Charles B. Hensley, 57, inventor of the zinc-based Zicam cold remedy, was arrested at his Redondo Beach, Calif., home and charged with a 12-count indictment for unlawfully importing a product called Vira 38 and selling it to consumers nationwide.
According to the U.S. Attorney's Office for the Central District of California, the indictment included four misdemeanor counts of introducing an unapproved new drug into interstate commerce, four misdemeanor counts of introduction of a misbranded drug into interstate commerce, and four felony counts of illegally importing an unapproved drug into the U.S.Hensley's company, PRB Pharmaceuticals Inc. of Irvine, Calif., first attempted to market Vira 38 as an influenza medication in Hong Kong in 2005. But when the lack of clinical data demonstrating the product's effectiveness stymied those efforts, the attorney's office said, Hensley began promoting Vira 38 in the U.S. as a treatment for the H5N1 virus, which leads to an influenza commonly know as bird flu.
According to a press release issued by the company, "VIRA 38, PRB Pharmaceuticals' over-the-counter broad spectrum anti-viral medication, is known for its effectiveness in treating and preventing influenza. VIRA 38 has recently been shown to contain compounds that inhibit the bird flu (H5N1) virus."
Although Hensley promoted Vira 38 as a bird flu cure, the indictment notes it hasn't been approved by the U.S. Food and Drug Administration. The indictment also charges that the introduction of Vira 38 from Hong Kong for domestic distribution represented the illegal importation of an unapproved drug and unlawful dispensation of a prescription drug without a prescription.
In 2009, the FDA warned consumers to stop using all nasal versions of Zicam, which it said could destroy their sense of smell, a condition called anosmia. In 2006, Zicam's parent company, Matrixx Initiatives Inc., paid some $12 million to settle 340 lawsuits from customers who claimed to have lost their sense of smell. Not long after the FDA warning, Matrixx recalled all nasal versions of Zicam.