On the developments in the USA and the demands of the FTC

A bad day for homeopathy: On November 15, 2016, the U.S. Federal Trade Commission (FTC) issued its statement that in future, over-the-counter homeopathic remedies will have to be labelled as the product’s efficacy is not proven – unless, of course, the manufacturer can provide such evidence. As expected, the German homeopathy associations reacted immediately by pointing out that this demand could not be transferred to Germany. This wouldn’t also be necessary, as the German Medicines Act already would have stricter requirements than those resulting from the requirements of the FTC in the USA.

Requirements of the FTC

The FTC considers it necessary that manufacturers of products should only be allowed to claim that their products are suitable for the treatment of certain health conditions if they have an appropriate basis for doing so. This applies to over-the-counter (OTC) medicines, dietary supplements or food, including homeopathic preparations for self-medication of complaints that would also disappear on their own (“self-limiting”, e.g. a cold – only such can be sold freely in the USA). It was further concluded that health claims for homeopathic products are generally not based on modern scientific methods. For giving health, safety or efficacy claims, manufacturers need proper and reliable evidence, which in the case of medicinal products require well-done human clinical trials. However, these requirements are not met by the vast majority of OTC homoeopathic medicinal products, which is why corresponding claims of efficacy are misleading.

This misleading of customers can be remedied by the fact that manufacturers state the following in their marketing materials:
1. “There is no scientific evidence that the product works.”
2. “The products claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”)

It is expressly pointed out that it is not permissible to compensate the reference to the lack of evidence by other claims or references. Since the indication of a field of application and the simultaneous reference to the lack of evidence could also be confusing, the manufacturers would have to check by means of surveys whether the information was understood by the customers.

Comments of the German Homeopathy Associations

The Verband der klassischen Homöopathen Deutschlands (Association of Classic Homeopaths – VKHD) and the Deutsche Zentralverein homöopathischer Ärzte (Central Association of Homeopathic Practicioners – DZVhÄ) are in agreement that the situation in the USA cannot be transferred to Germany. In Germany, homeopathic medicinal products are subject to pharmacy duty and, as registered medicinal products, are not sold under indication. As a result, they claim that there are already now stricter requirements than those resulting from an implementation of the FTC requirements in the USA.

We will not go into the usual misinformation that can be found on the homoeopath websites, such as that there is sufficient evidence or that homoeopathy is subject to examination. Simply for space reasons.

Comment of the INH

In principle, VKHD and DZVhÄ are certainly right: The situation in the USA is not directly comparable with the situation in Germany in detail – but is the matter settled? Certainly not.

The aim of the FTC is to ensure fair competition, which in the case of pharmaceuticals in particular means that customers are not misled as to the nature of what they are purchasing.

It is true that in Germany not the same methods are used as in the USA – but aren’t consumers also deceived about the nature of homeopathic remedies? Shouldn’t measures also be taken in Germany to prevent this deception? These may be different from those in the USA – but the claim that there are no explanatory models or evidence for a mode of action is certainly also necessary in Germany. Currently such is nowhere to be found.

Unlike in the USA, no indication is given for registered homeopathics in Germany. But does not the mere statement that the product sold is a medicinal product in the first place and, unlike in the USA, may only be sold in a pharmacy, lead much more astray than a manufacturer’s statement on a product in a supermarket could ever do?

Even if they do not specify any indications, the manufacturers in Germany have nevertheless found sufficient ways to overturn the ban on advertising with indications for registered homeopathic remedies. Simply stating that the product is a pharmacy-only product will raise the question in the patient as to what it can be used for or against. And the manufacturers will certainly be happy to help finding an answer. Doctors, pharmacists, non-medical practitioners, midwives are trained there:

Pharmacies then logically advertise in their displays with the information on homeopathics, which the manufacturers are not allowed to name directly. One sponsors relevant lectures by pharmacists, doctors, alternative practitioners on the application of homeopathy in the spring, in the flu season, in old age, on journeys etc..:

The number of guidebooks on self-medication is immense, divided into all possible fields of application for humans, animals and plants. On the Internet, relevant websites are promoted by means of advertisements:

Summary

Wee see, it is no need at all that an indication appears on the package insert. This “knowledge” is widespread and freely available – and this is increased by the manufacturers to the best of their ability. All this is presented to the customer as true and justified by the statement ‘Homeopathic medicine – pharmacy compulsory’ – even though it’s sugar only.

The requirements in Germany are not stricter than in the USA; on the contrary, the misleading of the consumer in Germany is much stronger than it was ever the case in the USA considering the overall system. There it was a pure manufacturer’s statement for which a homeopathic remedy can be used, and at least skeptical consumers will have been just as suspicious of such statements in the advertising country USA as they were of the praises of other products, which are supposed to make slim, eternally young, beautiful and of course healthy.

However, the situation in Germany is that pharmaceutical law encourages quackery in homeopathy by promoting what makes a remedy appear to be an effective medicine – pharmacy duty – but at the same time refrains from demanding what makes a remedy a remedy at all, namely demonstrable efficacy. The fact that universities, medical chambers and health insurance companies additionally strengthen this impression by dealing with homeopathy has a much greater potential for deception than manufacturers statements in the USA ever had.

In Germany, in view of this, even more far-reaching demands must be made in order to eliminate the deception of the consumer:

• Marking of packages with the clear name of the product
• Specification of the quantity of ingredients in an absolute unit of mass
• Disclaimer that the efficacy of the product has not been demonstrated and that an efficacy would be contrary to scientific knowledge
• Identical warning notices in the self help literature, “Quickfinders” and in relevant Internet pages as well as at lecture events
• Elimination of the waiver of a proof of efficacy for homeopathies in pharmaceutical law
• Abolition of the pharmacy obligation for homeopathic remedies for which there is no proof of efficacy according to recognised scientific standards
• Elimination of the ‘additional designation homeopathy’ and further training offers for doctors
• Elimination of the reimbursement for homeopathic therapies within the statutory health insurance
• Elimination of homeopathy courses in the licensing regulations and in the curricula of the universities

Only when these points have been implemented will we have a situation like that which is now to be achieved in the USA through the FTC demands.

Author: Dr. Norbert Aust

Supplement, 07.07.2019

The implementation of the FTC’s demands is sluggish in the USA, to put it mildly. In contrast to decisions of the Food and Drug Administration (FDA), the publications of the FTC are not directly legally binding. As expected, this leads to a high degree of ignorance among most manufacturers.

However, the FDA confirms that it is preparing a basic regulation with legal force for homeopathics and related products that will probably include the demands of the FTC. We will report in due course.

Picture credits: Screenshots, Photo: Wikipedia Commons Bhavesh Chauhan