The Food and Drug Administration (FDA) responded with a “no questions” letter acknowledging that it has no present objections to Kaneka Probiotics’ and AB-Biotics’ declaration that the probiotic strain Lactobacillus plantarum DR7 is Generally Recognized as Safe (GRAS).

The GRAS declaration affirms that the ingredient is suitable for use in conventional foods without additional safety approvals.

“This regulatory win comes at a time when FDA recognition of GRAS status is more important than ever,” said Jordi Riera, chief business officer at Kaneka Probiotics.  “As policymakers are moving to potentially eliminate the self-affirmation process, this FDA ‘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.”

L. plantarum DR7 has been assessed in three clinical studies, with evidence suggesting it supports certain digestive, respiratory, and cognitive health outcomes.

For example, in one randomized, double-blind, placebo-controlled study, adults receiving the strain for 12 weeks experienced reductions in stress and an improved stress response compared to the placebo group. A subsequent study found that the probiotic was able to modulate levels of key enzymes involved in the production of neurotransmitters in ways that may support serotonin and dopamine production.

“With this robust scientific backing, our L. plantarum DR7 strain offers a valuable tool for formulators of supplements and functional food and beverages,” Riera said. “The market for cognitive support in these categories is projected to grow annually by more than 10% over the next 5 years, with products that offer benefits regarding stress support receiving particular interest from consumers. 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.”