By Craig Clough

Law360 (April 17, 2020, 7:34 PM EDT) -- A Florida federal judge on Friday ordered​​​​​​ a "nonreligious church" to immediately stop selling its "Miracle Mineral Solution" after the U.S. Food and Drug Administration sought an injunction to halt the sale of the concoction the church claims can cure COVID-19, Alzheimer's, multiple sclerosis and other diseases.

The FDA told the court Thursday that the Genesis II Church of Health and Healing and its leaders are violating the Federal Food, Drug, and Cosmetic Act by selling unapproved and misbranded drugs through interstate commerce. The agency also said in a statement that Miracle Mineral Solution, or MMS, when combined with the included activator has a chlorine dioxide content equivalent to industrial bleach. 

The defendants claim through their websites that MMS can cure, mitigate, treat or prevent COVID-19 and other diseases through "sacramental dosing," despite there being no evidence of any reputable scientific studies to back the claims, the FDA said.

The FDA also said that after warning the church in an April 8 letter that it was violating federal law, it received a response from the church's "archbishop" Mark Grenon two days later that said there "will be NO corrective actions on our part … You have no authority over us! … Never going to happen."

The complaint for a preliminary and permanent injunction named Genesis II Church as well as Mark Grenon, Joseph Grenon, Jordan Grenon and Jonathan Grenon as co-defendants. The FDA said the defendants are violating the FDCA by introducing into interstate commerce a "new drug" that is "neither approved by FDA nor exempt from approval."

Genesis II Church describes itself on its website as "a nonreligious church … focus[ing] on 'restoring health' to the world" that "was formed for the purpose of serving mankind and not for the purpose of worship," the FDA said.

The FDA said the defendants through websites that were still active as of Friday afternoon made various claims about the healing powers of MMS, including through a video where Mark Grenon said: "The coronavirus is curable. You believe that? You better."

The FDA also pointed out in the complaint that the World Health Organization has said "there is no evidence that current medicine can prevent or cure [COVID-19]."

In his written response, the FDA said Mark Grenon responded that the defendants "can say cure, heal and treat as a Free Church. Don't need you [sic] approval or authorization for a Church Sacrament."

As part of U.S. District Judge Kathleen M. Williams' order, she said the FDA can enter and search the church's place of business in Bradenton, Florida, to monitor and ensure compliance with the order.

"Despite a previous warning, the Genesis II Church of Healing has continued to actively place consumers at risk by peddling potentially dangerous and unapproved chlorine dioxide products," FDA Commissioner Stephen M. Hahn said in a statement Friday. "We will not stand for this, and the FDA remains fully committed to taking strong enforcement action against any sellers who place unsuspecting American consumers at risk by offering their unproven products to treat serious diseases."

The Genesis II Church did not immediately respond to requests for comment.

The government is represented by Ross S. Goldstein and David A. Frank of the U.S. Department of Justice and Matthew J. Feeley of the U.S. Attorney's Office for the Southern District of Florida.

Counsel for the defendants was not immediately available.

The case is U.S. v. Genesis II Church of Health and Healing et al., case number 1:20-cv-21601, in the U.S. District Court for the Southern District of Florida.

--Editing by Orlando Lorenzo.

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