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Why Third-Party GMP Certification Should Not Be Optional for Dietary Supplement Firms

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 SupplySide West, held in Las Vegas, Nevada from October 29-31, 2024, 

 spoke with Jennifer Clancy, Nutriventia’s head of global marketing, on the technology platforms for five ingredients: Melotime, Prolanza, C-Fence, CaffXtend, and TurmXTRA.

At this event, Nutriventia focused on showcasing the Art of Delivery, their philosophy of combining ingredients, technology, and innovation to deliver health solutions. “Our ingredients are obviously science-backed, but without these unique delivery solutions, it really is leaving the consumer or formulators out there unable to move to the next stage,” explained Clancy. “Our cutting-edge delivery platforms solve formulation challenges, ensuring products are easy to absorb, taste great, and deliver results.”

“Consumers just want to step away from the traditional capsules,” she added. “I think they're inconvenienced. You need water, they’re hard to swallow, and they are quite large, so everyone is really looking for alternatives. What we're highlighting here is our ingredients designed for gummy format, sustained or modified release. We're truly one of the only ones that are able to provide sustained release in the gummy format, dispersible solution, ensuring efficient absorption and maximum bioavailability.” Clancy also noted that there is no sugar added to the gummies and natural flavor is added in.

Melotime, a melatonin ingredient, is one of the time-released ingredients that comes in a gummy format, as well as tablets, capsules, stick packs (powder). It is designed to support 8-hour, restorative sleep and mimic the body’s natural sleep pattern. The release profile ensures up to 50% release in the first hour with a periodic release in a 6-hour interval for maintenance. Clancy also highlighted Nutriventia’s taste masking technology, their solution to melatonin’s bitter taste. Melotime was nominated for the 2024 Nutra Ingredients Awards.

Additionally, the Prolanza ingredient, also known as ashwanova, is an ashwagandha root extract designed for stress management. “It’s sustained release, so over time it's giving you that all-day stress support,” Clancy explained. Practical applications for Prolanza include capsules and stick packs (powder). The ingredient was rebranded as ashwanova and trademarked in New Zealand and Australia to offer better name recognition with regard to ashwagandha. The company is also working on global trademarks to rebrand the ingredient in multiple other jurisdictions. 

Their C-Fence ingredient, a direct compressible granular system, is another example of sustained release technology. “It provides 24-hour immune protection and antioxidant support with 12-hour sustained release for vitamin C. Nutriventia is the only one that is able to provide the sustained release of vitamin C,” Clancy stated. The findings were supported in a pharmacokinetic study, and other health benefits include brain health, cardiovascular health, and skin health.

Nutriventia’s CaffXtend product offers a solution to the diminished effects of caffeine due to its quick absorption in the body, plus caffeine tolerance effects from repeated dosing, known as ‘caffeine crash.’ The one-a-day single dose CaffXtend comes in stick packs (powder), hard capsules, chocolates, with gummies under consideration. CaffXtend is designed to last up to 12 hours, and is reported to reduce consumers’ perception of tiredness, fatigue, and jitters, according to a 2023 clinical study.

TurmXTRA, low dose curcuminoids for supporting joint and muscle health, is a 250mg one-a-day dose with a versatile range of applications, including powdered beverages, stick packs, capsules, tablets, gummies and chews, shots, and RTDs. “That's really what makes us different than the industry, that it’s not 500mg, it's 250mg,” explained Clancy. “You'll see TurmXTRA in a lot of ready to drink sports and active nutrition. We actually just met with the owner of Gold's Gym, and they're introducing two new pre-workout products, both contained through TurmXTRA, and two after workout products.” The ingredient also won NIE New Ingredient Award in 2023 in the Sports Nutrition category and was a finalist for 2023 NutraIngredients USA Awards in the Sports Nutrition category.

A recently published study found that TurmXTRA at 250 mg taken once per day had better absorption compared to a turmeric extract capsules with 500 mg curcuminoids and 5 mg of piperine taken three times per day for a 500 mg daily dosage. The comparison is apt because piperine is often used in combination with curcuminoids to support absorption.

“The heartbeat of our group this year is all around our innovation lab,” Clancy stated. “So we're really able to showcase our ingredients, but in various application formulas to be able to take it one step further and not just be a supplier of ingredients, but really to show at SupplySide West that we can take it one step further and offer concepts and solutions beyond just the brand of ingredient.”

Thanawala, S.; Shah, R.; Doyle, L.; Upadhyay, V. Comparative Pharmacokinetics of Curcuminoids from Water-Dispersible Turmeric Extract Against a Curcuminoids-Piperine Combination: An Open-Label, Randomized, Balanced, 2-Treatment, 2-Sequence, 2-Period Crossover Study. 

At SupplySide West 2024, Nutriventia showcased their innovations for five ingredients. These technologies offer consumers alternatives to traditional supplement forms.

Nutriventia showcases innovative ingredient delivery at SupplySide West 2024

Supplement launches featuring 5-MTHF are on the rise with double digit growth. In this episode of Nutritional Outlook’s podcast, we explore Optifolin⁺, a new ingredient in the market that offers essential nutrition from prenatal through adulthood. Join us as we uncover the potential impact of the next evolution in folate, setting the stage for a healthier future.  

Balchem’s Newest Launch Optifolin⁺® Brings Innovation to the Folate Market 

Balchem’s Newest Launch Optifolin⁺® Brings Innovation to the Folate Market (September 2024)

On October 29, 2024, the Council for Responsible Nutrition (CRN) revealed the results from their 2024 Consumer Survey. According to the report data, three-quarters of Americans utilize dietary supplements and reflects the 75% usage rate that was witnessed in the previous year (1). Conducted by Ipsos, the CRN’s 2024 Consumer Survey highlighted the continuous presence nutritional supplements have in consumers choices in their health and wellness, as well as any changes in decisions with products (1).

