Companies producing homeopathy medicines in US must state they do not work

The Federal Trade Commission building in Washington DC

Producers of homeopathic treatments sold over the counter (OTC) in the United States must state on their labels and marketing materials that the products do not work or provide evidence of efficacy for any claims made, a US government agency says.

The US Federal Trade Commission (FTC), an agency set up to protect consumers and promote competition, issued a new ‘Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs’.

The statement, which was published on 15 November 2016, says that companies making claims about OTC homeopathic drugs must meet the same standards as companies making similar claims about non-homeopathic products, meaning they must have “competent and reliable scientific evidence for health-related claims”, including claims that a product can treat specific conditions.

For the vast majority of OTC homeopathic drugs, the policy statement says: “The case for efficacy is based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy.”

As such, “marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading in violation” of the policy statement.

Marketing claims made for OTC homeopathic drugs that are not backed up by reliable scientific evidence must be accompanied by additional explanatory information to prevent those claims made from being misleading, the FTC says.

It also says that while an OTC homeopathic drug claim may not be substantiated by reliable scientific evidence, it might not be deceptive if its advertisement or label where it appears communicates that there is no scientific evidence that the product works; or that the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

However, the policy statement emphasises that any explanatory information should stand out and be in close proximity to the product’s efficacy message.

The FTC says it “will carefully scrutinise the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted”.

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Citation
The Pharmaceutical Journal, PJ, November 2016, Vol 297, No 7895;297(7895):DOI:10.1211/PJ.2016.20201998