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What have we learned in the past year, and how should industry proceed in 2020?

NDIs for dietary supplements: How to proceed in 2020

Where do hemp and cannabinoid companies fit in the manufacturing standards regimen? This has become the question in the absence of clear FDA guidance and regulations for manufacturing.

Which GMPs for the cannabis industry? Pharmaceutical, food, or dietary supplement?

Analytical testing and regulatory experts advise on how to test for CBD quality.

Best practices for CBD testing, from industry experts

The authors write: “It seems that foods and beverages containing CBD are likely to remain high-risk, while dietary supplements would appear to be a slightly lower-risk option for manufacturers or distributors of CBD-containing products.”

What is CBD’s regulatory status, and how should companies proceed with caution? Leading industry regulatory consultants chime in.

OmniActive Health Technologies (Bridgewater, NJ and Mumbai, India) has announced a partnership with the Council for Responsible Nutrition (CRN; Washington, D.C.) to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. This knowledge will be shared at The American College of Obstetrics and Gynecology’s (ACOG) Annual Clinical & Scientific Meeting. OmniActive is 

one of six companies CRN has partnered with

 to showcase the latest research and developments in prenatal nutrition through a specially designed “Prenatal Nutrition Center” at the conference. 

“It’s wonderful to have OmniActive as one of our featured partners during the ACOG annual event to help spread the word on the importance of prenatal nutrition,” said Andrea Wong, PhD, senior vice president, Scientific & Regulatory Affairs for CRN, in a press release. “CRN continues our efforts in supporting supplement manufacturers and ingredient suppliers in bringing clinically studied products to consumers to help meet their nutritional needs. Advancing awareness at the physician’s level is a huge part of this equation and this meeting is an effective way of reaching them.”

Citing market research from SkyQuest Technology, OmniActive explains in its press release that prenatal supplement sales were estimated to be at $740 million in 2023 and projected to rise to $1.4 billion by 2031. Similarly, a recent 

 found that about 60% of gynecologists think that 80-100% of their pregnant patients take dietary supplements. There is therefore a great deal of opportunity to grow and advance this category. Lutein and zeaxanthin are known for their support of eye health, but these benefits are relevant during pregnancy as well, says Deshanie Rai, PhD, FACN, vice president of Global Science, Regulatory and Advocacy at OmniActive Health Technologies.

“Current evidence supports the preferential accumulation of lutein and zeaxanthin in the human eye and neural tissues during pregnancy, especially during the third trimester. This suggests that lutein may play a functional and protective role in infant visual and cognitive development. As part of our Lutein for Every Age campaign, our goal is to help educate healthcare practitioners on this latest nutritional science research and the benefits of achieving adequate dietary lutein during pregnancy,” said Rai, in a press release. “OmniActive is proud to partner with the CRN Foundation’s Prenatal Nutrition Centre to promote awareness among healthcare practitioners on the nutritional relevance of lutein for both mom and baby.”

The educational initiative, “Lutein for Every Age,” focuses on raising awareness of early and consistent lutein and zeaxanthin intake to help support eye, cognitive, and general health throughout life, explains OmniActive. The AOCG meeting is taking place from May 17-19, 2024 in San Francisco, CA.

OmniActive Health Technologies has announced a partnership with the Council for Responsible Nutrition to educate and raise awareness about the role of lutein and zeaxanthin in supporting maternal and fetal health during pregnancy among obstetricians, gynecologists, and other maternal healthcare practitioners. 

Topic

OmniActive partners with CRN to raise awareness about macular carotenoids for prenatal health

During SupplySideWest 2024, NutriSciece’s Edward Dosz, PhD, and Michael Lelah, PhD, highlighted the company’s diverse portfolio of innovations used for dietary supplementation.

NutriScience: New Ingredient Innovations with Groundbreaking Benefits

NutriScience has recently expanded its portfolio of innovative ingredients which covers a wide array of sought after health benefits, backed by clinical science. This video showcases some of their exciting new additions, along with one of their most tried and trusted ingredients.

 Digestive Wellness, Leaky Gut & Heartburn Relief with Antioxidant Benefits

 Cardiovascular, Bone Health & PMS Symptom Management

NutriScience’s Edward Dosz, PhD, and Michael Lelah, PhD, highlight the company’s diverse portfolio of innovations used for dietary supplementation.

NutriScience: Exciting New Ingredient Innovations

Certified Nutraceuticals (CN) has announced in a recent press release

 that it has started a new clinical study investigating the cognitive properties of KollaJell, which is a patented jellyfish collagen supplement that was created to help aid brain health. The main purpose of the clinical study will be to confirm KollaJell’s place as the first collagen-based health supplement verified with clinical trials.

To get to these results, researchers will be using advanced brain imaging technologies, such as, electroencephalographic (EEG) scans

. These technologies will help track the brain activity as well as the cognitive function before and after consuming KollaJell. Another component of the clinical study will be conducting computerized cognitive assessments which will then be utilized to figure out mental performance. For example, multitasking and memory. With the clinical study is underway, researchers are hoping to have results by April 2025 and then be able to publish the data in peer-reviewed scientific journals

The clinical study research group will be managed by Dr. G.M. Haase and Neil Wolkodoff, Ph.D. “CN has been at the forefront of nutritional innovation, with KollaJell standing as a testament to our commitment to science-backed health solutions. This clinical study represents a significant step toward establishing KollaJell as the only brain health supplement with academic-led clinical validation,” said Abdul Alkayali, Senior Vice President of Certified Nutraceuticals

. Alkayali added that, “The study will solidify the product's credibility and enhance our global market presence.”