“The stability in supplement use reflects the enduring trust that consumers place in our FDA-regulated industry,” Jeff Ventura, Senior Vice President of Communications at CRN mentioned (1). Ventura added that, “At the same time, we continue to see consumers exploring new specialty products and embrace personalized health solutions. This speaks to the evolving landscape of wellness, where supplements are becoming more integrated into individualized health practices.”

 disclosed how almost eight in 10 consumers “…prefer using supplements over over-the-counter or prescription medications whenever appropriate,” (1). Brand loyalty was also shown as 71% of the participants preferred repeatedly using specific brands consistently. The supplements showing increased usage were ashwagandha, magnesium, and prebiotics. This year, ashwagandha rose to 8% use in supplement users which is a significant increase from 2% that was reported in 2020. Utilization of magnesium was 23%, higher than the previous year where data listed usage at 19% (1). The report also mentioned that the use of the sleeping aid, melatonin, rose from 10% which was reported back in 2020, and is now 16%. The press release explained how the results regarding melatonin usage, mean that the supplement is one of the top specialty supplements researched in the Consumer Survey (1).

Information from the survey highlighted that consumers are consistently choosing to turn to nutritional supplements because of health and wellness which was the main reason reported in 2023 as well. In regard to supplement use, young women showed higher usage than men (1). The primary reason for the higher female utilization was displayed in supplement choices that would help benefit hair, skin, and nail health. Aside from those types of supplements, energy and immune health were additionally significant reasons for consumer use, according to the data (1).

According to the press release (1), “…supplement users generally are more likely to report participating in healthy behaviors compared to non-users. Regular users are more likely to report visiting their doctor regularly and trying to eat a balanced diet. While 41% of non-users cite lack of perceived need as the main reason for not taking supplements, a notable portion, 27%, also mentions cost as a barrier. Despite stable overall trust in supplements, non-users report lower levels of confidence in supplement effectiveness and safety compared to prior years, underscoring ongoing challenges in expanding the user base.” CRN performed the report online and in English. It took place from August 7-12, 2024 (1). During that time period, the survey received participation from 3,194 adults. From that pool of responses, there were 2,332 supplement users and 862 non-users. The press release mentioned that the demographics from the 2024 Consumer Survey included, “oversamples of Black, Hispanic, and Asian/Pacific Islander respondents to ensure diverse perspectives,” (1). The survey also measured credibility intervals. For all participants, the credibility interval was ±2.1 percentage points, supplement users was ±2.5 percentage points, and ±4.1 percentage points was reported for non-users (1).

To learn more about the survey, please visit: 

CRN survey shows consistent supplement usage with increase of specialty product use over time 

https://crnusa.org/newsroom/crn-survey-shows-consistent-supplement-usage-increase-specialty-product-use-over-time

The Council for Responsible Nutrition (CRN) revealed the findings from their 2024 Consumer Survey.

Council for Responsible Nutrition discloses 2024 Consumer Survey results showcasing increasing of specialty product usage

 compared different probiotic formulations marketed for the reduction of colic symptoms. The study compared AB-Biotics and Kaneka Probiotics’ probiotic formulation of 

The randomized, multicenter, parallel, single-blind trial was conducted in 112 colicky infants over 21 days. The primary study outcomes of the study were the percentage of responders, defined as a ≥ 50% reduction in crying and fussing time from baseline, as reported by parents in a structured diary, and daily crying and fussing time (minutes/day) on days 7, 14, and 21 after randomization. The results showed that the group taking the BP+PP saw a significantly higher responder rate compared to LR after seven days (61.1% vs. 37.5%) and 14 days (84.6% vs. 59.3%), as well as a significantly lower crying and fussing time after 7, 14, and 21 days.

Jordi Espadaler, director of innovation at AB-Biotics explained to 

 at SupplySide West 2024 that LR is a well-established strain, but that most of its research shows efficacy of breast-fed babies and that research on formula-fed babies taking this strain is scarce. The goal of AB-Biotics was therefore to create a product that showed efficacy regardless of the mode of feeding. Because of the lack of research on formula-fed babies for LR, the company has been unable to accurately compare the different products.

“So, we took a decision some years ago to run a head-to-head clinical study, which is quite standard in pharma where we use them to develop better treatment strategies, but in the dietary supplement that is not common,” said Espadaler. Ultimately, the study’s results showed that BP+PP may be more effective than LR for colicky infants, and “proved that [BP+PP] was effective regardless of the mode of feeding, which was essentially the reason for developing that product from the beginning.”

“This study is the culmination of years of dedicated research and development by our team of experts,” said Sergi Audivert, executive director and co-founder of AB-BIOTICS, in a press release. “Our unprecedented trial comparing the established support for infant colic with our new probiotic solution, not only strengthens the position of our probiotic for colic as the most effective probiotic for colic, but supports our ultimate goal to increase the quality of research around probiotics for infants, ensuring we strive to further alleviate the severity of functional gastrointestinal disorders globally.”

Moreno-Villares, J.M.; Andrade-Platas, D.; Soria-Lopez, M.; Colome-Rivero, G.; et al. Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial. 

The study compared AB-Biotics and Kaneka Probiotics’ probiotic formulation of Bifidobacterium longum KABP®-042 and Pediococcus pentosaceus KABP®-041 to Lactobacillus reuteri DSM17938 (LR) from Biogaia.

Scott Ravech

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