In addition to FDA, the U.S. Federal Trade Commission (FTC) has issued measures to mitigate the prevalence of unsubstantiated health claims made by homeopathic drug manufacturers. A 2016 FTC Enforcement Policy Statement requires homeopathic drug labeling to communicate that “there is no scientific evidence that the product works.” The label must also indicate that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”
A December 2017 FDA draft guidance explains that the Agency intends to prioritize enforcement on products that are known to cause harm to patients, including those with reported health issues and those deemed adulterated under section 501 of the FD&C Act.
FDA states it will also focus increased attention on homeopathic drugs with less overt health concerns. According to the guidance, unapproved drugs intended to treat serious or life-threatening conditions may cause a patient to delay or discontinue treatment already generally recognized as safe and effective (GRASE). Homeopathic drugs designed for vulnerable populations (e.g. infants and the elderly) may pose significant health risks even in small concentrations, in spite of treatments that have already been determined GRASE. For this reason, these drug categories may see increased regulatory enforcement.
In the previously referenced Warning Letters, FDA maintains that “nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval.” The letters and newly issued guidance suggest that FDA intends to expand efforts to hold homeopathic drug manufacturers accountable to the regulations derived from the FD&C Act.
