TriNutra, the supplier of the first cold-pressed black seed oil standardized to 3% thymoquinone, announced it achieved self-affirmed GRAS (Generally Recognized as Safe) status for its black seed oil, Thymoquin.
 
TriNutra, with assistance from Marc C. Sanchez, the founder of Contract In-House Counsel and Consultants, LLC, engaged experts to proactively gather and provide the scientific evidence necessary to affirm the FDA designation. The independent panel declared Thymoquin 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,” Morris Zelkha, co-founder of TriNutra, said. “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 program to produce plants with higher thymoquinone content than other more common varieties. Through a proprietary cold-press extraction process, ThymoQuin is able to be standardized 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,” Chris Holland, VP of sales at Barrington Nutritionals, the North American distributor of ThymoQuin, said. “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 like Thymoquin with which to improve new and existing formulations.”