Regulatory Status

Originally, all preparations of hawthorn were approved under one German Commission E monograph based on historical experience. However, in 1993, the preparations were reevaluated and it was concluded that sufficient scientific evidence was lacking to justify use of the flowers, leaves, and berries as individual compounds. As a result, there are currently four hawthorn monographs: three Unapproved monographs for the berry, flower, and leaf individually and an Approved monograph for the flower with leaves. In addition, the Approved monograph has only one approved indication: treatment of "decreasing cardiac output according to functional stage II of the NYHA (11)." In Canada, hawthorn carries new drug status and is not approved, as self-treatment of cardiovascular conditions is deemed inappropriate. Hawthorn is not on the General Sales List in the United Kingdom. In France, the flower and flowering top are permitted for oral use, and in Switzerland, the leaf and flower are permitted as herbal teas. In Sweden, hawthorn is classified as a natural product, whereas in the United States, it is considered a dietary supplement (6).

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