Future of Marketing Homeopathic Remedies in Doubt – By Slade Cutter

by Sara Szado on January 20, 2016

feedfront-33 cover-188x240Homeopathy is a controversial form of alternative medicine that has faced intense criticism from the scientific community for years. The practice is based on the idea that a substance known to cause certain symptoms in healthy people can be used to relieve those symptoms when given in a sufficiently minute dose to sick people.

Indeed, homeopaths typically dilute doses to the point that they no longer contain any detectable amount of the active ingredient, theorizing that the hyper-diluted solution carries a “memory” of the active ingredient’s “electromagnetic signature.”

Although some early studies appeared to support the efficacy of homeopathy, these initial findings have been thoroughly refuted in a wide range of scientifically-controlled clinical studies.

The most recent of these was a meta-study completed last year by the Australian National Health and Medical Research Council. This study rigorously examined the procedures and results of 1,800 other studies and concluded that homeopathic remedies are no more effective than placebos, and the theory of “water memory” has no basis in science.

Despite this scientific smackdown, homeopathic medicine has grown into a multi-billion dollar industry in the US, with significant sales driven through affiliate marketing. This has been possible because the Senate sponsor of the 1938 federal law governing manufacture and marketing of drugs was a prominent New York homeopathic physician who specifically exempted homeopathic remedies from many of the rules regulating other drugs.

The Federal Drug Administration (FDA) requires homeopathic marketers to follow the 1988 “Compliance Policy Guide,” which does not require over-the-counter (OTC) homeopathic drugs to be approved by the FDA as safe and effective, as long as they satisfy certain conditions, including that the product’s label must contain an “indication for use” (i.e., a claim that the drug is effective for specific uses). But the FDA does not require marketers to have any evidence supporting the specified use.

If you’re scratching your head, you’re in good company. The Federal Trade Commission (FTC) has noted on multiple occasions that the FDA’s requirement that homeopathic marketers specify an indication for use even when there’s no supporting evidence for that use conflicts with the FTC’s commonsense requirement that all health claims be substantiated by competent and reliable scientific evidence.

This interagency regulatory disconnect, along with the recent rapid growth in the homeopathic industry, has prompted the agencies to work together to find a solution. To that end, the FTC held a workshop on homeopathic marketing in September 2015, and the FDA closed an extensive public comment period regarding the regulatory framework for homeopathic medicines in November 2015.

There are a number of ways the agencies might address the regulatory question, but preserving the status quo is very unlikely. Consequently, any marketers relying on revenue from homeopathic products should stay tuned because there are big changes coming soon.

Slade Cutter is a digital advertising lawyer at Wittliff Cutter, PLLC in Austin, Texas.

This article appeared in issue 33 of FeedFront Magazine, which was published in January 2016. http://issuu.com/affiliatesummit/docs/feedfront-33

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