An Important Message About Dietary
Supplements Containing Kava:
. On March 25, 2002, the Food and Drug Administration issued a Consumer Advisory on the dietary supplement kava (Piper methysticum ). The FDA is advising consumers of the potential risks of liver injury associated with the use of kava-containing dietary supplements. FDA has not determined that there is a causal link between kava-containing dietary supplements and liver injury. FDA notes that it will continue to investigate the relationship, if any, between the use of kava-containing dietary supplements  and liver injury. This Consumer Advisory is available at http://www.cfsan.fda.gov/~dms/addskava.html.

. FDA has determined that although liver damage appears to be rare, FDA believes consumers should be informed of this potential risk. FDA is accordingly advising that persons who have liver disease or liver problems, or persons who are taking drugs that can affect the liver, should consult a physician before using kava-containing dietary supplements. Also, consumers who use a kava-containing dietary supplement and who experience signs of illness associated with liver disease should also consult their physician. Symptoms of serious liver disease and non-specific symptoms are provided by FDA in the Consumer Advisory.

WARNING: The US FDA advises that a potential risk of rare, but severe, liver injury may be associated with kava-containing dietary supplements. 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, including jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other nonspecific symptoms of liver problems could include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain and loss of appetite. Not for use by persons under 18 years of age, or by pregnant or breastfeeding women. Not for use with alcoholic beverages. Not intended for use by persons operating a vehicle or heavy equipment. Discontinue use two weeks prior to surgery. Do not exceed recommended dosage.

It is important to note that FDA did not issue a product recall or request that any action be taken regarding kava-containing dietary supplements.