Deerland Probiotics and Enzymes (Kennesaw, GA) has announced that it has received a GRAS (generally recognized as safe) no-objection letter for FDA for its Bacillus subtilis DE111 branded probiotic. The letter was sent in response to a GRAS self-affirmation dossier submitted by Deerland and means that FDA does not question the basis of the GRAS self-affirmation, following a review of the scientific data.
“We are excited to receive the FDA’s no objection letter for DE111,” said Scott Ravech, CEO of Deerland, in a press release. “It highlights the extensive research, including the clinical trials that have been conducted by our team, and we are proud of this accomplishment.”
In addition to this, DE111 has received non-novel food status in both Canada and Australia, and has been approved as a natural health product ingredient by Health Canada.