If you are new to this blog, you should know that our laboratory and collaborators work on all aspects of physiologically-active compounds from natural sources – plants, fungi, bacteria, marine organisms, etc.
So, I am equally interested in prescription drugs and herbal or non-botanical dietary supplements. There are still some products on the shelves of health food stores that can actually provide health benefits if manufactured properly and taken in high enough doses.
A common practice by unscrupulous supplement manufacturers is to add prescription drugs, or close structural relatives, to their herbal product to make it appear to the consumer that their product has beneficial effects.
In the last two weeks, the US FDA MedWatch program has announced two voluntary product recalls for dietary supplements adulterated with undeclared prescription drugs.
Another in a long litany of erectile dysfunction products boosted with compounds like those found in Viagra or Cialis comes to us from Vialipro by Good Health, Inc.:
Good Health, Inc. is conducting a voluntary recall after an FDA lab analyses found that the product tested from certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making this product an unapproved drug. The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs.
The Vialipro product website is dead as of the time of this writing.
Such practice with this product class is extremely sophomoric: the FDA has had a testing program running for several years to detect these compounds in male sexual enhancement products. The FDA hasn’t updated their consumer information page since February, 2009, but this guide lists a large number of herbal products identified since 2004 as having prescription, phosphodiesterase-5 inhibitors in them.
The practice is simply disingenuous and damages the reputation of botanical supplement manufacturers (and botanical researchers) who are trying to play by the rules and rigorously study these products.
Case two comes courtesy of J&H Besta Corporation and their Joyful Slim/Slim-30 “Natural Herb for Weight Loss”:
FDA lab analysis of this herb supplement was found to contain the undeclared drug, desmethyl sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
The Joyful Slim website is still live (because they sell other products) but contains this ironic image:
This is cheating, my friends, and these are only the cases that are detected by the FDA. These incidents make me wonder just how many cases of reported dietary supplement efficacy are due to physiologically-active adulterants – the abundance of clinical trial failures of well-characterized, chemically-qualified herbal supplements may speak to this very issue.