NXT USA has received independent third-party testing to back the claims of its patented blend of tender okra pods (Abelmoschus esculentus) and winter cherry (Withania somnifera), Digexin, in supporting digestive health. This enables brands to use “compliant, ready-to-use claim language” for finished products in accordance with the supplement’s recommended use in the US.
Digexin is “neither a probiotic nor a laxative,” but claims to ease physical discomfort related to an upset stomach within seven days. It simultaneously relieves various symptoms often associated with occasional constipation, including occasional gastrointestinal discomfort, gas, and bloating.
Human research conducted on Digexin produced clinical evidence supporting the herbal formula’s “expeditious” support for these gastrointestinal health functions.
“This is extraordinary for a digestive health product,” says Eric Anderson, managing director of NXT USA. “‘May help with occasional constipation, bloating, and gas’ is the province of every probiotic.”
“With 40% of Americans still experiencing all too regular digestive discomfort, Digexin offers a new approach to the category that customers can count on.”
Rejimus, a US regulatory compliance firm overseeing responsible dietary supplement marketing, provided the claims substantiation dossier. It affirms that “solid research on Digexin can lead to strong claims by supplement finished-product brands that utilize the recommended usage.”
Clinical evaluations
Rejimus’ regulatory experts confirm that Digexin is backed by reliable scientific and clinical evidence, comprising double-blind, placebo-controlled human trials.
These include 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,” says 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.”
Compliant claims
After evaluating Digexin’s clinical studies alongside the published literature, Rejimus issued a comprehensive Claims Substantiation Dossier aligning with US federal requirements for marketing adequately substantiated claims.
“This gives supplement companies confidence that they can communicate with consumers in a way that attracts new customers — and keeps them,” says 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.”
Digexin won the SupplySide West 2023 Ingredient Idol competition for “best-in-class” ingredient in the microbiome category, based on its science, innovation, and market potential.
“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,” says Anderson.
“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.”
