United States of America

In October 2013: The US Food and Drug Administration (FDA) has released new guidance on so-called medical foods. You can see it at the following site.


This guidance stipulated the requirements for components used in medical foods, such as amino acids. In addition, the draft application requirements for IND were significantly revised.

In Dec. 2018, the US Department of Agriculture (USDA) released the final rule establishing the national mandatory bioengineered food disclosure standard. The rule will be implemented from January 1, 2020. The final rule includes several significant provisions related to so-called bioengineered (genetically modified, GM) food ingredients, some of which are listed below:
(1) Purified ingredients, potentially including some amino acids, are excluded from the rule’s definition of “bioengineered food” if the GM material is undetectable. The rule also includes provisions for companies to demonstrate that GM material is not detectable.
(2) The rule adopts a threshold for technically unavoidable presence of bioengineered substances of up to 5% for each ingredient, with no allowance for any GM presence that is intentional.
(3) In addition to the conventional text labeling (“bioengineered food” or “contains a bioengineered food ingredient”), the rule also adopts a symbol and an electronic disclosure.


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