The best starting point is to have a very clear picture of what is going on in the US market, to have a deep knowledge of FDA regulations and a clear idea of how to set about complying with the criteria.
Geffken explains that with this knowledge, brand owners have a clear idea of the principles of compliance and can then set about cluing in on the key differences with international compliance.
In Japan, Europe, the ASEAN markets and in Canada, significant differences exist, which have to be identified in order to avoid brands being rejected or refused entry.