ANOTHER DAY, ANOTHER RECALL

On July 28, 2008, Jack Distribution LLC of Pompano Beach, Florida announced a recall of its male and female sexual enhancement “supplements”, Rize 2 The Occasion and Rose 4 Her, due to the presence of thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction.  This is only the latest episode of what seems to be the recall of the week for products in this category for the undeclared presence of prescription drugs with potentially serious side effects.  Remarkably, this is the second recall in less than a month by this company for precisely the same reason.  With each passing recall, the supplement industry looks more and more reckless and FDA more and more ineffective.

Is there any end in sight to these events?  We can only hope so.  Industry must make clear that companies that sell this kind of adulterated product are not selling dietary supplements.  They are selling adulterated unapproved new drugs.  Industry also needs to let FDA know that the time has come to hold companies accountable for their refusal to understand what they are selling.  By now, anyone in the business of selling a “sexual enhancement supplement” should be aware that there has been a pattern of contamination in this category.  Failure to test for the purity of the materials that go into the manufacturing of these products is inexcusable. 

We can only hope that FDA will actively enforce the GMPs in a manner that will put a stop to this.  Meanwhile, we wonder whether the time will ever come when FDA will refer a matter involving this kind of adulteration to the US Attorney’s office for consideration for prosecution under the Food and Drug Act’s provisions calling for strict criminal liability for the sale of adulterated food.