CSPI calls for St John’s Wort warning labels
CSPI is sending a petition to the US Food and Drug Administration (FDA) calling for a warning label to caution about potential interactions between come commonly used prescription and over-the-counter drugs and St John’s wort (Hypericum perforatum), a herbal typically used against anxiety and depression.
Interactions
According to the National Center for Complementary and Alternative Medicine, the herb may interact with a range of prescription and OTC products.
"Companies have taken a minimalist approach designed to protect themselves from litigation, rather than actually protecting consumers' health," said CSPI litigation director Stephen Gardner. "FDA should mandate a standard warning label for St. John’s wort to protect consumers based on the research outlined in this petition."
The specific warning would read: “CAUTION: St. John’s wort interacts with some commonly used prescription and over-the-counter drugs. DO NOT USE this supplement if you are taking contraceptives, antidepressants, immunosuppressants (such as cyclosporine), anticoagulants, Digoxin, HIV medicine, blood thinners, seizure-control medicine, cancer medicine, or any other medications.”
CSPI claims that some products already have warnings on labels, but the consumer advocacy group calls dismisses current efforts as “boilerplate warnings on the label”.
A spokesperson for the FDA told NutraIngredients-USA that the agency has received CSPI's 'Petition to Require Cautionary Statements On the Label of Dietary Supplements Containing St. John’s Wort' and "will give it careful consideration".
Existing guidance
A spokesperson for the American Herbal Products Association (AHPA) told NutraIngredients-USA that the association already has two longstanding “Guidance Policies” that are recommended but not mandatory for AHPA members, which relate to the CSPI petition.
A policy adopted in October 2001 notes that: "AHPA recommends that consumers of herbal supplements inform their healthcare provider(s) of such use. In the interest of seeing this recommendation broadly accepted by consumers, AHPA encourages healthcare providers to receive such communication with respect for the consumers’ healthcare choices. In addition, AHPA encourages healthcare providers to seek out accurate and truthful information about herbs."
Another policy adopted in July 2000 recommends products containing St. John's wort display a notice on the label with language similar to "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."
