Citizen Petition Asks FDA to Restrict Availability of St. John’s Wort

January 28, 2013

By Ricardo Carvajal

Pharmacists Planning Service, Inc. ("PPSI"), a California-based “nonprofit public health, consumer, pharmacy education organization,” submitted a citizen petition asking FDA to make St. John’s Wort ("SJW") available only behind the counter.  Specifically, the petition asks FDA “to remove sales of [SJW] from Herbal Dietary Supplement to behind the pharmacy counter status to Pharmacists-Only Class of Drugs with Mandatory Consultation, Patient History Review, Identification and Registration.”  The petition cites no specific authority for the requested action.

The petition contends that SJW can cause a number of adverse effects and “has the potential for many drug interactions with at least one… having caused a patient’s death.”  For additional support, the petition points to bans and restrictions of SJW in certain foreign countries.  PPSI has previously filed petitions with FDA, including a petition to remove pseudoephedrine from the market which FDA denied (see here). Comments on the SJW petition can be submitted here