Alison Young,USA TODAY
GUADALAJARA, Mexico - A Mexican dietary supplement called Reumofan has gained a loyal following in the United States as a "100% natural" treatment for arthritis and joint pain. It's supposedly made by a company called Riger Natural from ingredients such as shark cartilage, white willow and glucosamine, or so the labels say.
But consumers who buy Reumofan products are risking dangerous side effects and trusting their lives to a company that uses fake addresses, lies about the ingredients in its products and may not even exist, a USA TODAY investigation has found.
The newspaper set out to find Riger Natural and the people responsible for producing and selling the supplement, searching corporation records and visiting addresses in Mexico where it had been listed on the Web as having a lab. Those addresses are fake and there's no evidence the company ever had facilities in the locations. Some Mexican retailers who once distributed the product say their contacts have simply disappeared. Even Mexican health authorities have been unable to track down the company.
Meanwhile, U.S. consumers - desperate to curb arthritis and joint pain - continue to buy Reumofan over the Internet and by crossing the border. They are running a high risk: Dozens of Reumofan users have suffered serious and sometimes life-threatening health effects after taking the pills, including liver injury, strokes and severe episodes of bleeding, according to federal records obtained under the Freedom of Information Act. Three reports involve deaths, though the full toll of those injured will never be known because most adverse events involving supplements and drugs are never reported to the FDA.
Lab tests by U.S. and Mexican health authorities have detected up to three powerful and potentially dangerous prescription drugs hidden in Reumofan products. While government officials have warned the public of this finding, they haven't revealed anything about the company behind the products, other than its name. And nobody has been able to explain how a mysterious "M" logo identical to one used by a Mexican pharmaceutical company has ended up on at least some batches of the pills.
"We've made more than eight visits to addresses for which we've had intelligence and we've not located the business," Alvaro Perez Vega, commissioner of health operations at Mexico's federal commission for the protection against sanitary risk (Cofepris), said through an interpreter. The agency issued its first public warning about Reumofan in May 2012.
The FDA declined to discuss what it knows about Riger Natural.
"As an open investigation, there's not much we can really say about who actually was responsible for putting the product into commerce," said Daniel Fabricant, director of FDA's dietary supplement division. The FDA has issued several warnings about the product since June 2012.
Thousands of Americans have bought Reumofan from one small U.S. reseller that conducted a recall. But the full scope of Reumofan usage is impossible to gauge because of the shadowy nature of the product's maker and the multiple Internet and Mexican border stores that have sold it over the years.
Fabricant and other experts said that Reumofan is indicative of larger problems in the $30 billion supplement industry, where limits on federal regulation make it easy for almost anybody to sell products that claim to be all-natural remedies - even if they aren't. More than a dozen times each year, the FDA's limited testing finds that potentially dangerous pharmaceuticals are being used to secretly spike products sold as dietary supplements. It also can be difficult to locate companies selling risky and questionable products.
"It can be more challenging than people think. There isn't product registration. So products can come in and out of the market without FDA having knowledge of it," Fabricant said. "It's pretty easy to open up one website and shut it down the next day. ... It's kind of like one big game of Whack-A-Mole."
More than 85,000 supplement products are estimated to be on the market, Fabricant said.
Although the FDA has no authority to require registration of individual products, federal law requires supplement companies to register their facilities so the FDA can quickly contact them in an emergency. Yet 28% of companies selling a sampling of weight-loss and immune support supplements had failed to register any facilities with the FDA, federal auditors found last year. Among those that registered, 72% failed to provide complete and accurate location and contact information.
Dietary supplements - such as vitamins, minerals, herbal extracts and protein powders - are taken by an estimated half of U.S. adults and are regulated as a type of food because they are supposed to contain only natural nutrients. Although they often are marketed as health remedies, the FDA does not have the authority to require pre-market testing for safety or effectiveness as it does with medications prior to sale.
Supplement industry officials maintain that supplements like Reumofan represent a "few bad actors" and that most firms sell safe products that enhance consumers' health.
The Reumofan case "is a classic example of a company masquerading as an industry player taking advantage of consumers selling a dangerous product," said John Shaw, CEO of the Natural Products Association, a supplement trade group.
Adds Cara Welch, a senior vice president with the association: "These are straight-up criminals. I don't know that adding regulation to the responsible industry will solve the problem."