Certified Nutraceuticals Inc. Certified nutraceuticals partners with Colorado Researchers for groundbreaking study on KollaJellTM and Brain Health 

https://www.prlog.org/13055456-certified-nutraceuticals-partners-with-colorado-researchers-for-groundbreaking-study-on-kollajell-and-brain-health.html

A new study will look to explore how KollaJell may be the only collagen-based brain health supplement.

Certified Nutraceuticals announce partnership with Colorado researchers for KollaJell study

On December 19, 2024, a sleep supplement called Somato from Nutraland USA, was awarded the Alkemist Assured designation which is a part of the Alkemist Labs’ quality transparency program. According to a press release (1), this award is meant to be a “mark of excellence” and is bestowed upon products that have shown that they’ve met high quality standards during a very rigorous verification process.

“We are thrilled to receive the Alkemist Assured seal for Somato,” said Gene Bruno, CSO of Nutraland USA (1). “Transparency and quality are at the heart of everything we do, and this certification reinforces our dedication to providing our customers with products they can trust. Somato's innovative formula is the first of its kind, and we are excited to bring it to a broader audience with the confidence that it meets the highest industry standards.”

Well known in the nutritional industry for their natural products testing, Alkemist Labs’ “Alkemist Assured” program helps provide credibility to products, this can help consumers with deciding on what items meet their supplement quality standards (1).

“Nutraland USA's decision to bring their Somato™product into the Alkemist Assured program demonstrates their commitment to quality,” said Petra Erlandson, director of sales and marketing, for Alkemist Labs. “We are pleased to have them as our newest partner in quality transparency.”

Nutraland’s sleep supplement contains phytomelatonin which is naturally found in tomatoes, along with compounds such as gamma-aminobutyric acid (GABA) and Lycopene (1,2). Somato provides consumers with another option to synthetic melatonin and is 100% plant based. In order to receive the Alkemist Assured™ designation, the sleep supplement needed to undergo thorough testing for ingredient authenticity, purity, identity, contaminants, and potency (1). The press release (1) mentioned that the seal from the Alkemist Assured program gives consumers clarification by showing them that the product meets the programs highest standards for transparency and quality, as well as with providing an independent verification highlighting Somato’s origin from tomatoes.

Nutraland USA Inc. SomatoTM: A breakthrough in natural sleep support, now Alkemist AssuredTM 

https://www.prnewswire.com/news-releases/somato-a-breakthrough-in-natural-sleep-support-now-alkemist-assured-302335876.html

Alkemist assured transparency program – alkemist labs 

https://www.alkemist.com/alkemist-assured/

Somato, a sleep supplement, received an Alkemist Assured designation before the new year.

 Somato sleep supplement receives Alkemist Assured designation

A recent publication on a randomized, double-blind, placebo-controlled study

investigated the effects of a proprietary 

 extract on sleep quality. In the study, 80 participants with sleep complaints were randomized to receive either 200 mg of the extract or placebo for eight weeks and evaluated on the following sleep parameters: sleep time, sleep latency, and sleep efficiency using wrist actigraphy device. Results showed that after a single dose, people taking the Valerian extract experiences an acute benefit on sleep, namely a significant increase in actual sleep time compared to baseline. 

“We observed a 9% improvement in actual sleep time over baseline in our study. This is an important finding as the actual sleep time is crucial to improve brain performance, mood and overall health,” wrote the researchers. “In addition, VE supplementation showed marginal non-significant improvements in sleep latency (8.49%) and sleep efficiency (4.69%) compared to baseline, whereas subjects in the placebo group showed significant worsening of these parameters. This could be due to the change in sleep environment of subjects as they were housed at the study facility, a different environment than their regular sleep environment at home. However, it is important to note that even in this situation, VE supplementation showed significant effects on actual sleep time and slightly improved sleep latency and sleep efficiency which could be a point of further research in future studies.”

The extract used in the study was Sleeproot from OmniActive Health Technologies (Bridgewater, NJ), which is standardized to 2% total valerenic acid.

Shekhar, H.C.; Morde, A.; Padigaru, M.; Joshua, L.; Thomas, J.V. Single Dose Administration of 

 Extract Improves Actual Sleep Time: A Randomized, Double-Blind, PlaceboControlled Study. 

Updated on January 6, 2025 at 12:15PM EST.

Results showed that people taking the Valerian extract experiences an acute benefit on sleep, namely a significant increase in actual sleep time compared to baseline. 

Standardized valerian extract shows acute sleep benefits after one day, says recent study

Radicle Science represents major progress in the substantiation of health benefits by offering an innovative model that is more streamlined than traditional clinical trials. This not only makes clinical validation more accessible, but also builds upon the body of scientific literature around supplement ingredients, helping brands make better products, and in turn giving consumers novel and effective ways to support their health.

managing editor, Sebastian Krawiec, interviews Radicle Science co-founders, Pelin Thorogood and Jeff Chen, MD.

Nutritional Outlook's managing editor, Sebastian Krawiec, interviews Radicle Science co-founders, Pelin Thorogood and Jeff Chen, MD. Radicle Science has been selected as this year's Best of the Industry, Service Provider. 

Katrina Emmel

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