Regulatory Status

The proposed United States Pharmacopoeia National Formulary (USP-NF) monograph for hypericum requires that products contain a minimum of 0.04% of hypericins (95).

The German E Commission has approved St. John's wort for internal consumption for psychogenic disturbances, depressive states, sleep disorders, and anxiety and nervous excitement, particularly that associated with menopause. Oily Hypericum preparations are approved for stomach and gastrointestinal complaints, including diarrhea. Oily Hypericum preparations are also approved by the Commission E for external use for the treatment of incised and contused wounds, muscle aches, and first degree burns (96).

The USP advisory panel recognizes that St. John's wort has a long history of use. However, because of a lack of well-controlled clinical trials its use is not recommended (2).

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