FDA is reconsidering kava's safety following reports the German government might ban its sale due to a possible link between the botanical and liver toxicity.

Agency staff have been trading e-mails and informally discussing possible actions FDA could take if the German government prohibits the sale of kava, according to the agency.

However, the German government has not taken any official steps yet, and the agency was quick to note that even if Germany bans the herbal, FDA would not necessarily follow suit.

Trade associations such as the American Herbal Products Association and Council for Responsible Nutrition also said they are closely monitoring the kava issue. Neither has released a public statement or contacted FDA, though, preferring to wait for the agency to make its position known.

In the interim, CRN said it is reviewing the German adverse event reports to better understand how strong the science is linking kava to liver toxicity.

AHPA staff and members of its Kava Commission have been communicating with the association's German members about the potential ban by the country's Federal Institute for Drugs & Medical Devices (BfArM).

The association also announced it is partnering with the American Botanical Council to evaluate the AERs submitted to BfArM.

The German institute initially issued a Nov. 8 letter to German kava companies explaining the government's intention to prohibit sale of the ingredient; the letter gives the firms until Dec. 10 to reply.

BfArM's "proposed action is based on 24 adverse event reports from Germany and Switzerland," AHPA stated Nov. 21. "Several of the AERs resulted in severe cases of hepatotoxicity, which were reportedly associated with the use of kava."

Some of the AERs cited by BfArM involved situations in which "other medications were being consumed in tandem with the consumption of kava," APHA said. However, "it was also reported that there were cases in which kava was being taken independently of any other therapeutic drug."

The German government's recent scrutiny of the herbal prompted Darmstadt-based ¹ Merck KGaA to withdraw its OTC Kytta-Kava and Kavadura products on Nov. 28, even though the company maintained "there have so far been no [adverse] indications...with the two Merck products."

Merck KGaA had sold Kytta-Kava since 1998 and Kavadura since April 2001. Both products were only available in Germany and had combined annual sales of less than $500,000, the firm said.

Even if the German government bans kava's sale, similar actions in the U.S. appear unlikely due to the botanical's established presence and an apparent lack of domestic AERs.

Despite the 24 AERs linking kava to liver problems in Germany, ² 'kava' on FDA's Special Nutritionals Adverse Event Monitoring System (SN/AEMS) turned up only one AER involving a single-ingredient kava supplement. The adverse event reported was deep somnolence, not liver toxicity.

SN/AEMS showed 34 other AERs for multiple-ingredient products containing kava; none of the reports listed a liver complication as the adverse event. However, the SN/AEMS has not been updated since October 1998.

The botanical also has recorded relatively substantial sales. In 2000, kava products posted $14.7 mil. in revenues in food, drug and mass channels, according to Chicago-based Information Resources, Inc. ("The Tan Sheet" Feb. 26, p. 25). The majority of the botanical's sales, however, likely come from health food stores.

If Germany pulls kava, it will mark the second time in the past six months a botanical has been banned in a country with a large dietary supplement market.

FDA stated in July that companies marketing comfrey products should recall the supplements or face enforcement actions, although the agency subsequently said it would "not necessarily object" to comfrey supplements that have had pyrrolizidine alkaloids removed (³ 'The Tan Sheet' Nov. 12, In Brief)

Kava Safety Reconsidered In Germany, FDA/Trade Associations Take Note

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