacillus plantarum probiotic strain iso- Suitable for elite athletes, so-called “weekend warriors”, company, is one of the primary beneficiaries of this great cranberry capsules with no fillers or lubricating agents. lated from naturally fermented Taiwanese Kimchi. The first and active individuals alike, TWK10® probiotic helps news. More companies are calling us looking to formulate How to reach the top even faster “So far, Fruit d’Or is the only company that can provide probiotic ingredient to deliver sports nutrition benefits for improve athletic performance through greater energy with whole fruit cranberry powder because no one else has Leclerc acknowledges that it is possible to use the quali- this level of seed-to-table purity.” both elite athletes and active consumers, TWK10® brand harvesting. By enhancing muscle endurance, TWK10® is clinically shown to enhance endurance, improve body probiotic allows consumers to train for longer. Derived composition and energy levels. Licensed exclusively from from vegetables, TWK10® probiotic also enables brands KSM-66 Ashwagandha Root Extract shown to Synbiotech for North America and Europe, the clean label, to meet the increased consumer preference for vegan, vegan ingredient can be used in dietary supplements and in plant-based sports nutrition products. enhance the quality of sleep in a randomized, foods, with additional applications already in development. TWK10® probiotic is the latest addition to Lonza’s TWK10® probiotic is available now in North America. growing clean-label sport nutrition ingredient portfolio. double blind, placebo controlled study Dr. Thomas Kiy, Vice President Strategy and Portfolio The vegan MuscleGuard™ formulation comprises a Development at Lonza Capsules & Health Ingredients, unique blend of ingredients to offer clinically significant A clinical study published in the Journal of marketer of KSM-66, said: “Sleep is critical to be healthy, comments: “At Lonza, we continue to look for and benefits for muscle strength, mass and activity. Ethnopharmacology, (https://doi.org/10.1016/j. to recover from exercise and to function optimally both develop science-backed ingredients to help brands create A sustainably-sourced phytoplankton ingredient, jep.2020.113276) demonstrated that an 8-week physically and cognitively. Ashwagandha root has been cleaner, more effective products that active consumers Oceanix™ brand offers clinically-studied benefits for supplementation of KSM-66 Ashwagandha root extract led referenced for centuries for its sleep benefits. This study demand. TWK10® probiotic is a world-first for the sports Mr. Kuei-Ming Lee, Vice President of Human Healthcare sustained strength and power, and short-term recovery. to significant improvement in sleep quality parameters in “withania somnifera” is indicative of this important benefit. is the first clinical study to evaluate the effect of Ashwa- nutrition market, and a true innovation.” of Synbiotech adds: “Fermented dairy products with active Carnipure® L-carnitine delivers both exercise and both healthy and insomnia participants. The study used a This is the fourth clinical study that has demonstrated the gandha root extract on sleep quality in both healthy “Isolated from fermented vegetables, specifically bacterial cultures are the typical source of many probiotics muscle recovery benefits. While UC-II® undenatured sample size of 80 in a double-blind, randomized, placebo- effect of KSM-66 Ashwagandha in enhancing the sleep adults and insomnia patients and demonstrate significant Taiwanese Kimchi, the unique patented TWK10® strain currently on the market. However, our extensive research type II collagen improves joint health to further support controlled, parallel-group, stratified, comparative clinical quality. A previous study published in Cureus (https://doi. positive effects on sleep quality in the participants.” He is the next generation of probiotics. It is scientifically exploring over 300 plant-derived probiotic strains revealed active lifestyles. study. Participants taking KSM-66 Ashwagandha root org/10.7759/cureus.5797) in 2019 showed that KSM-66 added, “The paper is published in a prestigious journal proven to effectively modulate gut microbiota for sports a unique strain with excellent survival rates. Currently two The new TWK10® ingredient will officially be extract had improved measures of sleep onset latency, sleep Ashwagandha significantly improves sleep efficiency, total and is a valuable contribution to the scientific literature. endurance and performance benefits. TWK10® vegan human clinical trials have been completed on TWK10® unveiled at Lonza’s Virtual Innovation Day on October efficiency, total sleep time and waking after sleep onset. sleep time, mental alertness on rising, and sleep quality in It substantiates the use of Ashwagandha root extract as probiotic also appears to support increased butyrate- probiotic, and studies have shown that it delivers significant 1, 2020 — interested parties can email Ashwagandha root extract is long known for its potential healthy adults. an adaptogen that helps reduce anxiety and promote producing bacteria in the gut for a positive increase on benefits for fitness enthusiasts and active individuals, vaughn.dubow@lonza.com for more information in helping sleep quality. Even the herb’s botanical name, Kartikeya Baldwa, CEO of Ixoreal Biomed Inc, the restful sleep. energy metabolism,” continues Kiy. including increasing muscle endurance.” or to request a sample. 8 | Nutraceuticals Now October Edition 2020 | 9
