The Florida-based Genesis II Church of Health and Healing must stop distributing an unproven “miracle” treatment for Covid-19 in the U.S., under a federal court order.
Judge Kathleen M. Williams, of the U.S. District Court for the Southern District of Florida, entered a temporary restraining order Friday against the organization and four of its members.
The court’s action is a win for the FDA and Department of Justice and signals that the government could likely prove Genesis is violating the Federal Food, Drug and Cosmetic Act by distributing the product.
The complaint alleges that the Bradenton, Fla.-based entity sells the Miracle Mineral Solution through its websites and claims it will cure, mitigate, treat, or prevent Covid-19 and other diseases. Claims made on the Genesis websites include, “the Coronavirus is curable” and “MMS will kill it,” according to the complaint.
The individual defendants are Mark, Joseph, Jordan, and Jonathan Grenon. Mark Grenon holds the title archbishop and is described in the complaint as one of the Genesis founders. The others have the title bishop. Nonetheless, the government asserts in the complaint that the organization is a “secular entity.”
A representative for Genesis didn’t immediately respond to a request for comment.
The Food and Drug Administration described the product in a statement as a “potentially harmful treatment” that, when combined as instructed, has a chlorine dioxide content equivalent to industrial bleach. The agency said the solution was “unapproved” and “misbranded.”
“Americans expect and deserve proven medical treatments and today’s action is a forceful reminder that the FDA will use its legal authorities to quickly stop those who have proven to continuously threaten the health of the American public,” FDA Commissioner Stephen M. Hahn said.
“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,” he added. “We will not stand for this.”
The FDA and the Federal Trade Commission issued a warning letter to Genesis on April 8 and gave it 48 hours to correct the violations.
The government told the court in its motion for a restraining order that the defendants made it clear they would continue to sell the solution.
The FDA has publicly warned consumers multiple times in the past decade not to purchase or drink chlorine dioxide products sold as medical treatments. The FDA has received reports of people experiencing serious adverse events, including respiratory failure, life-threatening low blood pressure, acute liver failure, and heart rhythm disorders after drinking certain chlorine dioxide products.
The federal court’s decision comes as New York Attorney General Letitia James issued orders directing four different entities, including Genesis, to stop selling “misleading” cures and “unauthorized” Covid-19 testing kits.
Calling the actions “reckless,” James alleged that Genesis and Sustainable Forestry Solutions were selling the unapproved cures, while Hong Kong Royal Resource Technology Co. and Rightangled were selling unauthorized test kits.
Rightangled CEO Abdullah Sabyah said in a statement to Bloomberg Law that his company delivers “screening and diagnostic services via home-delivered testing kits, with samples returned to the lab for analysis.” The company is registered and regulated in the U.K.
“We have not promoted or marketed any of our testing kits in the US. None of the orders we received online were purposely targeting NY residents,” he said.
Williams scheduled a hearing for May 1 on the government’s motion for a preliminary injunction against Genesis in the case in Florida.
The case is U.S. v. Genesis II Church of Health & Healing, S.D. Fla., No. 1:20-cv-21601, Temporary Restraining Order issued 4/17/20.