Angry in the Great White North

The latest recall from Health Canada concerns a male potency pill, Zencore Tabs, that has a surprise ingredient, tadalafil, also known as Cialis:

Warning

2007-90
July 20, 2007
For immediate release
Health Canada warns consumers not to use Zencore Tabs due to potential health risks

OTTAWA - Health Canada is warning consumers not to use Zencore Tabs, a product advertised as a dietary supplement for sexual enhancement, because it contains an undeclared pharmaceutical ingredient similar to the approved drug tadalafil. Tadalafil is a prescription medication indicated for the treatment of erectile dysfunction and should only be used under the supervision of a health professional. The use of Zencore Tabs could pose serious health risks, especially for patients with existing medical conditions such as heart problems, those taking heart medication, or those at risk of stroke.

Products containing tadalafil should not be used by individuals who are taking any nitrate medication because combining these products could result in the development of potentially life-threatening low blood pressure.

The use of products containing tadalafil has been associated with serious side effects including serious cardiac events such as heart attacks, sudden cardiac death, angina, irregular heart rate, or stroke. In extremely rare instances, use of tadalafil may potentially result in penile tissue damage and permanent loss of potency.

Zencore Tabs is not authorized for sale in Canada and the Canadian importer has been contacted and is recalling the product. Consumers who have purchased Zencore Tabs are warned not to use the product and to consult with a medical professional if they have used it or have concerns about their health.

Zencore Tabs is sold in blister packages of two pink-purple capsules. There have been no reports of adverse reactions associated with the use of this product. Health Canada is taking steps to confirm that the product has been removed from the Canadian market. The product was available at retail outlets and may also be sold over the Internet.

Zecore Tabs is described by the manufacturer as an herbal solution to male potency challenges:

Zencore Tabs are an all natural herbal supplement for enhancing male sexual stamina. Our powerful blend of herbs will provide you with long-lasting, firm erections and increased energy for a great night of sexual pleasure.

We are sure that Zencore Tabs will increase your sexual stamina, desire, and pleasure the first time you use them! If you are looking for a natural alternative for increasing sexual stamina, restoring your sexual energy and vigor, or having an unforgettable night of passion, then Zencore Tabs are right for you!

You take Zencore Tabs 45 minutes before sexual activity and enjoy an intense sexual experience that will amaze both you and your partner. We are sure you will increase sexual stamina, desire, and pleasure the first time you use them.

Zencore Tabs describes itself as depending on Traditional Chinese Medicine (TCM) in designing the product.

So who makes Zencore Tabs? I'm not really sure. The site is registered through a domain privacy shop out of Yarmouth, Nova Scotia. The only face on the site is a head shot of Dr Richard Sandore. A former obstetrician, Sandore went to the Andes and became a shaman. No longer practising medicine, he is a motivational speaker who helps individuals and businesses "bask in the light of their own sun to part the clouds".

He has no ties to Traditional Chinese Medicine that I can see, or to Zencore Tabs other than a pre-shaman photo appearing on the Zecore Tabs Research page.

That page does list the major ingredients of Zencore Tabs, a veritable salad of weeds and mushroom and roots designed to fire the rockets:

• Maca root
• Epimedium leaf
• Cordyceps
• Tribulus
• Chinese dodder seed

Taken together, these herbs will boost the libido, bless you with longevity, strengthen the immune system, and balance your kidney yang.

I read up on each of these herbs and on tadalafil, and I couldn't see any obvious link. Though it is possible, none of these herbs is said to work via a substance that is chemically similar to tadalafil.

I had assumed that one of the ingredients of Zencore Tabs, though "natural", was a tadalafil look-a-like, and that is what triggered the Health Canada warning. But I couldn't find an obvious culprit.