What You Don’t Know About Label Claims Is as Important as What You Do N SF International asked its con- cy disease (like vitamin C and scurvy), sultants to share the biggest as long as the statement also tells how struggles they’ve seen com- widespread such a disease is in the DIFFERENTIATE panies have with claims sub- U.S.; otherwise, it may NOT describe a stantiation. Here are the most common relationship with a disease aspects that can cause confusion and YOUR BRAND harm brand reputation. These categories can contain subcat- egories, each with its own requirements. When It Comes to Claims, There’s Here’s an example of both claim speci- More Than Meets the Eye – A Lot ficity and latitude, in the category of nu- ON THE SHELF More trient content claims: Manufacturers don’t always grasp the complexity, technicality or scope of Specificity: There are requirements information for substantiating claims. about the specific words a manufacturer There are numerous categories of may use, particularly around quantifiable test subjects vs. the recommended use claims, and each category can have its claims such as “high in,” “rich in” and of the product? Are there any other in- own individualized requirements and “contains.” Saying “low” is not the same gredients present in the study that could requirement latitude. The requirements as saying “less,” but saying “reduced” is have contributed to the effect? > GMP Registration around claims are varied and depend on the same as saying “less.” the type of claim. Categories include: FTC Requirements Are Just as Latitude: While the words themselves Important as FDA Requirements > FSMA Compliance Nutrient content claims: are closely watched, the format of those Companies often focus primarily on • Directly or indirectly characterize the words is often given a great deal of lee- FDA regulatory compliance, while not level of a nutrient way. A claim may be presented in a font paying enough attention to FTC re- > Product Certification • Must be permitted by a regulation in size or style on the label which is more quirements around claims. But even order to be used than twice as prominent as the rest of the highest quality product cannot > Banned Substance the product’s identity style. reach the market if it does not comply Health claims: with the business law of the land. The Screening • Describe the relationship between a Study Details Matter FDA’s focus is on manufacturing and la- nutrient and risk reduction of a disease or health-related condition When building a case to substantiate health claims, the study details matter. beling. The FTC enforces laws against “unfair or deceptive acts or practices” > Customized Virtual • Must be permitted by a regulation in Both the U.S. Food and Drug Administra- in advertising. Law enforcement action Training order to be used tion (FDA) and the Federal Trade Com- applies not only to product labels, but mission (FTC) apply a claim substantia- also to internet, print, broadcast, info- Consumer value claims (label claims of tion standard of “competent and reliable mercials and catalogs. The lines be- consumer concern): scientific evidence.” They look at the tween the jurisdiction of each agency • Natural meaning of the claim being made, with are not black and white, and they often • Organic an eye toward: collaborate on the same case against • Non-GMO a company. FTC enforcement actions • Allergen claims such as gluten-free and • The relationship of the evidence to the can have a devastating impact on ad dairy free claim agencies, distributors, retailers, catalog • Keto, paleo, vegetarian and vegan • The quality of the evidence companies and infomercial producers. • The totality of the evidence Unlike your facility, your advertising Structure/function claims that convey: and social media is public-facing and • The role of a nutrient or dietary ingredi- FDA and FTC closely scrutinize the stud- accessible. Complaints filed with the ent intended to affect normal structure ies being used to support the claim. Is Better Business Bureau can make their or function in humans the study test substance the same as the way to the FTC. Warning letters are only • How a nutrient or dietary ingredient product dietary