Like many Reumofan users, Deanna Bertrand and Lyman Dye don't speak much Spanish and it didn't matter to them that much of the product's label was written in that language.
Deanna Bertrand of Morris, Ga., says knee pain made it difficult to climb these stairs at the Clay County Courthouse where she works. Since she began taking Reumofan about a year ago, Bertrand says her pain is gone and the stairs are no longer a problem. [Via MerlinFTP Drop](Photo: Alison Young / USA TODAY)
"It works. So long as it works, I don't care what it is," says Bertrand, 74, a court clerk in rural Clay County, Ga.
Before she began taking Reumofan about a year ago for knee pain, climbing the steep stairs at the historic courthouse was slow torture. Now she goes up and down with ease. "You're not in pain. You can do whatever you want to do. And it doesn't cost you an arm and a leg to take it," she said.
Dye, 80, who lives in Ucon, Idaho, says Reumofan has allowed him to enjoy an active life - working on old cars, climbing mountains - despite "bone on bone" scraping in his shoulders. "It immediately eased the pain," he said.
Silvano Marangone, 81, of San Gabriel, Calif., was suffering from hip pain until he heard about Reumofan two years ago. Like most Reumofan users interviewed by USA TODAY, Marangone started taking the product based on the recommendation of a trusted friend or relative. "I took the pill and within one day, all my pain was gone. I said, my gosh, this is a miracle."
Marangone said he stopped taking Reumofan after the FDA issued warnings. Hip surgery has since ended his pain and his need for any pills.
But Bertrand and Dye are among consumers who continue to take the pills. Both noted that plenty of FDA-approved drugs also have the potential for serious and sometimes deadly side effects. "I'm not really concerned about it," Dye said.
Last summer, the FDA began issuing a series of safety alerts after tests found hidden pharmaceutical ingredients in Reumofan products. One version of the pills, Reumofan Plus, contained three medications: dexamethasone, a corticosteroid; diclofenac sodium, a non-steroidal anti-inflammatory drug; and methocarbamol, a muscle relaxant. Reumofan Plus was also sold in bottles repackaged as a product called WOW, the FDA said.
The FDA's tests of another version of the pills, called Reumofan Plus Premium, found it contained two of the drugs: diclofenac sodium and methocarbamol.
The corticosteroid is of particular concern because it carries life-threatening risks if it is used long term then stopped abruptly. Symptoms of this withdrawal syndrome include fatigue, nausea, low blood pressure, low blood sugar levels and dizziness. Dexamethazone can also reduce the body's ability to fight infections, raise blood-sugar levels, and cause bone and muscle injuries and psychiatric problems, the FDA said.
The anti-inflammatory drug can increase the risk of cardiovascular events, such as heart attacks and strokes, as well as serious gastrointestinal problems, including bleeding, ulcers and fatal tears of the stomach and intestines. The muscle relaxant can cause drowsiness, dizziness and low blood pressure.
The FDA's Fabricant said Reumofan was of significant concern to the agency because so much of the product was being sold. "The product had three drugs we hadn't seen before in terms of spiking supplements. And they have a very dangerous safety profile, usually the types of drugs that are only used under the care of a physician," he said.
Historically, drug-tainted supplements have been found most often among pills and powders sold for bodybuilding, weight loss and sexual enhancement. But the FDA says it is seeing the dangerous practice showing up in supplements used by the growing population of aging Americans.
In July, the FDA issued warnings about more than a dozen firms selling natural remedies for the estimated 26 million Americans who have diabetes. Its tests showed some of the pills contained one or more pharmaceutical ingredients found in prescription drugs to treat type 2 diabetes.
"What I think that Reumofan and some of the other ones teach us is that it's a moving target," Fabricant said.
The FDA received two initial reports of adverse events involving Reumofan Plus in November 2011. A dozen more came in during April and May 2012, before the agency issued its first alert, records show.
A family physician who had treated two Reumofan users, told the FDA: "It is alarming to see this product otc [over the counter] in the marketplace." One patient had developed a dangerous adrenal suppression syndrome "even though the Internet claims it does not contain [a] steroid. The patient's back pain felt so much better I was suspicious," said the doctor, whose name was redacted by the FDA for privacy reasons. The second patient, a diabetic, developed sudden worsening of glucose control.
