Oliphenol LLC’s Announces HIDROX® as a GRAS Food Ingredient
HAYWARD, CALIFORNIA, UNITED STATES: Oliphenol LLC is pleased to announce that the Company has received a “No Question” Letter from the FDA, dated 12.10.21 for its GRAS Notice No. GRN 000978. The Company’s notice, submitted last November 2020, was for use of its hydrolyzed aqueous Olive Pulp extract, called Hidrox®, as an ingredient in foods.
Hidrox®, a proprietary blend of natural olive polyphenols, is obtained from the juice of the olives subjected to mild acidic hydrolysis and has been shown in the course of the last decades, to provide unique antioxidant, anti-inflammatory, and antimicrobial benefits when used as a dietary supplement. The manufacturing process of Hidrox® was discovered by Prof. Roberto Crea in early 2000, covered by several US and International patents, and the resulting product commercialized under the brand names of Hidrox® and Olivenol™ for dietary supplement applications and cosmetic/skincare products. The Company has requested the FDA to review its GRAS (Generally Recognized As Safe) dossier for Hidrox® for extending its use as an antioxidant and food ingredient in many food categories. FDA concluded, based upon the scientific evidence provided by Oliphenol LLC and additional data available, the Agency has no questions for the use of Hidrox® as a GRAS ingredient in foods.
“Olive polyphenols have become a familiar name in the food industry for their several attributes, including antioxidants, anti-inflammatory and antimicrobial natural agents” declares Dr. Crea “in order to provide them for foods and beverages you need to ascertain their safety first. The FDA has recognized that based on scientific evidence and historical use of hydrolyzed olive pulp extract, the resulting product can be indeed considered safe when used appropriately in human foods”.
“Next step will be to work with the food and nutritional health industry” continued Dr. Crea “to promote the various benefits of olive polyphenols in the daily food consumption with the support of solid science”.
To make Hidrox®, Oliphenol uses olives grown organically in California and uses the juice of the olives after the removal of oil and natural debris, to produce Hidrox powder (9 to 12% Total Polyphenols) and concentrated liquid Hidrox 10X (7.5 to 8% Total Polyphenols) by a process that is also organic, Halal and Kosher.
Oliphenol GRAS notice is only the second one that received the nod by the FDA, after DSM Nutritional Products in 2015, for an olive formulation rich in natural hydroxytyrosol and other polyphenols, directly obtained from the fruit of the olive. Two other companies have filed with FDA for the GRAS of pure/purified Hydroxytyrosol, chemically and/or microbially produced.
