Austin, TX – The success of AlphaSize® Alpha-Glyceryl Phosphoryl Choline (Alpha-GPC; A-GPC) the past nearly 20 years in the dietary supplement, food, and beverage arenas, has enticed other companies to offer an alternative, “generic”, fully synthetic, A-GPC to the marketplace. This A-GPC is produced via synthetic chemistry, using vastly different, unnatural, starting raw materials and using vastly different production schemes. So is this generic, fully synthetic A-GPC the same as AlphaSize® A-GPC? The short answer is no, it is not the same.

Proof of purity, history of safe use, FDA regulatory compliance, and research validation are critical requirements these days, and for good reason. This exists abundantly for AlphaSize® A-GPC, as it is safe, legal, full FDA GRAS, 100% natural (not synthetic), water soluble, tasteless, odorless, extremely stable and nonreactive, IGEN™ Non-GMO Certified. This is why AlphaSize® A-GPC is widely used in dietary supplements, sports nutrition and healthy aging finished products, in beverages shots, bars, chewing gum, gummies, and in conventional foods and pet supplements.

Generic, fully synthetic, A-GPC may in fact be manufactured using genotoxic (chemical toxins that damage genes) and/or endotoxic (toxins form bacteria that cause disease) impurities present in the starting raw materials, which can also be present in the finished ingredients. In contrast, AlphaSize® A-GPC is 100% natural, and no synthetic chemicals that might contain impurities are used in its manufacture. In addition, AlphaSize® A-GPC is the only A-GPC ingredient whose GRAS dossier, related to safety, was submitted in its entirety to FDA for review. And in addition, it has been evaluated in a multitude of published human studies, demonstrated to providing a variety of profound mental and physical performance benefits, as well as in its complete safety profile.

Through intensive testing, we have identified generic, fully synthetic, A-GPC ingredients with impurities and non-bioavailable components, and the sellers of this material have been known to provide Chemi Nutra’s regulatory documentation, not their own, for these adulterated A-GPC ingredients. In fact, these generic, fully synthetic A-GPC ingredients are not supported by sufficient safety data or by FDA’s review, and it is not legal per existing FDA regulations. Therefore, generic, fully synthetic A-GPC is unfit for consumption, and knowingly distributing and using this adulterated material is not only unethical, but it poses a liability risk to the manufacturers and to the health of end user customers. In the end, these practices severely undermine the credibility of our industry.

One path to proven safety requires evidence, reviewed by FDA acting as the ultimate authority, that ingredients are safe for human consumption. The Dietary Health and Education Act (DSHEA; 1994) requires every manufacturer of an ingredient introduced after 1994 to file for New Dietary Ingredient (NDI) acceptance with FDA, which maintains a listing of all NDI notifications and who explicitly states:

1. “The listing of a new dietary ingredient in this table does not mean that another manufacturer can lawfully market the dietary ingredient in a dietary supplement. Each manufacturer is responsible for ensuring compliance with the Act.”

2. “Importantly, if a product containing a new dietary ingredient is marketed without the required notification, unless exempt, the product may be adulterated as a matter of law.

A second path to proven safety is the GRAS (Generally Recognized As Safe) process, and under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive.

“Nearly 20 years ago, Chemi Nutra introduced our branded, high quality, AlphaSize® A-GPC, “The Original A-GPC”, to the supplement, food, and beverage industries. It is proven safe and legal for use, unlike generic, fully synthetic, A-GPC, and it is patented and produced in our own facility in Italy, where any customer can audit its production and see firsthand our extreme attention to quality control. Our all-natural, branded, AlphaSize® A-GPC is used in thousands of finished products – nutritional supplements, sports supplements, gummies, RTDs, beverages, and shots. Consumers look for the AlphaSize® A-GPC logo on finished product labels, as their assurance of highest quality, safety, and validated health benefits. We have sponsored numerous published studies on our branded A-GPC, demonstrating its impressive mental performance and physical performance benefits”, stated Scott Hagerman, president of Chemi Nutra.

