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Toxicologist Concludes Kava Does Not Damage Liver
Lauren Piscopo
A University of Illinois researcher is disputing recent claims that kava is linked to liver problems. Donald P. Waller, Ph.D., professor of pharmacology and toxicology, analyzed the same adverse event reports that led to the herb's safety being questioned throughout Europe as well as North America, Australia and New Zealand (see "European Studies Link Kava To Liver Damage," NFM, February 2002). In Report on Kava and Liver Damage, Waller concluded that there is "no clear evidence that the liver damage reported in the United States and Europe was caused by the consumption of kava."
A coalition of dietary supplements industry associations, including the American Herbal Products Association, National Nutritional Foods Association, American Botanical Council, Council for Responsible Nutrition and Utah Natural Products Alliance, commissioned Waller to evaluate 26 kava-related AERs received by the FDA between May 1998 and September 2001, as well as 30 Swiss and German AERs gathered in the last 11 years.
"We wanted to know, from an unbiased and qualified scientific perspective, whether the case reports that emerged are evidence of an actual association between kava and liver damage," said Michael McGuffin, AHPA president. "If that is the case, we need to know that to carry out our mission to promote responsible commerce; if that is not the case, we need to know that so we can be prepared to respond appropriately."
Although all of the German AERs reported liver problems, only five U.S. cases involved liver effects. Waller reported "no scientifically supported association of liver disease with the use of kava ... using the FDA AERs."
Further, when Waller reviewed the nonliver-related FDA AERs, he found two cases of excessive kava consumption that, "from a toxicological perspective ... provide some evidence that kava itself is not a direct hepatotoxin, even in extremely high concentrations."
In the report, delivered to the FDA on Feb. 19, Waller criticized the German and Swiss case reports as lacking in "specific clinical and historical information" and recommended they be "revisited where possible to obtain further information."
Waller concluded: "Kava when taken in appropriate doses ... has no scientifically established potential for causing liver damage." But he warned that any pharmacologically active agent can interact with drugs, pre-existing conditions and hypersensitivity reactions, possibly affecting the substance's toxicity.
Waller also said taking kava may not be appropriate with "concomitant intake of prescription drugs associated with liver damage, excessive alcohol consumption and pre-existing liver disease with compromised liver function."
This advice matches industry recommendations, including AHPA's suggested label statement for kava products, NNFA's position on the herb (www.nnfa.org/services/science/background.htm) and ABC's recommendations to kava consumers ((see "European Studies Link Kava To Liver Damage," NFM, February 2002).
The industry coalition is awaiting a response from the FDA and "will continue to evaluate the situation," said Loren Israelsen, UNPA executive director. "We want to work closely with the FDA to find the best solution where everybody is in agreement that the goal is to protect consumer safety. But [the goal is] also to not preemptively remove a product from the market unless there is a good reason to do so."
Scholar disputes warnings on kava
By Jan TenBruggencate
Advertiser Science Writer
LAWA'I, Kaua'i — A federal warning last month about the potential health hazards of kava slammed the industry in Hawai'i and across the Pacific, but a prominent ethno-botanist has said he doubts the claims of liver damage.
Paul Alan Cox, director of the National Tropical Botanical Garden on Kaua'i, will lead a team of physicians and botanists to Samoa next month to confer with native healers about its use.
Many South Pacific islanders use the drug, made from the roots of the pepper relative Piper methysticum, recreationally and ceremonially. In the West, kava is sold as a food supplement to promote relaxation and ease insomnia, menopause symptoms and muscle discomfort.
During his extensive ethnobotanical studies in island groups where the drug is used regularly, Cox said he has seen no evidence of liver problems.
"When I heard of the problem, the first thing I thought was, what other things are these people taking?" he said.
Growers in Fiji have suggested the problem may be with chemicals used to process kava for marketing. Native people generally use the roots of the plant simply pounded with water.
Concerns about the drug surfaced last year in Germany, where officials reported that as many as 25 people suffered liver ailments after using kava — 'awa in Hawaiian — ranging from hepatitis to cirrhosis and liver failure.
The U.S. Food and Drug Administration issued a consumer advisory March 25 that recommended seeing a health professional at signs of liver damage, such as brown urine, yellowing of the skin and eyes, nausea, vomiting, abdominal pain and light-colored stools.
The warning devastated the kava-growing industry. Some European nations removed kava products from stores, while others issued warnings. The drug company Merck announced a permanent halt to sale of its two kava products in Europe.
Hawai'i growers said prices and demand have plummeted. Fijian government officials are calling for an international medical inquiry into the claims of liver damage.
Cox said the indigenous people of the Pacific have used kava longer than anyone in Europe, and if there is a liver threat, they should be suffering from it.
"I think the Polynesians would have figured this out if there were cases of severe liver failure," he said. "I have lived in indigenous villages, and I have not seen this kind of toxicity."
He said he would take a team of ethnobotanists and physicians to talk to natives on Savaii in Western Samoa and the Manua island chain in American Samoa.
"These people know more about kava than anyone in the world," he said.
If there is a toxicity issue, indigenous people may have developed specific restrictions on kava use to minimize the risk, he said.
"I find that indigenous people are very adept at excluding toxic compounds," he said.
A recent study indicated as many as 50 farms on Hawai'i growing kava, and a farm value of hundreds of thousands of dollars.
The FDA did not ban the product, but cited European restrictions and recommended that "persons who have liver disease or liver problems, or perhaps who are taking drug products that can affect the liver, should consult a physican before using kava-containing supplements."
