This article about MMS for COVID-19 was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
On April 17, 2020, a Federal judge issued a temporary order prohibiting the Church of Genesis II from selling its Miracle Mineral Solution (MMS) for COVID-19 – in reality, MMS is a dangerous industrial-strength bleach. The order is a response to an action by the FDA based on the Church’s promotion of MMS for COVID-19. The response of most reasonable people familiar with MMS is, probably, “about time.”
Miracle Mineral Solution is an industrial-strength bleach. As far as I know, it has no proven benefits, and obviously, ingesting concentrated, industrial-strength bleach – or worse, taking it as an enema – can cause harm.
It has been sold by the Genesis II Church both as a sacrament and as a miracle cure for all ills. Among other uses, it has been used by parents of children with autism against their autistic children, either by providing it orally or as an enema, with harmful results.
The FDA has warned about MMS in the past and conducted several investigations and actions addressing it.
On April 8, 2020, the Food and Drug Administration (FDA) issued a warning letter to the Genesis II Church stating that:
[b]ased on [FDA’s] review, MMS is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a)…
They also demanded that the Church,
cease the sale of such unapproved and unauthorized products for the cure, mitigation, treatment, or prevention of COVID-19. Further, FDA has previously warned consumers about the dangerous and potentially life-threatening side effects of MMS…
In other words, the FDA concluded that MMS, to be sold, needs to be licensed as a drug – which would require the sellers to provide evidence that it’s safe and effective (which they’re unlikely to be able to do, but they have as much chance of trying as any other sellers). Since MMS has not gone through the approval process, it’s in violation of the act.
On the FDA’s site, the FDA Commissioner, Stephen M. Hahn, MD, added more:
Despite previous warnings, the FDA is concerned that we are still seeing chlorine dioxide products being sold with misleading claims that they are safe and effective for the treatment of diseases, now including COVID-19. The sale of these products can jeopardize a person’s health and delay proper medical treatment. 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 health care providers.
After the Church, apparently, did not stop selling and promoting MMS, the FDA went to court. Under the Food, Drug, and Cosmetics Act, the FDA can request an immediate temporary restraining order in situations like this, for the public health, and does not have to meet the high bar regular civil plaintiffs would have to meet to get such an order.
The Court granted the order, ordering the church, among other things, not to:
directly or indirectly, label, hold, and/or distribute any drug, including but not limited to MMS, that does not have an approved new drug application pursuant to 21 U.S.C. § 355(b) or abbreviated new drug application pursuant to 21 U.S.C. § 355(j), or an investigational new drug application in effect for its use pursuant to 21 U.S.C. § 355(i), or any drug that is misbranded within the meaning of 21 U.S.C. § 352.
This means that the Church is not supposed to sell MMS for any use, not just as a (fake) treatment for COVID-19 for the moment. The next step is a preliminary injunction hearing, and it may end with the prohibition extending until the end of the case (though it can be lifted).
As I said, about time. Here is hoping the prohibition becomes permanent, and that appropriate sanctions be imposed on those promoting MMS for COVID-19, a dangerous substance, as a cure.