Supplement industry flies under the radar, poses deadly risk

May 5, 2017 by Danny Robbins, The Atlanta Journal-Constitution

Beny Mesika and Wes Houser had little in their backgrounds besides criminal convictions and failed businesses, but their fortunes turned when they began concocting dietary supplements.

Within five years, they were awash in cash as they blended and bottled products promising a shortcut to size, strength and muscle from their warehouses in the northern Atlanta suburbs.

It was a fast and improbable ride to a life of $300,000 sports cars, ornate mansions, even a 43-acre farm.

Now it's a cautionary tale showing how easily unscrupulous operators can find a home in the supplement industry and the irreparable harm that can result.

Mesika and Houser are key figures in a criminal case currently playing out in Atlanta federal court that is painting one of the most damning pictures to date of the largely unregulated industry. Prosecutors assert that the pair made millions manufacturing supplements that in fact were illegal anabolic steroids and that one of those products was potent enough to kill.

The case is one of several in recent years in which the U.S. Food and Drug Administration has sought to crack down on supplements containing so-called designer or synthetic steroids.

But the case against Mesika and Houser - a rare instance of prosecutors specifically referring to a product causing death or injury - has opened a particularly revealing window into just how far behind the curve the government can be in catching up to dangerous supplements.

"When you have a market driven by sales instead of safety and efficacy, it's kind of inevitable that this (kind of harm) would result," said Dr. David Seres, an associate professor of medicine and nutrition specialist at Columbia University. "Snake oil is pushed to the limit."

In a plea deal struck with the government on April 19, Houser acknowledged that he and Mesika obtained synthetic steroid compounds from China and Hong Kong and used them to manufacture body-building supplements for at least 18 months.

The plea acknowledges that two of those supplements contained Methasterone, a particularly potent designer steroid that has been classified as a controlled substance, as well as a "slightly adjusted" similar compound. Neither of the supplements - one called Mutant Plexx, the other Mass Destruction - listed the illegal substances on their labels. Moreover, the government contends, Mass Destruction "resulted in serious bodily injury and death."

Prosecutors have not specified who was harmed or how. But court records and other documents reviewed by The Atlanta Journal-Constitution identified at least one injured consumer, a 28-year-old North Carolina man who suffered acute liver failure and needed a transplant two months after using Mass Destruction in October 2013.

Marcus Joyner, a shift worker at a manufacturing plant in Wilson, N.C., is now suing Mesika, Houser and others, contending they are responsible for his condition and the "significant" medical issues he still faces.

Houser, who pleaded guilty to a single count of conspiracy and is due to be sentenced in July, declined to discuss the case when contacted by the AJC.

In exchange for the guilty plea, the government dismissed charges of distributing controlled substances, introducing misbranded drugs into interstate commerce and money laundering.

The plea requires Houser, the 40-year-old son of an Atlanta physician, to cooperate with the government, forfeit property obtained as a result of the conspiracy and make restitution to victims.

Mesika, 47, who has pleaded not guilty, referred all questions to his attorney, Bruce Harvey.

Harvey said there is no evidence to suggest that Mesika participated in anything illegal. He added that the government's own lab reports show that only a "minuscule" amount of Methasterone was found in the two products, raising the question of whether it was used intentionally.

Of Houser's plea, the attorney said: "If it comes down to a trial, we are prepared to contest the deal he made to save himself. Beware the man who points the bloody finger."

Among the items cited by the government as subject to forfeiture are a 9,722-square-foot riverfront home in Sandy Springs purchased by Mesika for $1.9 million, a 43-acre farm he and Houser bought together in Coweta County for $740,000 and 11 vehicles, including four Ferraris, two Porsches and a McLaren.

Because can enter the market without prior screening for safety and effectiveness, the FDA, responsible for regulating them, is perpetually challenged in trying to deal with problem products.

The upshot is an environment in which those who would break the law see the lure of easy money outweighing the concern for getting caught.

"They are making a calculated decision that they are going to be able to avoid a criminal prosecution and just take the hit and close up shop if the FDA shows up for an inspection," said Ben England, a Maryland attorney who spent 17 years with FDA, including a stint as an agent in the criminal investigations division. "In other words, they're going to play their money and go as long as they can before they hit the wall."

With that attitude holding sway, supplements containing designer steroids, sometimes known as prohormones, have become a huge part of the market.

First developed by chemists more than a decade ago to help elite athletes beat drug tests, designer steroids mimic the properties of known steroids. Technically, they can be considered unapproved drugs. However, because many have yet to be classified as controlled substances, they have been openly sold as supplements by operators willing to risk the fines that can be levied for such conduct.

"If you want to make millions selling illegal stuff, we can start doing it tomorrow, my friend," said Oliver Catlin, president of Banned Substances Control Group, a company that tests and analyzes supplements. "The pathway has been laid out. Who chooses to walk that pathway is the question."

