Health Canada Stops Kava Sales

Health Canada Stops Kava Sales

OTTAWA--Health Canada issued a stop-sale order forall products containing kava after its six-month safety assessment concludedthere was "insufficient evidence" to support safe use of the herb. Inits order (www.hc-sc.gc.ca/english/protection/warnings/2002/2002_56e.htm),Health Canada also mandated a recall of these products from the Canadianmarketplace.

The agency issued a health advisory in mid-January askingconsumers not to use kava and requesting that health practitioners report anycases of liver toxicity associated with the products. It noted there have beenfour Canadian cases of liver toxicity associated with kava use, though noneresulted in death. Health Canada noted that those at risk of liver toxicityassociated with kava are those with compromised liver function due topre-existing liver problems related to disease, age or drug/alcohol abuse.

The Canadian Health Food Association (CHFA) issued a statementcondemning Health Canada's decision, adding there is no new evidence to warrantthe order. "Cautions for responsible use can be put on the label, but afull out ban without additional research or confirmed incident is irresponsibleon the part of the government," said Donna Herringer, president of CHFA (www.chfa.ca)."This is a perfect example of why there is a need for a unique regulatorybody for natural products."

In its stop-sale order, Health Canada noted it is creating anexpert advisory panel on the kava issue and will continue to address the safetyof the herb as additional scientific information becomes available. CHFA hassupplied Health Canada with a list of industry experts and practitioners thatcould assist with such a panel.

For the time being, however, Health Canada is requiring allsales of kava products be stopped and any products on the market be recalled. Itwill monitor the removal of the products and will issue a customs alert toprevent further shipments of kava products from entering Canada.

The actions of Health Canada will not necessarily impact thestatus of kava in the United States. According to the American Herbal ProductsAssociation (AHPA), the U.S. Food and Drug Administration (FDA) informed AHPAthat its position to allow kava to remain on the market with cautionary labelinghas not changed. In late July, AHPA released revised warning label language forkava products, which includes a sentence that "FDA advises that a potentialrisk of rare, but severe, liver injury may be associated with kava-containingdietary supplements."