FDA Crackdown of Bleach 'Miracle' Cure

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When federal authorities filed a lawsuit on April 16 to stop a company from selling a bleach-like solution as a “miracle” cure for COVID-19, they described the move as a quick response to protect consumers from illegal and potentially harmful products.

“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,” FDA Commissioner Stephen M. Hahn, M.D., said in a statement announcing the suit.

But the agency’s action wasn’t as swift as Hahn made it out to be, according to a Consumer Reports review of FDA filings, court records, and documents obtained through the Freedom of Information Act.

The company—which is called Genesis II Church of Health and Healing, though it’s not recognized by the government as a religious institution—got the FDA’s attention for marketing a “cure-all” remedy called Miracle Mineral Solution, or MMS. The product, a liquid meant for drinking, contains a mix of sodium chlorite, a chemical compound used to make disinfectants, and citric acid. It has been on the FDA’s radar since at least 2008, long before the coronavirus crisis erupted, and records show the agency has been aware of Genesis’ relationship to MMS for years.

The combination of chemicals in MMS, the FDA says, creates chlorine dioxide at levels equivalent to that found in industrial bleach. The FDA has issued several warnings about the potential dangers of drinking MMS since at least 2010. Adverse event reports filed with the agency by consumers and healthcare professionals have linked the ingestion of MMS to serious health problems, including acute liver failure and even death. Those reports don’t prove that a product caused an injury, but the FDA uses them to investigate potential risks.

The timing of the government’s action makes sense, experts say, given the concern that some consumers, fearful about the coronavirus pandemic, might be especially susceptible to bogus claims of miracle cures. That concern took on new urgency in recent weeks, after President Donald Trump suggested in April that injecting disinfectants could be a way to fight the virus.

Genesis claims that in addition to curing COVID-19, MMS cures many diseases and disorders, including Alzheimer’s disease, autism, and brain cancer, according to the FDA suit. Its chief advocate is Genesis’ founder, Jim Humble, who has inspired supporters and purveyors of MMS around the globe. While Genesis has sold MMS, it also provides information on how to make the product at home and how to buy it from Genesis’ approved distributors, and sometimes hosts seminars on how to use it.

For more than a decade, the product has periodically been the subject of negative news coverage. Yet despite that media attention, the FDA’s own warnings about MMS, and the fact that the agency once blocked Genesis from importing MMS products produced elsewhere into the U.S., it took a pandemic for the agency to finally clamp down on Genesis itself.

The FDA tells CR that it’s the agency’s standard practice to give a company the opportunity to voluntarily correct compliance issues, typically by issuing a warning letter, before launching an enforcement action.

The law governing how the FDA polices supplements sharply limits the agency’s power, says Peter Lurie, M.D., a former associate commissioner for public health strategy and analysis at the FDA and now president of the Center for Science in the Public Interest, a consumer advocacy group. Warnings might compel some companies to correct problems, but others, like Genesis, may pay no attention.

Consumer advocates, while acknowledging that the FDA lacks the resources to adequately oversee the marketplace, say that it often takes the agency too long to use all of its legal authority to remove unsafe products and that the case of Genesis underscores systemic issues with the agency’s policing of dietary supplements.

“It’s resources, it’s a lack of will, it’s foot dragging, it’s all of the above,” says Michael Carome, M.D., a director at the consumer advocacy group Public Citizen.

In an email to CR, Mark Grenon, one of Genesis’ leaders, characterized the lawsuit as an “unconstitutional attack on the G2 church” and provided 33 pages of “testimonies” claiming that MMS works. In letters filed to the court, Grenon and Genesis co-leaders accuse the government’s attorneys of treason and, citing their First Amendment rights to freedom of religion, say they’re not required to obey any judicial order.

But consumer advocates find that defense suspect. “Being or claiming to be a church does not give you a free pass to sell dietary supplements with dangerous, unapproved ingredients, or to make false and misleading claims that a product prevents or treats serious diseases and disorders such as COVID-19 and autism,” says Chuck Bell, programs director for advocacy at CR.

“To protect consumers, the FDA and the Department of Justice should take prompt enforcement action against companies or organizations that break the dietary supplement law,” he says. “It’s alarming that it has taken years to get this product out of the U.S. marketplace.”

