Posted May 17, 2013

Hoodia, Sexual Enhancement Supplements and More Found To Be Adulterated, Misbranded

On March 01, 2013, the FDA issued a warning letter to Desert Rose Manufacturing, Inc. following a facility inspection which found the company’s nuphedrine, alfa PXP Plus, Lithium Orotate, zialipro and cleanseRX , to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish specifications for the identity, purity strength, and composition of the finished batch dietary supplement, failure to include complete information in batch production records and failure to collect representative samples of a subset of finished batches of dietary supplements before releasing them for distribution to verify that the finished batch of dietary supplements meet established product specifications.

The FDA found Desert Rose’s written response regarding these violations to be inadequate.

Nuphedrine contains hoodia and is promoted for appetite control and weight loss.

Alfa PXP Plus contains extracts of polysaccharides and polypeptides and is promoted for energy.

Zialipro contains Tribulus terrestris, epimedium, Muira puama, yohimbe, ginseng, catuaba and damiana. It is promoted for sexual enhancement.

(See ConsumerLab.com’s Review article on Hoodia and Reviews of Milk Thistle and Liver Formula Supplements and Sexual Enhancement Supplements for tests of related products.)

In addition, zialipro, alfa PXP Plus, and cleanseRX were found to be misbranded because the labels did not provide information required by federal regulations.

To read the FDA’s warning, use the link below.