Hello everyone!
Already posted my question below to the community, but also would like to target the question to my State Chapter. Looking forward to your guidance/responses--
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,
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Rhona Applebaum
Atlanta GA
United States
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