On 15 November 2016, the US Federal Trade Commission (“FTC” or the “Commission”) issued an “Enforcement Policy Statement” (“Policy Statement”) to provide guidance about its enforcement policy on marketing claims for over-the-counter (“OTC”) homeopathic remedies. The FTC concluded that marketing claims that OTC homeopathic products have a therapeutic effect (beyond placebo) lack a scientific basis. Consumers were therefore likely to be deceived by labels that do not disclose the lack of “adequately substantiated evidence” that those products have the claimed treatment effects.
Unlike, for example, US Food and Drug Administration (FDA) regulations that govern prescription drug labels, the FTC’s Policy Statement does not constitute binding regulatory action. However, it lays out the governing principles that the FTC will apply in evaluating whether OTC homeopathic advertising and labeling is deceptive.
The Concept of Homeopathy
The concept of homeopathy was developed at the beginning of the 19th century by German physician and pharmacist Samuel Hahnemann. The therapeutic method is based on the belief that disease symptoms can be treated by minute doses of substances that are capable of producing in healthy people symptoms like those of the disease. In its Policy Statement, the FTC was especially critical of the fact that many homeopathic remedies were diluted to such an extent that they no longer contained detectable levels of active ingredient. Still, the homeopathic drug market has become a multimillion dollar industry with many faithful adherents.
The Commission’s Reasoning
The Policy Statement was informed by a one-day public workshop and related public comments on how homeopathic remedies are marketed to consumers. In its “Staff Report on the Homeopathic Medicine & Advertising Workshop,” the Commission concluded that efficacy claims for traditional OTC homeopathic products were not valid. They were only supported by theories that are not accepted by most modern medical experts and provings that did not constitute “competent and reliable scientific evidence” that these products have the claimed therapeutic effects. The FTC further concluded that no convincing reasons were brought forward as to “why […] OTC homeopathic drugs should not be held to the same truth […] as other products claiming health benefits.”
Notably, the Commission stressed the inherent contradiction that underlies the assertion that a product is effective while at the same time disclosing that there is no scientific evidence for the efficacy claim. Therefore, depending on how the disclaimers were presented, many of them could be insufficient to adequately convey the “extremely limited nature of the health claim being asserted.”
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