FDA Warns Of Possible Criminal Charges Against Weight-Loss Product Firms
This article was originally published in The Tan Sheet
Executive Summary
FDA's enforcement action against 28 weight-loss products found to contain undeclared pharmaceutical ingredients drew applause from GlaxoSmithKline, marketer of alli, the only OTC drug approved for weight loss in the U.S
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Tainted Supplement Warnings Stress FDA’s Enforcement Limitations
FDA issued public notifications against 20 products marketed as weight-loss supplements containing the withdrawn Rx ingredient sibutramine.
Multi-agency investigation stops weight-loss pill scheme
FDA's Office of Criminal Investigations assists an investigation leading to the arrests of Sengyang "Tom" Zhou and Qingming Hu for allegedly attempting to counterfeit and sell unapproved OTC weight-loss pills to U.S. distributors. FDA said March 25 it collaborated with U.S. Immigration and Customs Enforcement and the Postal Inspection Service to determine the origin of Superslim, 2 Day Diet and other products with the active pharmaceutical ingredient sibutramine for obesity (1"The Tan Sheet" Jan. 5, 2009). An affidavit says Zhou, a Chinese national who was arrested in Hawaii, imported the drugs and was involved with making counterfeit versions of GlaxoSmithKline's weight-loss OTC alli (2"The Tan Sheet" Jan. 25, 2010). Zhou, who operates the Web site 3www.2daydietshopping.com, and Hu, who was arrested in Plano, Texas, each face three years in prison and fines up to $250,000 if convicted in the case that will be prosecuted in U.S. District Court for the District of Colorado
Slim Fast, other supplements recalled
Supplement firm Universal ABC Beauty Supply International voluntarily recalls 34 products found by FDA to contain an undeclared substance, sibutramine, a prescription weight-loss drug, the Brooklyn, N.Y.-based company says in an April 20 release. The products, including Slim Fast, ProSlim, and Slim 3in1 formulas, have not been approved by the agency and the ingredient is known to potentially cause cardiovascular issues in some users, the firm notes. When FDA announed a crackdown on adulterated weight-loss products in January, the agency warned that selling unapproved drugs may lead to criminal action, though it did not identify the firms suspected of marketing the products (1"The Tan Sheet" Jan. 5, 2009, p. 8). Universal's recalled products were on FDA's list of more than 70 products identified as tainted with undeclared drugs. Only three products had been recalled through April 8, FDA said