Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs

The US ‘FEDERAL TRADE COMMISSION’ has issued an important statement about homeopathic products. The full text with references can be found here; below are a few quotes which I thought were crucial:

“…Homeopathy, which dates back to the late-eighteenth century, is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people.  Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance.  In general, homeopathic product claims are not based on modern scientific methods and are not accepted by modern medical experts, but homeopathy nevertheless has many adherents…

Efficacy and safety claims for homeopathic drugs are held to the same standards as similar claims for non-homeopathic drugs.  As articulated in the Advertising Substantiation Policy Statement, advertisers must have “at least the advertised level of substantiation.”  Absent express or implied reference to a particular level of support, the Commission, in evaluating the types of evidence necessary to substantiate a claim, considers “the type of claim, the product, the consequences of a false claim, the benefits of a truthful claim, the cost of developing substantiation for the claim, and the amount of substantiation experts believe is reasonable.”  For health, safety, or efficacy claims, the FTC has generally required that advertisers possess “competent and reliable scientific evidence,” defined as “tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and [that] are generally accepted in the profession to yield accurate and reliable results.”  In general, for health benefit claims, particularly claims that a product can treat or prevent a disease or its symptoms, the substantiation required has been well-designed human clinical testing.

For the vast majority of OTC homeopathic drugs, 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.  Accordingly, marketing claims that such homeopathic products have a therapeutic effect lack a reasonable basis and are likely misleading in violation of Sections 5 and 12 of the FTC Act.  However, the FTC has long recognized that marketing claims may include additional explanatory information in order to prevent the claims from being misleading.  Accordingly, the promotion of an OTC homeopathic product for an indication that is not substantiated by competent and reliable scientific evidence may not be deceptive if that promotion effectively communicates to consumers that: (1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.  To be non-misleading, the product and the claims must also comply with requirements for homeopathic products and traditional homeopathic principles.  Of course, adequately substantiated claims for homeopathic products would not require additional explanation.

Perfunctory disclaimers are unlikely to successfully communicate the information necessary to make claims for OTC homeopathic drugs non-misleading.  The Commission notes:

• Any 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 such qualifications with additional positive statements or consumer endorsements reinforcing a product’s efficacy.

• In light of the inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence for such an assertion, it is possible that depending on how they are presented many of these disclosures 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.

In summary, there is no basis under the FTC Act to treat OTC homeopathic drugs differently than other health products.  Accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence.  Nevertheless, truthful, nonmisleading, effective disclosure of the basis for an efficacy claim may be possible.  The approach outlined in this Policy Statement is therefore consistent with the First Amendment, and neither limits consumer access to OTC homeopathic products nor conflicts with the FDA’s regulatory scheme.  It would allow a marketer to include an indication for use that is not supported by scientific evidence so long as the marketer effectively communicates the limited basis for the claim in the manner discussed above.”