Though widely sold for years as a treatment for colds, Zicam Cold Remedy was never tested by federal regulators for safety. Then it was linked to 130 reports of users who lost their sense of smell.
Tuesday, the FDA warned consumers not to buy Zicam, and told the manufacturer to stop marketing it until it can prove its safety.
Zicam and hundreds of other homeopathic remedies — highly diluted drugs made from natural ingredients — are legally sold as medical treatments. Yet, like dietary supplements, they aren't regulated by federal authorities in the way that conventional medicines are. Here is a quick look at the situation:
What are homeopathic drugs?
They are highly diluted drugs made from natural ingredients, based on the principal that substances that create certain symptoms in healthy people are effective in treating the disease that causes the same symptoms.
Who ensures conventional drugs, homeopathic remedies and dietary supplements are made properly?
The Food and Drug Administration sets manufacturing standards for both conventional and homeopathic drugs. But homeopathic products are generally exempt from key requirements, like verifying the ingredients and the amount used.
As for supplements, the FDA in 2007 adopted manufacturing practices that set broad goals for safety and quality, which are being phased in through 2010.
Unlike conventional drugs, neither supplements nor homeopathic products are normally required to prove they are safe or effective before going on the market.
Are homeopathic remedies and dietary supplements labeled to say what medical problem they treat?
Homeopathic remedies, like regular drugs, must state what condition they are designed to treat. But supplements are forbidden from claiming to treat a specific condition.
What happens when safety problems arise with these alternative treatments?
The FDA may intervene and remove them from the market, as with conventional drugs.