FTC to FDA: Do Your Job! ISS - It's the Science, Stupid! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient.


Now, the Federal Trade Commission (FTC) is weighing in, calling on FDA to "consider amending or repealing its framework for homeopathic medications."

The issue, as FTC sees it, has to do with how over-the-counter homeopathic drugs are labeled and sold. Currently, FDA does not approve homeopathic drugs for safety or efficacy as long as they meet certain conditions, such as being sold "for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment," and are labeled for their intended use.


However, FDA does not require scientific or clinical data to back homeopathic products’ indications for use, which FTC says "may harm consumers and confuse advertisers."


FTC also says it has had issues with advertisers mistakenly thinking they "do not have to comply with FTC advertising substantiation requirements" if they meet the requirements in FDA's compliance policy guide.


Lastly, FTC says its research has shown that "most consumers do not understand homeopathy, how the FDA regulates homeopathic drugs, or the level of scientific evidence needed to support health claims for homeopathic products."