Probiotic strain from Kaneka Probiotics and AB Biotics receives “no questions” letter from FDA

Earlier this month, Kaneka Probiotics and AB Biotics announced the receipt of a “no-questions” letter from the U.S. Food and Drug Administration in response to their conclusion that the probiotic strain Lactobacillus plantarum DR7 is Generally Recognized as Safe (GRAS). The patented strain can be used as an ingredient in conventional foods. Kaneka is an affiliate company of AB Biotics.

“With this robust scientific backing, our L. plantarum DR7 strain offers a valuable tool for formulators of supplements and functional food and beverage,” stated Jordi Riera, chief business officer at Kaneka Probiotics, in the press release. “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^1,2. 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.”

Studies have previously been done on the strain’s effects on stress and anxiety, gut microbiota, and immune response. A 12-week randomized, double-blind and placebo-controlled human study published in 2019 demonstrated a reduction in stress and anxiety in adults, improved memory and cognition function, as well as the effects on brain neurotransmitter pathways for serotonin and dopamine-norepinephrine.³ Additionally, a 2020 study examined the correlation of the strain’s effects on gut microbiota and gene expressions of enzymes involved along serotonin and dopamine neurotransmitter pathways.⁴ Another 2019 randomized, double-blind, placebo-controlled study showed the strain’s immunomodulatory and anti-inflammatory effects.⁵

“This regulatory win comes at a time when FDA recognition of GRAS status is more important than ever,” Riera added.“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.”

In March 2025, U.S. Department of Health and Human Services (HHS) had announced efforts to eliminate independent conclusion of GRAS, with Secretary Robert F. Kennedy Jr. instructing the acting FDA commissioner to explore potential rulemaking for this action.

References

1. Grand View Research (2023).Brain Health Functional Food And Beverage Market Size, Share & Trends Analysis Report By Ingredient (Choline, Curcumin), By Product (Dairy, Bakery), By Distribution Channel (Specialty Stores, Online), And Segment Forecasts, 2023 - 2030. Available at: Brain Health Functional Food And Beverage Market Report 2030
2. Grand View Research, (2023).Brain Health Supplements Market Size, Share & Trends Analysis Report by Product (Natural Molecules, Vitamins & Minerals), by Application (Memory Enhancement, Attention & Focus), by Region, and Segment Forecasts, 2023 – 2030. Available at: Brain Health Supplements Market Size & Growth Report, 2030
3. Chong, HX.; Yusoff, NAAA.; Hor, YY.; Lew, LC.; Jaafar, MH.; Choi, SB.; Yusoff, MSB.; Wahid, N.; Abdullah, MFIL.; Zakaria, N.; Ong, KL.; Park, YH.; Liong, MT. Lactobacillus plantarum DR7 alleviates stress and anxiety in adults: a randomised, double-blind, placebo-controlled study, Beneficial Microbes, 2019, 10(4). DOI: 10.3920/BM2018.0135
4. Liu, G.; Chong, H.-X.; Chung, F.Y.-L.; Li, Y.; Liong, M.-T. Lactobacillus plantarum DR7 Modulated Bowel Movement and Gut Microbiota Associated with Dopamine and Serotonin Pathways in Stressed Adults. Int. J. Mol. Sci. 2020, 21(13). DOI: 10.3390/ijms21134608
5. Chong, HX.; Yusoff, NAAA.; Hor, YY.; Lew, LC.; Jaafar, MH.; Choi, SB.; Yusoff, MSB.; Wahid, N.; Abdullah, MFIL.; Zakaria, N.; Ong, KL.; Park, YH.; Liong, MT, Journal of Dairy Science. 2019, 102(6).DOI: 10.3168/jds.2018-16103