Around the same time, poison control centers were getting calls from both patients and doctors about Reumofan. "It was the same underlying theme: My patients or my friend is just swearing by it, it works fantastic ... what's in it?" said Keith Boesen, director of the Arizona Poison and Drug Information Center.
After searching the Web and reading consumer testimonials about fast relief of arthritis symptoms and pain, the center's staff suspected the product contained a steroid. "It seemed to make sense from the stories people were telling," he said. Steroids can make people feel better quickly, Boesen said, but because of their risks, they should be used only selectively and under a physician's care.
So far, the FDA has received more than 60 reports of consumers suffering adverse health events while taking Reumofan products, including 28 categorized as serious, seven as life-threatening and three involving deaths, records obtained under the FOIA show.
• A 76-year-old woman who had been taking three Reumofan Plus tablets daily for arthritis suffered from acute psychosis and other symptoms consistent with corticosteroid use, her doctor reported. After multiple clinic visits, she required inpatient treatment in a psychiatric ward.
• An 83-year-old woman with arthritis died of an infection after developing severe colitis. She was taking Reumofan Plus, "which we believed suppressed her immune system," her doctor told the FDA in a Jan. 2, 2013, report. The woman's husband, who also was taking Reumofan, developed C. difficile colitis and died in April 2012, the doctor reported.
• A Reumofan Plus user suffered life-threatening gastrointestinal bleeding that required a transfusion, a doctor reported.
Juana Anguiano, a 64-year-old retired county worker in Santa Barbara, Calif., took Reumofan for about 10 months for knee pain until she heard about FDA's health alerts last summer and stopped taking it - unwittingly triggering a dangerous steroid withdrawal syndrome that increasingly devastated her body's ability to function. "She was vomiting, getting very sick," said her lawyer, Wendy Behan. "It affected her kidneys and liver." Anguiano declined to be interviewed.
When people take corticosteroids for more than a few weeks, the body's adrenal glands decrease production of natural steroid hormones critical to the production of blood-sugar and helping the body respond to inflammation, infection and trauma. Anguiano was hospitalized for seven days last September, where doctors put her on prednisone, another corticosteroid, and then weaned her off of it over three months, Behan said.
SEARCHING FOR RIGER NATURAL
So where is Riger Natural? And who are the people behind the production of Reumofan?
Seeking answers, USA TODAY traveled to Mexico where government officials, retailers and others familiar with the product are based.
The first location visited was in Puebla, about a two-hour bus ride from Mexico City, where Riger laboratories was listed in a Mexican phone directory. The listed address was fictitious. The closest building was an animal hospital where a veterinarian said he'd never heard of the supplement maker.
A company called "Riger" had registered its name and a business address in another part of Puebla with Mexico's trademark office. But there was no laboratory there, either - just a giant wholesale grocery store that says it has nothing to do with the supplement maker Riger Natural.
Ricardo Hernandez, the person in charge of the store, said he tried to find Riger Natural two years ago to possibly pursue a trademark infringement case over the supplement firm's use of a similar name.
"I went to look, but I never found this business. It's a fictitious business. A ghost," Hernandez said. "Obviously there's no one to complain to or talk to about regarding the use of the name, nothing."
USA TODAY also visited an area along an industrial stretch of highway near Guadalajara's airport, where the website RigerNatural.com had listed its "Planta Jalisco" in Tlajomulco de Zuniga, according to an archived version of the now defunct website from January 2012. But there was no trace of the company there, either - just a nursery selling plants and a huge, gated complex for international technology manufacturer Sanmina.
Domingo Carrasco Trejo, whose family has owned a natural-products store in Guadalajara since 1981, used to sell Reumofan - before the Mexican government issued its health warnings last year. He first met a Reumofan distributor at a trade show.
"At the show it was an elite product," he recalled. "On the Internet, you would have this distributor who obviously didn't have a telephone number. But you would have a contact, then you deposit [money] into a certain account."
But it was unclear exactly where the product was coming from, Carrasco said. "I don't know where the supplier bought it from. They talked about it being from Veracruz. Another story was that it was from Nayarit."
The distributor has since disappeared. "We have lost all contact," Carrasco said.
Mexican health officials said they also have been unable to find Riger Natural. So far, if they've found anything at addresses associated with the company, it's been only distributors or storage facilities.
