Digexin digestive regularity claims confirmed by third-party regulatory compliance firm

In a recent press release, NXT USA disclosed that their ingredient Digexin, has received independent third-party substantiation of their claims from REJIMUS, Inc., which is a US regulatory compliance firm that focuses on dietary supplement marketing language.

REJIMUS’ claims substantiation dossier covers the human research that was performed and discusses the clinical evidence that supports how Digexin, a patented blend of tender okra pods (Abelmoschus esculentus) and winter cherry (Withania somnifera), can help benefit gastrointestinal health and function.

“This is extraordinary for a digestive health product,” said Eric Anderson, Managing Director of NXT USA. “May help with occasional constipation, bloating and gas’ is the province of every probiotic. Digexin is not a probiotic nor a laxative yet assures the consumer that within seven days they will be experiencing physical comfort, regular bowel movements, and overall increased well-being. With 40% of Americans still experiencing all too regular digestive discomfort, Digexin offers a new approach to the category that customers can count on.”

According to the press release, REJIMUS regulatory experts verified the scientific and clinical data such as those involving structure-function claims utilized in dietary finished products in the US market:

• Helps achieve daily regularity in seven days
• Helps relieve symptoms associated with occasional constipation in as little as seven days
• Helps reduce occasional gastrointestinal discomfort in as little as seven days
• Helps relieve occasional gas and bloating in as little as seven days
• Supports overall digestive comfort and regularity

Two clinical trials studying adults with occasional constipation investigated the okra pods and winter cherry ingredient’s effects on stress-sensitive digestive pathways, gut motility, and inflammation.^1,2 Both studies witnessed improvements in the participants by day seven with positive results being continued to be reported through day 14 and day 60.

“With this independent evaluation, brands formulating with Digexin can market with strong claims backed by human clinical research,” said Anderson. “We’ve invested heavily in comprehensive clinical research—we call it our ‘Four Pillars of Validation’—because consumers deserve products that actually work and brands that they can trust to keep working. And because our science delivers real-world results, our science sells supplements.”

With REJIMUS’s claims substantiation dossier, the firm’s review “provides compliant, ready-to-use claim language for finished products in accordance with the recommended use.”

“Digexin has extensive clinical and scientific evidence that supports the distinct structure-function claims that truly separates this ingredient from all others in the category,” said Brandon Griffin, CEO of REJIMUS. “The clinical studies performed demonstrate significant improvements can begin within 7 days of use. These benefits are reinforced by mechanistic research showing multiple benefits, all contributing to better digestive health and function.”

“This gives supplement companies confidence that they can communicate with consumers in a way that attracts new customers—and keeps them,” said Anderson. “When claims are backed by solid clinical and scientific evidence as well as verified independently, they become a real brand differentiator and the key to boosting consumer loyalty.”

“Our competition isn’t other ingredient suppliers in this category—it’s the mindset of end-consumers thinking that their gut health challenges have limited or no viable self-care solutions,” Anderson explained in the press release. “If the dietary supplement industry wants lasting credibility, brands and their supply-chain partners have to invest in real clinical research and third-party scientific validations. No brand wants an FDA Warning Letter or a class-action lawsuit, and the process we follow for our ingredient development helps ensure our downstream partners can confidently make strong structure-function claims that sell supplements—and genuinely change lives.”

References

1. Raghu, S. Chadalawada,A., Siddabattuni, K., Naga Gogineni,T. (2023) A blend of Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit extracts relieves constipation and improves bowel function: A proof-of-concept clinical investigation,Journal of Ethnopharmacology, Volume 318, Part B, 2024, 116997, ISSN 0378-8741,https://doi.org/10.1016/j.jep.2023.116997
2. Singh, G., Dixit, I., Kalman, D., & Gogineni, N. T. (2024). A Novel Herbal Composition Alleviates Functional Constipation, Reduces Gastrointestinal Transit Time, and Improves Bowel Function in Adults: A Double-Blind, Randomized Clinical Study. Journal of the American Nutrition Association, 43(6), 553–566. https://doi.org/10.1080/27697061.2024.2346073