ingredient? Is the form one mechanism for action. FTC action acts to maintain structure/function, for the same (e.g. extract vs. powder)? If it can also involve lawsuits, frozen assets, example “antioxidants maintain cell in- is a botanical, is the part of the plant the burdensome nonnegotiable settlement tegrity” same? Is the dosage in the study simi- demands and court orders. As the FTC • General well-being from consumption lar to or conservative when compared has said, “Generally, products related to of a nutrient or dietary ingredient to the serving size of the product? What consumer health or safety require a rel- Contact dietarysupplements@nsf.org for more information • A benefit related to a nutrient deficien- about the length of exposure of the study atively high level of substantiation.” 10 | Nutraceuticals Now
ROSELLA: 1.4 billion women. Genito-urinary issues, HOW TO PROBIOTICS PROMOTE including vulvovaginal candidiasis, uri- WHAT IS THE DIFFERENCE VAGINAL HEALTH, EVEN nary tract infections and bacterial vagi- BETWEEN BACTERIAL DURING TIMES OF OCCASIONAL nosis are the leading conditions, bring- VAGINOSIS AND VAGINAL BACTERIAL IMBALANCE ing women to seek out medical advices, YEAST INFECTION? Lactobacilli can help rebalance the HER ALLY FOR A HEALTHY prescriptive drugs and to investigate vaginal microflora and promote vaginal natural efficient complementary supple- Bacterial vaginosis comfort during times of occasional vag- ments, such as probiotics. is defined as a vaginal dysbiosis char- inal imbalance. Lactobacilli probiotics, acterized by a decrease in concentra- which have a positive effect on endog- INTIMATE FLORA Lactobacilli: The gatekeepers of tion of Lactobacilli in the vagina and enous microflora could thus help sup- feminine health an increase in concentration of an- port the vaginal microflora and protect The female vaginal microflora is a rich aerobic bacteria such as Gardnerella against some undesirable bacteria. and complex ecosystem, mainly con- vaginalis, Atopobium vaginae, My- sisting of Lactobacilli which support coplasma hominis, Prevotella, Por- Meet women’s new best friend: A convenient orally administered probiotic shown to support women’s intimate health the vaginal environment and health. phyromonas. It is the most common ROSELLA During her lifespan, every woman en- vaginal infection in women of child- To recolonize the vaginal microflora counters specific health and well-being bearing age. zone, choosing the right bacteria strain issues according to her lifestyle, physi- is crucial. Moreover, only a handful of Probiotics for women’s health ology, hormonal cycles and life stages. Vaginal yeast infection probiotic supplements taken orally can Over the past five years, the market Vaginal balance is fragile, and many in- is also due to an imbalance in the vag- do the trick. L. plantarum P17630 (Proge for nutritional ingredients for women’s ternal or external factors can affect this inal flora. In this condition, the prob- 17630®), ROSELLA, is one of them. health carried on evolving to a more balance: gut health, immunity, mood lem is a fungus called Candida, such mature market, driven by consumers’ balance, oral health, intimate health... as Candida albicans, which incapaci- L. plantarum P17630 (Proge 17630®), interest and research and development. they all have been linked by scientists tates commensal bacteria. Candida ROSELLA is a unique strain isolated With robust scientific backing and prod- to endogenous microbiota. Acting albicans are also often found in the from a healthy vaginal flora with full uct development on the rise, global pro- upon the gut or vaginal microbiota, gastrointestinal tract, as part of a com- mechanistic and clinical evidence of ef- biotic markets have been, in fact, grow- specific probiotics can help each indi- mensal bacteria. Candida can co-exist ficacy on a wide spectrum of benefits, ing fast for more than a decade. Lumina vidual woman at every stage of her life, normally in the vagina without any from helping to maintain proper vaginal Intelligence confirms products have di- from puberty to menopause. The ben- problem, and a proper Candida albi- balance, including from oral intake, to versified from initial cores of gastro-in- efits of probiotics to support women’s cans balance is an indicator of healthy being used for recurrent Vulvovaginal testinal health and immunity to a much health are increasingly recognised, vaginal microbiota. However, it may Candidiasis (rVVC). This probiotic strain broader range of benefits including skin, mainly due to their ability to maintain cause trouble if it outnumbers other is one of the most documented in the sports performance, brain health and and restore digestive and vaginal mi- microorganisms. Three out of four world in the women’s health area, as it more female-focused areas like vaginal croflora balance, with positive conse- women