I should probably create a new blogpost category just for erectile dysfunction dietary supplements adulterated with authentic or synthetic analogs of prescription phosphodiesterase-5 (PDE5) inhibitors (e.g., Viagra, Cialis).
However, FDA has already created a page for this earlier this year after dozens of companies have been identified as putting real drugs into their erectile dysfunction products.
Do the brains behind these companies not realize that FDA is now monitoring every erectile dysfunction supplement for all manner of PDE5 inhibitors?
For Immediate Release: Nov. 5, 2009Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDAFDA Warns Consumers on Sexual Enhancement Products
Another dietary supplement is found to be contaminated with potentially dangerous ingredient
The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal.
Over the past several years, the FDA has found many products marketed as "dietary supplements" for sexual enhancement that contain undeclared active ingredients of FDA-approved drugs, analogs of approved drugs and other compounds that do not qualify as "dietary ingredients." The FDA has issued multiple alerts about these contaminated dietary supplements.
Consumers and health care professionals should be aware of this problem and the health hazard it presents. Sexual enhancement products that claim to work as well as prescription products are likely to contain a contaminant. Use of such products exposes consumers to unpredictable risk and the potential for injury or even death.
In the case of Stiff Nights, following a consumer complaint, the FDA determined that the product contains sulfoaildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.
The product is distributed on Internet sites and at retail stores by Impulsaria LLC of Grand Rapids, Mich. It is sold in bottles containing 6, 12, or 30 red capsules or in blister packs containing one or two capsules.
"Because this product is labeled as an 'all natural dietary supplement,' consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA's Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications."
The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm
The FDA remains committed to stopping the illegal marketing of unapproved drugs and will continue to protect the public with vigorous law enforcement and criminal prosecution of violators.
I'll be very serious about this for a moment because, in this particular case, it appears that FDA was acting on a consumer complaint that I suspect arose from an adverse health reaction to the product. Taking a PDE5 inhibitor on top of prescription vasodilators can cause a very frightening drop in blood pressure that, at the very least, could cause one to briefly lose consciousness and fall.
I've got to get to work so I don't have time to go through all the ingredients but I just wanted to capture this content before their page goes down. The stuff sounds all sort of mystical with the use of the traditional Chinese medicine herb names. The misspellings in the salts of arginine must mean they have highly proprietary analogs of this amino acid precursor to nitric oxide - I'm sure that frequent blog commenter Daedalus can set us straight.
What's in Stiff Nights?
Stiff Nights is comprised of a special blend of Herbs, Mushrooms and Greens. This particular blend has taken us 7 years to perfect. It is this special blend that makes Stiff Nights so potent while being 100% natural.Stiff Nights is comprised of a special blend of Herbs, Mushrooms and Greens. This particular blend has taken us 7 years to perfect. It is this special blend that makes Stiff Nights so potent while being 100% natural.
[Yes, they really repeated the paragraphs above - APB]
Stiff Nights contains the following active ingredients:
Yi Ye Cao, Huang Jing, Rou Gui, Tongkat Ali, Turnera Aphrodisiaca, Cayenne 40M H.U., Sheng Jiang, Bo He, White Willow Bark, Huang Qi, Wu Wei Zi, Hui Jiao Zi, L-Arginine Monohydrate, Arginine Alphaketoglutararte, Arginine Ketoiscoaproate, Cordyceps sinensis, Ganoderma lucidum, Lentiunula Edodes, Auricularia auricula, Spirulina, Chlorella, Spinach, Barely Grass, Wheat Grass, Dulse Leaf, Kelp, Alfalfa, Beet Root, Orange Peel, Dandelion Leaf, Lemon Peel, Ginkgo Leaf,Inert Ingredients:
Barley Flour, Magnesium Stearate, Hypromellose, Water, Vegetarian Capsule.
While it's still live, take a gander at the Stiff Nights site, especially the lovely letter "To my Fellow Man" from Stiff Nights creator and CEO, Jaime Green. (You'll find that under "Regain The Thunder").
