• 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  • Draft guidance on new dietary ingredient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 
This guidance stipulates the requirements for medical Foods and ingredients to be used, including amino acids. In addition, substantial updates were made in the draft requirements for filling "Investigational New Drug" (IND).

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.