Reach Jan Tenbruggencate at (808) 245-7825 or at
Toxicologist Concludes Kava Does Not Damage Liver
Lauren Piscopo
A University of Illinois researcher is disputing recent claims that kava is linked to liver problems. Donald P. Waller, Ph.D., professor of pharmacology and toxicology, analyzed the same adverse event reports that led to the herb's safety being questioned throughout Europe as well as North America, Australia and New Zealand (see "European Studies Link Kava To Liver Damage," NFM, February 2002). In Report on Kava and Liver Damage, Waller concluded that there is "no clear evidence that the liver damage reported in the United States and Europe was caused by the consumption of kava."
A coalition of dietary supplements industry associations, including the American Herbal Products Association, National Nutritional Foods Association, American Botanical Council, Council for Responsible Nutrition and Utah Natural Products Alliance, commissioned Waller to evaluate 26 kava-related AERs received by the FDA between May 1998 and September 2001, as well as 30 Swiss and German AERs gathered in the last 11 years.
"We wanted to know, from an unbiased and qualified scientific perspective, whether the case reports that emerged are evidence of an actual association between kava and liver damage," said Michael McGuffin, AHPA president. "If that is the case, we need to know that to carry out our mission to promote responsible commerce; if that is not the case, we need to know that so we can be prepared to respond appropriately."
Although all of the German AERs reported liver problems, only five U.S. cases involved liver effects. Waller reported "no scientifically supported association of liver disease with the use of kava ... using the FDA AERs."
Further, when Waller reviewed the nonliver-related FDA AERs, he found two cases of excessive kava consumption that, "from a toxicological perspective ... provide some evidence that kava itself is not a direct hepatotoxin, even in extremely high concentrations."
In the report, delivered to the FDA on Feb. 19, Waller criticized the German and Swiss case reports as lacking in "specific clinical and historical information" and recommended they be "revisited where possible to obtain further information."
Waller concluded: "Kava when taken in appropriate doses ... has no scientifically established potential for causing liver damage." But he warned that any pharmacologically active agent can interact with drugs, pre-existing conditions and hypersensitivity reactions, possibly affecting the substance's toxicity.
Waller also said taking kava may not be appropriate with "concomitant intake of prescription drugs associated with liver damage, excessive alcohol consumption and pre-existing liver disease with compromised liver function."
This advice matches industry recommendations, including AHPA's suggested label statement for kava products, NNFA's position on the herb (www.nnfa.org/services/science/background.htm) and ABC's recommendations to kava consumers ((see "European Studies Link Kava To Liver Damage," NFM, February 2002).
The industry coalition is awaiting a response from the FDA and "will continue to evaluate the situation," said Loren Israelsen, UNPA executive director. "We want to work closely with the FDA to find the best solution where everybody is in agreement that the goal is to protect consumer safety. But [the goal is] also to not preemptively remove a product from the market unless there is a good reason to do so."
Scholar disputes warnings on kava
By Jan TenBruggencate
Advertiser Science Writer
LAWA'I, Kaua'i — A federal warning last month about the potential health hazards of kava slammed the industry in Hawai'i and across the Pacific, but a prominent ethno-botanist has said he doubts the claims of liver damage.
Paul Alan Cox, director of the National Tropical Botanical Garden on Kaua'i, will lead a team of physicians and botanists to Samoa next month to confer with native healers about its use.
Many South Pacific islanders use the drug, made from the roots of the pepper relative Piper methysticum, recreationally and ceremonially. In the West, kava is sold as a food supplement to promote relaxation and ease insomnia, menopause symptoms and muscle discomfort.
During his extensive ethnobotanical studies in island groups where the drug is used regularly, Cox said he has seen no evidence of liver problems.
"When I heard of the problem, the first thing I thought was, what other things are these people taking?" he said.
Growers in Fiji have suggested the problem may be with chemicals used to process kava for marketing. Native people generally use the roots of the plant simply pounded with water.
Concerns about the drug surfaced last year in Germany, where officials reported that as many as 25 people suffered liver ailments after using kava — 'awa in Hawaiian — ranging from hepatitis to cirrhosis and liver failure.
The U.S. Food and Drug Administration issued a consumer advisory March 25 that recommended seeing a health professional at signs of liver damage, such as brown urine, yellowing of the skin and eyes, nausea, vomiting, abdominal pain and light-colored stools.
The warning devastated the kava-growing industry. Some European nations removed kava products from stores, while others issued warnings. The drug company Merck announced a permanent halt to sale of its two kava products in Europe.
Hawai'i growers said prices and demand have plummeted. Fijian government officials are calling for an international medical inquiry into the claims of liver damage.
Cox said the indigenous people of the Pacific have used kava longer than anyone in Europe, and if there is a liver threat, they should be suffering from it.
"I think the Polynesians would have figured this out if there were cases of severe liver failure," he said. "I have lived in indigenous villages, and I have not seen this kind of toxicity."
He said he would take a team of ethnobotanists and physicians to talk to natives on Savaii in Western Samoa and the Manua island chain in American Samoa.
"These people know more about kava than anyone in the world," he said.
If there is a toxicity issue, indigenous people may have developed specific restrictions on kava use to minimize the risk, he said.
"I find that indigenous people are very adept at excluding toxic compounds," he said.
A recent study indicated as many as 50 farms on Hawai'i growing kava, and a farm value of hundreds of thousands of dollars.
The FDA did not ban the product, but cited European restrictions and recommended that "persons who have liver disease or liver problems, or perhaps who are taking drug products that can affect the liver, should consult a physican before using kava-containing supplements."
Reach Jan Tenbruggencate at (808) 245-7825 or at
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