“Chemi Nutra is now taking legal and regulatory actions, represented by the prominent law firm, Rivkin Radler LLP, and we will be taking additional wider ranging actions in the very near future. Without doubt, our AlphaSize® A-GPC is one of the most effective functional ingredients to ever exist, and our customers tell us they want 100% safe, research supported A-GPC specialty ingredients that are all natural, nonsynthetic, and GMO-free”, added Mr. Hagerman.

Chemi Nutra is the U.S. business unit of parent company Chemi S.p.A., a privately held pharmaceutical and nutraceutical company based in Milan, Italy. Chemi, with cGMP certified manufacturing facilities in Italy and Brazil, is best known in the U.S. nutritional arena for its introduction of both phosphatidylserine (PS) and A-GPC.

AUGUST 2019 – Equine osteoarthritis (OA), or the breakdown of joint cartilage and underlying bone due to inflammation, is extremely common in horses across a wide spectrum of age and activity level.1 Joint inflammation is often naturally occurring and may result from a myriad of factors, including infection, age, and years of joint use.1 Despite decades of research, a reversal of the OA disease process remains evasive.2 Because horses suffering from joint inflammation can experience pain, stiffness, and lameness, pain control is key in keeping arthritic horses comfortable.1

The results of a two-period crossover study performed at Louisiana State University School of Veterinary Medicine and presented at the American Association of Equine Practitioners (AAEP), suggests that Longvida® may help to reduce pain and alleviate lameness in horses with OA.3 The study sought to evaluate the effects of an oral herbal supplement containing Longvida® Optimized Curcumin on lameness and joint pain in horses with OA.3 A gastroscopy observation was also performed to observe the supplement’s effects on stomach health.3

The study evaluated six thoroughbred horses with naturally occurring OA.3 Test subjects either received grain (control) or grain top-dressed with the herbal supplement once per day for thirty days.3 Researchers collected lameness data on Day 0, Day 15, and Day 30 of the study, blood sample data on Day 1 and Day 14, and gastroscopy data on Day 0 and Day 31.3

The study concluded that the herbal supplement was safe when fed to horses, reducing pain on palpation and improving weight-bearing in lame legs after 30 days of feeding in Longvida® treated horses.3 No adverse responses were noted in the treated horses. Stomach health was also maintained throughout the treatment process.3

Despite the wide array of joint supplements available for horses, the majority of these products have been shown by independent laboratory analyses to contain less of their active ingredients than their labels suggest, creating what some call a “buyer-beware market” in which veterinarians and horse owners alike must rely on limited research and company reputations when selecting a supplement . For this reason, Longvida® stands out as an optimal alternative for owners seeking a reliable, research-backed alternative to improve their horses’ mobility and quality of life.3, 4

“As we celebrate 10 years of having Longvida® available on the market, our team at Verdure continues to be excited by the powerful ingredient’s seemingly limitless frontier of health applications. The results of this equine study yet again demonstrate Longvida’s robust potential for supporting healthy aging in animals as well as people, and if history is any indication, we anticipate that future studies will not only provide further substantiation of these benefits but also inspire research into new areas of potential application. Longvida® is show-safe, making it a viable option for a greater number of horses, including those that train often and might very well benefit most from the supplement. Longvida® is backed by the non-GMO Project Verified certification, glyphosate residue free certification, sports banned substances testing, NASC (National Animal Supplement Council) preferred ingredient status, roughly 30 clinical trials, and so much more. The past decade of mounting research and support for Longvida® truly sets the standard for high-caliber ingredients,” said Kristen Marshall, Marketing Coordinator at Verdure Sciences.

