DARMSTADT, Germany--Merck KGaA (www.merck.de) permanently discontinued the sale of its two kava products in Germany, three weeks after the German Federal Institute of Drugs and Medical Devices informed manufacturers of reports linking kava to hepatotoxicity. In most of these cases, however, prescription pharmaceuticals had also been used, which may have caused the liver failure. (For more on this story, visit www.naturalproductsinsider.com/hotnews/1bh26163742.html.)
The two products--kavadura 120 mg and Kytta-Kava--were permanently discontinued as of Nov. 29 as a precautionary measure. According to Merck, the products contributed annual sales of less than $220.9 million and the product cessation would not hurt the company. However, some in the natural products industry told INSIDER that this number--almost a quarter of a billion dollars--may be off a hundred fold, since the largest kava producers in the industry do not have this kind of revenue.
Merck, one of the largest pharmaceutical companies in the world, had acquired the kava line after buying Kytta, a German company specializing in herbal products. "These kind of products based on plants, with no standardization, are not part of our core activity," Hartmut Vennen, a Merck spokesman, told the Financial Times. "There is no potential for us in the area."
Some in the herbal industry were not surprised by the news. "In terms of a good business decision, I would say that anyone who doesn't care about the herb industry is better off not being in it," Michael McGuffin, president of the American Herbal Products Association (AHPA), told INSIDER. "However, what we know at this time is not enough to make a formal statement." He added that AHPA, the American Botanical Council (ABC) and the Council for Responsible Nutrition (CRN) are investigating kava and its effects on the liver, as well as possible regulatory issues affecting the United States. "We have initiated communication with the Food and Drug Administration to let them know we're aware of this issue, that we're investigating it and that we will look into what all of this means in the U.S. marketplace."