Last week, the Federal Trade Commission issued its new "Enforcement Policy Statement on Marketing Claims for Over-the-Counter (OTC) Homeopathic Drugs," as well as a staff report on a workshop that the Commission held last year on OTC homeopathic drug advertising. As many know, homeopathy is an alternative medical system from the 1700s based on the idea that substances causing disease indications in healthy people can cure similar symptoms in sick people. According to the FTC's Policy Statement, many of the claims currently in circulation for OTC homeopathic products actually derive from longstanding homeopathic theories, and not from valid or modern efficacy studies using up-to-date scientific methods. The FTC is therefore concerned that much of the current advertising for OTC homeopathic products is misleading or deceptive, in violation of Section 5 of the FTC Act.
The Policy Statement is the most recent development in the homeopathic product arena, currently jointly regulated and monitored by the FTC and the FDA, and is yet another indication of the current regulatory focus on health claims. Other recent examples include: Food for Thought: FDA Will Reconsider Rules Governing Use of "Healthy" on Labels; the FTC's recent warning letters on anti-Zika health claims; its $1.35 million settlement with Tommie Copper, which focused on allegedly misleading pain relief claims for the company's copper-infused compression wear; its settlements with two companies that said their apps could detect symptoms of melanoma; and the pending action against the marketer of Elimidrol, announced as part of a joint law enforcement sweep with the Department of Justice, FDA, and others, challenging representations that the supplement substantially reduces symptoms from opiate withdrawal. Marketers of OTC homeopathic products should take heed.
By issuing this Policy Statement, the FTC now makes clear its intention to treat OTC homeopathic drugs no differently than other advertised health products. The Commission therefore requires that all disease claims for OTC homeopathic drugs be substantiated by competent and reliable scientific evidence. As the Policy Statement makes clear, OTC homeopathic advertising based on traditional theories of homeopathy may still pass muster as long it effectively communicates to consumers that there is no current scientific evidence of efficacy, or that the science supporting the claim is not routinely accepted in modern medicine. In such cases, the FTC will require inclusion of clear, prominent and non-perfunctory disclosures explaining the limited evidence supporting the efficacy of the homeopathic product. As the FTC notes:
- Any such disclosure should stand out and be in close proximity to the efficacy message; to be effective, it may actually need to be incorporated into the efficacy message.
- Marketers should not undercut qualifications with additional positive statements or consumer endorsements reinforcing a product's efficacy.
- There is an inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence for such an assertion. Depending on how disclosures are presented, many will be insufficient to prevent consumer deception. Marketers are advised to develop extrinsic evidence, such as consumer surveys, to determine the net impressions communicated by their marketing materials.
- The Commission will carefully scrutinize 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. If, despite a marketer's disclosures, an ad conveys more substantiation than the marketer has, the marketer will be in violation of the FTC Act.
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