Undeclared drugs in herbal and non-botanical dietary supplements
This post appeared originally on 13 April 2009 at the ScienceBlogs home of Terra Sigillata.
An interesting question arose the other day when we discussed the Key West acupuncturist who was diverting prescription drugs for personal use as well as in her practice. While we are not certain that the defendant put the cited muscle relaxants and anxiolytics in remedies doled out at her practice, we doubt that the demographic she targeted would be too impressed if she were to hand out prescription drugs.
This scenario led our scientific and blogging colleague, DrugMonkey, to ask how common it might be for alternative practitioners to dope their herbs with prescription drugs exhibiting known efficacy. He also notes how disingenuous this practice might be in that the alternative practitioner is admitting in doing so that their herbs and elixirs have no efficacy on their own.
I can’t speak to trends among individual practitioners but this practice takes a page from the big boys: the dietary supplement industry.
Adulterating commercial herbal products with prescription drugs is so common that the US FDA is keeping a running tally of actions against companies selling supplements containing “undeclared drugs”: the polite regulatory term for deceptive doping of a useless product with a real drug.
We’ve spoken about these cases several times before [1, 2, 3, 4, 5, 6]. Most common approaches have been to dope weight-loss supplements with sibutramine, a prescription amphetamine-like, serotonin/norepinephrine reuptake inhibitor sold in the US and Canada as Meridia®. The US FDA list on this class of deception has increased from 28 to 69 products since 22 Dec 2008. For example, we get a large number of hits from readers searching for apple cider vinegar capsules and whether they can help one lose weight – well, yes they can, if they contain sibutramine, of course.
Another common adulteration tactic is for erectile dysfunction supplement manufacturers to boost their products with prescription phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®) or related compounds. So popular is this approach that the same manufacturer cited above for sibutramine-adulteration of apple cider vinegar products has also been found guilty of adding PDE5 inhibitors to their “Long Weekend” product. At least their business model is consistent, eh? A recent FDA investigation of such supplements sold online revealed that up to one-third of products are so adulterated.
This may all seem like fun and games but there is at least one case in the literature where supplement doping has been associated with unusual cases of prostate cancer (Clin Cancer Res 2008:607-11). In this case, the bodybuilding supplement Teston-6 was found to contain testosterone and other compounds more potent than testosterone in promoting prostate cancer cell growth in vitro.
As a natural products pharmacologist, I am all for researching botanical and non-botanical supplements that may intrinsically contain useful therapeutic molecules – that is the cornerstone of my field. Indeed, some traditional herbal medicines have been used as sources for modern pharmaceuticals.
But to dope supplement products with effective drugs is to admit that one is selling crap: a deceptive practice to prey upon those who choose to seek out “alternative” medical approaches.
This practice makes one wonder how many anecdotal cases of “success” with herbal products is due to adulteration with prescription drugs.