I also like how their FAQ makes a major distinction between Stiff Nights and drugs:
Stiff Nights vs. Viagra ®?Stiff Nights is different than Viagra ® because Stiff Nights is a nonprescription nutritional supplement. Stiff Nights is not a drug. Many users report a better experience than
Viagra ® because Stiff Nights also increases the male sex drive and somehow increases a male's endurance. Since the formula uses only all natural ingredients it seems logical that you reduce the risks of certain side effects associated with Viagra ®. No formal study has been done on this. In addition, Stiff Nights provides other essential nutrients that help you maintain your peak sexual health.Why take a supplement instead of a drug?
Nutritional supplements typically take a more gradual, gentle, and natural approach. Even though Stiff Nights isn't very gradual, it is still 100% natural. The focus with supplements is on the optimization of health and wellness. Drugs are used for the treatment of disease, and tend to work by modifying or altering specific biological pathways, sometimes in an unnatural manner.
d00d, you put a drug in your supplement.
Sheesh, this is easier than shooting fish in a barrel.
Medicine & Health
Comments
"Your partner will become a stiff" (sorry, could not resist)
Posted by: milkshake | November 6, 2009 8:43 AM
This is pretty fascinating. I worked for the FDA and a long time in the drug industry and have always feared the insanity of the dietary supp business. I feel naive though. I never realized they actually adulterated their products with real bulk actives.
That's insane. They're selling garbage based on false marketing anyway, why endanger themselves by making such an egregious violation. With the untested natural "remedies" they still sell stuff and they're legally safe. Once they start adding known pharmacologically active components, it's getting close to drug dealing.
Posted by: Dave | November 6, 2009 10:21 AM
I am just curious if it is possible that Sulfoaildenafil could be naturally found in one of those chinese herbs, or if it was specifically determined that the Sulfoaildenafil was synthetically produced.
Posted by: Ryan Koz | November 6, 2009 11:40 AM
Dave, they are not “insane”, they are just greedy, lying crooks who don’t care about following the law or about hurting people who buy their products; just like all other CAM “professionals”.
If you order their “free” samples, they put you on an auto-ship of 6 doses per month @ $5.00 per dose. $5 for something that costs a few pennies to make.
The way that erections happen is that nerves trigger the release of NO, the NO activated guanylyl cyclase which then makes cyclic GMP. The cGMP then relaxes smooth muscle which causes certain tissues to fill with blood.
These drugs actually reduce NO levels because they inhibit the phosphodiesterase enzyme that cleaves cGMP, so that there is too much cGMP around, so physiology down-regulates NO production. A single dose of Viagra makes obstructive sleep apnea worse, I think by feedback inhibition of NO production. Breathing is regulated by S-nitrosothiols which are decreased by low NO levels. That pathway is independent of cGMP.
Posted by: daedalus2u | November 6, 2009 2:06 PM
New bullshit for us all to make fun of:
'Kangen' water. It's alkaline and the makers claim it's hexagonal. The dumb people think it's good for them.
Posted by: Katharine | November 6, 2009 6:36 PM
To all here. I stumbled upon this article by chance and wanting to give some details for all of you.
I am an expert in this industry you could say. I have a company in Canada, it is an actual site licensed approved company that distributes herbs.
I can tell you as a fact that this product contains Viagra and I can also show you where the company actually tells you it contains Viagra.
These spiked product exist primarily in the US, as a Canadian company, we see these pop up regularly and they are a source of both aggravation as well as being a source of mininformation, which we find even more damaging.
As a clean company, producing clean product it is very hard for us to abid by NHP regulation in not producing marketing and advertising to jump on the money bandwagon is it is and instead play it very quite, meanwhile completley unscrupulous operations in the US go about poisoning for riches.
This company and all other like them have one clear signal they print on all their packages of 'herbal' products containing pharma-drugs.
"Do not take more than one pill per 36 hours".
Any sort of caution like this found on any 'herbal' product in fact tells you it is spiked.
