Some Homeopathic Products May Put You at Risk
Homeopathic products are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling
Consumers may use various types of unapproved drugs, such as homeopathic products, to treat or relieve different diseases and conditions. These products are often marketed as natural alternatives to approved prescription and nonprescription products and are widely available in the marketplace. Homeopathic products, however, are marketed without FDA review and may not meet modern standards for safety, effectiveness, quality and labeling.
It is FDA’s public health mission to protect consumers from unsafe, ineffective and poor-quality drug products, which may cause significant and even irreparable harm.
Homeopathic products are made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, including known poisons or toxins.
Some homeopathic products are indicated for treating conditions in infants and children, and are manufactured from ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury) and plumbum aceticum (lead). These ingredients pose potentially toxic effects.
For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. Producing such a product without proper manufacturing controls may result in products that exceed the labeled dilution/strength of the ingredients, which, given what they are made from, could place consumers at significant risk.
Examples of FDA’s concerns include:
- FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination, September 18, 2024
- HomeoCare Laboratories Inc. issues voluntary nationwide recall of Homeopathic Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse sue to microbial contamination, June 5, 2024
- Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination, June 9, 2022
- FDA warns four manufacturers of unapproved injectable drugs labeled as homeopathic, June 16, 2020
- FDA warns manufacturers of products labeled as homeopathic for putting consumers at risk with significant violations of manufacturing quality standards, May 14, 2019
- FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards, April 1, 2019
- FDA takes action against marketer of unapproved products claiming to treat addiction, chronic pain and other serious conditions, March 19, 2019
- FDA alerts consumers of Kadesh Incorporation’s voluntary nationwide recall of Puriton Eye Relief Drops due to non-sterile production conditions, November 8, 2018
- FDA alerts consumers of Sprayology’s voluntary nationwide recall of homeopathic water-based medicines due to microbial contamination, October 11, 2018
- FDA alerts consumers and pet owners of Silver Star Brand’s voluntary recall of homeopathic drug products, October 4, 2018
- FDA alerts consumers of BioLyte Laboratories voluntary recall of NeoRelief, September 14, 2018
- FDA alerts consumers of Beaumont Bio Med’s voluntary recall of all water- and alcohol-based products, September 7, 2018
- FDA alerts consumers of HelloLife’s voluntary recall of Neuroveen, Respitrol, Thyroveev and Compulsin, August 31, 2018
- FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products, August 28, 2018
- FDA warns consumers about homeopathic teething products, January 27, 2017
- FDA warns consumers about the potential health risks of over-the-counter asthma products labeled as homeopathic, March 20, 2015
- Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin, March 20, 2014
- Information on Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs and Zicam Cold Remedy Swabs, Kids Size, June 16, 2009
Risk-based approach to protect consumers
FDA uses a risk-based approach in monitoring homeopathic products and evaluating reports of adverse effects. The agency will continue taking appropriate regulatory and enforcement actions when we believe patients are at risk.