The Food and Drug Administration (FDA) has issued a joint warning letter with the Federal Trade Commission (FTC) to the Genesis II Church of Health and Healing for selling chlorine dioxide products known as “Miracle Mineral Solution” that claim to treat or prevent COVID-19.
The warning letter describes the product as a misbranded drug with unapproved claims to cure, mitigate, treat, or prevent COVID-19. The Agency has given the Company 48 hours to respond with how they plan to correct the violations; failure to do so may lead to legal action, including but not limited to seizure or injunction. Consumers are advised not to purchase or use these products.
Serious adverse events have been reported in patients following ingestion of chlorine dioxide, including severe vomiting and diarrhea, life-threatening hypotension caused by dehydration, QT prolongation, low blood cell counts and acute liver failure. Consumers are advised to seek immediate medical attention if they have experienced adverse effects after ingesting any of these products.
This is not the first time the Agency has sounded the alarm on chlorine dioxide products. The products, however, continue to be promoted and sold by many independent distributors on social media with unapproved claims to treat autism, cancer, HIV/AIDS, hepatitis, flu, and other conditions.
“The sale of these products can jeopardize a person’s health and delay proper medical treatment,” said FDA Commissioner Stephen M. Hahn, MD. “We continue to take action and keep up our efforts to monitor for fraudulent treatments during this public health emergency and remind the public to seek medical help from their healthcare providers.”
Health care professionals and consumers are encouraged to report adverse events related to these fraudulent products to the FDA’s MedWatch Adverse Event Reporting program.
For more information visit fda.gov.