Neither Mesika nor Houser had any particular expertise in health or nutrition when they started manufacturing supplements. Mesika was a wholesale art dealer. Houser was a personal trainer. Both had criminal records.

Mesika, born in Israel and raised in New York City, pleaded guilty when he was 20 to a federal kidnapping charge after he, his brother and father abducted a man in New Orleans and took him to New York in an attempt to obtain $100,000 in ransom. Mesika's sentence was five years' probation.

After moving to Atlanta, he ran afoul of the law again, this time over an accusation that he stalked a former girlfriend.

Prosecutors in Indianapolis, where the woman was then living, filed the charge in 2009 after Mesika messaged the woman more than 100 times in violation of a permanent family violence protective order. The woman had obtained the order after reporting that Mesika told her he had thoughts of blowing up her vehicle.

The charge was dismissed when Mesika agreed that he would have no contact with the woman for two years.

Houser, who grew up in Cobb County, was sentenced to a year in prison when he was 21 after he pleaded guilty to marijuana possession in Fulton County. The plea violated the terms of his probation from an earlier conviction for giving a false name to a police officer in Cobb.

At the sentencing hearing, Houser's father said his son had been addicted to drugs since he was 15. He also disclosed that his son had been connected to two individuals murdered during a drug-related dispute.

"The two people that were killed were friends of his who robbed another drug dealer," John Wesley Houser III told the court. "He was in association with these people. He did not kill anybody."

Houser's drug problem resurfaced in 2014 when police in Gwinnett County stopped him for driving on the wrong side of the road and found a bottle containing Xanax, a highly addictive anti-anxiety drug, in his glove box. He pleaded guilty to possessing a controlled substance and received three years' probation.

At that sentencing, Houser's attorney, Sean McIlhinney, told the court that his client had spent the previous six months at an inpatient drug treatment facility.

The notion of making supplements began with Houser, who would blend products at the Roswell gym where he worked, and soon expanded into an elaborate business in which he and Mesika acquired raw materials and processed them into capsules. They operated out of a warehouse in Doraville as well as a 10,000-square-foot facility in Norcross and had several corporate names.

Their most widely known company, DuraCap Labs, touted its ability to manufacture pre- and post-workout recovery products, fat burners, proteins and "all the popular nutraceuticals."

"With the help of our fully stocked warehouse of raw ingredients and ready-to-go products, we can move quickly to meet your needs," the company's website said.

By 2013 - just a year after formally going into business together - Mesika and Houser had made enough to invest in real estate, starting with the farm in Coweta County.

Jeffrey Towe, the owner, said Houser drove up one day in a black Maserati and asked to see the property, which includes a 8,280-square-foot house, horse barn and stock pond. A month later, Towe said, Houser returned with Mesika to buy the place, putting $200,000 down.

"Well, you know, I was concerned about how they were going to pay," Towe said. "But with them putting (so much) down, I didn't have a problem."

Curious to learn more about Mesika and Houser's business, Towe said he visited the DuraCap facility. He left impressed.

"They were moving pallets and pallets of products out of that facility," he said. "The business was quite successful, given what I saw there."

According to the government, Mesika and Houser invested in at least three other pieces of property, all modest homes in DeKalb County.

But storm clouds were looming. A break in an FDA investigation in another state had turned up their names. They were on the agency's radar.

In 2012, FDA agents in Memphis began looking closely at Joseph De Melo, a supplement distributor based in the Dallas suburb of Carrollton. When a cooperating witness agreed to make a phone call posing as a potential buyer, the agents struck gold.

Unaware that the call was being monitored, De Melo explained in detail how he managed to deal in designer steroids yet remain untouched by regulators.

The key, he said, was staying "ahead of the game" by working with compounds that had yet to be designated as controlled substances. He described one such product as "10 times stronger than testosterone." He also stated that, although he had once manufactured supplements himself, he had shifted to using third parties to avoid being targeted by the FDA.

Suddenly, the agents had leverage, and De Melo, who previously had spent time in prison for distributing Ecstasy, was willing to cooperate.

During seven hours of debriefings, he identified seven others who were distributing or manufacturing designer steroids.

De Melo, 61, ultimately pleaded guilty to distributing roughly 40,000 pills containing steroids and was sentenced to 15 months in prison, half of what he could have received under federal sentencing guidelines. He was also ordered to forfeit more than $650,000.

"It's a substantial industry, but it's under the radar," assistant U.S. Attorney Tony Arvin said, lauding De Melo at his sentencing hearing in April 2015 for providing significant information about other offenders. "It's already had an impact on changing peoples' conduct, which is of course what we want."

Not long after gaining De Melo's cooperation, agents searched his offices in Texas. There, they found purchase orders for products from a company the government contends was controlled by Mesika and Houser called Adrenaline Nutrition Supplements. One order was for Mass Destruction.

