The FDA Is Under More Pressure to Regulate Homeopathic Products
Federal agencies don't normally tell each other how to do their jobs. But the Federal Trade Commission, which polices advertising claims, did just that last week when it asked the Food and Drug Administration to reevaluate its light-touch regulatory approach to an obscure corner of the over-the-counter drug market: homeopathic products.
The FTC filed official comments that said it is "concerned" that the FDA's policy on homeopathy conflicts with the FTC's requirement that medical advertising claims be supported by evidence. The split "may harm consumers and create confusion for advertisers," the agency wrote in comments approved unanimously by the five FTC commissioners.
Homeopathy is based on the notion that substances that cause symptoms of an illness can treat the illness when delivered in highly diluted doses. Developed in the 18th century, the practice is unsupported by medical science. Yet homeopathic products are an estimated $3 billion industry in the U.S., and they're sold alongside conventional medicine at chain drug stores.
The FDA hasn't required homeopathic products to meet the same standards as other drugs. They can be sold over the counter for "self-limiting" conditions, meaning such ailments as colds that go away on their own. The agency has never evaluated them for safety or efficacy, though it oversees manufacturing practices. In April, the FDA held a meeting to evaluate whether such a hands-off policy makes sense, given the growth of the homeopathic industry and recent safety problems linked to some products.
The FTC's recent comments came in response to that meeting, but the regulator has been scrutinizing homeopathic advertising for a while. It cited focus groups (PDF) and other research (PDF) it conducted in 2010 and 2012 suggesting "that a significant percentage of consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, or the level of scientific evidence supporting homeopathic claims."
Part of the problem is that the FDA allows the makers of homeopathic drugs to put claims on their labels that other drugmakers, or even the sellers of lightly regulated dietary supplements, can't make without evidence. In fact, the FDA's policy requires that homeopathic drugs display an indication for use, "even when the product has not been demonstrated to be efficacious for that indication," the FTC wrote. This conflicts with FTC rules "that health claims be substantiated by competent and reliable scientific evidence."
The FDA is still examining "whether to adjust the current enforcement policies to reflect the dramatic increase in the homeopathic product marketplace over the last 25 years," says spokesman Chris Kelly. The agency plans to reopen its request for comments on the issue for anadditional 60 days. The FDA has already received thousands of comments, many from homeopathy supporters arguing against more stringent regulation.
The FTC is also asking for public feedback about homeopathic advertising for a workshop it will host in September. Spokesman Mitch Katz declined to elaborate on the FTC's comments to the FDA.
The FTC has records of 141 consumer complaints that mention homeopathy since 2007, according to files obtained by Bloomberg through a public records request. They describe a wide collection of alleged rip-offs and hard-sell tactics: An 80-year-old woman targeted by telemarketers paid $469 for an oral weight-loss spray purporting to contain human growth hormone, sold as homeopathic. A $82 tinnitus remedy sold online never reached the customer. Something called "homeopathic liquid oxygen" was intended to "heal any illness" that sold for $190.
In focus groups, the FTC found that "once consumers were given access to basic information about homeopathy, they were more skeptical of the homeopathic treatment than when they incorrectly believed that homeopathic was simply a synonym for 'natural' and had no knowledge of the principles behind homeopathy."
But the FDA's current approach allows some homeopathic marketing to muddy the waters, as some complaints to the FTC show. One consumer reported spending $100 on "teething tablets" from chain drug stores that claimed on the package to relieve "simple restlessness and wakeful irritability" in children with teeth coming in. When the consumer investigated, the person found that the products were so diluted that no active ingredient remained. "I was sold sugar tablets in a tiny cardboard box, and told that I was buying a medicinal product that would relieve certain symptoms," the person wrote to the FTC. "How is this legal? Seriously?"
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