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Earlier this year, the owner of a dietary supplement company was sentenced to 30 months in prison for selling “all natural” products that secretly contained harmful active ingredients that shouldn’t even be available to U.S. consumers. Today, the FDA announced recalls for more than a dozen additional products containing these same, unsafe ingredients.
The products — listed below — were all found to contain undeclared levels of sibutramine and/or phenolphtalein, two chemicals that had been previously used in weight loss drugs and laxatives, but which have long been deemed unsafe for general use by consumers.
Sibutramine, an appetite suppressant, was once sold under the Meridian brand as a weight-loss prescription drug. It has been off the market in the U.S. since 2010 when its maker pulled the product following studies that showed increased risk for heart attack and stroke in certain populations, including those with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
The tongue-twisting (metaphorically, at least) phenolphthalein was previously used in over-the-counter laxatives. In 1999, the FDA reclassified the ingredient as “not generally recognized as safe and effective” after studies indicated that phenolphthalein presented a potential carcinogenic risk. According to the FDA, phenolphthalein has also been found to be genotoxic, meaning it can damage or cause mutations to DNA.
FDA testing of the products below turned up evidence of at least one of these ingredients in the following:
• Asset Bold 500 mg capsules
• Asset Extreme Plus 500 mg capsules
• Evolve 250 mg capsules
• Infinity 500 mg capsules
• Jenesis (all lots)
• La Trim Plus (all lots)
• Oasis capsules (all lots)
• Prime 500 mg capsules
• SlimeX-15 capsules
• Slim Trim U 250 mg capsules
• Ultimate Formula 250 mg capsules
• Xcel capsules
• Xcel Advanced 350 mg capsules
• Zi Xiu Tang 250 mg capsulesIf you have any of these products, you should cease using them. If you’re a reseller or distributor of these products, you should stop selling them. Both consumers and retailers should discard any unused capsules.
Urgent: Drug Recall – Weight Loss Dietary Supplements with Undeclared Sibutramine and Phenolphthalein [FDA Notice]
среда, 23 декабря 2015 г.
FDA Recalls Several Weight Loss Supplements Containing Unsafe Ingredientsbo
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by Chris Morran
via Consumerist
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