In August 2015, the Federal Trade Commission (FTC) recommended that the U.S. Food and Drug Administration (FDA) reconsider its regulatory framework for homeopathic medicines. FTC’s recommendation was in response to FDA’s April 2015 request for comments on the matter.
Unlike most other drug products, homeopathic drugs do not have to be reviewed for safety and efficacy or approved by FDA before they may be marketed in the United States. According to FTC, FDA’s current regulatory framework “may conflict with the Commission’s advertising substantiation policy in ways that may harm consumers and create confusion for advertisers.”
A significant point of conflict between FTC and FDA regulations are requirements for substantiation of claims. The FTC Act requires companies to have a reasonable basis for making a claim that a product can treat a specific condition as well as competent scientific evidence for health, safety, or efficacy claims. FDA requires homeopathic drug labels to include an indication for use, but does not require proof of efficacy for the intended use. FDA also does not require homeopathic drug manufacturers to provide substantiation for health claims included on their labeling. FTC offered three potential approaches to eliminate this conflict:
- FDA could hold homeopathic drugs to the same regulatory standards as other drug products.
- FDA could stop requiring homeopathic drugs to display an intended use. In this scenario, homeopathic drug manufacturers could still choose to include an intended use, but would be required to provide proof of efficacy in order to comply with FTC regulations.
- FDA could itself require homeopathic drug manufactures to provide substantiation for intended use claims.
FTC is also concerned that FDA’s current regulatory framework for homeopathic drugs may harm and deceive consumers. FTC has found that many consumers have incorrect and incomplete ideas of homeopathic drugs, which sit on store shelves next to non-homeopathic drug products. Research by FTC shows that a significant number of consumers don’t understand:
- Homeopathy or homeopathic products
- How homeopathic products are regulated
- The level of scientific evidence supporting homeopathic claims
These concerns are what have led FTC to recommend that FDA change its regulatory framework. For more information on homeopathic drugs and other stakeholder opinions on FDA’s current regulatory framework, click here. Registrar Corp stays up-to-date on U.S. FDA regulations and will update industry as FDA’s decision on how to regulate homeopathic drugs progresses.
While homeopathic drugs are not currently required to undergo review and approval by FDA, they are still subject to other FDA regulations for drug products, such as registration and listing requirements. For information or assistance with current FDA regulations for drug products, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.