Stratum Nutrition, (a business of ESM Technologies), the sustainable supplier of world class ingredient solutions for pet and human health, announces another addition of expertise in their Sales Department.
Kyle Hicks has joined the Stratum Nutrition team as Solutions Consultant. He is responsible for prospecting potential clients using an intentional, relationship-based approach, with an emphasis on bringing value to the customer at all stages of the process. “I look forward to generating new, consistent pipelines for our sales department,” explains Kyle, “so that we might better diversify our portfolio of clients.”
“Kyle hit the ground running and has already shown his background, personality, process-driven mindset, and work ethic,” says Andrew Rice, Director of Product & Brand Strategy. “He will play a huge role in turning this new position for the company into something that contributes a great deal to developing new business relationships and opportunities.”
Stratum Nutrition acts as an extension of their brand partners’ teams by being the foundational layer of support and following their 5 Launch Product Development Layers process, including: Efficacy. Quality, Compliance, Story, and Demand.

April 4th, 2019 (Carthage, MO USA) Stratum Nutrition®, the Global Leader of eggshell and eggshell membrane wellness ingredients, announces continued market growth for their triple-action joint health ingredient, NEM®. Eggshell membrane has surpassed 100 licensed natural health products in Canada with the issuance of a new Natural Product Number (NPN) for its flagship ingredient, NEM® brand eggshell membrane.

Director of Global Sales, Chris Haynes, says, “All of us at Stratum Nutrition wish to thank each of our Canadian NEM® customers for their trust, faith and hard work to make NEM the #1 selling eggshell membrane in the Canadian market. We feel like there is still substantial market share to be gained in the joint health space for NEM. Stratum looks forward to helping our Canadian customers continue to grow the market share this year and beyond.”

Health Canada performs a pre-market review of the evidence regarding the safety and efficacy of natural health product ingredients and the labeling claims that can be supported by this evidence. If found acceptable, Health Canada will issue the finished product an NPN with allowed label claims.

Stratum Nutrition, through its ESM Technologies business, received new joint pain & stiffness reduction and cartilage protection claims in its recently issued NPN (#8009138). Products containing NEM can now claim that it helps to improve recovery from joint pain and stiffness and/or helps reduce levels of CTX-II, a biomarker of joint (cartilage) degradation due to moderate intensity aerobic exercise in post-menopausal women. These newly allowed claims are in addition to previously allowed claims that NEM helps to reduce pain and stiffness associated with osteoarthritis and NEM is research-proven to reduce joint pain in 7-10 days.

“These new cartilage protection claims approved by Health Canada are based upon our patented healthy population clinical trial design expanding the indications for NEM to healthy exercising individuals and providing label claims that will resonate with consumers“, stated Kevin J. Ruff Ph.D., MBA – Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition.

NEW BRUNSWICK, NJ, February 27, 2019 – Natreon, a leader in Ayurvedic ingredient research and innovation, is proud to announce the latest publication on patented PrimaVie shilajit showing benefits of PrimaVie supplementation on maintaining muscular strength and hydroxyproline levels in recreationally active men. This study marks the ninth clinical trial on PrimaVie and is published in the January 2019 edition of The Journal of the International Society of Sports Nutrition by renowned researchers in Sports Nutrition from the University of Nebraska-Lincoln, Dr. Joshua Keller and Dr. Terry Housh. PrimaVie shilajit expands on a rich history of use of shilajit in Ayurveda by investing in modern science, clinical efficacy and nutrient standardization to achieve a profile consisting of urolithins, fulvic acid and micro-minerals. In addition, GRAS affirmed PrimaVie is the only organic and Non-GMO project verified shilajit extract on the market.

This U.S. based study, conducted at The University of Nebraska-Lincoln, was an 8-week, randomized, double-blind, placebo-controlled, clinical trial to examine the impact of PrimaVie on fatigue-induced percent decline in strength, and concentric peak torque and hydroxyproline levels. Subjects were all recreationally active, healthy males randomized to receive PrimaVie at 500 mg/day, 250 mg/day or a placebo. In summary, the results of the study demonstrated that 8 weeks of PrimaVie shilajit supplementation at 500mg promoted the retention of muscular strength following the fatiguing protocol and decreased baseline hydroxyproline, which is a marker for collagen degradation. This suggested that the group supplementing with 500mg of PrimaVie shilajit was more resistant to fatigue and retained a greater level of maximal muscular strength.

