The U.S. Federal Trade Commission (FTC) has issued an Enforcement Policy Statement on homeopathic products.
The agency now notes that it will hold efficacy and safety claims for over-the-counter (OTC) homeopathic drugs to the same standard as other medicines. As such, any health-related claims these products make must be backed by scientific evidence.
“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,” says the FTC. “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.”
As such, the organization now requires manufacturers of homeopathic medicines to put disclaimers on their products. In particular, these disclaimers must convey that:
- There is no scientific evidence that the product works; and
- The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
This new development follows in the footsteps of Health Canada. As of July, the organization requires the manufacturers of homeopathic cough, cold and flu remedies to remove any labelling that suggests these products are appropriate for children 12 years of age or younger.
Industry professionals note that this new development reflects a power struggle between the FTC and FDA for control over the homeopathic market.
At this time, any Canadian manufacturers of homeopathic drugs that sell in the U.S. should check their labels to ensure that they are still suitable for the changing market.
