When a 'Miracle' Meets the FDA

Depending whom you ask, a Spokane business was either selling modern snake oil or a cure-all.

When a 'Miracle' Meets the FDA
Young Kwak
Daniel Smith’s Spokane business was raided last June by the FDA, but he has yet to be charged with any crime.

The “miracle” starts with three drops. Drip, drip drip. Three drops of sodium chlorite into a glass. Then three drops of citric acid.

Matthew Darjany sniffs the little puddle and swears it smells like fish or chlorine. He reaches for another glass, this one filled with water. The chemicals go into the water.

“Then you just drink it. There’s no particulate in there,” he says. The water glass goes to Darjany’s lips. He chugs it.

These little drops used to be Darjany’s livelihood, shipped in bottles from his downtown Spokane warehouse. The product was called Miracle Mineral Solution, and Darjany and his business partner, Daniel Smith, shipped thousands around the world.

Until the Food and Drug Administration shut it down last year, alleging that Smith violated federal laws and engaged in smuggling.

Now Darjany’s business is gone, and Smith is under federal investigation.

“Done,” Darjanny says, slamming the empty glass down. “That’s the big scandal. You, my friend, have witnessed a crime.”

There are two parts to Miracle Mineral Solution, or MMS: citric acid and sodium chlorite. Combine them and they become chlorine dioxide.

To doctors, chlorine dioxide is a bleaching agent with no medical use. According to Washington State University’s Drug Information Center, chlorine dioxide and sodium chlorite can both cause burns and irritation to the esophageal tract if ingested.

“It’s scary that you would drink or ingest or inject bleach into your body,” says Thomas Martin, a doctor with Washington Poison Control, which has received three reports of people having adverse reactions to MMS.

But to Smith, MMS is an alternative medicine that’s safe to use and effective against everything from earaches to malaria.

“We used it in the family,” Smith, a 42-year-old father of three, says. “It had some great benefits. Strep throats, ear infections, things like that were going away.”

When the tech business he was involved in went under in 2007, Smith started importing sodium chlorite from Canada and selling the product full-time, under the name PGL International.

It was about then that Smith started breaking federal law, the FDA alleges.

By last year, the FDA had recorded four complaints about the drug, including two reports of life-threatening conditions, according to an affidavit submitted by FDA Special Agent DaLi Borden.

By importing sodium chlorite from Canada and then shipping it along with citric acid, Borden says, Smith violated the federal Food, Drug and Cosmetic Act and was engaged in smuggling.

Both Smith and Darjany say they have taken MMS as medicine, though they never sold it as such. Darjany adds that he’s also used it to deodorize smelly laundry. People could do with it what they wanted, Smith says.

“A lot of people made claims,” he says. “We didn’t make claims.”

An FDA spokeswoman declined to comment about the case, saying it was still under investigation.

The agency came knocking in August of 2010, telling Smith that what he was doing was illegal, court records show. So Smith says he ordered a recall of MMS, then told the feds that he was going to reincorporate as a private membership club, which he believed allowed him to sell MMS legally.

Once he did that, he says, he sent a letter to the FDA asking if Project GreenLife, as the company was now called, was legal. He says he received no response.

That may have been because the FDA was busy building a case against Smith.

In California, agents were secretly placing orders of MMS and having them shipped to post office boxes, according to court records.

Those were just a few of the packages that went out every day, Darjany says. He estimates that they shipped hundreds of packages a day both within the U.S. and internationally.

By January 2011, all that business was being monitored by Borden of the FDA and France Brega, an inspector from the Postal Inspection Service, records indicate.

Using a GPS tracker placed on Smith’s longtime girlfriend’s car, agents were able to track packages of MMS from a downtown Spokane warehouse to a South Hill post office, where they were mailed by the dozens.

Meanwhile, Brega went through the trash from Smith’s house, looking for bank statements and other documents linking him to Project GreenLife, records state. Another FDA agent also analyzed Project GreenLife’s website and determined that Smith was running it.

Smith says he was unaware he was being watched. He only learned that the feds were on to him in June 2011, when Borden, Brega and a host of federal agents turned up at his house and at Darjany’s warehouse to serve the search warrant.

“Obviously, it’s a very, very freaky moment when a government agency raids your home,” says Smith, who was out of town when the raid occurred. “But they took everything, so what can you do? My business was done. And I’ve just spent my time pondering how we’re going to work our way through this.”

The raid netted over $22,000 and about five million Iraqi dinar, which Smith says he had as an investment (and is worth about $4,200 today). It also turned up boxes of sodium chlorite and citric acid, according to an inventory report.

But nearly a year after Project GreenLife was shut down, Smith has yet to be indicted.

Darjany remembers his time testifying before a grand jury as “genuinely conversational.”

“There were a lot of jurors,” Darjany says. “It was relatively informal, compared to a courtroom.”

That was in September. Smith had received a target letter from Christopher Parisi, a Justice Department attorney, who had also asked Darjany to testify before the grand jury, according to a summons Darjany received.

The grand jury met again this month, according to a letter Parisi sent to Smith. Yet Smith says he has not seen an indictment.

“They’ve had two shots at a grand jury and as far as I know the grand jury has not produced an indictment,” Darjany says.

Through a Justice Department spokesman, Parisi declined to comment.

Smith has seized upon the delay to petition U.S. District Court Judge Edward F. Shea to award him his property back. Smith also filed a suit against Brega and Borden last month for alleged infringement on his constitutional rights.

Annie Walsh, a former attorney for the FDA who now works in private practice in Washington, D.C., says getting seized money back is a tall order.

“There’s not a statutory requirement, as far as I know,” Walsh says. “They can hold it as long as there’s probable cause for them to believe there’s a crime.” And grand juries can take years to issue an indictment.

Meanwhile, Smith’s supporters, rallied by a website he set up called I Am Not an Animal (a reference to language in the Food, Drug and Cosmetic Act), have deluged the court with hundreds of declarations affirming their belief in the safety and efficacy of MMS. (Despite the raid on Project GreenLife, MMS is still available online from retailers such as eBay or Amazon.com.)

“He became pretty big, I think, which is why the FDA targeted him,” says Adam Abraham, an MMS advocate from Arizona who has followed Smith’s case.

In March, records show, Parisi offered Smith a plea deal, which would have him plead guilty to counts of introducing a misbranded drug into interstate commerce and conspiracy to violate the Food, Drug and Cosmetic Act.

“They’d like to get a plea bargain out of me, but it ain’t going to happen,” Smith says. “Why would I offer to be a felon to people who can’t prove their case?”

Jobless and living off donations from supporters, Smith spends his days filing court briefs in his own defense. He says he is innocent.

“If I went to prison, I would go with a clean conscience, knowing that other people’s lives were saved,” Smith says. “That’s got to be worth something.”