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March 24, 2009
A concentrated turmeric-based product sold by a California company into Europe via Sweden has caused numerous liver-related adverse events, and has prompted a health warning in the UK. The product, non-steroidal anti-inflammatory pain reliever branded as Fortodol or Leppin Miradin, contains the drug nimesulide, which is associated with hepatoxicity, especially in children under 12 and the elderly.
The California company that exported the product to Sweden, Donsbach, is associated with Kurt Donsbach, who has long been scrutinized and prosecuted for making unsubstantiated medical claims for his products, smuggling unapproved drugs into the United States, and failing to pay taxes on the profits made from selling them. Donsbach also founded a 'holistic hospital' in Mexico.
The situation highlights what some consider an Achilles heel of the supplements industry. Attorney Marc Ullman of Ullman Shapiro & Ullman, a New York firm that represents companies dealing with FDA violations, says, "Any time something like this happens there is the potential for 'bad' fallout. It will further tarnish the reputation of US supplements as unregulated and potentially unsafe, and could even cause certain countries to impose import restrictions on them."
Walter Postelwait, vice president of marketing and sales for BI Nutraceuticals, a worldwide supplier of herbs for the supplement and functional-foods industry, agrees. "The supplement industry in the US is very fragile. The general public in North America doesn't fully understand the issues around supplements and believes the government oversight alone makes these products completely safe. The regulations in place in DSHEA, the cGMPs, and the oversight by the FDA do provide the proper guidelines and structure to properly regulate our industry. The challenge is the FDA's resources to inspect and enforce all of the guidelines. With the new stimulus they received recently under the new administration, it is my hope their inspections and enforcement of the regulations will increase dramatically."
A warning about the product was issued by the Food Standards Agency following warnings issued by the Swedish Medical Products Agency about cases of liver damage among Swedish patients who have taken Fortodol. To date, eleven reports of liver damage possibly linked to Fortodol are under investigation in Sweden. Reportedly, five more cases, including a death, have been reported to the Norwegian Medical Products Agency.
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