In addition to the FDA letter, DE111 has previously received non-Novel Food status in both Canada and Australia, as well as approval as a natural health product ingredient by Health Canada
Deerland Probiotics and Enzymes is proud to announce that the FDA has issued a GRAS (Generally Recognised As Safe) No Objection Letter for its branded probiotic strain, Bacillus subtilis DE111.
A “Letter of No Objection” refers to the letter sent by the FDA confirming that they do not question the basis for the GRAS self-affirmation notification established and submitted by Deerland.
Through the GRAS notification programme, companies voluntarily submit their self-affirmation documentation dossier, substantiated by extensive research and independent, qualified subject matter expert review, that a specific ingredient is Generally Recognised As Safe.
The “Letter of No Objection” means that FDA has reviewed all of the scientific data on DE111, and has no questions or concerns regarding its safety.
Further, DE111 is Star-K Kosher certified and Non-GMO Project verified.
“We are excited to receive the FDA’s no objection letter for DE111. It highlights the extensive research, including the clinical trials that have been conducted by our team, and we are proud of this accomplishment,” said Scott Ravech, CEO of Deerland.