SIOUX FALLS, S.D. (AP) — The owner of a South Dakota-based dietary supplement business has been charged with allegedly rebranding and selling Mexico-manufactured pills that were the subject of a U.S. recall because they were linked to cases of bleeding, stroke and even death.
Stanley Brower is accused of tearing off the labels on bottles of the recalled Mexican pain-relieving supplement, Reumofan Plus, and selling them under a different brand name, WOW.
Over the years, the pills were sold online and in retail stores in the U.S. and Mexico under the name Reumofan Plus and were marketed as “100 percent natural” remedies for arthritis and muscle pain. The Food and Drug Administration, however, in 2012 warned consumers against using the supplement after it was discovered that the products actually contained several prescription drugs.
The FDA found that Reumofan Plus contained three drugs, including the muscle relaxant methocarbomal and the anti-inflammatory drug dexamethasone. These drugs can interact with other medications, causing life-threatening side effects in some patients and even causing deaths.
Mexican authorities issued a health alert about the product in May 2012 and the FDA followed with its own warning the next month. Despite the warning, prosecutors allege that Brower sold the relabeled pills through at least two websites between July and December 2012.
Authorities accuse Brower of shipping more than 220 bottles of WOW with 30 pills each from the Canton-based business to seven states and Canada.
Brower is the president of Brower Enterprises Inc., according with records filed with the office of the South Dakota secretary of state. The company’s website is still operating. Court records show Brower also managed the company Health Enterprises, which he used to market the re-labeled pills.
Brower, 68, has pleaded not guilty to two federal charges and is scheduled to face trial in April. He declined to comment on the charges and his lawyer, Jason Tupman, did not respond to a phone call seeking comment.
The pills were manufactured by Riger Naturals, S.A. and at least three companies that sold them in the U.S. have recalled them. Riger Naturals has not issued a recall, but FDA field agents have been ordered to seize any shipments of the supplement that arrive at a port of entry into the U.S.
Unlike prescription drugs, dietary supplements don’t need FDA approval before they are marketed. Still, their labels must list all ingredients and manufacturers are not allowed to sell products that are “adulterated or misbranded.”
Brittney Meyer, an assistant professor of pharmacy practice at South Dakota State University, said individuals can contact the state’s Board of Pharmacy to verify that the website through which they intend to buy a medication isn’t fraudulent.
“To really be sure you are getting what you are ordering it needs to be a licensed pharmacy because if it’s not, then it could be fake, it could be labeled or stored incorrectly, or it could have dangerous ingredients like that supplement,” Meyer said.
About 65,000 dietary supplements are on the market, consumed by more than 150 million Americans, according to a 2013 Canadian government study.
Earlier this month, the attorney general in New York ordered Wal-Mart, Walgreen’s, Target and GNC to stop selling store-brand herbal supplements that tests found questionable. Clarkson University researchers tested hundreds of bottles of store-brand herbal supplements sold as treatments for everything from memory loss to prostate trouble, and found 4 out of 5 contained none of the herbs listed on the labels.
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