FTC Wants FDA to Increase Regulation of Homeopathic Drugs
[Posted on: Thursday, September 17, 2015]

When a non-prescription drug is primarily sold over-the-counter (OTC) and online, the primary regulatory agency is Federal Trade Commission (FTC) and not FDA. FTC monitors advertisement of such products and regulates them under false promotion laws to assure that marketing of such products does not claim more than it should. FTC appealed to FDA to apply same rules as OTC drugs to homeopathic drugs. Homeopathic products form a special category of OTC products. Any drug manufactured per the Homoeopathic Pharmacopoeia of the United States (HPUS) is allowed in the US market. In 1970s, when FDA created rules for OTC drugs, it did not review homeopathic drugs recognizing their unique status as OTC drugs that we used under supervision of a homeopathic doctor. In 1988, FDA released a policy document outlining its policy for regulation of homeopathic products. However, there has been a dramatic change in the marketing of homeopathic drugs with these drugs being sold online with practically no homeopathic doctor intervention and making bold medical claims for treatment and prevention of diseases. This has lead to increased risk to consumers. FTC wants FDA to have strict requirements for labels for homeopathic drugs making it required that not only should manufacturers comply with the FDA policy from 1988 but also that any indication appearing on the labeling be supported by competent and reliable scientific evidence, namely clinical trials and other human data. Such data is currently not required and per FTC it creates an unsafe environment for such products. According to FTC, “the available evidence suggests that consumers have incomplete and sometimes incorrect information about homeopathy and homeopathic medicines” which should be rectified by FDA by amending its policy towards homeopathic products. No wonder, the industry insiders claim that the recommendations from FTC, if accepted, will create a very onerous requirement on homeopathic products, the like of which will potentially make these products no likely to survive. But this argument is probably too dire. OTC products meet similar requirements and are a well-established market. Getting FDA mandated quality and truthfulness of claim requirements will potentially translate into increased consumer confidence in such products. Most homeopathic products will likely meet the “Time and Extent” requirements, common to OTC products and stay in the market. Indeed, it may lead to increased cost of homeopathic products but consumers have increasingly shown tolerance for higher price for higher quality and reliable products. Last week FDA opened the docket again for extended public comments probably to gauge public opinion post FTC’s comments. The final FDA rules are expected within a year.

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research