Hitex, a subsidiary of Lavipharm Group, and P.L. Thomas announced today that Lipowheat oil™ natural ceramides has achieved NDI (New Dietary Ingredient) status after the recent application with the Food and Drug Administration (FDA). The FDA filed the NDI without objection. Lipowheat oil ™ is the only source of natural ceramides on the market with an NDI on file.
Dr. Athanase Lavidas, Chairman & CEO of Lavipharm, mentioned that “the NDI is a significant milestone in Hitex history. It represents recognition of our efforts to research and develop ingredients and products that optimize effectiveness and safety for human use. Since 2000, Lavipharm has invested in Supercritical Fluids and green technologies and development design acting proactively to the imperative need for environmentally friendly and natural food supplements and dermocosmetic products”.
François Laimay, Hitex R&D Director, underlined that “The Lipowheat™ R&D strategy integrated regulation aspects at the early stages of development. This NDI gives us a clear and obvious confirmation of this development design. Hitex’s Lipowheat™ is more than an ingredient, as its identity combines innovative actives –ceramides-, science, regulation, internal and external applications, and easy-to-formulate functionalities.“
Patented and scientifically supported by three clinical studies, Lipowheat ™ oral delivery of ceramides restores the skin barrier function, ensuring a healthy hydration mechanism. It fights against signs of aging and leaves skin soft and supple.
Dierdre Allen, President of Canadian American Resources, LLC, the consultant company, which prepared the NDI file for submission, said: “Our review of pre-NDI submission of Hitex’s Lipowheat oil™ data indicated that this was a solid entry. The quality of research behind this ingredient should set a standard for the industry.”