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Safety substantiation requirements for finished cosmetic products to comply 
with The Modernization of Cosmetics Regulations Act (MoCRA).

Keeping up with MoCRA

Industry and FDA share the same goal: to ensure a safe dietary supplements marketplace. 

FDA: Friend, Not Foe to Dietary Supplement Industry

Thanks to the efforts of one industry firm, self-affirmed GRAS records are now compiled in one, collective database.

Read about a New Database to Keep Track of GRAS Self-Determinations

By developing proper SOPs for laboratory qualification, industry can hopefully work to eliminate the problem of "dry labbing" altogether.

Dietary Supplement Testing: How to Detect “Dry Labbing”

Testing dietary supplements for quality, safety, and efficacy.

Testing for Dietary Supplements: Natural Concerns

GRAS Affirmation and the Development of Functional Foods

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

The Danish grower, manufacturer, and supplier of Nordic berries, Asiros Nordic, has announced that its prebiotic berry juice powder are now authenticated with nuclear magnetic resonance (NMR) technology. Polyphenol-fingerprinting with NMR is considered by many research scientists to be among the most accurate analytical tools used for botanical identification testing, ensuring purity, authenticity, and consistency.

“We believe that these NMR-authenticated powders will be a valuable addition to the dietary supplement and functional food-and-beverage markets,” said Jan Kuhlmann CEO of Asiros Nordic, in a press release.

The company’s prebiotic juice powders are derived from elderberry, 

, aronia, lingonberry, as well as red and black currant. They are available in both conventional and organic, are non-GMO, gluten-free, and vegan.

“Our vertical integration starts with carefully hand-selected berries that are harvested at the peak of ripeness from local farmers in Denmark and the forests of Sweden followed by a proprietary low-temperature process that ensures that the natural nutrients, bioactive compounds (including polyphenols) and flavors of the berries are preserved,” added Kuhlmann. The products can be incorporated into a variety of products that include 

Updated on July 26, 2024 at 7:29AM. A previous version of this article had a typographical error in the title. 

Polyphenol-fingerprinting with NMR is considered by many research scientists to be among the most accurate analytical tools used for botanical identification testing, ensuring purity, authenticity, and consistency.

Asiros Nordic’s prebiotic berry juice powders will now be authenticated with nuclear magnetic resonance

 found that supplementation with krill oil concentrate raise the omega-3 index of patients with systemic lupus erythematosus (SLE). The study was conducted at 20 research centers in the United States by Aker BioMarine and the Lupus Clinical Investigators Network (LuCIN) with oversight by Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance (LRA), and additional support from AMPEL BioSolutions in planning, execution, and reporting on the study.

In the multicenter, double-blind, placebo-controlled trial, 78 adult SLE patients were given either 4 grams of the krill oil extract (SuperbaBoost from Aker BioMarine, based in Kysaker, Norway) or placebo for 24 weeks. Changes in red blood cell Omega-3 Index was the primary outcome, however researchers also monitored SLE Disease Activity Index 2000 (SLEDAI-2K) disease activity scores as well. 

Results showed that patients taking the krill oil experienced significant increases in their Omega-3 Index as early as four weeks. At baseline, mean Omega-3 Index was 4.43%. After four weeks, those taking the krill oil saw their Omega-3 Index increase to 7.17%. After 24 weeks, their Omega-3 Index was 8.05%. No significant changes were observed in the placebo group. After 24 weeks, those in the placebo group were given the option to switch to krill oil for an additional 24 weeks. Those that did saw a rapid increase in Omega-3 Index from 4.63% to 7.50%.

When it came to disease activity, there were no significant changes in the study population overall, however those that had the strongest disease activity at baseline did see significant decreases in SLEDAI-2K following krill oil supplementation compared to placebo at four, eight, and 16 weeks, respectively.

“This clinical study is hopeful for the estimated 5 million people worldwide living with lupus,” said Line Johnsen, senior vice president of Human Health Ingredients R&D for Aker BioMarine, in a press release. “We were pleased to work with the Lupus Research Alliance and the clinical affiliate Lupus Therapeutics to conduct the study. We were also pleased to see that in a small subset of study participants with severe lupus, phospholipid-rich krill oil temporarily lessened the severity of symptoms associated with the disease while increasing the Omega-3 Index.”

“It’s gratifying that we were able to correct the deficiency of Omega-3 fatty acid levels in lupus patients,” said principal investigator Jane E. Salmon, MD, director of the Lupus APS Center of Excellence and co-director of the Mary Kirkland Center for Lupus Research, at Hospital for Special Surgery, in New York.“Restoring these levels has the potential to influence cardiovascular risk and there are suggestions that it improves disease activity. The clinical benefits must be demonstrated in future studies.”