'Sacrament' Kits

Jim Humble claims to have “discovered” the key ingredient in MMS in 1996, on a “gold mining expedition” in South America, according to his website. He says he discovered that chlorine dioxide “quickly eradicates malaria” and claims that it has since been found to restore health to people who have autism, cancer, diabetes, hepatitis (A, B, and C), Lyme disease, Parkinson’s disease, and more. “I’ve dedicated all my time and effort to helping others recover their health and to bringing this technology to the world,” he writes on his website.

It’s unclear when Humble first started to market MMS, but by 2008, reports of serious injuries involving the product began to emerge.

In January of that year, the FDA received its first known adverse event report about MMS from a consumer who claims to have found the product through a website, at miraclemineral.org. At the time, the site included a list of places where consumers could buy MMS. And it described Humble as the man behind the alleged cure, claiming that “thousands of cases of many different diseases have been treated with complete success.” (The URL, at the time of publication, redirected to Jim Humble’s website.)

The consumer who filed the adverse event report, obtained by CR through a Freedom of Information Act request, wrote that after taking 10 drops of MMS, “I developed a racing heartbeat and nausea, which resulted in vomiting of what appeared to be a yellow acid.”

The FDA didn’t take enforcement action related to MMS, though, until January 2009, when the agency issued a warning letter to a company, called True Renewal, over claims it made about Miracle Mineral Supplement, another name for MMS. (The company has no clear direct connection to Genesis, though the FDA said it quoted Humble’s book on its website.)

The agency took issue with True Renewal’s description of MMS as the “most powerful killer of disease ever known,” as well as statements on the company’s website about Humble’s aim to “establish MMS as a powerful alternative treatment to many pathogen-borne diseases.”

The following year Humble launched the Genesis II Church, according to an archived version of Genesis’ website. The group now has chapters around the world that provide the MMS mixture—which it calls a “sacrament kit”—to individuals online, for a “donation” starting at $20.

In July 2010, after receiving reports of consumers who experienced nausea, severe vomiting, and life-threatening low blood pressure caused by dehydration after taking MMS, the FDA publicly warned consumers not to drink MMS. Despite the warning, the FDA wrote several months later in a follow-up announcement that the product was still being sold online.

“FDA experts say MMS is dangerous,” the agency wrote, “and they’re advising consumers to stop using the product immediately.”

But Genesis and MMS advocates kept peddling it, consumers kept taking it, and reports of harm, including the death of a U.S. citizen overseas, continued to come to the FDA.

The agency was alerted to the death in August 2010, records show. In an adverse event report filed with the agency, the victim’s husband said his wife died after ingesting two drops of MMS mixed in lime juice, “the initial dose recommended in Jim Humble’s protocol.”

“She had decided to try MMS because she succumbed to the arguments of its proponents that MMS could aid in protecting the two of us against malaria in our current travels on our sailboat in the western Pacific islands,” the report said. (An email detailing the incident to the FDA had been sent a year prior, the report said, but no response was received.)

Her autopsy was reportedly inconclusive, but the husband blamed MMS for her death and pleaded with an FDA official to discuss the incident with him.

“From this experience I conclude that MMS is a dangerous and potentially lethal substance if ingested as a medical remedy,” he wrote.

An FDA spokesperson declined to comment about the incident, saying the agency doesn’t comment on open compliance matters.

A few years later, in 2013, the agency attempted to clamp down on the sale of MMS—but, notably, it wasn’t in an action against Humble and Genesis.

Instead, the feds indicted Louis Daniel Smith, who sold the bleachlike solution through a company called Project Greenlife.

Smith was eventually convicted and sentenced to 51 months in prison for marketing MMS as a miracle cure. The prosecutors made clear that Smith had a relationship with Humble.

“The Government proffers that Mr. Smith included Jim Humble’s book, pamphlets, and DVDs in the mailings when he shipped MMS to a customer, and that there is evidence that Mr. Smith communicated with Jim Humble regarding methods to avoid liability for the sale of MMS,” the prosecutors wrote in one court filing.

Raising an Alert

And yet, still no action was taken directly against Humble and Genesis, according to an exhaustive review of FDA enforcement data and court records. (When asked, the FDA wouldn’t say whether it had taken action against Humble in the past.)

The agency had some success in stopping the sale of some MMS products in mid-2014, when it detained 127 various MMS products that Genesis had attempted to import into the U.S. from a manufacturer in Ireland because they appeared to be dangerous unapproved drugs, according to FDA records.

When the FDA issues an “import refusal,” the shipment must either be destroyed or exported under the supervision of the agency within 90 days of the action. Though the products were seized, it’s unclear if they were destroyed or sent back. Grenon, of Genesis, didn’t respond to specific questions from CR about the group’s previous interactions with the FDA.

