A USA TODAY investigation finds that consumers buying Reumofan dietary supplements are trusting their lives to a company that uses fake addresses, lies about ingredients and may not even exist.
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…
…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…
…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.
…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.” Full Story & Video Here