FDA: Dangerous sexual enhancement booster

FDA NEWS RELEASE

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

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.

Have you explored the health benefits of soy?

I've recently been doing a fair bit of reading about the health benefits of soy products. Keep in mind, since I'm Korean and my wife is from Taiwan, we naturally eat a high volume of soy products in our regular diet. Tofu is cooked in many different ways and we may have some of it for breakfast, lunch, or dinner. You'll also see that we have soy milk in our fridge and there are various soy-based desserts that we often eat as well (not daily, but occasionally). If you find us in a Japanese restaurant, you'll see us munching on some edamame.

So when it comes to soy and health, what does the evidence reveal? One of the difficulties of interpreting the evidence is that some of the studies simply aren't robust like pharmaceutical clinical trials. It's often difficult to quantify soy consumption when you're evaluating it in someone's regular diet. When someone says that they eat 2-3 pieces of tofu each day, what exactly does that mean? What if they're taking some form of soy supplement? Since these supplements aren't regulated by the FDA, it's often very difficult to know how much people are taking. Make sure that your healthcare provider knows about any supplements you may be taking.

I believe that natural soy as part of a regular diet has significant health benefits. I also think that high-dose soy supplements can lead to adverse effects (that's what the evidence reveals). So, you won't find me taking any pills as supplements, but I'll continue with my Asian diet at home.

Wellness is a Hot Topic (Especially During the Summer)

Wellness is everywhere! We see celebrities promoting different ways of staying healthy and we even see commercials about age-defying products. What do you think about the commercials that you see on television? Are you a skeptic? Each year, consumers spend billions of dollars on nutritional supplements. We see products like Intramax and Poly MVA getting gobbled up by people who believe that these supplements and vitamins are promoting wellness and helping them defy the natural aging process. Patients are bringing all sorts of bottles to their doctors and asking questions like, "What do you think of this supplement?" Or, "Do you think I should continue taking all these supplements?"

As the summer approaches, I think about how many people fail to protect their skin from sun damage. People forget about the long-term consequences of their actions and they often focus too much attention on the immediate. Interestingly, more and more consumers are getting obsessed with organic products and they even choose to wear Natural Sunscreen. Instead of spending billions of dollars on age-defying products, people should spend less time sunbathing and smoking. Sun damage and smoking causes wrinkles that won't go away with age-defying creams, lotions, or potions. So what will you be doing this summer? If I see you at the beach, I'll be under an umbrella.

Herbal Nutritional Supplements in Medicine

I was trying to explain the concept of herbal nutritional supplements to someone the other day. This person really didn't seem to understand that herbal agents are not the same as prescription medications. We were talking about a bottle of 81 mg baby-strength aspirin that you can purchase at your local drug store. You don't need a prescription since this is an over-the-counter medication. However, Bayer has a new bottle of 81 mg aspirin called "Bayer with Heart Advantage." This is a bottle of aspirin that also includes a supplement called phytosterols, a natural plant-based supplement that are also known as plant sterols.

Some people are fanatical about nutritional supplements and they even become Herbalife distributors. I personally think you can have quite a successful business in this industry because there are so many people who want to engage in holistic medicine, complementary medicine, alternative medicine, herbals, nutritional supplements, and much more. Many clinicians are members of the American Holistic Medical Association (AHMA) and may even achieve board certification. Do you have an entrepreneurial spirit? Want to learn how to become an Herbal Life distributor? You don't need an MBA to build a successful business that integrates the distribution of herbal nutritional supplements.