Gnosis is pleased to announce that on March 19, 2014, the European Commission approved the use of Quatrefolic® in the European Union as a Novel Food Ingredient to be used in food supplements. This opens the way for the commercialization of Quatrefolic in the 28 EU-member state market to Quatrefolic.
The decision follows EFSA positive scientific opinion delivered in October 2013, which concluded that Quatrefolic is a safe and effective source of folate.
This key milestone is part of the global strategic plan that started in 2010 with the approval of Quatrefolic as New Dietary Ingredient (NDI) by FDA. In the USA Quatrefolic has become a benchmark for innovation, safety and quality in the folate supplementation.
Quatrefolic is a source of the active form of folate (6S)-5-methyltetrahydrofolate, the essential form utilized in the methylation cycle and stored in the human body.
Quatrefolic and Methionine are the key components of a vital biochemical process called the methylation cycle, also often referred to as one-carbon metabolism, which is required for normal cell function. Maintaining the balance and levels of folate, vitamin B12 and S-Adenosyl methionine (SAM-e) can be critical to the methylation cycle and various cellular processes.
Quatrefolic is also immediately available for use by the cells without the need for any further metabolic transformation. As a comparison and to the contrary folic acid needs to be metabolized to 5-methyltetrahydrofolate to be utilized by the body.
Very little is known and there is an ongoing debate about the metabolism and biological effects of unmetabolized serum folic acid (UMFA) after long term supplementation. There is an increasing evidence that the presence of UMFA may be a contributing factor in safety concerns associated with high intake of folic acid. Folic acid intake does not entirely explain the variability in the presence or persistence of UMFA in the population, suggesting that genetic differences in its metabolism may also be involved. A reduced folate such as Quatrefolic may benefit certain genetic defects that influence folate metabolism.
Gnosis’ history and product line has long been associated with providing solutions for supporting THE one-carbo-metabolism. The founders of the company are responsible for the commercialization of SAM-e for which Gnosis is still the global leader in innovation and supply.
With Quatrefolic, Gnosis has confirmed its commitment to this essential biochemical pathway and to creating a structured platform of bioactive nutrients for advanced nutrition.