On November, 10, 2011, the Washington, D.C.-based Center for Science in the Public Interest (CSPI) submitted a petition to the Food and Drug Administration (FDA) to require cautionary statements on the labels of dietary supplements containing St. John's wort.
In a press release, the organization noted that this popular herb may interfere with a number of drugs and petitioned FDA to require a black box warning to caution against use of any St. John's wort product when taking any medication.
The American Herbal Products Association (AHPA) established a Guidance Policy in 2000 recommending that St. John's wort products be labeled to suggest that consumers seek the advice of their physician if taking any prescription drug.
Additionally, AHPA established a related Guidance Policy in October 2001 that recommends consumers disclose the use of any herbal supplements to their health care provider. As part of this policy, AHPA encourages healthcare providers to seek out accurate and truthful information about herbs.
"CSPI has not discovered any new information, but 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," commented Michael McGuffin, AHPA's president. "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 black box warning--generally limited to only the most dangerous drugs--is warranted."
"Prescribers of medications need to inform patients of possible food-drug and herb-drug interactions," added Steven Dentali, Ph.D., AHPA's chief science officer. "Although specific drugs are not identified on the labels of grapefruit juice, leafy greens, or St John's wort extracts, it is widely known that these can affect drug metabolism. In the case of St. John's wort, this concern is limited to certain constituents, as there is no indication that low-hyperforin products cause clinically significant drug interactions."