TriNutra obtains new health claims for black seed oil on Canadian supplement market

25 Mar 2024 --- Health Canada authorities have granted new structure-function claims for TriNutra’s proprietary black seed oil (Nigella sativa), ThymoQuin. Finished product manufacturers can use the accepted claims to make specific recommendations based on the scientific data presented to the Canadian organization.

Manufacturers using ThymoQuin in an oral supplement (capsule or soft gel) can claim it helps to support healthy liver function, cardiovascular health, healthy glucose levels, stress relief and healthy gut microbiota. They can also claim the supplement helps to moderate general feelings of stress. 

“The granted claims by Health Canada are a confirmation by a highly respected health authority for the benefits one can derive from ThymoQuin. These can be naturally fully leveraged in the Canadian market and be used as testimonials for other markets as well in addition to the already approved novel food safety and claims by the Thai FDA,” Dr. Liki von Oppen-Bezalel, business development director at TriNutra, tells Nutrition Insight.

“Health Canada has approved the dosage form of soft gel capsules, which is also the most convenient. However, ThymoQuin can also be used in a drop bottle and combinations with other (synergistic) actives like omega-3 oils, vitamin D, carotenoids and hemp oil.” 

Health benefits 
The primary active component in black seed oil is thymoquinone. This compound is unstable in the presence of oxidants such as free fatty acids, leading to reduced potency and rancidity of the oil. TriNutra has standardized, stabilized and maintained the natural ratio and balance between the components of its black seed oil. 

ThymoQuin is standardized to 3% thymoquinone, low (<1.25%) free fatty acids and a p-cymene minimum of 1.2%. The ingredient has been clinically tested to support a balanced inflammatory response, improve mitochondrial activity, including adenosine triphosphate production and deliver antioxidant activity and antimicrobial effects.

Authorized health claims include helping to moderate feelings of stress, supporting liver function and heart health.With this clinical backing, Von Oppen-Bezalel explains that TriNutra’s ingredient “responds to the stress management, gut-brain axis and metabolic health markets of dietary supplements.” 

She adds: “ThymoQuin is the only cold-pressed, full-spectrum, standardized black seed oil in the market that meets the US Pharmacopoeia monograph. This means it is the best quality and potency black seed oil available in the market.” 

US patent 
TriNutra also recently received a US patent for the composition of its branded ingredients ThymoQuin, B’utyQuin and ThymoQuin-OCare, as the concentrations of thymoquinone are significantly higher than those obtained in other black seed oils. 

The patent states: “Since many of the therapeutic and health-promoting activities of Nigella sativa oils are related to their thymoquinone content, the oil compositions of the present invention provide a significant technical advance.” 

In addition, the patent concludes that TriNutra’s branded ingredients contain high concentrations of thymoquinone and maintain a full spectrum oil and inherent composition of the oils in the seeds. They are also free from the safety, regulatory, cost-related and other disadvantages associated with other high-thymoquinone black seed oil produced with solvent extraction. 

According to TriNutra, its black seed oil’s specific composition is the result of strict growing, harvesting and proprietary manufacturing processes. 

Morris Zelkah, the company’s CEO, concludes: “We are continually pushing for natural product education and ingredient differentiation through our unique growing conditions, proprietary processing and ongoing research to ensure a more potent, stable, bioavailable and efficacious product for the end consumer.”

By Jolanda van Hal