Homeopathic medicine is a billion-dollar business, with some of the biggest names in retail selling treatments that contain few — or no — active ingredients, like the CVS brand “Homeopathic Constipation Relief” that is nothing more than a 40-proof mixture of alcohol and water. In spite of the lack of actual medication or supporting evidence, some products still make claims that they can actually treat ailments or relieve pain. Now the federal government is confirming that homeopathic items will be held to the same standards as other products on drugstore shelves.
For those who don’t know what homeopathy is, or think it’s just another generic term for alternative medicine, here’s a brief history. In the late 18th Century, German physician Samuel Hahnemann came up with the notion that if a large quantity of a substance causes symptoms in a healthy individual, then a version of that same ingredient that has been repeatedly and heavily diluted through a specific process could have a mitigating effect.
As a result, some homeopathic products are so diluted as to have no discernible trace of the original ingredient, and while there is no shortage of proponents for homeopathy, there is very little science to back most of it up.
In 1988, the FDA issued a compliance guideline on homeopathic drugs, allowing these products to be sold over the counter without prior approval so long as they meet certain conditions, which include clearly labeling the item as “homeopathic” and that it or its ingredients are listed in the Homeopathic Pharmacopeia of the United States.
Additionally, these products must be “intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms).” A self-limiting disease condition is one that will resolve itself even if it’s not treated, like a headache or cold; something you could take medicine for, but which will pass regardless.
While eligible homeopathic drugs are allowed to be sold without FDA approval, the marketing of these products must still meet Federal Trade Commission guidelines for truthful and accurate health claims; you can’t say Drug X actually treats Disease Y if it hasn’t been scientifically shown to do so.
“For the vast majority of OTC homeopathic drugs, the case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy,” writes the FTC in a newly released policy statement [PDF] on homeopathic drugs. “Accordingly, marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading in violation of Sections 5 and 12 of the FTC Act.”
The FTC says that homeopathic drugmakers can make suck claims less misleading by including additional statements clarifying that “there is no scientific evidence that the product works” or that the product’s claims are “based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”
The government warns homeopathic producers who don’t have scientific evidence to back up their claims against trying to undercut these sorts of qualifications with additional positive statements about a product’s efficacy or with endorsements from users.
Makers of homeopathic drugs are also encouraged to take surveys on their marketing materials to determine if consumers are indeed clearly understanding that while these products might do no harm, there’s no evidence that they will help.
“In light of the inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence for such an assertion, it is possible that depending on how they are presented many of these disclosures will be insufficient to prevent consumer deception,” explains the FTC.
by Chris Morran via Consumerist