The Food and Drug Administration (FDA) has issued warning letters to several companies selling unapproved injectable products labeled as homeopathic.
These products are particularly concerning as they are injected directly into the body and may contain toxic ingredients, as well as pathogens, that could potentially lead to serious and life-threatening harm. The letters were sent to Hervert Pharmaceuticals LLC, MediNatura, Inc, 8046255 Canada, Inc., doing business as Viatrexx, and World Health Advanced Technologies, Ltd. Products manufactured by these firms were labeled with intended uses ranging from treating osteoarthritis pain to reducing HIV viral load. Some even claimed to treat tuberculosis, hepatitis, and cancer.
“These products are further concerning given that they are labeled to contain potentially toxic ingredients intended for injection directly into the body,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. These toxic ingredients include nux vomica (which contains strychnine), belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead).
Homeopathic products marketed in the US have not been evaluated for safety or efficacy by the FDA. These products can include several ingredients, including potential toxins. The Agency is currently working on a risk-based approach to prioritize enforcement and regulatory actions involving homeopathic products that could potentially put the public at risk. In the meantime, healthcare providers are urged to report adverse events related to these products to the FDA’s MedWatch program.
For more information visit fda.gov.