April 17, 2020
A federal court has entered a temporary injunction against the Genesis II Church of Health and Healing (Genesis) and four individuals associated with the entity requiring them to immediately stop distributing its “Miracle Mineral Solution” (MMS), an unproven and potentially harmful treatment offered for sale to treat Coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases.
In granting the government’s request for relief, the court found that the United States has demonstrated that Genesis and the associated individuals named in the injunction are violating the Federal Food, Drug, and Cosmetic Act (FD&C) by unlawfully distributing MMS, an unapproved new drug and misbranded drug. When combined with the included activator MMS has a chlorine dioxide content equivalent to industrial bleach. The court also found that there is a danger that the defendants will continue violating the law without the temporary restraining order.
The FDA has not approved Genesis’s product for any use, despite the defendants’ claims that these products can be used to cure, mitigate, treat or prevent diseases such as COVID-19, Alzheimer’s, autism, brain cancer, multiple sclerosis and HIV/AIDS. Claims made on the Genesis websites, which provide a link to purchase MMS, include, “The Coronavirus is curable, you believe that? . . . MMS will kill it.” The agency is not aware of any scientific evidence supporting the safety or efficacy of MMS to treat any disease and there are no approved drug applications in effect for the defendants’ MMS.
The FDA is particularly concerned that products that claim to cure, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm.
The FDA reminds the public to seek medical help from their health care providers. Additionally, children are a vulnerable population that may be at greater risk for adverse reactions from consuming chlorine dioxide products. The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program.