SAN RAFAEL, Calif. — Pharmacists Planning Services, Inc. earlier this month filed a Citizen's Petition with the Food and Drug Administration calling to move St. John's Wort, a mood enhancing supplement, behind the counter.
Specifically PPSI is asking that sales of St. John's Wort be restricted to behind a pharmacy counter, similar to pseudoephedrine. Sales of St. John's Wort totaled $12.3 million, down 2.4%, for the 52 weeks ended Oct. 28 according to SymphonyIRI Group data across total U.S. multi-outlet. The herbal ingredient ranked No. 9 in sales of all herbal supplements.
PPSI cited adverse events, including death, associated with drug interactions alleged to St. John's Wort use in combination with several prescription therapies.
This is not the first Citizen's Petition filed by PPSI, according to a blog published online Monday by Hyman, Phelps & McNamara, a law firm that specializes in FDA regulation.
The FDA in April 2012 denied a 2011 Citizen's Petition filed by PPSI that called for the outright ban of PSE sales because criminals still divert the cold medicine for the production of methamphetamine. "FDA shares your concern regarding abuse of prescription and OTC drugs," Janet Woodcock, director of the Center for Drug Evaluation and Research, wrote in response to that petition. "However, any additional measures restricting the sale of PSE to reduce the likelihood of product misuse must be balanced against the need to maintain access for legitimate and safe use."
This article has been amended with some clarifications.
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