And then I found an abstract for this paper written by scientists working for the Key Laboratory of Chemical Biology and Traditional Chinese Medicine Research, a branch of the Chinese Ministry of Education. It describes a method for finding the active ingredients of Viagra, Levitra, and Cialis in a sample of allegedly "natural" male potency products:

Simultaneous determination of sildenafil, vardenafil and tadalafil as forbidden components in natural dietary supplements for male sexual potency by high-performance liquid chromatography–electrospray ionization mass spectrometry

The paper was dated 2005. Now why would scientists work on a efficient means of detecting sildenafil, vardenafil and tadalafil in natural male potency pills? Is this a problem that needed solving? I mean the detection of the compounds, not the male potency thing.

This is what I think is going on. Zencore Tabs, with or without the help of Shaman Richard Sandore, comes up with yet another love potion made out of bits and pieces of Chinese pharmacology (aka folklore) to put on the market. But it doesn't work. At best, it's hit or miss. So the formulation is spiked with the decidedly unnatural product of Western pharmacology (aka science), tadalafil, which is clinically proven to work, but that is tightly controlled because of serious side effects.

Not to mention that Eli Lilly holds the patent.

So Zencore Tabs doesn't mention that the pills have a medically significant concentration of a cheap (and quite possibly unlicensed) tadalafil knockoff, but enjoys the reputation of actually working through all-natural components.

As such, it is sold to Canadian men without a prescription, eager to find a solution to their problem that is not as expensive as Viagra, Levitra, or Cialis.

Sales are made until Health Canada somehow figures out that the stuff is really Cialis served on a salad.

Seems plausible to me, especially since finding these drugs in "natural" potency products has happened over and over again:

• Male Power Plus, 2004, undeclared tadalafil (Cialis)
• V-King and V-King Extra, 1999, undeclared sildenafil citrate (Viagra)
• Urat Madu, 2007, undeclared sildenafil citrate (Viagra)
• Power 58 Extra, Platinum Power 58 Extra, Enhanix New Extra Men’s Formula, Valentino, King Power Oral Solution, Stretch Up Capsules, 2007, undeclared sildenafil citrate (Viagra) and vardenafil (Levitra)
• Vigorect Oral Gel Shooter, 2007, undeclared tadalafil (Cialis)
• Bell Magicc Bullet, 2003, undeclared sildenafil citrate (Viagra)

There are more -- I just got tired of linking them in.

Bell Magicc Bullet is interesting. Bell Distributors Ltd. of Mississauga refused to go along with the Health Canada recall:

The distributor of an unregulated food supplement is challenging a Health Canada request to remove the product from the market. The pill, marketed under the name Bell Magicc Bullet, contains the unauthorized chemical ingredient sildenafil.

A spokesman says the distributor has filed a lawsuit against Health Canada, arguing that the department discriminates against the health food industry.

The company says Bell Magicc Bullet does not contain sildenafil, but a natural herb that contains similar molecular markers.

The herb in question is butea superba. It's from Thailand, and local folklore pegs it as an aphrodisiac. As for the lawsuit, it might still be before the courts. I couldn't find any news reports describing the resolution. But looking at the list of natural male potency products taken off the market since 2003 for having measurable amounts of sildenafil, vardenafil, and tadalafil, it would look like the courts have not decided against Health Canada, at least not yet.

In the mean time, I can't help but think that the presence of cheap knockoffs these compounds in these products is not accidental, but is a way of making sure the product has some minimal effect. The fact that a group of scientists worked on a method to specifically look for these substances in "natural" products certainly makes me wonder.

With worldwide sales of Viagra, Levitra, and Cialis topping $2 billion a year, there is a lot of incentive to cheat in order to grab a piece of that pie.

I wonder too, if doctoring an all-natural product with knockoffs of the compounds is normal business practise in throughout this industry, and not just a case of a few bad apples. If so, maybe the onus has to be put on the manufacturer to prove that their products don't contain these compounds, and that they actually work under clinical testing. But then that would increase the cost of making these potency pills, and would probably drive a lot of them out of the market, especially the ones with disappointing performance results.