The American Herbal Products Association (AHPA), Silver Spring, MD, said it opposes the Pharmacists Planning Service's (PPSI) citizen's petition requesting FDA change the status of St. John's wort (SJW) (hypericum perforatum) from herbal dietary supplement to "behind pharmacy counter status" (BPCS).
"This petition exhibits a remarkable misunderstanding of the laws in the United States that govern drugs and dietary supplements," said AHPA President Michael McGuffin. "AHPA believes that ready access to a broad range of dietary supplements by informed consumers is always preferable to creating restrictions to access."
The petition, dated Jan. 9, 2013, requested that FDA Commissioner Margaret Hamburg, MD, issue a federal regulation to augment St. John’s wort to BPCS immediately, citing what it says are deaths from drug interactions; its "dangerous" interaction with prescription drugs; and FDA's SJW label warnings for two new Hepatitis C virus products, Boceprevir and Telaprevir.
McGuffin noted that since 2000, AHPA has had in place a guidance policy that recommends that SJW products be labeled with the following statement:
“Notice: Do not use this product while taking any prescription drug(s) without the advice of your prescribing physician. Avoid excessive exposure to UV irradiation (e.g., sunlight; tanning) when using this product.”
Additionally, AHPA established a related guidance policy in October 2001 that recommends consumers disclose the use of any herbal supplements to their healthcare provider. As part of this policy, AHPA encourages healthcare providers to seek out accurate and truthful information about herbs, such as the soon-to-be published American Herbal Products Association's Botanical Safety Handbook, Second Edition.
"PPSI is only acknowledging what AHPA has known for many years with regard to the possibility for some St. John's wort ingredients to interact with certain drugs," said Mr. McGuffin. "But this information is already disclosed through the broad use in the herbal trade of AHPA's labeling policy for St. John's wort, and we do not agree that a reclassification is warranted."
AHPA Opposes Petition to Move St. John's Wort Behind the Counter
Published January 31, 2013
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