The US Federal Trade Commission (FTC) announced on November 15th that OTC homeopathic drug claims will be held to the same standard as other products making comparable claims. The FTC has stated: “Companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions”. This statement also applies to safety and efficacy claims. Claims on most current OTC homeopathic drugs are not based on scientific methods but on traditional homeopathic theories.
The FTC will soon require homeopathic products making health, safety, or efficacy claims that can’t be backed up with scientific evidence to include one of these two statements:
- There is no scientific evidence backing homeopathic health claims
- Homeopathic claims are based only on theories from the 1700s that are not accepted by modern medical experts
It is considered deceptive and illegal for a homeopathic drug product to make a health claim without one of those two statements. This will only apply to the OTC homeopathic drugs themselves and any ads surrounding them, and not the practice of medicine.
More can be read on the FTC announcement here. If you have any questions, please feel free to contact Focal Point Research. We are industry leading Drug and Cosmetic Regulatory Consultants that you can trust to help guide your company in the right direction.