Last week, the Federal Trade Commission (FTC) recommended that the Food and Drug Administration (FDA) consider regulating homeopathic products more like other pharmaceuticals. The recommendation is in response to FDA’s call for input on how it regulates homeopathic products—the first time in 25 years they have done so since releasing the guidance document “Conditions Under Which Homeopathic Drugs May be Marketed.” The FDA has not scrutinized homeopathic products for safety or efficacy as it does with other conventional products. They can be sold over the counter (OTC) for “self-limiting” conditions, like headaches or colds, which go away on their own. However, things have changed since 1988 when homeopathic remedies were offered by a limited number of manufacturers. Today, the homeopathic market is a $3 billion industry, and, as FTC indicates in their comment, these products may confuse consumers into believing that they are subject to the same strict approval standards as other drugs.
As a background, homeopathy was developed in the 18th century and based on the idea that a product that causes an illness can also treat that same illness when taken in a highly diluted dose. “[H]omeopaths claim that a substance becomes more potent the more it becomes diluted by intense shaking” in a process known as “succussion,” indicates Forbes. However, in some cases the mixtures are so highly diluted that no molecules of the chemical remain in the final product. “Scientists now agree—overwhelmingly—that the remedies don’t work,” states a recent article in Bloomberg. “But each year, billions of dollars worth of homeopathic products are sold in the U.S.” Oftentimes these products are sold right next to pharmaceutical products, with little noticeable differentiation to consumers looking for treatment.
Back in March, the FDA stated that it was “evaluating its current enforcement policies for drug products labeled as homeopathic from scientific, risk, and process perspectives.” The agency noted it was “now soliciting opinions about whether and how to adjust the current enforcement policies to reflect changes in the homeopathic product marketplace over the last approximately 25 years.”
Last week, FTC, which acts as the government’s consumer watchdog, took the opportunity to provide their recommendation that FDA should revise or repeal its current regulations for homeopathic products. This is a noteworthy comment; as Bloomberg notes, “Federal agencies don’t normally tell each other how to do their jobs.”
FTC indicated that FDA’s current approach to homeopathic products may conflict with advertising regulations, which often align well with FDA requirements, that require advertisers to have “competent and reliable scientific evidence” for any claims related to health, safety or efficacy. “Neither the FTC Act, nor any FTC rule or policy statement, exempts advertising claims for homeopathic drugs from these standards,” the FTC wrote in its comment.
Further, FTC offered evidence that consumers are confused about the evidentiary or approval requirements for traditional pharmaceuticals compared to homeopathic products, and this confusion is magnified when the products are side-by-side in the store. Forbes writer David Kroll notes that homeopathic products “can confuse consumers because they make disease treatment claims but then carry, in very small print, the disclaimer that, ‘These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.’”
In addition to consumer confusion, FTC also points to issues with advertisers “mistakenly” believing that compliance with FDA’s 1988 homeopathic guidance “exempts them from compliance with the FTC Act’s substantiation requirement.” In fact, FTC points out that these companies may “unwittingly subject themselves to liability for injunctive and monetary remedies in an FTC enforcement proceeding.”
View FTC’s full response to FDA’s request for comments on “Homeopathic Product Regulation: Evaluating the Food and Drug Administration’s Regulatory Framework After a Quarter-Century,” here.