DSM awaits FDA approval of 'bioactive' vitamin D3 additive for turkey and swine feed
James La Marta, senior manager, regulatory affairs, at DSM Nutritional Products, said the company's application for the use of its 25-hydroxyvitamin D3 in new livestock sectors, should it be successful, will expand the use of an efficacious feed ingredient that benefits both production animals and producers.
The additive, 25-hydroxyvitamin D3, was authorized by the US regulator for use in the supplementation of feed for the US broiler chicken sector in 2007.
It is also sold in other parts of the world as an additive for poultry and swine feed.
25-hydroxyvitamin D3 is a metabolite of vitamin D3, the first step in the metabolism of vitamin D3 into the final bioactive form.
“This material is a more efficient means of providing vitamin D3 activity in feed,” said the DSM regulatory specialist.
Approval expected in 12 months
It is very difficult to project when the US Food and Drug Administration (FDA) will be able to complete their review, said La Marta.
The agency is “currently under considerable resource constraints due to the implementation of the Food Safety Modernization Act.
We are hopeful that approval will be within 12 months and are prepared to meet market needs as soon as we have approval from FDA,” he told FeedNavigator.com.
He said that DSM has sponsored dozens of research trials globally and "in each instance animals fed 25-hydroxyvitamin D3 exceeded the control group fed vitamin D3 for industry metrics such as yield, feed conversion and leg bone health."
Meanwhile, last month saw DSM receive FDA approval for its benzoic acid product, which is used as an acidifying agent in swine feed.
In response to the regulatory backing, La Marta said: “VevoVitall has been a successful product for DSM in Europe and we look forward to similar success in the US.”
Piglet weight performance research
A recent study, looking at the role of vitamin D3 during gestation and lactation of sows, found that feeding the animals with 25-hydroxyvitamin D3 (25-OH-D3) improved maternal supply of vitamin D3, and thereby maintained calcium homeostasis during gestation and lactation.
The authors, including a DSM employed researcher, conducted two experiments.
The first study comprised 39 primi and multiparous crossbred sows fed one of three barley meal-based diets fortified with 200 IU/kg vitamin D3 (treatment DL), 2,000 IU/kg vitamin D3 (cholecalciferol treatment DN), or 50 μg 25-OH-D3 (calcidiol treatment HD) per kilogram of feed.
The second study was performed in a commercial farm with 227 primi and multiparous sows allocated to two dietary treatments. The control consisted of 114 sows receiving 2,000 IU vitamin D3 per kg (equivalent to 50 μg/kg) feed and the test which was supplementation of feed for 113 sows with 50 μg 25-OH-D3 per kg of feed.
In the results for the first study, most characteristics of sow reproductive performance responded similarly to the two sources and levels of vitamin D3 but weight gain of piglets between birth and weaning was decreased in offspring of DL and HD sows compared with animals of treatment DN, said the authors.
The outcome for the second study, said the authors, showed total litter weight and birth weight per piglet were increased with 25-OH-D3 supplementation in comparison with the control.
Publication: Journal of Animal Science
Date: 2014 Mar; 92(3):899-909. doi: 10.2527/jas.2013-7209. Epub 2014 Feb 3.
Title: TRIENNIAL GROWTH SYMPOSIUM-- Effects of dietary 25-hydroxycholecalciferol and cholecalciferol on blood vitamin D and mineral status, bone turnover, milk composition, and reproductive performance of sows.
Authors: Weber, GM, Witschi, AK, Wenk, C. Martens, H