will have an imbalance with has been studied in over 800 women, health, urinary tract infections (UTIs), quences on feminine health as well as a Candida albicans prominent micro- in six clinical studies, including two by pregnancy and osteoporosis. Probiotics on digestive health, occasional stress flora at some point in their life. oral intake. In combination or not with research and development is undeniably or natural defenses. As per most of conventional treatments for candidiasis popular, with over 1600 ongoing human the beneficial effects of probiotics, the (anti-fungal) women saw an improve- clinical trials on probiotics listed in clini- benefits on intimate health are not ho- ment in candidiasis with a decrease in caltrial.gov and WHO’s trial database. mogeneous for all the probiotics but symptoms including less swelling, red- are strain specific. ness, burning or itching infection that According to Grand View Research, the can be caused by an overgrowth of women’s health and beauty supplement bad bacteria. This probiotic strain also market has reached $49.8 Billion in helped reduce the risk of recurrence of 2019 and the estimated compound an- this candidiasis*. nual growth rate (CAGR) for 2020- 2026 is 4.75%. The probiotics for women’s ROSELLA is scientifically backed by health core growth areas are: vaginal mechanistic data. Studies showed this health, urinary tract infections, pregnan- specific strain was able to adhere and in- cy and skin health. Among non-supple- terfere with C. albicans (in vitro studies). ment women users, 40% of them think factor for product development, explain- tion as they are a natural alternative to It demonstrated vaginal colonization their « feminine health issues » could be ing why, since the past two years, a lot of the conventional over-the-counter so- and persistence following oral intake improved by using supplements. new probiotic products target women, lutions for vaginal health. Women are (validated efficacy dose: 5B CFU/day). and consequently consumers online willing to try them out especially when Probiotics for women’s health is a fast- engagement is increasing: between vaginal health conditions are recurrent, ROSELLA restores flora diversity associ- growing market, increasingly attracting December 2017 and January 2020 the which alters general quality of life. ated with a healthy vaginal flora and pro- women through online and on-site re- number of reviews for women’s intimate motes vaginal diversity associated with tail places. Although women’s probiotic health probiotics increased by 804%, on Probiotics for women’s health is a major a healthy vaginal microbiota by normal- market used to be a niche market, it is average from the 20 countries studied. opportunity to expand brand portfolios izing pH. Furthermore, there are clini- now becoming a strong differentiation Specific probiotics are gaining attrac- with a potential target audience of over cal evidences that this unique strain ➜ 12 | Nutraceuticals Now October Edition 2020 | 13
helps promote continued vaginal health have an abnormal vaginal flora (LBG IIa VAGINAL INTAKE PROOF OF [Nava 2002, results] in Vulvovaginal Candidiasis and in recur- to LBG III). In the ROSELLA group, there EFFICACY: REDUCTION OF PH, rent Vulvovaginal Candidiasis as adjunc- was a significant increase (p
tract which combines Cocoa bean (The- obroma cacao) and pomegranate peel (Punica granatum) which helps to im- An Exceptional Approach to prove testosterone levels, while reduc- ing Aging Male Symptoms (AMS) scores. Andropause Tesnor™ increases in-cell testosterone production and inhibits Aromatase ac- tivity, while also aiding with AMS scores and muscle strength and growth in By Maggie McNamara, young males. The ingredient is mar- Marketing Director keted as a food-derived, standardized and IP protected testosterone-boosting only accounted for about 13% of the extract and is a well-researched, with an prescriptions written for testosterone in excellent safety profile that meets global the United States.1 regulations. Testosterone Decrease The Promise for Andropause Decreased testosterone production The onset of andropause begins with the causes the levels of testosterone in the gradual decrease in testosterone. Unlike blood to decline. Testosterone produc- menopause, the resulting symptoms tion declines partly because the number develop much slower than they do for of Leydig cells in the testes decline with women. Given the tentative perspective ageing. This also appears to be related toms, including fatigue, depression, of the scientific community, men are left to changes in the hypothalamus and pi- mood swings and loss of libido. Adding with few reliable options in addressing tuitary glands. supplements like Testofen to one’s daily their needs. The phenomenon of andro- dietary intake can help to keep testos- pause is a reality and supplements