De Melo had ordered the product as part of an arrangement with Travis Edmundson, the owner of a supplement store in Wilson. Edmundson was developing his own brand of supplements under the name Blunt Force Nutrition. De Melo was supplying the products.

Mass Destruction, which touted its ability to provide "incredible size, incredible strength, incredible power," was never distributed widely because only one batch of 800 bottles was made, according to Edmundson. There was a misspelling on the label - "capsules" was spelled "capsuless" - so most of the bottles were returned to De Melo, he said.

But several remained with the store owner, and two found their way to a health club in nearby Rocky Mount where Joyner, then working with a personal trainer, was looking for something to help jump-start a fitness program.

According to adverse event reports filed with the FDA, Joyner had used the product for three or four weeks when he began experiencing symptoms that included dark urine, abdominal pain, jaundice and dizziness. Initially, he was thought to have a urinary tract infection, but then it was discovered that his enzymes were elevated, and a liver biopsy was ordered.

He was diagnosed with at Duke University Medical Center and underwent the transplant there.

Shortly after Joyner's surgery, the FDA learned of it from public health officials in North Carolina and issued a safety alert advising consumers to stop using Mass Destruction immediately.

Joyner declined to be interviewed for this story. His attorney, Lynwood Evans, said he cannot discuss the situation because of his client's lawsuit, which was filed in 2015 and remains unresolved.

It is unclear whether additional bottles of Mass Destruction were distributed by De Melo, Houser or Mesika. Houser's plea agreement indicates that at least 3,600 units of Mutant Plexx, the other product containing steroids, were distributed.

DuraCap Labs has since been sold.

In an interview with the AJC, Edmundson said he relied on De Melo for everything regarding Mass Destruction, including choosing the ingredients, and had no knowledge of Mesika and Houser's role until the FDA got involved.

"The person I paid for the product was Joe De Melo, and, as far as I knew, he made it," he said. "I didn't know (Mesika and Houser) had anything to do with it."

Calling himself "very duped," Edmundson said he has learned a tough lesson about the supplement industry.

"It's sort of a business where people kind of do their own thing and there's no oversight," he said. "I guess you really have to look closely at who you're doing business with."

—-

ABOUT DESIGNER STEROIDS

Designer steroids are chemical compounds that are similar to known steroids, but with slight modifications. That means they have the same muscle-building properties as the actual drugs, which are available only by prescription, as well as the same potential for liver damage.

Many are former investigational drugs that were revived by chemists in the last decade to help elite athletes beat drug tests. The substances involved in the BALCO scandal that ensnared home run king Barry Bonds, track and field star Marion Jones and other high-profile athletes were designer steroids.

As more of the substances have become known, they have been banned by sports organizations and anti-doping agencies. Some have been classified as Schedule III controlled substances by the U.S. Drug Enforcement Administration.

But that hasn't stopped manufacturers and distributors of dietary from using them in their body-building products, often identifying the ingredients right on the labels.

Typically, the raw materials are imported from China, processed into capsules in the U.S. and sold online and in retail stores as "prohormones."

In December 2014, President Barack Obama signed the Designer Anabolic Steroid Control Act. It designated 25 ingredients already known to federal regulators as controlled substances and made it easier for other compounds to be similarly classified in the future.

Explore further: FDA warns of liver injury from muscle-building supplement

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SuzSez
5 / 5 (1) May 07, 2017
The headline and premise of this article are FAKE. These men are charged with illegal drug dealing and leaving ingredients off the the ingredients list, which is fraud (and technically, assault by poisoning). (Hell, the vaccine industry does this.) False labeling drug products AS "dietary supplements", when they're not, is fraud.

AND these guys got CAUGHT.

This has nothing to do with the dietary supplement industry itself.
pfbonney
5 / 5 (1) May 07, 2017
"This has nothing to do with the dietary supplement industry itself." - post

Good point. And as anyone who watches weekday daytime TV knows, there is class action lawsuit after class action lawsuit always in progress against any number of FDA-approved medications and devices. FDA regulation of food and drugs has solved little, if anything.

Yes, the FDA has identified bad drugs and has kept them/taken them off the market. But how many lives could have been saved had life-saving drugs been placed on the market immediately?

Also, there is what can be called a conspiracy between the FDA and the pharmaceutical companies where the companies have the FDA to keep competitor's products off the market. How does this serve America's interests?

Just let the individual states and the free market handle the food, drug and medical devices market. The FDA is also working against our interests. Lets save some tax dollars.
derphys
not rated yet May 08, 2017
Nearly all the US industrial food, even FDAcontroled, is junk food, dangerous, ( like aspartame and others ) and this is very visible with the epidemy of obesity, of diabete, heart attacks, of Alzheimer (10 times more than in old Japaneses ), starting from US to all the world.

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