Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Section 331(ll) of the FDCA provides that once a substance is the active ingredient of an approved new drug - or the active ingredient of a new drug in clinical trials that have been made public - a food containing that substance cannot be shipped in interstate commerce, unless such drug or such biological product was marketed in food before any approval of the drug…
Does anyone know if there is a similar drug exclusion rule in other countries, coalitions, trading blocs? I'm particularly interested in the European Union, UK and Canada, but any and all entities with a similar rule/law/regulation are of interest.
Many thanks in advance, 

Hi Anonymous,

RAPS did a really nice explanation of the IND preclusion rule, in reference to CBD, back in 2019.
https://www.raps.org/news-and-articles/news-articles/2019/6/update-on-the-regulatory-status-of-cannabidiol-in

I haven't seen other jurisdictions with an equivalent statute. 

Karen

------------------------------
Karen Long RAC
Vancouver BC
Canada
------------------------------

Original Message:
Sent: 19-Apr-2021 13:28
From: Anonymous Member
Subject: Drug Exclusion Rule

This message was posted by a user wishing to remain anonymous

Section 331(ll) of the FDCA provides that once a substance is the active ingredient of an approved new drug - or the active ingredient of a new drug in clinical trials that have been made public - a food containing that substance cannot be shipped in interstate commerce, unless such drug or such biological product was marketed in food before any approval of the drug…
Does anyone know if there is a similar drug exclusion rule in other countries, coalitions, trading blocs? I'm particularly interested in the European Union, UK and Canada, but any and all entities with a similar rule/law/regulation are of interest.
Many thanks in advance,