dsm-firmenich's faster-acting vit D gains novel food approval
Clinically backed by more than 15 human studies, ampli-D is a calcifediol (calcidiol) ingredient that helps raise blood vitamin D levels 2.5 times faster and more effectively than conventional vitamin D3.
The official EU authorization, which comes three years after EFSA green lighted the ingredient's safety and bioavailability profile, approves ampli-D for a maximum daily dose of 10 µg in children over the age of 11 and adults including pregnant and lactating women, and a maximum daily dose of 5 µg for children between the ages of 3 and 10. The delay on the official approval was due to the need to confirm conversion factors for different ages.
The firm said the approval marks a major milestone in dsm-firmenich’s ambition to help consumers in the EU unlock the health benefits of the ‘sunshine vitamin’ more rapidly—which include support for immunity, healthy aging, mobility and more. A five-year exclusive use period has been granted for dsm-firmenich to place ampli-D on the market starting May 1.
"With 88% of the global population having sub-optimal vitamin D levels, the approval of our game-changing ampli-D ingredient as a novel food in the EU means more people will have access to a solution that can raise levels of this essential vitamin in weeks, rather than months," said Catherine Mignot, head of regulatory affairs HNC, EMEA at dsm-firmenich. "This landmark approval further demonstrates our role as an end-to-end partner for nutraceutical brands, with our scientific and regulatory expertise paving the way for the commercialization of fast-acting, consumer-centric products that make the world a healthier place."
As well as its well known benefits for muscle and bone health, a growing bank of scientific evidence shows that vitamin D can reduce the risk of acute respiratory infections, with the vitamin gaining particular attention during the pandemic as it was also found to reduce COVID-19 infections and deaths.
Yet deficiency is common, especially in populations in the northern hemisphere. In fact, 88% of individuals globally are reported to have sub-optimal vitamin D levels.
Hilger et al. in a systematic review of studies from 44 countries with data from 112 articles (168,389 participants), reported a wide range of serum 25(OH)D between 4.9 and 136.2 nmol/l with age and sex variations. Mean levels of < 50 nmol/l were reported in one third of these studies.
Most commercially available products contain the cholecalciferol form of vitamin D3 which must be processed by the liver and converted into calcifediol. However, this form of supplementation can take months to bring the body to optimum sufficiency.
Calcifediol (25-hydroxyvitamin D3) is an immediately metabolically available form of vitamin D naturally present in food sources like fish, milk and eggs and it is the most common form of vitamin D in our body.
Research indicates that this form of the vitamin as a supplement is three to five times more efficient than cholecalciferol and that it has a higher rate of intestinal absorption and thereby can improve vitamin D status in days to weeks.
