PRESS RELEASE
Hitex’s Lipowheat oil™ natural ceramides receives NDI (New Dietary Ingredient) Status
April 6, 2010………………………………….. Paris, France and Morristown, NJ
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”.
Lipowheat oil™ 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 oil™ 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 oil™ 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. (link to Lipowheat page)
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.”
P.L. Thomas is the exclusive marketer for Lipowheat oil™ in North America. “The nutricosmetic category, to which Lipowheat oil™ belongs, is gaining acceptance by customers as a convenient skincare product taken orally. In addition, the preclinical research of Lipowheat oil™ indicates that this extract is a versatile topical cosmetic which regenerates and hydrates the skin. The FDA is very selective in filing an NDI application and a successful NDI, as in case of Hitex’s Lipowheat oil™, is still a rarity ”, stated Vladimir Badmaev, MD, PhD, PL Thomas’ Director of Medical & Scientific Affairs,.
Alda Brandao, Head of PLT’s cosmeceuticals and nutricosmetics division, said: “We are proud that Hitex is giving us the opportunity to bring to the cosmetics and nutrition markets a very innovative and clinically-researched ingredient that will ensure the efficacy and safety of finished products.”
Hitex has received two prestigious awards for Lipowheat oil™ including from the SFA scientific committee of French Association of Antioxidants prize for the best Health and Beauty Ingredient in 2007. The committee praised Hitex on the innovation of the product, the quality of clinical studies, as well as its potential in cosmetics and nutricosmetics. In October 2009, Hitex received the award of the best innovation in dietary ingredients for Lipowheat oil™ from Isogone Association in France.
About Hitex
HITEX, a subsidiary of Lavipharm based in France, focuses on high tech and clean extraction technology that answers to the growing demand of safe, innovative, environmental no impact products.
Lavipharm is an integrated Group engaged in the research, development, manufacturing, marketing, sales, wholesaling, and retailing of pharmaceutical, cosmetic and consumer health products in Greece with a strong international activity. Founded in 1911, Lavipharm S.A. is listed on the Athens Stock Exchange since 1995 (ASE : LAVI). Today, Lavipharm holds a prominent position in pharmaceutical technology internationally. Focusing on the research of the technologies of particle design and drug delivery systems, as well as on the development of natural products, Lavipharm develops high technology products always aiming to the improvement of quality of Human life.
HITEX, Lavipharm’s R&D engine in France specialized in Supercritical Fluid and green technologies, combines the benefits of applying these technologies in product development design developing safe and science driven products.
www.Lavipharm.com www.Lipowheat.com www.Hitex-CO2.com

About PL Thomas
PL Thomas, a New Jersey-based ingredient supplier, serves the food/beverage, supplement and cosmetic industries with distinctive, scientifically-supported ingredients which enhance the naturalness and comprehensive functionality of the client formulations.www.plthomas.com
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