FTC said it will hold homeopathic drugs to the same standards as other drugs that claim to treat or cure specific diseases. That means they must have scientific evidence for health-related claims.
In a statement released on November 15, FTC said over-the-counter (OTC) homeopathic drug labels and advertisements must clearly disclose that:
- There is no scientific evidence that the product works
- Any claims are based on theories that are not accepted by modern medical experts
Homeopathy is an idea from the 1700s that a poisonous substance in tiny amounts will cure the same symptoms it causes in large amounts.
Many are so diluted that they contain no detectable level of the ingredient at all, according to the FTC. Others, like Hyland’s Teething Tablets for babies, were found to have “inconsistent” amounts of belladonna, one of the most toxic plants in the world, in laboratory tests by the FDA in 2010.
Last month, the FDA said it was investigating 10 infant deaths and over 400 reports of children who had seizures, fever, vomiting, and other symptoms of belladonna poisoning after being given homeopathic teething products since the FDA’s last warning in 2010.
The FDA permits homeopathic products to exist in a regulatory “gray” area. Unlike vitamins and herbal supplements, homeopathic products can claim to treat or cure diseases. Unlike pharmaceuticals, homeopathic products do not have to prove they actually work.
This loophole has created a billion-dollar niche industry, and confusion for consumers, as stores like CVS and Walgreens usually organize homeopathic drugs alongside pharmaceuticals and supplements.
According to Mark Land of the American Association of Homeopathic Pharmacists (AAHP), the U.S. market for homeopathic products is estimated to be $1.1 billion to $1.3 billion annually. The majority are sold for cough, cold and flu, muscle pain, and children’s ailments.
Mr. Land said studies showing high levels of consumer satisfaction could not be explained by the placebo effect alone, which he estimated at “around 30%.” He said sales are primarily driven by those happy customers and their “word-of-mouth” recommendations, rather than labels or advertisements.
Staff Report on the Homeopathic Medicine & Advertising Workshop — Federal Trade Commission (November 2016)