NXT USA has announced that Digexin has received independent third-party substantiation of its claims from REJIMUS, a leading US regulatory compliance firm specialising in responsible dietary supplement marketing language.
Digexin is a patented blend of tender okra pods (Abelmoschus esculentus) and winter cherry (Withania somnifera).
The claims substantiation dossier is notable as the human research conducted on Digexin shows robust clinical evidence and support, revealing that the herbal combination can expeditiously improve lives when it comes to gastrointestinal health and function.
REJIMUS affirmed that the solid research on Digexin can lead to strong claims by supplement finished-product brands that utilise the recommended usage.
The structure-function claims of Digexin differ from other ingredients in the gastrointestinal health claim category in both the speed and breadth of beneficial 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.”
The regulatory experts at REJIMUS confirmed that Digexin is supported by reliable scientific and clinical evidence, including multiple double-blind, placebo-controlled human trials.
This substantiates the following structure-function claims intended for use with dietary supplement finished products in the US marketplace:
- 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.
These resulting benefits are based on two clinical trials in adults with occasional constipation and a mechanistic review outlining the ingredient’s effects on gut motility, inflammation and stress-sensitive digestive pathways.
Each study demonstrated meaningful improvements by day seven, with continued gains 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."
"Plus, because our science delivers real-world results, our science sells supplements.”
Third-party regulatory assurance for finished product brands
REJIMUS evaluated Digexin’s clinical studies alongside the published literature and issued a comprehensive Claims Substantiation Dossier that aligns with federal requirements for marketing adequately substantiated claims.
The 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 separate this ingredient from all others in the category,” said Brandon Griffin, CEO of REJIMUS.
“The clinical studies performed demonstrate that significant improvements can begin within seven 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.”
Raising the bar for the supplement industry
Anderson emphasised that creating rigorous substantiation isn’t optional — it’s the future of responsible dietary supplement product development and marketing.
“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,” said Anderson.
“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.”