US
- New FDA GRAS rules
On August 17, the US FDA published a new set of rules for the “Generally Recognized As Safe (GRAS)” substances added to food.
This rule affects the food-use of amino acids for nutrition/health purposes.
The Agency allows for public comments until Oct. 17 and ICAAS is currently preparing a position paper to submit in due time.
- Draft guidance on new dietary ingredient
In September - October 2013, the US FDA published new guidance on so-called Medical Foods
The 21 CFR 312.2 (b), which govers IND was adjusted in such a way that almost any new substance (including a food ingredient not used for strictly nutritive purpose) would require an IND filing with hte FDA. This is a regulatroy step that may affect future amino acid clinical research in the USA.