On prowl for bogus claims about coronavirus treatments, FDA targets Miracle Mineral Solution
In its attempted crackdown on bogus coronavirus remedies, the U.S. Food and Drug Administration has encountered an old nemesis: a “miracle” solution made of chlorine dioxide that experts say is akin to drinking bleach.
But the Florida church peddling Miracle Mineral Solution, or MMS, as the chlorine dioxide drink is called, this week told the Department of Justice that it will not stop selling it, in defiance of a temporary restraining order issued by a federal judge last month.
“We DO NOT want to pursue this,” Mark Grenon, who calls himself a bishop at the Genesis II Church of Health and Healing, wrote in an email to federal prosecutors on Monday. “We have much more important things to do in our Church. STOP TODAY! DISMISS THIS CASE!”
The Genesis II Church was founded by an ex-scientologist named Jim Humble who also invented MMS. The FDA began issuing warnings about MMS nearly ten years ago. It has been linked to numerous injuries and at least two deaths, and one of its marketers was convicted of selling misbranded drugs and sentenced to four years in prison in 2015.
But while the sales volume is unknown, the popularity of the drink appears to be increasing, as FairWarning reported last year, and the COVID-19 pandemic appears to have offered the Genesis church a gift in the form of a new marketing opportunity.
In late April, Grenon wrote a letter to President Trump stating that chlorine dioxide “can rid the body of COVID-19,” according to a report by The Guardian. Later that week, Trump promoted the idea on national television that disinfectants could knock-out the virus, though it’s uncertain if Trump read or was influenced by Grenon’s letter.
On April 17, after church leaders ignored the latest warning letter from the FDA, the Justice Department filed a civil complaint against Genesis and bishops Mark Grenon, Joseph Grenon, Jordan Grenon, and Jonathan Grenon, demanding that they stop selling MMS immediately. A federal judge in the U.S. District Court of Southern Florida granted a temporary restraining order that was set to expire on May 1. But the bishops made clear that they have no plans to follow the order.
“You think we’re afraid of some Obama-appointed judge that broke their oath?” Grenon said in a podcast on May 10, apparently referring to federal judge Kathleen M. Williams, who issued the restraining order. “Once you break your oath, you’re not even a judge. You’re no judge.”
On Monday, Justice Department lawyers filed a motion to hold Genesis and its principals in contempt of court, citing the email, the podcast and other messages as evidence. The church leaders did not respond to an email from FairWarning seeking comment.
Miracle Mineral Solution is perhaps the most prominent but not the only product targeted by the FDA in what it has dubbed Operation Quack Hack. Since March, the FDA has issued 42 warning letters demanding that firms stop making false claims about preventing or treating Covid-19.
“We are actively monitoring for any firms marketing products with fraudulent COVID-19 prevention and treatment claims,” the agency said, noting that it has discovered “hundreds of such products including fraudulent drugs, testing kits and personal protective equipment (PPE) sold online with unproven claims.”
The warning letters give businesses a chance to voluntarily comply with FDA regulations that they are accused of violating. Recipients include conspiracy theorist and Infowars host Alex Jones, the televangelist Jim Bakker, and a Florida chiropractor named John Lieurance, who was selling suppositories, nasal sprays and oral sprays as part of “viral protection” kits priced anywhere from $300 to $1,000 on his website Glutagenic.com.
Lieurance has been in practice for over 20 years and describes himself as a Naturopathic Physician and Chiropractic Neurologist, which his website acknowledges are not recognized medical specialties.
He offers stem cell therapy and other experimental treatments at a clinic in Sarasota called Advanced Rejuvenation. In 2013, a woman who visited the clinic for help with her chronic obstructive pulmonary disease suffered a seizure in the clinic and died shortly after receiving an injection, according to a lawsuit filed by her husband in Sarasota County. The doctor who performed the procedure, Dr. Mark Kantzler, eventually surrendered his medical license, as reported by the South-Florida Sun Sentinel in 2017. Lieurance was assisting in the procedure and initially told the paramedics not to come, according to the newspaper report and the lawsuit.
In an email, Lieurance told FairWarning that in response to the FDA warning letter Glutagenic “promptly contacted the FDA, took responsive action, and are committed to ongoing compliance with the federal Food, Drug, and Cosmetic Act.”
Several companies that received warning letters were promoting ingestible silver as preventing COVID-19. Silver is known to have some antibacterial properties, and was used as medicine before the invention of penicillin, but ingesting silver has also been linked to the disease argyria, an irreversible condition in which the skin turns a bluish-grey. As a result, the FDA banned over-the-counter sales of silver-based medications in 1999. Online advertisers, including the websites of Alex Jones and Jim Bakker, continue to offer silver-based products.
“I’ve been taking it for 10 years and I have beautiful skin and I’m not blue,” said Maryam Henein, a former journalist and YouTube personality who received a warning letter from the FDA this month over unproven claims the agency said she made about her silver products and COVID-19. Henein denied that she violated any FDA regulations, but confirmed that a friend received the letter and forwarded it to her.
“I am not in the country, because guess what, there’s a Plandemic going on,” Henein told FairWarning in an interview, a reference to the widely-viewed “Plandemic” video that promotes conspiracy theories about the origin of the coronavirus.
The FDA also issued warnings to makers of cannabis-based products, essential oils, herbal supplements and alcohol-free hand sanitizer.
An Iowa-based hand sanitizer company, Prefence LLC, told IowaWatch that it makes no claims about preventing Covid-19, and blamed independent distributors who have been selling the product online. A letter that the firm provided to IowaWatch shows that they told their distributors to stop making claims about Covid-19 on March 12, more than a month before the FDA issued a warning letter to Prefence.
In most instances, the FDA said that online marketplaces have agreed to voluntarily remove postings that violate regulations. “We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic,” the agency said.
FairWarning is a nonprofit news organization based in Southern California that focuses on public health, consumer, labor and environmental issues.