Australasian Science: Australia's authority on science since 1938

US Mandates “No Evidence” Labels for Homeopathic Products

By Justin Coleman

Before advocates of science get too excited, though, a number of caveats may limit its effect.

The US Federal Trade Commission (FTC) has issued an enforcement policy statement requiring the marketers of homeopathic products to “effectively communicate the lack of scientific evidence” on product labels (http://tinyurl.com/h8yzsla). This is the first time in the USA that homeopathic products will legally require a label stating that they don’t work.

Numerous submissions to the FTC report cited the National Health and Medical Research Council’s 2015 Statement on Homeopathy (http://tinyurl.com/zztzm4q), which concluded there is no reliable evidence that homeopathy is effective for any health conditions.

At the time, the NHMRC review copped some flak from both sides. Some evidence-based proponents argued that spending a couple of million dollars to confirm what we already knew was a waste, while homeopathy advocates argued that the report’s conclusion was, well, just wrong. This concrete outcome – regulating the world’s most profitable homeopathy market – must now provide a fillip to the hard-working NHMRC reviewers.

Although the evidence overwhelmingly supports the new FTC policy, much of their report deals with legal issues, possibly pre-empting industry arguments that regulating advertising claims might be inconsistent with the US First Amendment around free speech.

The FTC policy does not constitute a new law, but it clarifies the minimum standards for homeopathic health claims, which until now have largely been left to self-regulation. Homeopathic products will now “be held to the same truth-in-advertising standards as other products claiming health benefits”.

Before advocates of science get too excited, though, a number of caveats may limit the effect.

First, the policy hasn’t yet specified the exact wording, nor how prominently it should appear. Many homeopathic products already make health claims accompanied by an asterisk, pointing to a buried disclaimer. In fact, the larger corporate manufacturers mimic pharmaceutical labels on their products, complete with Latin ingredient names, warnings about use in pregnancy and keeping out of reach of children although it’s hard to imagine why this is necessary for pure homeopathic doses. Labels even describe what to do for overdoses. Presumably, take another 99 pills to undilute the toxicity?

Second, labels are exempted if products have an “adequate substantiation for their efficacy claims”. This is quite sensible, but relies on a reasoned interpretation of what constitutes evidence. If, as I would contend, no ultra-diluted substance can ever directly improve health, then the existence of “evidence” actually measures something else altogether, such as chance, bias, placebo or poor study design.

Third, the FTC ruling also requires health claims to state that they are “based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts”. This seems to me to be a curious afterthought, because any decent advertiser could surely turn that into a marketing tool: “our 300-year-old treatment pre-dates men in lab coats”.

The FTC ruling isn’t necessarily the last word, of course. Lawyers are expensive in the land of the free, but the US$3 billion industry can afford a few. During the FTC hearing, attorneys for the American Association of Homeopathic Pharmacists fired a warning shot “that requiring homeopathic advertisers to have RCTs [randomised controlled trials] would be overly costly and could result in their ceasing advertising”. They also argued that, regardless of the FTC recommendation, the US Food and Drug Administration (FDA) “would still have to take additional legal actions to establish that homeopathic drugs were misbranded”.

Despite these caveats, the FTC has certainly taken a step in the right direction. Even if homeopathy continues to be displayed on the shelf next to FDA-approved medication, at least the difference in efficacy will be in print for consumers who wish to read it.

Before its ruling, the FTC commissioned independent focus groups to better understand consumer beliefs. Most consumers used the words “homeopathic”, “herbal” and “natural” interchangeably, and many believed that claims of efficacy on homeopathic labels had already been substantiated by government.

So, given that current safeguards are based on “buyer beware”, at least now US buyers will be made slightly more aware. Australian consumers, for now, will remain in the dark.


Justin Coleman is a Brisbane GP and medical writer who represents The Royal Australian College of General Practitioners on transparency and conflicts of interest, and hosts the GP Sceptics podcasts at drjustincoleman.com