HomeopathyOn 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.”

 

This article was originally published on AllAboutIP – Mayer Brown’s  blog on relevant developments in the fields of intellectual property and unfair competition law. For intellectual property-themed videos, Mayer Brown has launched a dedicated channel available here.

iStock_000014287752_Large (2)On 26 November 2015, the Regional Court of Düsseldorf (14c O 124/15) ruled that a condom manufacturer’s claim that its condoms correspond to up to three orgasms each was deceptive and could tempt people to use the condoms several times. The company, Einhorn, a Berlin-based company that produces fair trade and vegan-friendly condoms, declared on its packaging that the seven condoms contained therein were good for up to 21 orgasms (1 Tüte á 7 Stück entspricht bis zu 21 Orgasmen). Fair Squared, one of Einhorn’s competitors, was not amused and obtained an injunction from the Regional Court of Düsseldorf barring Einhorn from advertising with that slogan. Einhorn in turn asked the Regional Court to overturn the injunction it had granted on the grounds that the slogan was (supposedly) misleading.

Einhorn’s lawyers argued that the slogan was obviously satirical and not to be taken as a statement of fact. The slogan was not intended to mean that a man can get three orgasms out of each condom. Rather, it was quite likely that his (female) sexual partner climaxes twice during an appropriately passionate session, thus, a total of three orgasms. The Court, however, did not agree with the lawyers’ contention and concurred with the view of Fair Squared that the three-orgasm claim was both confusing and potentially dangerous. It might confuse consumers into thinking that the condom was reusable, which could increase the danger of contracting sexually transmitted diseases and raise the risk of unwanted pregnancies. The Regional Court emphasized that condoms were medical products and, thus, were subject to “particularly strict standards” when it comes to advice on their packaging.