Deerland Receives GRAS No-Objection Letter from FDA for Probiotic DE111®
Deerland is proud to announce that the FDA has 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 that they do not question the basis for the GRAS self-affirmation notification established and submitted by Deerland.
Through the GRAS notification program, 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 Recognized 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.
“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.
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.
About DE111® and Deerland Probiotics & Enzymes
DE111 is a genome sequenced and clinically tested strain of Bacillus subtilis, a probiotic spore that supports digestive and immune health. The genome sequencing confirmed the strain contained no plasmids, antibiotic resistant or deleterious genes; multiple human clinical studies support the strain’s benefits for digestive and immune health, including supporting regularity, controlling microbial populations in the gut while optimizing digestion, and improvements in body composition, strength and recovery in athletes. DE111 has the ability to form spores that protect the microbes from harsh conditions until they enter an environment ripe for germination, such as the GI tract. Because of this spore-forming ability, DE111 remains viable under a wide temperature and pH range, making it ideal for use in supplements as well as food and beverages.
Deerland Probiotics & Enzymes, based in Kennesaw, Ga., specializes in developing science-backed solutions that benefit microbiome health, using probiotic, prebiotic and enzyme technology. The company offers a line of unique, clinically supported branded products, including DE111®, PreforPro®, ProHydrolase®, Solarplast® and Glutalytic®. Deerland collaborates with customers to develop innovative and often proprietary solutions in the dietary supplement and food and beverage markets. In addition to branded ingredients and customized formulations, Deerland offers full turn key manufacturing services, including bulk blends, capsules, stick packs and tablets; as well as bottling and labeling. To contact Deerland Probiotics & Enzymes, call 800.697.8179 or visit www.deerland.com.
