Warning Label For Kava Products
Silver Spring MD, 27 March 2002
American Herbal Products Association (AHPA) yesterday adopted new
cautionary language to appear on food or dietary supplement products
containing the popular herb kava (Piper methysticum), commonly
used for anxiety and stress.
this year, the Association outlined specific health information
that consumers should take into consideration prior to taking kava
-- and provided this information to the US Food and Drug Administration
(FDA). The safety of the South Pacific herb began to be re-examined
when rare case reports in the United States and Europe suggested
a potential relationship between the use of kava-containing dietary
supplements and liver injury.
no actual relationship between the use of kava and any liver problem
has been established by the FDA or any scientific reviewers, it
is sensible that consumers of kava are informed in the light of
the recent case reports," said Michael McGuffin, President of the
American Herbal Products Association.
policy adds to existing cautions on product labels
originally adopted a label for kava products in 1997 to restrict
against use by children or by pregnant or nursing women and to caution
against use with alcohol or when driving. The new policy retains
all of those earlier parts and adds the following language:
Ask a healthcare professional before use if you have or have had
liver problems, frequently use alcoholic beverages, or are taking
any medication. Stop use and see a doctor if you develop symptoms
that may signal liver problems (e.g., unexplained fatigue, abdominal
pain, loss of appetite, fever, vomiting, dark urine, pale stools,
yellow eyes or skin).
revision reflects the concerns identified by the recent US and European
cases," said McGuffin. "The message provided here is consistent
with the consumer information we have published since January and
with the advisory issued from FDA."
March 25, the FDA cautioned consumers about the potential link,
citing approximately 25 reports of liver-related injuries in other
countries and several reports of liver problems in the United States.
The FDA reiterated that the cases appear to be extremely rare and
acknowledged that kava might not be responsible for the problems.
in 1983, The American Herbal Products Association (AHPA)
is the leading botanical trade association representing growers,
processors, manufacturers and marketers of herbal products.
Herbal Products Association via PR Newswire, 27 March 2002.