Terra Sigillata

Blue Steel Hero

No, it’s not a song by Foreigner – these are the names of two products “promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement.”

In yet another instance of a trend that would be comical if not so serious, the US FDA has announced that “Blue Steel” and “Hero” supplements contain chemical relatives of sildenafil, the active constituent of the prescription medication Viagra.

“Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking.”

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, these men may seek products like Blue Steel and Hero because the products are marketed as “all natural” or as not containing the active ingredients in approved ED drugs.


The FDA notes that the products were manufactured by Active Nutraceuticals (“Contract manufacturing at it’s [sic] best”) or the Marion Group of Carrollton, GA (no website found). Active has offices in Skeneatles, New York and Yongzhou, Hunan, China. I was tempted to use their “request a quote” form to find out how much it would cost to produce a product called Pharmboy Power and what the extra cost would be to throw in a little bit of sildenafil. But that might be illegal.

The unusual aspect of this particular warning is that FDA did not announce that the company(ies) were issuing a “voluntary” product recall, as has been done in past cases. If FDA was unable to cultivate the cooperation of the manufacturers for whatever reason, they are empowered by dietary supplement regulation to order the product removed from the market. The reasons for this missing link are presently unclear to me.

Again, this trend has become so common that FDA now maintains a separate consumer information page about these online ED products and their growing list of product names including one, Lady Shanghai, that has been targeted to women.

As I’ve written before, dietary supplements do indeed sometimes work – especially if they illegally contain undeclared prescription drugs.

Comments

  1. #1 Anonymoustache
    March 27, 2008

    It is indeed mystifying and worrisome that these products are not being recalled one way or another.
    Also, Pharmboy Power huh? Hmmm…it has a certain gravitas. Anyway, I think it is a great idea to find out what the deal is with these contract manufacturers—it can’t be illegal if you, say, make an affidavit in advance making it clear that you are doing this for research purposes, or something on those lines, no?
    Also, you can tell them that you already have a slogan for Pharmboy Power and you need the medicine to live up to it—”The Penis Mightier Than the Sword”.
    thank you. i’m here all week. be sure to tip your wait staff.

  2. #2 trrll
    March 30, 2008

    So are these “chemical relatives” naturally present in these supplements, or are these companies doping their products with synthetic chemicals? In the latter case, the FDA clearly would be on strong grounds to ban these products. The former case is more difficult, and the FDA would probably need to mobilize evidence of harm.

  3. #3 gary
    April 1, 2008

    The ads for these types of supplements can oftentimes be misleading and as consumers we should also take safety measures prior to intake. Bona Fide natural supplement products are made of ONLY natural ingredients (herbal or homeopathic), comes with a literature (or a list of its ingredients), registered with the FDA and conform to standards in its production with the manufacturer within reach at any time. If any of these requisites could not be satisfied, then one should be aware of the potential health risks should you decide to pursue its intake.

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