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.
However.
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:
A reason to shop from them is that they let you know about product recalls? Well, I guess that's a nice consumer feature. (From joyfulslim.com on 27 July 2010)
The FDA press releases to which I’ve linked (1, 2) contain information for the consumer on returning the products for refund and reporting any adverse reactions associated with product use.
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.
Abel Pharmboy's Scratchin' Post 
What would be the motive for conducting trials with adulterated substances? Dietary supplements are naturally-occurring and unpatentable. Or maybe you think supplement researchers are a clueless bunch who don’t bother to qualify their materials?
Research into naturally-ocurring molecules involves not only clinical trials, but cell studies and epidemiological studies. You might be interested in Byron Richards’ review of recent nutrition research. He includes links to the abstracts of all the studies mentioned:
Top 10 Nutrients of 2009
Resveratrol is one compound being studied intensively by scientists around the world. Here is the press release for a recent review by researchers at the University of Queensland:
A red-wine polyphenol called resveratrol demonstrates significant health benefits
How could any true scientist dismiss such a growing body of evidence?
@Jeff “What would be the motive for conducting trials with adulterated substances?”
This is so simple: drugs are added to “supplements” (and homeopathic preps) to make them effective since most supplements are as inactive as lettuce.
“True scientists” are aware of the potential for pharmacological activity in herbs. We just don’t get our information from press releases and merchants’ web pages. And we also know the importance of non-clinical research, preceding clinical work. However, we recognize that only clinical studies support for-profit traffic in such supplements.
I think that there is any number of qualified, well-intentioned researchers and manufacturers of natural products/supplements. However, a quick look at the television on a weekend or very early in the morning will show any number of hawked wares that promise to have multiple effects with no side issues. There are a lot of people just one step above con artist in the supplements universe, just as there have been for thousands of years.
On a side note, this love of all things ‘natural’ does not make sense to me. Some of our deadliest poisons are natural. In a darwinian environment, the organism with the strongest defenses survives. The sheer abundance of chemical and biological toxins is testament to this. While it is clear that there are numerous beneficial compounds, they are genereally isolated and purified prior to use in order to hopefully avoid armful side effects.
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