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Federal officials arrested six executives of a big Texas supplement maker on Tuesday as part of a larger operation cracking down on the less savory offshoots of a $15 billion industry.
Authorities released an 11-count indictment against USPLabs for falsely claiming its popular workout and weight loss supplements were made using natural ingredients.
The feds also filed a complaint against Bethel Nutritional Consulting Inc., of New York and New Jersey, saying it sold “natural” supplements that in fact contained prescription drugs, and filed civil charges against a batch of smaller supplement makers.
“The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements,” the Department of Justice said in a statement.
The target is a multibillion dollar industry that’s been operating with very little regulation because of federal laws exempting supplement makers from Food and Drug Administration oversight.
“Much of the alleged fraud focused on the defendant's claims that their products were made from natural plant extracts."
“Many of the cases we have brought relate to products that misrepresent the ingredients they contain,” Benjamin Mizer, head of the Justice Department’s Civil Division, told a news conference.
"We have also brought cases against products that make unsupported claims about their effects. In numerous cases, products are touting curative properties for diseases ranging from cancer to herpes."
They include products like USPLabs’ Jack3d and OxyElite Pro.
"When they found an ingredient they believed was promising, knowing full well how the market for dietary supplements worked, they doctored packaging, labeling, and other paperwork to defraud others about what the product was,” Mizer said.
“Much of the alleged fraud focused on the defendant's claims that their products were made from natural plant extracts. The truth, as one defendant put it, ‘LOL’, (the) stuff is completely, 100% percent synthetic’.”
NBC News has reported on some of USPLabs’ products, which contained 1,3 dimethylamylamine -or DMAA. It's sometimes called a geranium extract on product labels. Two soldiers died after taking DMAA, which can cause heart attacks.
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“There was an outbreak of liver injuries associated with the OxyPro New formula,” Mizersaid. “Several people experienced jaundice. Some needed transplants to save their lives.”
Dr. Pieter Cohen of Harvard Medical School, who studies supplement safety, says the “big news” is the arrest of Jacobo Geissler, the CEO of USPLabs, the company’s president Jonathan Doyle and four other executives.
“This is a major U.S. company that has been selling hundreds of millions of dollars worth of supplements to consumers for very many years,” Cohen told NBC News. “There has been no consequence to doing that.”
Cohen said he’ll be waiting to see if any of the charges lead to convictions. What he would really like to see is reform of the 1994 Dietary Supplement Health and Education Act (DSHEA), which exempts products from FDA’s pre-marketing oversight.
“We need a system that prevents these dangerous supplements for arriving on store shelves in the first place,” Cohen said.
The DOJ also said Bethel Nutritional Consulting distributed adulterated and misbranded dietary supplements and unapproved new drugs throughout the United States.
“Additionally, certain tainted products falsely marketed as dietary supplements by Bethel contained potentially harmful active pharmaceutical ingredients, including sibutramine and lorcaserin,” the FDA said.
“Sibutramine was an active pharmaceutical ingredient in Meridia, a drug approved by the FDA in 1997 for prescription treatment of obesity. Meridia was removed from the market in 2010 because of risks of serious adverse cardiovascular events, including heart attack and stroke. Lorcaserin is the active pharmaceutical ingredient in Belviq, a drug approved by the FDA in 2012 for chronic weight management in some overweight or obese adults.”
It can cause serious side effects.
“We need a system that prevents these dangerous supplements for arriving on store shelves in the first place."
Other cases were filed against a company called Vibrant Life that sold tea that it claimed could treat Alzheimer’s disease and cancer, a company called Viruxo that sold a supplement it claimed could treat herpes and against Sunrise Nutraceuticals for a product it said could aid withdrawal from opiate addiction.
Last month, researchers reported that 23,000 people end up in emergency rooms each year because of supplement mishaps. A large percent involved weight-loss or body building supplements, the team at the Centers for Disease Control and Prevention reported.
According to the National Center for Health Statistics, more than half of Americans took some sort of dietary supplements in 2003-2006, 40 percent of them multivitamins.
“We are not here to criticize the entire supplement marketplace. Not every supplement contains an undisclosed ingredient. Not every label lies about what is in the bottle,” Mizer said.
The Council for Responsible Nutrition,which lobbies on behalf of supplement makers, says it pressed for Tuesday actions. "In May of this year, CRN reached out to the Department of Justice, noting our concerns that companies engaging in blatant criminal activity were presenting a serious public health risk and hijacking the credibility of the reputable industry," the group said in a statement.