08.19.19
Deerland Probiotics and Enzymes, a leading formulator and contract manufacturer of enzyme-based diet supplements, announced the U.S. Food & Drug Administration (FDA) issued a GRAS (Generally Recognized 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 it does not question the basis for the GRAS self-affirmation notification established and submitted by Deerland. Simply stated, the FDA has reviewed all of the scientific data on DE111, and had no questions or concerns regarding its safety.
Through the GRAS notification program, companies voluntarily submit self-affirmation documentation dossier, substantiated by extensive research and independent, qualified subject matter expert review, that a specific ingredient is Generally Recognized As Safe.
“We are excited to receive the FDA’s no objection letter for DE111,” said Scott Ravech, CEO of Deerland. “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 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. Further, DE111 is Star-K Kosher certified and Non-GMO Project verified.
A “Letter of No Objection” refers to the letter sent by the FDA confirming it does not question the basis for the GRAS self-affirmation notification established and submitted by Deerland. Simply stated, the FDA has reviewed all of the scientific data on DE111, and had no questions or concerns regarding its safety.
Through the GRAS notification program, companies voluntarily submit self-affirmation documentation dossier, substantiated by extensive research and independent, qualified subject matter expert review, that a specific ingredient is Generally Recognized As Safe.
“We are excited to receive the FDA’s no objection letter for DE111,” said Scott Ravech, CEO of Deerland. “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 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. Further, DE111 is Star-K Kosher certified and Non-GMO Project verified.
