Life Sciences Blog

Over-the-Counter Drug Product Monographs: FDA Requirements for Homeopathic Products

by | Aug 5, 2021

Reed Tech recently hosted the fifth in a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues. The series has taken place throughout this summer. For more fundamental information on OTC drug monographs, provided in the first webinar of the Reed Tech OTC series, read the blog or view the webinar.

This fifth webinar featured speakers Caitlin Osborn of Reed Tech and Shelly Garg and Natascia Roman of Amin Talati Wasserman LLP. In this webinar, the speakers provide guidance for companies who produce homeopathic products, including those with ingredients derived from plants, healthy or diseased animal or human sources, minerals, and chemicals. As FDA regulation of homeopathic products has changed over the years, we will provide an overview of FDA risk-based enforcement approach.

This webinar began by defining Homeopathy as alternative medical practice that was developed in the late 1700s with two main principles: a substance that causes symptoms in a healthy person can be used in diluted form to treat symptoms and illnesses, a principle known as “like-cures-like”; and the more diluted the substance, the more potent it is, which is known as the “law of infinitesimals”. The FDA does not currently approve any homeopathic products, so anything labeled as homeopathic has not been tested for safety or efficacy. These products often contain ingredients derived from plants, animal or human sources or certain minerals and chemicals.

The webinar then examines the FDA guidance that governs homeopathic marketing and claims. Homeopathics originally were to abide by the Compliance Policy Guide (CPG) but in 2019, FDA withdrew CPG due to many instances of homeopathics posing a significant risk to patients since its inception in 1988. The new draft guidance takes a risk-based approach considering formulation, labeling and safety requirements.

While FDA has less involvement with homeopathics than other typical Rx or OTC drugs, they typically get involved with safety issues and enforcement. Homeopathic drugs are not approved by FDA but usually go through the New Drug Approval Process.

To learn more about homeopathic drugs, the drug listing process, and more, contact Reed Tech at [email protected].

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