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Nutraceutical Faces Kava Lawsuit, Renews FDA-Ephedra Case
January 15, 2007
2 Min Read
ORLANDO, Fla.—A lawsuit filed in Circuit Court here in mid-December alleges Nutraceutical Corp. (www.nutraceutical.com) and its “Happy Camper” dietary supplement were to blame for the death of an Orlando woman. The civil lawsuit claims Nutraceutical, Natural Balance Inc. (a company Nutraceutical acquired in late 2004), and retailer Chamberlin Natural Foods sold the dietary supplement, which contained kava, without appropriate warnings of possible liver toxicity, which led to the death of Laura Starks.
Among the counts in the suit are:
Defective manufacture of an unreasonably dangerous product with harmful side effects that outweighed any potential benefit;
Insufficient and misrepresenting label warnings that misled consumers;
Negligence in failing to test the product for safety and labeling it appropriately, particularly after safety concerns were made public; and
Culpable negligence and fraud.
The Food and Drug Administration (FDA) issued a consumer advisory about potential hepatotoxicity in 2002; shortly thereafter, the American Herbal Products Association (AHPA) expanded its existing kava labeling recommendation to note: “Caution: U.S. FDA advises that a potential risk of rare, but severe, liver injury may be associated with kava-containing dietary supplements. Ask a healthcare professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication. Stop use and see a doctor if you develop symptoms that may signal liver problems.”
Dan Gerber, an Orlando-based attorney with Rumberger, Kirk & Caldwell, is representing Nutraceutical in the kava suit and stated: “Nutraceutical has reviewed the complaint and intends to defend this lawsuit vigorously.”
In additional Nutraceutical news, the company filed a motion in U.S. District Court, Utah, charging FDA’s 2004 final rule banning ephedra in dietary supplements violates the Administrative Procedure Act (APA), creating a new adulteration standard without advance notice and opportunity for public comment. Nutraceutical further contends the final rule is “arbitrary and capricious” to the requirements of APA, by banning ephedrine alkaloids from supplements but allowing them in conventional foods and Asian medicines available without prescription. Under court order, FDA must respond to the company’s motion by Jan. 18; oral arguments are scheduled for March 21.
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