FDA Grants Notification of GRAS to Alltech's Sel-Plex®
Lexington, KY - In recognition of Alltech's extensive research data on the safety of its flagship brand Sel-Plex®, the FDA's Center for Food Safety and Applied Nutrition has granted notification of GRAS for the use of Sel-Plex® as a human food additive. Sel-Plex® is a selenized yeast produced by Saccharomyces cerevisiae CNCM I-3060.
"Based on the information provided by Alltech, as well as other information available to the FDA, the agency has no questions at this time regarding Alltech's conclusion that high-selenium yeast is GRAS under the intended conditions of use," stated Dr. Mitchell Cheeseman, acting director of the Office of Food Additive Safety at the FDA's Center for Food Safety and Applied Nutrition, in a notification letter sent to Alltech.
"We are delighted with this notification, which serves to reaffirm the confidence Alltech and its customers have in Sel-Plex®," said Steve Traylor, Alltech's director of regulatory affairs. "Alltech is committed to pioneering research and development as well as the manufacturing of traceable, high quality ingredients that are safe for the animal, consumer and environment and in compliance with the highest regulatory standards in the United States and around the world."
Sel-Plex® is the only FDA reviewed form of organic selenium and was the first product of its kind to receive European Union (EU) authorization as a nutritional feed additive for use in all species diets under EU regulation 1750/2006. It is the only product with safety and toxicity data that has been FDA-reviewed and EU-approved. Additionally, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition, and Allergies (NDA) has accepted health claims linking the dietary intake of Sel-Plex to: "protection of DNA, proteins, and lipids from oxidative damage, normal function of the immune system, normal thyroid function and normal spermatogenesis."
"Sel-Plex® has been used effectively in animal nutrition for more than 18 years, and we are grateful that the FDA's experts recognized the wealth of safety and efficacy data behind this product," said Suniti Mujumdar, Alltech's global brand manager for Sel-Plex®. "The notification of GRAS moves Sel-Plex® into a host of new nutrition opportunities in human health, including application in medical foods."
Selenium is considered an essential nutrient for both humans and animals, aiding in the body's metabolism, immunity, growth and reproduction. Selenium in the safe, organic form of Sel-Plex® is considered to be more bioavailable to the animal or human, more digestible and better retained without risk of toxicity.
For more information, visit www.Sel-Plex.com.
Founded by Dr. Pearse Lyons, Alltech is a global animal health and nutrition company with more than 30 years' experience in developing natural products that are scientifically proven to enhance animal health and performance. With more than 2300 employees in 125 countries, the company has developed a strong regional presence in Europe, North America, Latin America, the Middle-East, Africa and Asia. For further information, visit alltech.com.For media assets, visit www.alltech.com/press.
Press Contact:
Susanna Elliott
Corporate PR Manager, North America
Alltech Corporate Headquarters
3031 Catnip Hill Pike
Nicholasville, Kentucky
United States
Telephone: (859) 887-5144
Mobile: (859) 473-2696
Email: SuElliott@alltech.com
Web site : www.alltech.com
