Tersus Life Sciences LLC (“Tersus” – Bonita Springs, Florida) announces that its submission demonstrating the safety of its patented and proprietary ingredient, Provinal®, has been accepted by the U.S. Food and Drug Administration under the FDA’s New Dietary Ingredient Notification process.
After rigorous evaluation of significant preclinical and clinical data, the FDA decided that the evidence presented substantiated the safety of Provinal® and accepted the NDI with no objection.
Tersus’ NDI submission process was led and coordinated by Dr. Tina Sampalis, M.D., PhD, Tersus’ Chief Scientific Officer along with the assistance of Clemson University and Harvard School of Medicine, Harvard Public Health. Dr. Sampalis states “We are extremely pleased to achieve such important milestones for Provinal® and Tersus. On one hand, the safety of Provinal is acknowledged by the US-FDA. Furthermore, we are proud that Tersus is the first ever company to prove that ethyl esters comply with the requirements to be classified as a dietary supplement. An achievement that has been considered unattainable in the Industry for many years. The acceptance of both the safety and supplement classification of Provinal® are landmark milestones which, along with the significant international intellectual property protection secured, place Tersus and Provinal® in a high league of their own.”
Unique advantages of Tersus Provinal® to date:
1. First ethyl ester form of fish oil to meet the rigorous NDI notification requirements of the FDA.
2. Novel patented fish oil composition consisting of no less than 50% palmitoleic acid and no more than 1% palmitic acid.
3. Currently supported by 10 issued and enforceable international patents of which seven are in the USA and multiple pending patents worldwide
4. Provinal safety and efficacy are proven by clinical and preclinical studies conducted with the same ingredient as in the commercialized product
Timothy Gooding, CEO and Chairman of Tersus Life Sciences commented, “Receiving NDI status further validates the rigorous path Tersus has always endorsed by reinforcing the importance of evidence-based claims substantiated by preclinical and clinical research. This has been our path over the last five years and continues rigorously today for Provinal®. Achieving NDI status represents another very significant milestone in the development and commercialization of Provinal® and further validates the safety and quality of the product and our regulatory progress being made in multiple jurisdictions.”
Tersus remains committed to substantiating Provinal’s® health benefits with in vitro, in-vivo and human clinical focusing on improvements in blood lipid markers, improved vascular function, eye health and improved glucose metabolism.