FDA, FTC Actions Against COVID-19 Products Continue with Florida TRO

A federal court in Florida has entered a temporary restraining order against the Genesis II Church of Health and Healing (Genesis) and four principals associated with the entity. The order requires defendants to immediately stop distributing “Miracle Mineral Solution” (MMS), an unapproved and unproven product that can have a chlorine dioxide content equivalent to industrial bleach.

FDA has been actively monitoring the market during this health emergency for products with fraudulent COVID-19 claims. FDA issued its first round of warning letters in conjunction with FTC on March 6, as we previously reported. The agencies demanded several companies stop claiming their products—teas, essentials oils, tinctures, and colloidal silver—could prevent or treat COVID-19. And as we analyzed here, once FDA learned that various startups were gearing to launch at-home COVID-19 testing kits, it advised that such kits had not received its blessing.

This month, FDA and FTC likewise warned Genesis about marketing MMS for prevention or treatment of COVID-19 in adults and children. In a corresponding press announcement, FDA explained that such unapproved, unproven chlorine dioxide products “can jeopardize a person’s health and delay proper medical treatment.” The agency has not approved Genesis’s product for any use, despite defendants’ claims that MMS can be used to prevent or treat COVID-19, in addition to Alzheimer’s, autism, brain cancer, multiple sclerosis, and HIV/AIDS. Nor is FDA aware of any scientific evidence supporting these claims. Meanwhile, it has received reports of people experiencing serious adverse events to chlorine dioxide products, including changes in the electrical activity of the heart, life-threateningly low blood pressure caused by dehydration, and acute liver failure.

FDA and FTC asked Genesis to describe the specific steps it had taken to correct the violations within 48 hours of the April 8 warning letter. But defendants made clear that they would not take corrective action and would continue to sell MMS. In turn, FDA asked the Department of Justice (DOJ) to bring a lawsuit on behalf of the U.S. Government.

This tension came to a head Friday, April 17, when U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered the temporary restraining order against Genesis and the four individual defendants until May 1, 2020, when she will hear the United States’ request to extend the injunction. The complaint ultimately seeks to restrain and enjoin defendants from labeling, holding, and distributing unapproved new drugs and misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act, including MMS, in interstate commerce on a permanent basis.

FDA shared the development here. Further, FDA reiterated its concerns that fraudulent COVID-19 products may cause consumers to delay appropriate medical treatment, as well as its promises to monitor social media, online marketplaces, and incoming complaints to ensure companies do not sell such products.

The Morrison & Foerster COVID-19 Task Force will continue to provide updates as FDA issues guidance for consumer-facing product manufacturers.