NXT USA announced that Digexin, a patented blend of tender okra pods and ashwagandha, received third-party substantiation of its claims from Rejimus, Inc., a U.S. regulatory compliance firm that specializes in marketing language for dietary supplements.

Human research conducted on Digexin strongly supports claims that the herbal combination can improve gastrointestinal health and function. Rejimus affirmed that finished product brands that utilize the recommended dosage can make structure-function claims that are unique in the digestive health category, both in terms of the breadth of benefits and the speed of efficacy.

“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.”

Rejimus confirmed that Digexin is supported by reliable scientific and clinical evidence, including multiple double-blind, placebo-controlled human trials (published in 2023 and 2024, substantiating the following structure-function claims intended for supplements in the U.S. market:

• Helps achieve daily regularity in 7 days
• Helps relieve symptoms associated with occasional constipation in as little as 7 days
• Helps reduce occasional gastrointestinal discomfort in as little as 7 days
• Helps relieve occasional gas and bloating in as little as 7 days
• Supports overall digestive comfort and regularity

These claims are based on two clinical trials involving adults with occasional constipation, and a mechanistic review outlining the ingredient’s effects on gut motility, inflammation, and stress-sensitive digestive pathways.

“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.”

The claims substantiation dossier from Rejimus provides ready-to-use claim language for finished products in accordance with recommended use which aligns with federal requirements.

“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 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.” Rigorous substantiation will be a baseline requirement in future dietary supplement marketing, Anderson noted. “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. 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.”