Homeopathic medicine company fights off Zicam lawsuits

— -- Consumers across the country have alleged in more than 400 lawsuits filed in courts and complaints logged with federal regulators that Zicam nasal gel, meant to relieve cold symptoms, has destroyed or diminished their sense of smell or taste.

Some consumers and experts say the controversy shows there hole in the government's oversight of homeopathic products such as Zicam.

Zicam's manufacturer, Phoenix-based Matrixx Initiatives, says its Zicam medicines are safe and that it has research to back it up.

Matrixx settled a batch of 340 lawsuits for $12 million in January 2006, court and SEC documents show. The company did not admit fault. Since then, Matrixx has fought off more lawsuits using a panel of medical experts and piles of scientific evidence.

Matrixx representatives say the controversy over Zicam boils down to one Colorado doctor, who first publicly linked Zicam to smell loss, and lawyers out to make a quick buck. Since September 2006, six federal courts have tossed out expert testimony from the doctor, Bruce Jafek, a University of Colorado School of Medicine ear, nose and throat specialist.

Companies that sell homeopathic products are not required to go through the same rigorous approval process and government-vetted clinical trials that pharmaceutical companies must complete before the Food and Drug Administration will allow them to make a prescription drug available for public consumption.

The FDA has received more than 200 complaints from consumers about Zicam gel, which is sold over-the-counter.

The agency, which must deal with urgent public health issues such as the contaminated toothpaste ingredients from China, recalls only few over-the-counter products. For example, it banned the nutritional supplement ephedra in 2004 after it was linked to increased blood pressure and irregular heart rhythm.

"I don't know of any immediate action on Zicam," said FDA spokeswoman Sandy Walsh.

David Richardson, a packaging equipment salesman in Greensboro, N.C, wants the FDA to require an independent study of the safety of Zicam gel, which uses a long, narrow nozzle to pump zinc gluconate into the nose.