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Bacillus Coagulans

Low concern

Multiple Bacillus coagulans strains have FDA GRAS Notices (e.g., GBI-30 6086 in GRN 660, SNZ1969 in GRN 597 and 864). Toxicology studies establish NOAEL above 1,000 mg/kg/day with no genotoxic, mutagenic, or clastogenic effects.

Found in

1,406 products

What it is

Spore-forming, lactic-acid-producing probiotic bacterium (formerly classified as Lactobacillus sporogenes). Heat- and acid-stable, allowing survival through processing and digestion.

Probiotic ingredient in foods and supplements; transient colonizer of the gut.

Why it's flagged

theoretical caution in severely immunocompromised individuals (general probiotic caution)

What regulators actually say

"FDA has no questions at this time regarding [Ganeden's] conclusion that Bacillus coagulans GBI-30, 6086 is GRAS under the intended conditions of use."

FDA GRAS Notice 660 - Bacillus coagulans GBI-30, 6086 — fda.gov

"Toxicological safety assessment results indicate that B. coagulans does not demonstrate mutagenic, clastogenic, or genotoxic effects... NOAEL greater than 1000 mg/kg per day."

FDA GRAS Notice 597 - Bacillus coagulans SNZ1969 spores preparation — fda.gov

Regulatory status

United States — FDA

GRAS via FDA no-objection letters (GRN 660, 597, 864).

European Union — EFSA

Several B. coagulans strains assessed under QPS approach; permitted as feed additive and probiotic.

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