All foreign facilities that manufacture, process, pack, or hold food for human consumption in the United States must register with the FDA.  The FDA code is called 21 CFR 1.227. Holle products imported into the USA by JSG Organics LLC are all FDA-registered.  Products that come into the USA from "other sources" may not have FDA registration.  Without specific FDA registration, these products are not approved for retail sale in the USA.  It takes time to secure FDA registration, and JSG Organics is working to obtain more product registrations. Please note that Holle products that do not have FDA registration still meet the highest manufacturing standards globally, but the United States has regulations for imported products for reasons stated above.