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FTC Requiring New Labeling Disclaimers for Homeopathic Drugs

The Federal Trade Commission (FTC) recently announced a new enforcement policy for homeopathic drugs. The policy requires homeopathic drug packaging to display the following disclaimers in cases where marketers cannot adequately substantiate their claims:

  1. There is no scientific evidence that the product works.
  2. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts

The FTC issued the enforcement policy after releasing a 24-page report that contained public comments and findings from commissioned studies. The report concluded that “customers were likely to be deceived by labels that did not carry the appropriate disclaimers.”

Prior to the new policy, homeopathic drugs were not required to prove their effectiveness or abide by U.S. Food and Drug Administration (FDA) regulations for other types of drug products. Despite being deemed by the FTC as having “no scientific evidence” to support effectiveness, homeopathic drugs have avoided regulation due to the nature of homeopathy. Homeopathy is built on the belief that small doses of substances that cause symptoms in healthy people can cure similar symptoms in unhealthy people. FDA defines a homeopathic drug as “any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.” Homeopathic drug potencies consist of substances that are diluted from 1/10 to 1/50,000 or higher.

FDA has been considering changes to homeopathic drug regulations since 2014 due to homeopathy growing into a multimillion dollar industry in the United States. In addition to the growth of the industry, homeopathic drugs have been seen to cause adverse effects on consumers.  A 2012 report showed there were 10,311 poison exposure cases related to “homeopathic agents”.  In August 2015, the FTC recommended that FDA reevaluate its regulatory framework for the regulation of homeopathic drugs after FTC research found 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

Registrar Corp is an FDA consulting firm that helps drug companies understand and comply with FDA regulations.  For any questions about changes to homeopathic drug regulations or other current FDA regulations for drug companies, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Advisor 24 hours a day through Live Help.