Kaneka and AB-Biotics’ DR7 probiotic gets FDA nod as gut-brain axis interests surge

Kaneka Probiotics and AB-Biotics reveal the US Food and Drug Administration (FDA) formally acknowledges the safety of Lactobacillus plantarum DR7 — a patented probiotic strain developed in partnership with both companies — and grants it Generally Recognized as Safe (GRAS) status.

According to the companies, the designation, delivered through a “No Questions Letter,” clears the way for the strain’s use in conventional food products across the US without the need for further regulatory approvals.

The GRAS status paves the way for food and beverage formulators to incorporate the probiotic into consumer products targeting gut and brain health.

“This regulatory win comes at a time when FDA recognition of GRAS status is more important than ever,” Jordi Riera, the chief business officer at Kaneka Probiotics, underscores.

“As policymakers are moving to potentially eliminate the self-affirmation process, the FDA’s ‘No Questions Letter’ brings peace of mind to customers and consumers alike that our probiotic strains meet the highest quality and safety standards and are well-researched for their intended application.”

Science-backed benefits

Backed by three clinical trials, L. plantarum DR7 has demonstrated efficacy in promoting digestive, respiratory, and cognitive health. Of particular interest is its impact on the gut-brain axis — the complex communication network linking the gastrointestinal tract to the central nervous system.

The companies stress that in a recent placebo-controlled, double-blind clinical trial, participants who consumed the DR7 strain daily over 12 weeks showed reduced levels of stress and an improved stress response compared to those in the placebo group.The US FDA’s GRAS acknowledgement means the L. plantarum DR7 can be easily integrated into functional F&B products (Image Credit: Kaneka Probiotics and AB-Biotics).

A follow-up study revealed that DR7 modulated enzymes linked to neurotransmitter production, suggesting a role in supporting healthy serotonin and dopamine levels, two key chemicals that influence mood, cognition, and emotional well-being.

“With this robust scientific backing, our L. plantarum DR7 strain offers a valuable tool for formulators of supplements and functional food and beverages,” Riera explains. “The market for cognitive support in these categories is projected to grow annually by more than 10% over the next five years, with products that offer benefits regarding stress support receiving particular interest from consumers.”

Growing gut-brain axis focus

The gut-brain axis has become a growing area of interest in both scientific and wellness communities, as researchers continue to uncover connections between gastrointestinal health and mental function.

The companies point out that the FDA’s recognition of DR7’s safety supports its use in functional foods and reflects a broader shift toward holistic, evidence-based approaches to mental health through nutritional interventions.

The regulatory green light positions Kaneka Probiotics and AB-Biotics to expand the presence of DR7 in the US market and offer brands a clinically studied and clean label ingredient to meet the rising demand for gut-brain support.

“The official FDA recognition of the GRAS status for L. plantarum DR7 means that our customers can quickly tap into this demand, without concern regarding the upcoming changes to GRAS legislation,” Riera concludes.