“The results of our study demonstrated the robust, positive effects of PrimaVie shilajit on important aspects of Sports Nutrition including strength, fatigue, and the maintenance of collagen health.” Dr. Terry J. Housh, Professor and Director of the Human Performance Laboratory, Department of Nutrition and Health Sciences, University of Nebraska-Lincoln.
Prior to the UNL trial, Natreon had conducted 8 clinical studies on PrimaVie to unlock the full potential of this important ayurvedic nutrient.

“We are very excited about these results of from the University of Nebraska-Lincoln (UNL) as this enhances our growing body of research highlighting PrimaVie’s role in collagen support. Our previous clinical studies at Ohio State University, discovered that PrimaVie upregulates collagen and other extra cellular matrix protein genes synergistically with exercise. Furthermore, the UNL study results show PrimaVie supplementation decreases degradation of collagen in the body as evidenced by decreases in hydroxyproline. These are significant findings because it shows that PrimaVie can work two ways to enhance collagen in the body and additionally it upregulates other extra cellular matrix protein genes.” said Dr. Sanni Raju, CEO of Natreon.

The new study reaffirms PrimaVie’s use in sports performance products and expands its benefits into healthy aging and strength by demonstrating reduction in hydroxyproline (a marker of collagen degradation) along with increases in strength in athletic males.

“Sports Nutrition is a primary focus for Natreon and PrimaVie is our lead ingredient in the category given its historical use as an adaptogen for energy. PrimaVie’s historical use in Ayurveda, positive clinical trial results, natural, botanical, organic and non-GMO project verified attributes, clearly differentiates PrimaVie from other ingredients in the market,” said Bruce Brown, President of Natreon.

VANCOUVER, Wash. — March 2, 2019 — Bergstrom Nutrition is pleased to announce that shipments of OptiMSM®, a branded form of methylsulfonylmethane (MSM), will feature the “Informed-Choice®” logo, representing the company’s continued commitment to the quality, consistency, and safety of its products. Bergstrom Nutrition began producing and testing material under the “Informed-Sport®” certification in 2014 for distribution exclusively in the EU. After four years of consistent results, the company is now offering OptiMSM under the Informed-Choice certification both domestically and to its distributors outside of the EU.

Informed-Choice is a quality assurance program for sports nutrition products, raw ingredient suppliers to the sports nutrition industry, and supplement manufacturing facilities. The monitoring program certifies that a supplement product and raw material bearing the Informed-Choice logo are skip-lot tested (tested at least on a monthly basis) for banned substances by LGC’s world-class sports anti-doping lab.

“Since 2014, Bergstrom Nutrition has trusted LGC’s Informed-Choice Raw Material certification as evidence of their commitment to quality by supplying the market with clean and tested OptiMSM,” Ryan Bellone, Senior Business Development Manger, LGC Standards.

The Informed-Choice raw material certification provides assurance that OptiMSM production lots are regularly tested for substances considered prohibited in sport. In addition, Informed-Choice also ensures ingredients are manufactured to high-quality standards. Responsible ingredient suppliers are making Informed-Choice part of their existing quality assurance systems to ensure their ingredient is not contaminated before blending.

“Bergstrom Nutrition continues to invest in quality assurance measures so that our customers, and their end-users, can be confident that OptiMSM is safe for all applications, including sports nutrition products used by competitive athletes,” said Tim Hammond, Vice President of Sales and Marketing, Bergstrom Nutrition.

