FDA warning on 26 tainted ED products illustrates point of widespread counterfeiting, expert says

Public health risk​

FDA said the products contained sildenafil​ (Viagra) or analogues thereof and said it found the products after examing international mail shipments. The agency’s public health concern stems from the counter indications of the pharmaceutical, as it can cause an unsafe drop in blood pressure if a user is already taking a blood pressure medication.  So ingesting an undeclared ingredient is an obvious public health risk in these cases, the agency asserts.  That concern is coupled with the question of dosage, which is not specified on any of the tainted products.

Many of the products feature lettering of various East Asian languages and seem obviously to have been manufactured overseas.  They include the various double entendre, poorly translated brand names, including “Hard Wang,”​ and “Bigger Longer More Time Sperms,”​  among the more entertaining.

But not all products fell into that category.  One of the cited products, called Stiff Nights, has in the past been marketed under the aegis of a Salt Lake City, UT company called NovaCare LLC.  NovaCare in 2011 issued a voluntary recall on a long list of erectile dysfunction and sexual health products​, a list which included Stiff Nights.  All of the products in that recall were said to have contained sulfoaildenafil, a sildenafil analogue.  In the most recent warning on Stiff Nights​, FDA said the product contained sildenafil.

Rampant counterfeiting​

So was NovaCare stealing back into the market with a newly-tainted version of the product?  Calls to the company went unanswered.  But it is possible that the company was a victim of a counterfeiter, said Justin Prochnow, a Denver-based lawyer in the firm Greenberg Traurig.

“One of the really interesting things in dealing with these products is there is a lot of product that moves back and forth.  So much of this type of product in particular is counterfeited by companies in China. A lot of time FDA has trouble determining whether it is the actual company’s product or the counterfeiter’s product,”​ Prochnow told NutraIngredients-USA.

In the case of Stiff Nights, the package of the most recently cited version and the representation of the product that NovaCare recalled looked identical except that one blister pack contains one capsule while the most recent version contains two. Prochnow said if the most recent version is in fact a counterfeit, that would square with his experience in how carefully the bogus products mimic the original packaging.

“We’ve dealt with one company that had this issue and I had copies of the knockoff and you can’t tell which is which,”​ Prochnow said. “The only difference was a very slight variation in one color, and you couldn’t tell that unless you had the packages side by side.  Another name that we have seen come up over and over in these products is Black Ant​.”​

Prochnow said the warnings to consumers should also serve as a warning to companies.  Sexual enhancement, weight loss and sports performance products are categories of special concern to FDA because of the higher incidence of contamination, and companies playing in these fields need to be extra vigilant, Prochnow said.

“The biggest thing for companies that are operating in this industry need to remember is it is really imperative that they are testing their product to make sure that there aren’t active drug ingredients in there,” ​he said.