Japan safety claims

Echinacea must first be approved as a GRAS ingredient before it can legally be added to food. In many European countries, health claims are not permitted on food products, while in other countries, such as Japan, claims are allowed under the Foods for Specified Health Use (FOSHU) system. The benefits of Echinacea in laboratory studies show promise and potential that functional foods may come from this research, provided that the studies support the safety of Echinacea. 

The evasion of formulation and toxicological testing by herbal medicine manufacturers is completely illogical in this context. For example, Peta-sites hybridus (the butterbur or bog rhubarb) contains well-characterized carcinogens. Butterbur extract tables are sold as chronic oral therapies for bladder dysfunction and migraine prevention, and claimed to be innocuous on chemical purity grounds. Similarly, oral melatonin has an absolute bioavailability of about 15% maximum, and has been withdrawn in the UK and Japan due to concerns about safety (DeMuro et al 2000). 

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