Singapore Bans Kava, U.K. May Follow

Singapore Bans Kava, U.K. May Follow

JALAN BUKIT MERAH, Singapore--Kava and itsextracts have been banned from sale in Singapore, according to a July 25announcement from the country's Health Sciences Authority (HSA). This move comessix months after HSA issued precautionary advice to consumers to avoid kava,since which time kava products have not been available on the Singapore market,according to HSA (www.hsa.gov.sg). While noadverse events regarding kava consumption have been identified in Singapore, HSAprohibited the importation and sale of kava products in the country based onGerman and Swiss studies linking the herb with liver failure.

"The result [of banning kava] is going to be that peoplehave removed access to a material that if it affects people, affects very fewpeople," said Stephen Dentali, Ph.D., vice president of scientific andtechnical affairs at the American Herbal Products Association (www.ahpa.org)."Granted, those are very extreme cases, but it's likely that if there's anissue, it's idiosyncratic like peanut allergy. A lot more people die from eatingpeanuts than have problems with kava and their livers."

HSA has placed kava and its constituents under the control ofthe Poisons Act, a violation of which can be punished by fines up to $10,000and/or imprisonment of up to two years per offense. HSA informed dietarysupplement importers, manufacturers, wholesale dealers and retailers that theherb is prohibited "so as to protect consumers from the health risk posedby kava-kava containing products." HSA cited actions taken by the Germandrug regulatory authority (BfArM) after its review of adverse event reports--BfArMprohibited German sales of all kava products due to an alleged link with anincreased risk of liver toxicity and "insufficiently proven efficacy ofthese products." HSA noted the German reports linked more than 40 cases ofliver toxicity to kava consumption, six of which resulted in complete liverfailure and three of which resulted in death.

"Most all of the case reports have confoundingfactors--they were taking drugs that have known effects on the liver or theywere alcoholics," Dentali said. "It doesn't explain away all of thecases, but the majority of them."

In light of the recent bans on kava-containing supplements, aspokesperson at the Council for Responsible Nutrition (CRN) told INSIDERthe association had nothing new to add to its March 28 recommendations, at whichtime it suggested manufacturers voluntarily label kava products to warnconsumers of a possible liver toxicity problem, as noted by the Food and DrugAdministration's March 25 advisory. CRN's suggested labeling statements, whichcan be found on its Web site (www.crnusa.org),include the recommendation that consumers ask a physician about using kava ifthey have liver problems, frequently use alcoholic beverages or take anymedication.

Prior to Singapore's actions, the United Kingdom's MedicinesControl Agency (MCA) (www.mca.gov.uk)reported it is considering a proposal that would prohibit the sale of unlicensedkava-containing products. This follows a provisional opinion from the Committeeon Safety of Medicines (CSM), which concluded the possible therapeutic benefitsof kava products do not outweigh the health risks.

MCA will be consulting on a proposal that would prohibitunlicensed kava products until Sept. 27, during which time MCA will alsoconsider public comments. From these comments, MCA will decide whether toproceed with the proposal to ban unlicensed kava products. For those kavaproducts with marketing authorizations--which make up a minority of kavaproducts currently sold in the U.K.--CSM will create a final report to bediscussed at a later date.

If the proposal passes for prohibiting unlicensed kava products,an order will be made under Section 62 of the Medicine Act of 1968 to prohibitthe sale, supply and importation of these products.

"There may be some people out there who do not do well withkava, but that doesn't mean that it isn't safe and effective for the rest of thepopulation and should be pulled off the market," Dentali stated.