"The company that was responsible for the commercialization and production ... up to this moment we have not found it," said Perez, the official at Cofepris, the federal agency that oversees drugs and supplements.
Perez said regulators' actions seizing Reumofan products and publicizing the product's danger are making a difference. "We're financially damaging the company," he said.
But does Riger Natural even exist? "We still can't affirm that," he said.
At a pharmacy in the Mexican border town of Los Algodones, near Yuma, Ariz., USA TODAY bought a bottle of Reumofan Plus this past summer. The purple pills inside are stamped with a stylized "M" logo. The same imprint is on some of the pills purchased by Deanna Bertrand, Lyman Dye and other U.S. consumers.
The logo is the same as one used by a Mexican pharmaceutical company: Laboratorios Marcel, which until December had operated a manufacturing plant in Guadalajara since 1954. Marcel made a medication called Rumoquin N.F. that on some bottles lists the same three-drug combination the FDA has found in Reumofan Plus: dexamethasone, diclofenac and methocarbamol.
When shown a photo of one of the "M" pills found in a bottle of Reumofan during an interview in Mexico City, Perez, the Mexican health official, said he doubted that a pharmaceutical would be repackaged as a supplement. In recent e-mails, Perez has further disputed any connection between Laboratorios Marcel and Reumofan pills bearing the company's logo.
Perez said that Laboratorios Marcel has registered only one version of Rumoquin with his agency and it contains phenylbutazone, a pain-killing ingredient not found when regulators tested Reumofan supplements. He said he had no information about the second version of Rumoquin - without phenylbutazone - that USA TODAY found being sold that matches the combination of drugs found hidden in Reumofan Plus.
Perez said the Reumofan pills seized by Mexican regulators do not have the "M" logo on them and that "the confidentiality of Laboratorios Marcel's information is appreciated since there is no evidence to date of a link between the products."
Perez said Cofepris has an open investigation involving Marcel, but that he can't provide details until it is concluded.
It's unclear how pills with Marcel's logo ended up in bottles of Reumofan. Did another company stamp Marcel's logo on the pills? Did someone possibly repackage Marcel's pills as Reumofan? Repackaging has already occurred in the U.S., the FDA has warned, when Reumofan was repackaged and sold as a product called WOW.
After 58 years in business, the family that has run Laboratorios Marcel closed the company late last year and sold its factory in Guadalajara. At the same location, a member of the same family opened a different pharmaceutical manufacturer under the name: Laboratorios Schoen.
Marcel officials, including shareholder and board member Vanesa Garcia Mendez Sereni, say their company has nothing to do with Riger Natural and they don't know how pills with Marcel's logo got into some bottles of Reumofan.
But before giving any substantial answers to USA TODAY's questions, they initially provided vague and misleading information about the Garcia Mendez family's involvement with both Marcel and the new pharmaceutical company at the same location.
CHASING DOWN THE LEADS
• After initially not returning calls, Elena Hernandez, a spokeswoman for Laboratorios Schoen, said in an e-mail there is no commercial relationship between her company and Marcel. When asked for the contact information of any former Marcel officials, Hernandez responded Sept. 4, "Regrettably, we don't have the contact information for anyone."
• Vanesa Garcia Mendez Sereni, whose e-mail address - but not her corporate title - was listed in a Marcel trademark document for Rumoquin, referred USA TODAY to a longtime lab employee when asked for the name of someone in charge at the company. That employee, Maria Silvia Chavez, said in an e-mail she was a health official at Marcel for about 15 years and there was no connection between the lab and Reumofan. When asked for the names and contact information of Marcel officials, she said: "I lost contact with them."
Yet when USA TODAY checked corporation records filed with the public registry in Guadalajara, they showed that Vanesa Garcia Mendez Sereni and members of her family were Marcel board members and shareholders for years.
• Corporation and marriage records also show that one of Laboratorios Schoen's shareholders, Sandra Julieta Villasenor Moreno, is a member of the same family. She is the wife of Marcel shareholder and board secretary Esteban Garcia Mendez Sereni. In state records, Laboratorios Schoen is misspelled as "Shoen."
Esteban Garcia Mendez Sereni could not be reached for comment and refused to accept a message sent to him by USA TODAY on Sept. 9 through the business networking site LinkedIn, then deleted his online account.