But the product seizure may have been the reason Genesis landed on an import alert in August of 2014 for attempting to bring “unapproved” drugs into the U.S. that presented “serious safety and effectiveness concerns.”

Import alerts are intended to prohibit potentially harmful products from being distributed in the U.S., but their effect is limited. The inclusion of a company on the list doesn’t necessarily prevent it from continuing to sell potentially harmful products. (In 2015, for example, a brand owned by Keurig Dr Pepper was cited for attempting to import bottled water made in Mexico that contained excessive arsenic. But CR found the company was still able to sell it in the U.S. for years after.)

Indeed, Humble and MMS proponents continued marketing and distributing the product to consumers. In June 2015, the FDA received a report from a parent who reported using MMS to help treat their daughter’s flu.

The parent bought MMS from an online manufacturer and, according to the report, spoke with the apparent owner of the company about how to use MMS. “He told me that I needed to give my daughter a drop of the MMS every hour,” they wrote in the report.

“My daughter started to violently vomit and had severe diarrhea,” they went on. “I can’t believe this person is allowed to give medical advice and sell this bleach smelling toxic crap!!! My daughter could have died!!! I looked up this MMS which is sodium clorite and it’s been flagged by the FDA as not safe for people. How is he still selling this then?”

Around the time of the report, Genesis and Humble generated substantial national media attention. In 2016, an ABC News investigation found that Genesis was holding seminars to train “health ministers” sanctioned by the company to sell MMS. A year later, state prosecutors in Texas successfully sued an affiliate of Genesis, as well, to block the sale of MMS.

But Humble and the company continued on.

When asked, the FDA declined to comment on why Genesis and Humble were able to keep promoting and selling MMS, despite the import alert and serious adverse event reports.

“As a matter of policy, the FDA generally does not comment on open compliance matters, its compliance or enforcement strategy, its legal strategy, or open legal matters,” the agency says.

Weak Enforcement?

The example of MMS and Genesis is not the only one in which the FDA failed to act to correct violations that put consumer safety at risk.

A 2018 study published in the journal JAMA Open Network found the agency had, between 2007 and 2016, tested and detected unapproved drug ingredients in 776 dietary supplements, a violation of federal law. But the agency never issued a mandatory recall and referred only one case to the Department of Justice for investigation. Only seven warning letters were issued, the study found.

“The FDA has been extremely weak on enforcing the law,” says Pieter Cohen, M.D., an associate professor of medicine at Harvard Medical School. “When they do warn companies, it usually involves just a warning letter, which is a minor slap on the wrist. Very rarely does the FDA use its full enforcement powers to eliminate prohibited supplements from the marketplace.”

Genesis also drew attention in 2019, when The Guardian reported that the group was planning an event in Washington state to offer membership to the organization and packages of MMS to attendees for a donation. Later that year, the FDA—without naming Genesis—only issued a renewed warning to consumers about the potential harms of drinking MMS.

Yet this is a clear case where the FDA should’ve been more proactive, consumer advocates say. “There are times when it’s just remarkable that they have failed to act,” says Carome at Public Citizen. “It’s clear why they’re acting now in the scope of the coronavirus pandemic. They’re afraid people will, particularly with the president’s encouragement, they’re afraid people might try ingesting things like this to protect themselves or treat the disease.”

That Genesis was essentially unfettered by the FDA until the pandemic has perhaps emboldened it to even more flagrantly violate orders to stop selling MMS.

On April 30, the government asked a judge to hold Genesis and its leaders in contempt, after alleging in court documents that Grenon directed an undercover FDA investigator a few days prior by email on how to obtain MMS through an “alternate” source—a Genesis affiliate known as Bob the Plumber—as the company had temporarily stopped letting consumers obtain the product through its website.

What You Should Do

If you have MMS in your home, the FDA says, do not give the product to children for any reason. If you’re taking it, stop immediately.

It’s also important to keep in mind that hucksters commonly emerge during public health crises to sell consumers bogus products that may be unsafe, says CR’s Bell.

“We are constantly being enticed to buy supplements that manufacturers assure us are safe, without a full understanding of what the ingredients are, or whether there is high-quality scientific evidence that supports their use,” he says. He emphasizes that consumers should approach all supplements, especially those that offer quick cures, with a healthy dose of skepticism.

If you experience an adverse event or quality problem with a product, including any related to COVID-19, the FDA says you should file a report through the agency’s adverse event reporting program.

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