like The testosterone produced in an age- terone levels stable, bringing much re- Testofen® and Tesnor™ can significantly ing man’s body is also less efficient in lief to men suffering the symptoms of improve physical symptoms, metabolic performing its functions. This is because andropause.2 abnormalities (e.g. strength) and qual- older men produce more of a hormone ity of life. Of course, any ongoing strat- A ndropause (or “Male Meno- This, in turn, causes symptoms that can Age takes its toll on everyone, and a de- called “sex hormone binding globulin”, Why supplement? egy to reduce the symptoms and risks pause”) is rarely discussed in interfere with a full and satisfying life- crease in hormone production over time which binds to testosterone and reduc- Supplementing the diet with nutrient, of andropause should incorporate life- the medical community. While style. Through natural therapies, men is common for both men and women. es the amount available to fulfil its func- along with regular resistance exercise, style approaches such as an optimal female menopause is an ac- can reduce their andropausal symp- Testosterone levels in men begin to de- tions. Thus, while testosterone produc- can help overcome some of the chal- balanced diet, regular exercises, stress cepted medical condition with an array toms, and enjoy a rich and fulfilling “sec- crease as early as age 30 and continue tion declines by only around 1% each lenges related to reduced testosterone. management with tobacco and alco- of treatments and therapies, andropause ond act” of life. to decline at an estimated 1% per year year, there is a 2–3% per year reduction Testofen® is a fenugreek extract stand- hol consumption in moderation. These is often dismissed or downplayed as a through the age of 50 and above. Add in the amount of testosterone available ardized for 50% Fenuside™. It contains measures will help men to achieve the figment of the patient’s imagination. This Supplements have been shown to help to that the natural fluctuation of other to support the male sex drive and sec- many bioactive compounds that have ultimate goal of providing dignified perspective, however, is beginning to men experiencing moderate levels of natural hormones and chemicals within ondary sex characteristics. The numer- been carefully selected and standardized healthy ageing, and maintain highest change. And, Andropause is starting to sexual dysfunction brought on by mid- the body and its little surprise that men ous challenges the male body faces in to a 50% minimum content of furostanol quality of life, thereby adding life to years garner the attention it deserves. As any dle age. For sufferers of andropause, the begin to show symptoms of a “change maintaining testosterone levels whilst saponins. This clinically studied and pat- and not simply years to life. middle-aged man knows from personal supplements offer some relief from the of life” as they move into middle age. ageing sometimes lead to testosterone ent ingredient has shown to be suitable experience, the symptoms of andro- natural loss of libido and sexual stami- deficiency. Sex hormones are key ana- for any healthy ageing formulation. pause are very real indeed. Conventional na. Testofen, is a unique extract from More than 20% of men aged 65 years bolic factors, which is why their decline References medicine offers few alternatives for men fenugreek standardized to a proprietary and older have low total testosterone is associated with loss of lean muscle Gencor conducted a double-blind pla- 1. Glenn R. Cunningham, MD, is Professor of Medi- experiencing its effects, and more and matrix of saponin glycosides that Gen- levels and a higher percentage have low mass, increased abdominal fat, loss of cebo-controlled trial to demonstrate cine and Professor of Molecular and Cellular Biology more sufferers are turning to natural cor has branded as their patented Fe- free testosterone levels. drive, libido and stamina, which inevita- the safety and efficacy of Testofen® at Baylor College of Medicine, Houston, Medical treatments to find relief from their symp- nuside™. Fenuside™ contains many bly impacts quality of life. among healthy adult males. (Steels et al, Director of St. Luke’s Episcopal Hospital Diabetes toms. bioactive compounds that have been A recent report from the BACH survey 2011, Wanhkede et al, 2015). The study Program, and is a member of the Endocrine Today carefully selected and standardized to indicates that these older men are like- Data from surveys conducted in oth- showed that Testofen® is a safe and ef- Editorial Board. Laughlin GA, Barrett-Connor E, Berg- The scientific community has also a 50% minimum content of furostanol ly to have symptoms consistent with er developed countries indicate that fective treatment for reducing symp- strom J. Low serum testosterone and mortality in lagged in its acceptance of andropause. saponins. This clinically studied ingre- testosterone deficiency. Recently re- around 20% of men aged > 50 years toms of possible androgen deficiency older men. J Clin Endocrinol Metab. 