Laboratorios Schoen shares the last name of a founder of Laboratorios Marcel: Esteban Szerenyi Schoen was listed as the majority shareholder in Marcel when it was incorporated in 1954. Hernandez did not reply to follow-up questions seeking clarification of her statements that there's no relationship between the two companies. Chavez also didn't respond.
• After being presented with the information from public records, Vanesa Garcia Mendez acknowledged a family relationship among shareholders in both Marcel and Schoen and said none of Marcel's owners wanted to appear in this article for "security" reasons, "given the situation of violence and insecurity that prevails in Mexico."
She did not respond to questions about why answering USA TODAY's questions posed a greater security risk than the family's regular appearance in photos in a society supplement to the Guadalajara newspaper Mural. Also left unanswered: questions about why there were two versions of Marcel's Rumoquin medication on the market - and why one of them wasn't registered with Mexican health officials.
"Marcel closed operations by virtue of some of the partners deciding to undertake an internal restructuring," Garcia Mendez said. She did not respond to questions about whether Marcel's "M" logo appearing on pills in some bottles of Reumofan played a role in the family's decision to close Marcel after nearly six decades in business.
"We think that it is out of proportion and far from reality to involve [Laboratorios Marcel] in a topic related to a laboratory that we don't know anything about," she said in her Sept. 17 e-mail. She added that Marcel officials feel they "are victims of a forgery."
THE U.S. SELLERS
In the U.S., federal regulators pursuing Riger Natural also have nabbed only a few small players in the story. None appears to have any direct link to the product's purported maker, Riger Natural.
Samantha Lynn Inc., which the FDA announced was recalling Reumofan in August 2012, was just an Internet business run from a kitchen table by stay-at-home mom Patricia Kovacevich, according to Tony Thomas, the Norwalk, Calif., company's accountant who was handling the recall, told USA TODAY earlier this year. The family put up a website and tries to identify products to sell by watching talk shows and monitoring other media. The goal was to try to make money "on the spread between what she could buy it for and what she could sell it for."
Thomas said he thinks Kovacevich, who he said declined to be interviewed, bought Reumofan somewhere in Mexico. Just over 6,000 customers bought Reumofan from her website and were notified of the recall, Thomas said.
The FDA publicly cited a natural-products website run by Brower Enterprises of South Dakota in a December health alert about Reumofan sold as WOW. "I don't really want to have any comments," said Stan Brower, when reached by phone recently. "We were importing it from a company in California and they would never give us the name of the manufacturer." He then abruptly ended the call.
In February, the FDA issued an alert that another Web-based business enterprise - Reumofan Plus USA LLC and Reumofan USA LLC - was recalling the pills.
The websites were owned by Joseph McLean, a retiree from Pennsylvania who says he was new to the supplement business. McLean started selling Reumofan in 2012 to earn some extra money after trying the product for his tendinitis at the suggestion of a golf pro during a vacation in Mexico, he said.
It worked great and after sharing it with friends at his local golf course, he created a website to sell it online "thinking all along it was an all-natural product."
McLean declined to say who sold Reumofan to him. "I was just buying it from someone who was getting it out in California."
When the FDA contacted him, McLean wondered why they were going after him and not the manufacturer: "They're the culprits on the matter here."
"What are they worrying about a little guy like me for selling it?" he said. "Probably 100 people, maybe more than 100 people, resold the product. ... It was all over eBay and Amazon." McLean said the FDA told him they hadn't been able to locate the manufacturer and they weren't even sure Riger Natural existed.
After hearing the findings of USA TODAY's investigation, Deanna Bertrand said she's reconsidering whether she'll continue using Reumofan. Lyman Dye said he may continue to take the risk, because he uses it only occasionally and it gives him such relief.
The FDA spotlight has made Reumofan more difficult to find in the U.S., but consumers are still buying it from a variety of sources online and by crossing the border into Mexico.
Deanna Bertrand has been ordering her pills in recent weeks from Farmacia del Nino, an online Mexican pharmacy.
Karla Rivera, a customer service representative at Farmacia del Nino said the pharmacy began selling Reumofan about a year ago in response to consumer demand - much of it from the United States.
Where is the pharmacy getting its Reumofan? She wouldn't say.