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US: Marketing claims for OTC homeopathic drugs

Nov 24, 2016

On 15 November, the US Federal Trade Commission published a new ‘Enforcement policy statement on marketing claims for over-the-counter (OTC) homeopathic drugs,’ requiring efficacy and safety claims for OTC homeopathic medicines to meet the same standard as other products making similar claims.

The Federal Trade Commission (FTC) is the United States federal agency dedicated to protecting and educating consumers and promoting competition; its remit includes the advertising of homeopathic medicinal products.

The new policy statement gives the FTC’s view of the requirements of the Federal Trade Commission Act as applied to homeopathic products. It explains that the FTC will hold efficacy and safety claims for OTC homeopathic medicines to the same standard as other products making similar claims; that is companies marketing these products must have ‘competent and reliable scientific evidence’ for health-related claims, including claims that a product can treat specific conditions. If they cannot show such evidence, they need to include additional explanatory information to prevent claims from being misleading (disclaimers).

The policy statement was informed by an FTC workshop held last year on ‘Homeopathic Medicine & Advertising’ to evaluate advertising for over-the counter homeopathic products. The transcript of the workshop is available on the FTC website, and FTC also released its staff report on the workshop, which summarizes the panel presentations and related public comments in addition to describing consumer research commissioned by the FTC.

This announcement has received widespread media coverage in the US and elsewhere. It remains to be seen what will be the impact of this new policy statement on the availability of these products in the US.

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