Yes, you have heard this before: another company selling erectile dysfunction dietary supplements has been nailed by the US FDA for adulteration of their product with prescription drugs used for erectile dysfunction.
From the FDA (full press release here):
Bodee LLC, Inc., issued a nationwide recall of Zencore Tabs, a product marketed as a dietary supplement, because it contains undeclared ingredients. FDA laboratory analysis of Zencore Tabs found that the product contains aminotadalafil, an analog of tadalafil, and sildenafil, both of which are active ingredients of FDA-approved drugs used for Erectile Dysfunction. The product also contained sulfosildenafil and sulfohomosildenafil which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
When I tried to look up Zencore’s webpage today (purely for the sake of the story, mind you), I was met with the following:
The Zencore Tabs website is currently unavailable as we are evaluating its content and it is under reconstruction.
We apologize for any inconveneince . If you have any questions regarding this notice or the product, please e-mail us at firstname.lastname@example.org.
The link then takes you to the text of their product recall notice. Again, as a service to our readers in the Great White North, Zencore was sold in Canada as well as the US.
Another site did have information on what Zencore was supposed to contain: a mix of 21 herbs with purported activity in “enhancing male sexual stamina.”
What I find interesting about this case of adulteration is that, with the exception of sildenafil itself, the adulterants were chemical analogs of tadalafil (Cialis®) and sildenafil (Viagra®). This approach was also reported in 2006 in adulterated products in Singapore. In these cases, we never know what source is responsible for the adulteration – the herb grower, the wholesaler, the manufacturer, etc. – but it seems clever for to try and use chemical analogs of the prescription drugs as the analogs would not necessarily be considered prescription drugs. In fact, I wonder if the FDA would have been able to take action had sildenafil itself not been in the herbal supplement.
By the way, such a tactic has been used in recreational psychoactive chemical synthesis: chemists have tried to stay one step ahead of the DEA by making chemical analogs, or relatives, (“designer drugs”) with the same activity of an outlawed psychoactive but with a chemical structure that is not yet explicitly deemed a controlled substance. An amendment to the US Controlled Substances Act was enacted in 1986 that made analogs of illegal substances also illegal by association – an extremely broad and imprecise definition that continues to create confusion and controversy.
But back to Zencore – yet another herbal remedy attracts government intervention because of the intentional addition, at some point in the supply chain, of compounds known to be effective in erectile dysfunction. There is no precedent for these compounds existing naturally, hence my designation of this case as an adulteration.
Yet again, someone involved in the manufacture of an herbal product attempts to sneak under the radar enabled by the weak 1994 DSHEA legislation that regulates dietary supplements in the US. The legislation absolves herbal companies of testing their supplements for safety – instead, the FDA must prove that a supplement is unsafe before it can be removed from the market.
And while we don’t know how much of a safety issue this episode represents (i.e., we don’t know how much of the drugs were present in each dose of the supplement), adding prescription drugs to a dietary supplement is a subversive, deceitful, and disingenous way to encourage repeat business.
Oh yeah…it’s illegal too.