FDA Approves Sel-Plex? for Sheep and Goats
[Lexington, KY] - The Food and Drug Administration recently gave Alltech a letter of non-objection for the use of Sel-Plex? in the diets of sheep and goats. This follows a similar letter from the FDA to Dr. Karl Dawson, Alltech director of worldwide research, which states the FDA's non-objection to the use of selenium yeast in the diets of poultry, swine, dairy, beef, and equine diets. The FDA clearance follows the assertion by the Center for Veterinary Medicine (CVM) who will not "object to the inclusion of selenium yeast in complete feeds of sheep or goats at a level not to exceed 0.3 ppm added selenium." The CVM based its assertion on the information derived from the studies on Sel-Plex that Alltech submitted to the FDA which resulted in the 2003 approval for the selenium yeast product in beef and dairy cattle, and on the information from studies with
Sel-Plex that Alltech submitted leading to the approval of the product in chicken, turkey, and swine feeds, which occurred in 2000 and 2002.
"We are very proud of the fact that Sel-Plex was used to set the standard for the federal regulations and AAFCO definition. Alltech is very excited about this clearance, because Sel-Plex represents a nutritional breakthrough that will help professionals address problems of marginal selenium status that affect health and productivity of all sheep and goats, particularly pregnant ewes and newborn lambs," said Dr. Dawson. "It should also be noted that since laboratory analyses have clearly established that the distribution of selenium in various selenium yeast products is different, and it has been established that not all selenium yeast products are same, the FDA's review of the Sel-Plex data should give customers confidence when making their buying decisions."
The selenium in Sel-Plex is in the same form that is naturally present in plants such as pasture grasses, wheat and soybeans, because it is biosynthesized by yeast. These forms include selenoamino acids and related compounds. Sel-Plex selenium is more digestible and better retained in tissues than inorganic forms of selenium, which lets the animal build nutrient reserves against periods of increased demand without risking toxicity.
The year 2005 marks Alltech's 25th anniversary in the animal feed and food business. In the span of those 25 years Alltech has grown into a multinational company with offices and distributors in 85 countries and more than 1,500 employees around the world. Alltech focuses on three pillars of its business: Research, Marketing, and Production. In 2004, seven students ( five Ph.D., two M.Sc.) completed graduate course work funded wholly or in part by Alltech. Coupled with more than 400 controlled field and university trials in 2004, Alltech's commitment to research is as strong as ever. Alltech also values local production, which has lead to the development of 14 production facilities around the world, with two more to be completed in 2005.