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Caught By FDA: Supplement Manufacturers Boost Efficacy By Adding Real Drugs To Mix

Stiff Nights.jpgI 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?

Apparently not:

For Immediate Release: Nov. 5, 2009

Media Inquiries: Christopher Kelly, 301-796-4676, christopher.kelly@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers on Sexual Enhancement Products
Another dietary supplement is found to be contaminated with potentially dangerous ingredient

FDA Hidden risks of ED products online.jpgThe 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.

*This blog post was originally published at Terra Sigillata - PostRank (PostRank: All)*


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