2008;93:68-75. The research in this area is certainly less dient has shown to be suitable for any viewed in Endocrine Today is a report have either low levels of testosterone (i.e. increase libido, sexual desire, muscle 2. www.ncbi.nlm.nih.gov/pubmed/11818427 robust that research on menopause. healthy ageing formulation. from Laughlin et al, which showed that in their blood, or exhibit symptoms of mass), improvement of sexual function 3. Testofen, a specialized Trigonella foenum-grae- While the recognition is beginning to men with testosterone levels in the low- testosterone deficiency (e.g. excessive and an increased serum testosterone in cum seed extract reduces age-related symptoms change and new research is being con- Causes and Symptoms of est quartile had a 40% increased risk of breast growth, loss of facial hair, rising healthy middle-aged and older men.3,4 of androgen decrease, increases testosterone levels ducted, men need not wait for accept- Andropause mortality during a 20-year follow-up, in- voice). and improves sexual function in healthy aging males ance from conventional medicine. Our The underlying cause of andropause is dependent of multiple risk factors and In addition, Gencor has also sought a in a double-blind randomized clinical study. Rao A1, bodies age as we get older, causing hor- the decrease in production of naturally pre-existing medical conditions. None- The decrease in testosterone production solution to help give male testosterone Steels E2, Inder WJ3, Abraham S1, Vitetta L1,4. mone and chemical levels to decrease. occurring hormones within the body. theless, men aged older than 65 years is at the root of all andropause symp- levels a boost. Tesnor™ is an herbal ex- 4. www.ncbi.nlm.nih.gov/pubmed/26791805 16 | Nutraceuticals Now October Edition 2020 | 17
Originally developed for long-distance lorry drivers, Driver’s Friend Energy Chews have proven to be appealing for a wide range of consumers who want NEW! increased alertness, energy, and focus. ENERGY & ALERTNESS SUPPORT Driver's Friend® is a new, better way to maintain energy, focus, and alertness. With just two delicious, mocha-flavored chews, Driver's Friend provides energy within 30 minutes that lasts up to 4-6 hours.† To help support and maintain energy, alertness and focus, Driver’s Friend combines a unique blend Consumers seek better of ingredients in our proprietary formula – Caffeine (equivalent to one ways to increase alertness, L o cup of coffee per serving), B-Complex vitamins that help release energy, and focus r e energy from food, and our patented HydroQsorb® CoEnzyme Q10 that is essential for energy production. No water needed. By Arun K. Chopra – Sr. VP/ Chief Operating Officer – Tishcon Corp. H umans have been look- appealing both for their taste and their More than just energy ing for sources of mental stimulation for much of our role in social settings, the logistics of brewing and transporting hot beverages makes them less than ideal in today’s At the same time consumers are looking for ways to stay sharp and alert, many Alert • Energized • Focused existence. While the use of have also come to be more aware of coffee dates back to the 15th century, fast-paced, on-the-go societies. This ex- the health consequences of what they caffeinated tea has been brewed for plains, in part, the popularity of energy put in their bodies. Manufacturers have over 5,000 years. The quest for effec- drinks with younger consumers. With seized on this trend and created energy tive, safe, and convenient stimulants energy drinks, there’s no time lost brew- products that also deliver a variety of Delicious Mocha Flavor Chews has only accelerated in modern times ing and no fear of spilling a hot drink on vitamins, minerals, and nutrition sup- as evidenced by the explosive growth your lap while driving. plements. From vitamin B complex to in the use of energy drinks around ginseng, manufacturers are testing the the globe. Today, maintaining an alert The form factor consumer appeal of a wide range of If for any reason you are not 100% state of mind is critical to everything One down side of the surging popular- popular health supplements in their en- • Vitamin B-Complex energy releasers satisfied, contact us for a full refund.