The unsettling secret of Zicam Cold Remedy finally spilled out this week. Though sold for years as a drug for colds, it was never tested by regulators for safety. And that was perfectly legal -- until scores of consumers lost their sense of smell.
One little word on Zicam's label explains all this: "homeopathic."
Zicam and hundreds of other homeopathic remedies -- highly diluted drugs made from natural ingredients -- are legally sold as treatments with explicit claims of medical benefit. Yet they don't require federal checks for safety, effectiveness or even the right ingredients.
They're somewhat similar to dietary supplements, which use many of the same ingredients and also aren't tested for safety or benefit. Many scientists view homeopathic remedies as snake oil -- ineffective but mostly harmless because the drugs in them are present in such tiny amounts.
But an Associated Press analysis of the Food and Drug Administration's side effect reports found that more than 800 homeopathic ingredients were potentially implicated in health problems last year. Complaints ranged from vomiting to attempted suicide.
In the case of Zicam, the FDA says it tied the drug to reports from 130 consumers who said they lost their sense of smell. The agency on Tuesday told Zicam maker Matrixx Initiatives to stop marketing three products that carry zinc gluconate -- Zicam Cold Remedy Nasal Gel, Nasal Swabs and discontinued Swabs in Kids' Size. The agency said the drug must be tested for safety and benefit, like a conventional drug, before it is again marketed.
Matrixx Initiatives was originally incorporated in Utah in 1991 as Gum Tech International. In 2002, it changed its named to Matrixx Initiatives and reincorporated itself in Delaware. Its executive offices are in Scottsdale, Ariz.
In its review, the AP also found that the FDA has set limits for alcohol in medicine, especially for small children, but they don't apply to homeopathic remedies. And at least 20 ingredients used in conventional prescription drugs, such as morphine for pain, are used in homeopathic remedies.
Homeopathy sprang from the inventive mind of German physician and chemist Samuel Hahnemann in the late 1700s. In 1938, Congress passed a law granting homeopathic remedies the same legal status as regular pharmaceuticals, which has remained in force ever since.
Almost reduced to obsolescence, homeopathic remedies have revived in recent decades with the burst of interest in vitamins, herbs and other unconventional treatments. By 2007, homeopathic remedies were taken by almost 4 million Americans, or 2 percent of adults, federal data show.
Even before the FDA action this week, the Federal Trade Commission was investigating whether Zicam was deceptively marketed. Zicam seller Matrixx Initiatives paid $12 million in 2006 to settle lawsuits with about 340 Zicam patients. It has won a lawsuit in California, and several other federal cases were dismissed.
The company, which has sold 1 billion doses since the products came to market in 1999, says it settled in the past simply to reduce its legal exposure. The remedy has recently been sold with a redesigned spray nozzle, and the company argues that it is safe.