Miami, Florida - The United States District Court for the Southern District of Florida has entered a temporary injunction halting the sale of an unapproved, unproven, and potentially dangerous coronavirus (COVID-19) treatment product, the Department of Justice announced Friday.
In a civil complaint and accompanying court papers filed in U.S. District Court for the Southern District of Florida, the Department of Justice alleges that the defendants, Genesis II Church of Health and Healing (Genesis) and its principals, Mark Grenon, Joseph Grenon, Jordan Grenon, and Jonathan Grenon sell and distribute a product called Miracle Mineral Solution, also referred to as MMS. Genesis sells MMS through its websites claiming that it will cure, mitigate, treat, or prevent Coronavirus, which includes COVID-19, as well as other diseases including Alzheimer’s, autism, brain cancer, HIV/AIDS, and multiple sclerosis, among others. MMS is a chemical product which, when combined with the included activator, creates a powerful bleach product that the defendants market for oral ingestion. The Food and Drug Administration (FDA) has previously issued public warnings to consumers that MMS can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration. The Justice Department sought preliminary relief from the court.
“The Department of Justice will take swift action to protect consumers from illegal and potentially harmful products being offered to treat COVID-19,” said Assistant Attorney General Jody Hunt. “We will continue to work closely alongside our partners at the Food and Drug Administration to quickly shut down those selling illegal products during this pandemic.”
“We will zealously pursue perpetrators of fraud schemes seeking to take advantage of the COVID-19 pandemic,” said U.S. Attorney Ariana Fajardo Orshan for the Southern District of Florida. “Not only are these products potentially harmful, but their distribution and use may prevent those who are sick from receiving the legitimate healthcare they need.”
The complaint alleges that defendants’ disease-related treatment claims are unsupported by any well-controlled clinical studies or other credible scientific substantiation. Additionally, the complaint asserts that MMS’s labeling is false and misleading and that since defendants make disease-related treatment claims about MMS in the absence of any clinical data, the products are misbranded.
On April 8, 2020, FDA, jointly with the Federal Trade Commission, issued a Warning Letter to Defendants notifying them that they are violating federal law (both the Federal Food, Drug, and Cosmetic Act as well as the Federal Trade Commission Act) by, among other things, distributing unapproved new drugs and misbranded drugs in interstate commerce. Despite this warning, the complaint alleges, the defendants not only continue to sell MMS with claims that it cures, mitigates, treats, or prevents Coronavirus, which includes COVID-19, but they have also expressly stated that they will not take corrective action.
“Americans expect and deserve proven medical treatments and today’s action is a forceful reminder that the U.S. Food and Drug Administration will use its legal authorities to quickly stop those who have proven to continuously threaten the health of the American public. It is vital that sellers of drug products comply with the FD&C Act and do not sell products with false and misleading claims, especially to treat COVID-19 and other debilitating diseases, such as autism and Alzheimer’s disease,” said FDA Commissioner Stephen M. Hahn, M.D. “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. 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.”
FDA’s previous warning to consumers about the dangers of MMS can be found here: https://www.fda.gov/consumers/consumer-updates/danger-dont-drink-miracle-mineral-solution-or-similar-products.
The enforcement action filed today is being prosecuted by Senior Litigation Counsel Ross S. Goldstein and David A. Frank of the Department of Justice, Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Matthew Feeley of the U.S. Attorney’s Office for the Southern District of Florida, with assistance from Associate Chief Counsel for Enforcement Joshua Davenport of the FDA, Office of General Counsel, Department of Health and Human Services.
The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove to receive a permanent injunction against the defendants.