RIMOUSKI (QUEBEC), February 12, 2019 – innoVactiv, a Canadian company dedicated to the development of science-based speciality ingredients, is pleased to announce the publication of its latest human clinical trial on its ingredient InSea2® in the peer-reviewed journal Phytotherapy Research.

The publication presents the results of a 6-month, randomized, double-blinded, placebocontrolled clinical trial involving 65 disglycemic subjects not using medication. Findings include significant reductions in glycated hemoglobin (HbA1c), fasting plasma glucose, post-prandial glucose and insulin-resistance index (HOMA-IR) compared with placebo, as well as normalization of glycemic status in 18.2% of treated subjects versus 0% in placebo group.

“We are thrilled about these new results, as they demonstrate the dramatic impact the use of InSea2® can have when taken on a daily basis. While all treated and placebo subjects followed the same strict diet and exercise regimen, researchers noticed a clear degradation of the glycemic condition in the placebo group, while two thirds of InSea2® subjects improved their glycemic status over the 6 months of the trial period”, said Jocelyn Bérubé, Executive Vice-President, Science and Regulatory Affairs for innoVactiv. “While our previous clinical studies have shown an immediate benefit of a single InSea2® intake on glycemic stress and brain acuity, these new results now clearly demonstrate the benefits of a daily use of InSea2® on glycemic health when taken over a longer period of time”, added Mr. Bérubé.

The published article can be found directly on the journal website, or through scientific index services such as Pubmed using the following reference:
Derosa G, Cicero AFG, D’Angelo A, Maffioli P. Ascophyllum nodosum and Fucus vesiculosus on glycemic status and on endothelial damage markers in dysglicemic patients. Phytother Res. 2019 Feb 3.

Companies and formulators interested to hear more on these results can meet innoVactiv at upcoming Natural Product Expo West (Anaheim Convention Center, March 7-9, Booth #4771) and SupplySide East (Meadowlands Exposition Center, April 9-10, Booth B115) tradeshows.

February 12th, 2019 (Carthage, MO USA) Stratum Nutrition®, the Global Leader of eggshell and eggshell membrane wellness ingredients, announces a progressive joint health clinical trial underway evaluating the triple-action joint health ingredient, NEM®. This trial is being conducted in an exercising, healthy population and is an expanded follow-up trial to Stratum’s 2018 healthy post-menopausal women trial. [Clin Interv Aging. 2018 Feb 19;13:285-295. doi: 10.2147/CIA.S153782] These back-to-back, healthy population exercising studies are evaluating whether NEM® would reduce cartilage turnover or alleviate joint pain and stiffness.

The previous 2018 study found that a once daily, 500 mg dose of NEM® rapidly improved recovery from exercise-induced joint pain and stiffness, as well as significantly reduced discomfort immediately following exercise. A substantial chondroprotective effect was also demonstrated from NEM® supplementation through a lasting decrease in the cartilage degradation biomarker, CTX-II.

This new trial includes a larger population, (84 subjects vs 60 in the prior trial), as well as a demographic of both men and women ages 40-75. The women in this study were not required to be post-menopausal, as was the case in the previously published study. As before, subjects were truly healthy and could not have had persistent knee or ankle pain while at rest in order to participate. The unique, patented trial design looks at changes in a cartilage degradation biomarker (CTX-II) in exercising healthy individuals and allows for new joint cartilage protection claims on product labels. This design of these two clinical trials marks the first evidence suggesting the biomarker, CTX-II, can be used to evaluate the chondroprotective efficacy of joint therapeutics in healthy individuals, as well as other populations.

Kevin J. Ruff Ph.D., MBA, CCRP – Sr. Director of Scientific & Regulatory Affairs for Stratum Nutrition – comments on the new study, “With this ongoing study, we intend to satisfy both FDA’s and FTC’s strong preference for 2 randomized controlled trials (RCTs) to substantiate labeling and advertising claims. With the added benefit that both RCTs were conducted in exercising healthy populations brand marketers will have access to meaningful claims that will resonate with end consumers.”