Salmon, J.; Wallace, D.J.; Rus, V.; Cox, A.; Dykas, C.; Williams, B.; Ding, Y.; Hals, P.A.; Johnsen, L.; Lipsky, P.E. Correction of omega-3 fatty acid deficiency and improvement in disease activity in patients with systemic lupus erythematosus treated with krill oil concentrate: a multicentre, randomised, double-blind, placebo-controlled trial. 

The study was conducted at 20 research centers in the United States by Aker BioMarine and the Lupus Clinical Investigators Network with oversight by Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance.

Krill oil supplementation raises Omega-3 Index of Lupus patients in recent study

Glutathione is becoming more and more well known among consumers, but some of us are still strangers to this extremely powerful antioxidant. It supports our body’s natural defenses, bolstering our immune system’s natural defense network by fortifying natural killer cells (NK cells).

So while some of us are aware of the power of glutathione, there may still be some benefits that aren’t on your radar yet. Here’s three benefits that you and your consumers could benefit from knowing about:

Cellular metabolism, the process by which cells make energy to perform life processes, involves the chemical breakdown of oxygen molecules. This reaction causes the production of unstable molecules called free radicals. If left un-neutralized, free radicals accumulate in the body, causing oxidative stress, a type of cell damage that can harm DNA, proteins, and other vital molecules. Oxidative stress is associated with the development of immune disorders, aging, and numerous diseases such as rheumatoid arthritis, cataracts, and cancer.

Studies have shown that the body’s natural defenses against free radicals can be supported by increasing levels of glutathione in the body.

analyzing the metabolism of glutathione and its possible effects in cancer therapy, it was revealed that glutathione has a potential protective role for cancer cells and should be considered under medical supervision.

2. May reduce respiratory disease symptoms

Certain respiratory diseases such as asthma and cystic fibrosis have been treated with the medication N-acetylcysteine. It functions as an inhalant, helping to thin mucus and reduce inflammation. 

According to a study analyzing the role of N-acetylcysteine supplements,

 N-acetylcysteine was shown to be a byproduct of glutathione.

3. Reduces cell damage in alcoholic and nonalcoholic fatty liver disease

Glutathione supports the body’s detoxification process by aiding the function of our liver, kidneys, GI tract, and intestines — our body’s major detoxification pathways. But when it comes to the liver, cell death can become exacerbated by a deficiency in antioxidants, including glutathione. Unfortunately, this can lead to fatty liver disease — also known as hepatic steatosis —in those who misuse alcohol and those who don’t.

In a study analyzing both alcohol and non-alcohol related fatty liver diseases

, it was noted that glutathione was effective when given to individuals in high doses. Reductions in malondialdehyde, a marker of cell damage in the liver, were also reported among study participants.

Orally administered glutathione paired with proactive lifestyle changes revealed to have had positive effects on individuals with nonalcoholic fatty liver disease 

. This particular study provided glutathione in supplement form in a dose of 300 milligrams per day for four months.

Make your mark with the standout glutathione, Setria

 Glutathione, by Kyowa Hakko, is a standout antioxidant. Glutathione is a tripeptide found in every cell of the body and it’s critical to preserving cellular integrity. Setria

 supports immune health by replenishing the body’s primary defense system, helps fight oxidative stress, supports healthy respiratory function, and promotes healthy aging and overall health. As the world’s top-selling branded glutathione ingredient, Setria

 stands out from generic glutathione options with its long-standing reputation, high-quality manufacturing, clinical studies, and established safety record.

Three Glutathione Benefits You May Not Know About 

Bioiberica (Barcelona, Spain) has announced self-determination of GRAS (generally recognized as safe) for its Collavant n2 native (undenatured) type II collagen at 40 mg/day. This allows manufacturers in the U.S. to use the ingredient in food and beverage products. The conclusion was reached by an independent panel of scientist who conducted a comprehensive evaluation of the ingredient’s safety data.

“Obtaining self-determined GRAS status for Collavant n2 is a very exciting milestone, both for us and our North American customers,” said Antonio Vendrell, marketing and communication director at Bioiberica, in a press release. “For years we’ve seen the positive impact of our ingredient in the nutraceutical and dietary supplement space, with its low daily dose of just 40mg, neutral sensory properties and evidence-backed, immune-mediated mechanism of action. We’re delighted to now offer these benefits to functional food and beverage brands, and work with them to craft exceptional, collagen-enriched products that speak to the modern health and wellness movement, as well as today’s busy lifestyles.”

This announcement comes in advance of IFT First which is taking place in Chicago, IL between July 14 and 17, 2024. Bioiberica will be at book #2025 in the South Building to exhibit its branded ingredients with its U.S. partner, Lugo Nutrition, Inc.

Bioiberica (Barcelona, Spain) has announced self-determination of GRAS (generally recognized as safe) for its Collavant n2 native (undenatured) type II collagen at 40 mg/day.

John R. Endres

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