FORT LEE, N.J. -- A dietary supplement maker with a facility in Fort Lee used an ingredient the government removed from the market five years ago because of its association with heart attacks and strokes, federal authorities said.
Bethel Nutritional Consulting also used an ingredient that posed "a potential carcinogenic risk," U.S. Attorney Paul J. Fishman said.
Neither ingredient was listed on the labels of Slim-K and B-Lipo, both of which claimed to be fat burners, he said.
As part of a nationwide sweep involving more than 100 supplement makers and marketers, the Justice Department filed civil charges against Bethel and principals Felix Ramirez and Kariny Ramirez.
They, in turn, "agreed to be bound by a consent decree of permanent injunction banning them from selling dietary supplements until they come into compliance with the law," Fishman said.
The suit follows the discovery of Sibutramine, the active pharmaceutical ingredient in Meridia, which "was removed from the market in October 2010 because of data indicating that its use was associated with an increased risk of serious adverse cardiovascular events," a complaint filed in U.S. District Court in Newark says.
When it was legally available, the prescribing information included warnings for "people with a major eating disorder (anorexia or bulimia) and warnings about the potential for serotonin syndrome, a potentially life-threatening drug interaction," the complaint says.
Despite Bethel's claims, sibutramine "is not a dietary supplement," it notes.
Also found was phenolphthalein, which was used in certain laxatives until the FDA re-classified the drug in 1999 as "not generally recognized as safe and effective" and "posed a potential carcinogenic risk."
Investigators said they also found lorcaserin, which has health risks, as well.
The various cases are part of a year-long effort begun in November 2014 "to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide," Fishman said.
"In each case, [federal authorities] allege the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence."
The sweep included federal court cases in 18 states in which 117 people and companies were pursued criminally and civilly, the U.S. Attorney said.
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