TriNutra, with assistance from Marc C. Sanchez, founder of Contract In-House Counsel and Consultants, LLC, engaged experts to proactively gather and provide the scientific evidence necessary to affirm this important FDA designation.
The independent panel declared TriNutra’s ThymoQuin black seed oil as safe for foods, beverages, and dietary supplement applications.
“We strongly believe in the importance of the standardization of black seed oil, and obtaining GRAS status is an important step toward greater awareness of our ingredient,” said Morris Zelkha, cofounder of TriNutra.
“We take the safety and efficacy of our ingredients very seriously and this allows us to better deliver on our promise to deliver research-supported ingredients at the proper therapeutic dosage.”
For an ingredient to be considered GRAS, scientific data and information about the intended use of the substance must be widely known, and there must be a consensus among qualified experts that the data and information established is safe under the conditions of its intended use.
Black seed oil has been used for thousands of years and recently has seen a resurgence in interest. TriNutra developed a unique Nigella sativa breeding programme to produce plants with higher thymoquinone content than other more common varieties.
Through a proprietary cold-press extraction process, ThymoQuin is able to be standardised to 3% thymoquinone and contains very little fatty acid, delivering a highly potent black seed oil.
“Black seed oil has a history of not only safety but efficacy as well. With this new GRAS status, we hope to continue to develop lasting relationships with a wider range of customers that are looking for top-notch ingredients such as ThymoQuin with which to improve new and existing formulations,” said Chris Holland, VP of Sales at Barrington Nutritionals, the exclusive North American distributor of ThymoQuin.
