The FDA is proposing a new risk based enforcement approach to regulate homeopathic products with the potential to be harmful to people.
Existing current policy on the regulation of homeopathic drugs will be updated to address the issue of some of these homeopathic drugs claiming to have the ability to treat serious conditions without having shown or provided any clinical benefit of said product. Homeopathic products that contain harmful substances and/or products that do not meet current manufacturing requirements will also be address.
Current laws state that homeopathic drugs are supposed to be held to the same standards and meet the same requirements regarding approval, misbranding, and adulteration as those that apply to any other type of drug. Some nonprescription and prescription products that are labeled as being homeopathic have been produced and distributed even though they are not FDA approved.
In many cases people put their money and trust into therapies that offer up little to no benefits, especially in the treatment of serious diseases, even worse some may cause harm due to being poorly manufactured or not being adequately test to before being sold, according to Scott Gottlieb of the FDA.
According to Gottlieb the FDA has a responsibility to protect the public from products that may cause harm or not be beneficial at all, the regulation of these homeopathic products must evolve and follow a more risk based approach. The new approach will prioritize the enforcement and regulatory actions for any unapproved drugs labeled as homeopathic which are most likely to pose harmful risks to the public focusing on products with safety concerns, products with administration routes that are not topical or oral, Products targeted at what is considered to be vulnerable populations, products claiming to contain substances linked with potentially significant safety concerns, and products that by law do not meet the standards for purity, strength and quality.
The public is encouraged by the FDA to comment on the draft guidance during a 90 day comment period. It is also encouraged for patients and healthcare professionals to report any adverse events or effects and quality problems they have found associated with any homeopathic drug or product to the FDA’s MedWatch program for investigation.