There is no herb formula that is a clean product that one has to be concerned about taking too much (ex, one pill) too frequently (ex, per 36 hours).
This standard caution, I believe is something these crooks do believing it may in fact relieve them from lawsuits generated by someone who suffers a heart attack, as I am not American, I do not know for sure.
But I do know for sure that no herbal product contains that cautionary warning. As in the case of our product sold here in Canada for over 5 years and is suppled to the health clinic market as well as retail, you could eat every single pill all at once and the only difference you'd find is that you paid the same amount as someone taking only one dose.
I see that cautionary warning on a lot of 'suspicious' US based product and often wonder why ordinary consumers don't.
This is more than likely due to the amount of 'mininformation' that people are operating on, for example I often tell customers that the first mistake they committed when looking for these products, was actually looking for them.
In Canada, NHP regulation weeds out these elements, not entirely, but certainly to the point where doing regular business is difficult and therefore, not worth attempting.
But in the US this Natural Health Product regulation isn't there...leaving all Americans vulnerable to quack medicines.
I remember having a conversation with a big player in Florida who is involved in the adult store industry.
They were very interested in the work our company has done here in Canada and our formula. When I told him how much the raw cost of materials were in answering why I was quoting prices that he considered 'out to space'....he laughed at me and told me he could get generic viagra for pennies per pill and 'why would I spend that much on your product, when I'm going to throw it on 'lube gel bottles' as a sampler?'
At that point I understood the problem and how deep it goes in the US.
So take this advice.
First and foremost, do not source out and buy product from 'websites'. This seems draconian but the truth is there is NO ONE with creditials or HONEST PASSION for herbal medicians that sells buy internet, all you'll find is people with HONEST PASSION to make a lot of money.
Secondly, do not source out and buy product unless it comes recommended by a qualified ND (naturalpathic doctor).
DO NOT trust your local health food store. There are no regulations in your country that force integrity on the store. There is no one government department licensing honest herbal manufacturing/distributors there fore there is no way for a health food store to make sure they are buying product from a legit honest dealer.
And most important, look at the packaging. If there is a caution about dosage amount and time, then they are telling you it has a prescription drug inside.
Hope this helps you all out.
Posted by: J. | November 8, 2009 12:46 PM
I never realized that J, that's insightful. I thought everything here are strictly regulated, I mean that's what we're paying taxes for right? Here I am thinking that nutritional supplements are all safe, geez, you got to be careful nowadays.
Posted by: john sutton | November 8, 2009 6:11 PM
This pill is amazing! I used in with my boyfriend and I was satisfied! I have some problems with staying hard, and this pill solved the probelm. I highly reccomend this to anyone. I have tried many other products that did not work, but this one is amazing
Posted by: ben | November 8, 2009 6:13 PM
Heh. "Hard Times" would be a good name for this sort of product, wouldn't it be?
Posted by: idlemind | November 8, 2009 11:39 PM
Tried Stiff Nights for the first time this past weekend, before seeing articles like this, for a cheaper alternative to the Viagra I've been taking over the last four years.
For the one pill I took, not only was it less than half the price of Viagra, the effects have lasted, so far as of this posting, 30 hours longer than Viagra.
So far, the wife and I are fans of the product and will continue to use it.
Posted by: Naj Le'Kim | November 9, 2009 4:07 PM
This product is AWESOME!! I love it!! Say what you will, but I hope they get this on the market..I'm an avid user of this, and it has helped SAVE my life, not hinder it!
Posted by: Jame | November 11, 2009 5:23 PM
This is also in response to #4 on this list...Look pal, I don't give a rat's-ass if you think you are a Dr. of Dick, the bottom line IS...this has made a world of difference in my sex life. And so far as spending $5 for something that cost pennies? I'm the one spending the money, not you- and for me it's worth it! BTW, wanna buy a comic book for $10,000? No? What if it was Superman #1? No...? But SOMEBODY will, because it's worth it TO THEM!! C'pish? :P
Posted by: James | November 11, 2009 5:28 PM