Weight-loss supplement laced with Prozac 'a fake'

FDA building signA weight-loss supplement sold by USPlabs was found to contain the active ingredient in Eli Lilly's antidepressant Prozac, according to the FDA, although the manufacturer disputes the claim.

The US regulator issued an alert late last month after it emerged that samples of OxyElite Pro Super Thermogenic (OEP) were found on analysis to contain fluoxetine. USPlabs is claiming that the product tested was however counterfeit.

The genuine OEP product, it says, has not been manufactured since October 2013 and has always been had a three-year expiry date, with the last batch labelled as expiring in 10/16. The product tested by the FDA was marked with an expiry date of 04/17, so is "therefore fraudulent," according to USPlabs.

Moreover, the company says the lot number used on the suspect product - 216372 - has never appeared on its own OEP brand, and it maintains that "neither USPlabs nor its contract manufacturers has ever ordered or in any way handled fluoxetine for any purpose of any kind."

The company stopped marketing OEP and other brands containing dimethylamylamine (DMAA), an ingredient linked to cardiovascular side effect, after being sent a warning letter by the FDA that they were misbranded and did not meet Good Manufacturing Practice (GMP) standards.

"Although USPlabs discontinued the manufacture and distribution of its products containing DMAA in October 2013, other companies did not," it says.

"Numerous dietary supplement products containing DMAA are still available through the internet."

The FDA issues dozens of warnings about dietary supplements laced with pharmacologically-active compounds each year, with products sold for weight-loss and sexual enhancement the most common culprits.

"FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients," said the agency this week, after discovering another illegal product - called Vigoiur 300 - which contained the active ingredient in Pfizer's erectile dysfunction medicine Viagra (sildenafil).

"Consumers should exercise caution before purchasing any product in the above categories," it cautioned.

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