In February 2022, the active ingredient diamine oxidase – or DAO – produced by AB Biotek’s DR Healthcare division, as well as the solutions derived from it, have obtained the GRAS (Generally Recognized As Safe, per sections 201(s) and 409 of the U.S. Food & Drug Act) qualification from the U.S. Food & Drug Administration. This allows for the upcoming launch in the U.S. marketplace.
From the FDA regulations 21 CFR 170.3 and 21 CFR 170.30, the use of a food substance may be GRAS through scientific procedures and scientific evidence and is based on in published studies.
Additionally, at the same time, the Directorate-General for Hygiene, Food Safety & Nutrition in Rome, Italy, and the Ministry of Finance, Economy & Recovery in Paris, France, both approved the launch of DAO products in those two countries.
These three steps represent new support for continued international expansion of DR Healthcare’s solution portfolio targeting consumers with DAO deficiency.
DAO – an enzyme naturally secreted by the human body – is frequently used as a nutritional supplement to treat disorders from histamine accumulation including migraines, fibromyalgia, irritable bowel syndrome (IBS), atopic skin or even attention deficit hyperactivity disorder (ADHD). Approximately 15 percent of the population suffers from a DAO deficiency, both genetic and acquired.
About DR Healthcare
Founded in Barcelona, Spain, in 2007, DR Healthcare is a biomedical company specialized in medical nutrition and dedicated to the research, development, innovation, marketing and licensing of new nutraceuticals, functional foods, active ingredients and customized solutions. Our medical nutrition products are aimed at dietary management of chronic diseases, physiological dysfunctions and/or metabolic diseases, mainly associated with metabolic disorders caused by a deficiency of the intestinal enzyme diamine oxidase (DAO). DR Healthcare also produces DAO for both human and animal use and offers proprietary solutions for the food, veterinary and animal health industries. More information is available at www.dr-healthcare.com/en.
About AB Biotek
AB Biotek contributes to the success of customers through the delivery of customized fermentation-based, sustainable solutions containing proprietary and/or purposefully sourced microorganisms to created differentiated food, beverage, health & nutrition business opportunities. Science and advanced microorganism fermentation technology are core enablers. AB Biotek has commercial scale production and research development facilities located around the world. For more information about our product applications and unmatched technical service capabilities, please visit www.abbiotek.com.