January 10th, 2019 (Carthage, MO USA) Stratum Nutrition® announces they have been accepted as a Preferred Supplier by the National Animal Supplement Council (NASC) for their NEM® brand eggshell membrane, organic ESC® brand eggshell calcium, Curcumin 95, and eggshell collagen ingredients.
The NASC is a nonprofit industry organization dedicated to protecting and enhancing the health of companion animals and horses throughout the United States. Ingredients that tout the NASC Preferred Supplier Seal must adhere to NASC quality standards, as well as have multiple batches of the ingredients tested by an NASC-approved laboratory to ensure the ingredients’ compliance to their rigorous quality standards.
NASC-approved Preferred Suppliers are pre-qualified companies that can supply ingredients or other supporting products or services to NASC Primary Suppliers (of finished products) who are also required to uphold strict requirements for the NASC Quality Seal. Currently, only about 80 companies have been accepted as a Preferred Supplier and can now serve as a pre-qualified supplier to the almost 170 Primary Suppliers.
Stratum’s manufactured ingredients, such as its flagship ingredient NEM® eggshell membrane for joint health, are produced in NSF-certified GMP facilities and are Kosher and Halal certified. NEM is supported by an impressive published research portfolio, including a multi-center, randomized, double-blind, placebo-controlled canine study, as well as other animal studies.
Chris Haynes, Director of global sales for Stratum Nutrition comments: “We are excited to be approved as a Preferred Supplier by NASC. Our ingredients are tested, validated, safe and effective for animals. Stratum has a keen focus to extend our very successful ingredient offerings into the pet health supplement and pet food market and NASC’s assent is a key first step.”

Rimouski (Quebec), December 3, 2018 – innoVactiv, a Canadian company dedicated to developing science-based specialty ingredients, and Nippon Flour Mills, a Japanese ingredients and food manufacturer, are pleased to announce that their nutraceutical ingredient Myoceram® has been granted two health claims by the Natural and Non-Prescription Health Product Directorate of Health Canada.

The following approved claims confirm the safety and efficacy of Myoceram® for use in beautyfrom-within dietary supplements:

1) Helps support healthy skin barrier function;

2) Helps lessen the loss of water through the skin.

Natural Product Number (NPN) #80089056 has been obtained following a strict safety, efficacy and quality evaluation of the technical dossier of Myoceram®. These claims are associated with a daily intake of 30 mg of rice-derived Myoceram® (Myoceram®-RPS), which offers a superior alternative to other commercially-available vegetable ceramides in terms of daily dosage and allergen-free labelling.

“Myoceram® offers a strong support to skin by promoting endogenous skin ceramide production, to support optimal skin’s texture and appearance over the entire body surface” said Jocelyn Bérubé, Executive Vice-President at innoVactiv. “This approval means that Myoceram® meets the highest levels of quality, safety and efficacy to ensure that end users will benefit from its use.”

The upward trend in beauty supplements has been present in Asia for many years now and is just starting to hit the North-American market. “The Beauty-from-Within segment is one that is set to grow rapidly in the next years, as consumers see the benefits of nourishing the skin from the inside as a complement to their cosmetic routine”, said Patrice Dionne, CEO of innoVactiv. “Our Health Canada approval means that dietary supplements formulated with Myoceram® can now be marketed using strong health claims that resonate with consumers.”

Myoceram® has been introduced recently in North America but has been commercialized for many years in Japan and other Asian countries by Nippon Flour Mills, the company thatdeveloped the ingredient along with its impressive technical background and clinical studies. Myoceram® has shown in human clinical trials its capacity to decrease trans-epidermal water loss over the entire body in a period as short as 4 weeks, leading to improvements in skin texture and appearance. Available in powder and liquid forms, Myoceram® offers tremendous flexibility allowing formulation in capsules, shots or other delivery forms.