** from driving to parenting, and to work- ity of energy drinks is their environmen- ergy products. ing and studying. Manufacturers from both the food and beverage and sup- tal impact. Energy drinks are served al- most exclusively in non-reusable cans Consumers becoming • Caffeine: 2 chews = www.driversfriend.com plement industries are striving to cre- and plastic bottles. Every time they’re more selective ate new and better solutions. consumed it’s an addition to the waste While growth of the energy products in- • Increased energy within 30 minutes. Lasts up to 4-6 hours† stream and the global struggle against dustry continues, many consumers are While coffee and tea remain as popular environmental pollution. While cof- increasingly inquiring into the possible as ever, the demands of modern life- fee and tea are often served in reus- negative effects of their energy supple- Proprietary Driver’s Friend® Energy Chews are available for distribution under styles and the preferences of today’s able cups, mugs, and thermoses, the ment choices. Judging by the number younger population are creating a de- use of non-reusable containers for tea of online search inquiries and threads our registered trademark, or they can be PRIVATE LABELED to your brand. mand for new ways to increase alert- and coffee service outside of home, on social media, the amount of sugar in To learn how Driver’s Friend® Energy Chews can benefit your company, or to request a quote, call Peter Lambrechts at +32 468 078 101 or email peter.lambrechts@2q2q.eu 10 ness, energy, and focus. work, and restaurant environments energy drinks is a primary concern, and Q Co has climbed steadily around the world. that concern is well-deserved. Some Convenience is King This puts additional strain on the waste popular energy drinks have as much as †Study available upon request. D While many adults find coffees and teas stream. 58 grams in a single serving - almost ➜ N TE driversfriend.com for refund details. TE **See P A 18 | Nutraceuticals Now © 2020 Driver’s Friend, LLC. All Rights Reserved. Manufactured in a cGMP Certified USA Facility October Edition 2020 | 19
50% more than in a typical 250 mL can of sugar-sweetened soda. The newest option - energy chews Energy chews were originally developed and marketed to athletes and active consumers as a means of replacing car- bohydrates and electrolytes expended during activities. Some manufactur- ers then added caffeine to their for- mulas to provide an additional energy boost. More recently, the market has seen the introduction of energy chews specifically formulated to provide in- creased alertness, energy, and focus, without the large amounts of carbohy- drates and electrolytes found in chews designed for athletic activity. According to Raj Chopra, CEO / Chair- man of Tishcon Corp., “we saw the demand for a highly convenient and healthy option for consumers who want an occasional boost in energy and mental sharpness, and so we created Driver’s Friend Energy Chews are extremely easy to keep on hand and create much less packaging waste Driver’s Friend Energy Chews (drivers- than energy drinks or carry-away coffee drinks. friend.com). In addition to the caffeine equivalent to one 250 mL cup of coffee, we formulated Driver’s Friend Energy Chews with our patented HydroQsorb® CoEnzyme Q10.” Coenzyme Q10 is essential for the pro- duction of ATP, which nutritionists have called the «energy of life.” Chopra notes, Our HydroQsorb® CoEnzyme Q10 pro- vides up to 8 times more absorption of ordinary Coenzyme Q10. There is no other energy shot, drink, supplement, or chew in the marketplace that contains this revolutionary, powerful and very beneficial ingredient.” While the first generation of energy chews were developed for active adults, Compared with traditional energy chews, Driver’s Friend Energy Chews are formulated with less sugar and Driver’s Friend Energy Chews were origi- more vitamins, as well as Hydro Q Sorb® Coenzyme Q10. nally developed for long-distance truck drivers. However, the convenience of the chews have appealed to a wide au- traditional energy chews,” says Chopra. ter, and more unique energy supple- dience of consumers. “The simple en- “Instead of excess sugar, we added Thia- ments continues. But today, consumers ergy chew form eliminates the need for mine, Riboflavin B2, Niacin, Vitamin B6, have never had a greater range of choice bottles, cans, and cups – it’s extremely Biotin B7, and Pantothenic acid B5, as or more healthy options for gaining in- convenient and has less environmental well as our Hydro Q Sorb® Coenzyme creased alertness, energy, and focus. impact,” states Chopra. In addition, a Q10. We also added Magnesium, which relatively low level of sugar has made is involved in over 300 vital reactions in For more information on the Driver’s Friend formulation appeal- the body and is involved in the produc- Driver’s Friend Energy Chews: ing. “We find that many consumers just tion of energy. Peter Lambrechts want to be alert and focused. They don’t +32 468 078 101 necessarily need or want the high lev- More choices, better choices peter.lambrechts@2q2q.eu els of sugar and electrolytes found in The competition to develop, new, bet- www.driversfriend.com 20 | Nutraceuticals Now October Edition 2020 | 21
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