The FDA has recently sent out warning letters to all the manufacturers of Androstenedione, asking them to discontinue selling Andro or prove to them that it is an unadulterated food compound and safe for human use. This doesn't surprise me, however, what does surprise me is that it has taken the FDA so long to respond. Mark McGuire made Androstenedione famous when critics claimed that his batting average was improved by this use of Andro. First appearing on the market in the mid 1990's, it has continuously been sold through the Internet as well as health food stores.

Since its introduction, several other variations of the product have been introduced called Androstenediol and Norandrostenedione. To date, there have not been any reported complications from users of these products. And although there have not been reports of any harm from using Andro and similar compounds, its safety should be called into question.

What is it?

In case you're unfamiliar with Androstenedione, it is a compound that is derived from the pollen of Scotch pine trees. In the human body, it is an androgenic hormone produced by the adrenal glands and the gonads. Athletes use it because it is converted into testosterone by the liver, and this may increase strength and muscle mass. The reason I use the word "may", is because although testosterone can do those things, no one really knows for sure what kind of muscle gains using this hormone can make. Andro is actually a pro-hormone, meaning that your body has to convert it into the active ingredient. While it does increase strength and testosterone levels, the benefits are unclear and the risks are unknown. The more serious problem arises with the fact that the newer compounds like Androstenediol and Norandrostenedione have never been adequately tested on humans. There are animal and test tube studies, but no double blind, long-term human studies have been conducted, and therefore the safety of these products in humans is not known.

Why should I care if this product is sold or not?

If you have a teenager who begins taking this product to gain muscle or improve his performance, you should tell them to stop immediately. In young people where their hormonal levels are high, using a product such as this can actually suppress their own natural output of testosterone. As the levels of testosterone rise above normal, the body's feedback loop will send a message back to the adrenal glands and gonads to quit producing as much Androstenedione. Now, after your child quits using the Andro, his own natural production of this hormone can become suppressed. Also, keep in mind that Andro is a hormone, and higher levels of hormones can alter moods. I personally tried Andro when it first entered the marketplace back in 1995, and became depressed and generally felt blue. I stopped taking it and my mood returned to normal. I decided that it must have been a coincidence, so I added it back into my supplement program only to find that the same feelings of depression came back. I haven't used it since. There are many women, particularly those in bodybuilding who use Andro to help them build muscle, and I can honestly say that it works. However, I can also say that the women who used it also looked a bit manly. (It may be possible that they were using anabolic hormones but just didn't want me to know).

Additionally, if you want to continue buying supplements over the counter, you should be concerned. As supplement manufacturers continue to produce unsavory products that fall within the gray areas of the law, the government gains more momentum and justification to regulate the industry. Make no mistake about it, the FDA has been trying to control the supplement industry for some time now, and if they do, supplements may become available only by prescription. If you think I'm being unrealistic, there are three bills presently being considered in Congress to observe into this very situation. One bill provides for Congress to make supplements available by prescription, the second provides to regulate only certain supplements and the third proposes that everything shall remain as they are.

Could there be any health problems from using Andro and similar compounds?

Absolutely! Because this pro-hormone is processed by the liver, it places a strain on the liver. Therefore anyone with any liver condition should avoid using these products. If you have hepatitis C, cirrhosis, elevated liver enzymes, fatty liver syndrome or any other condition that involves the liver, you should not use Andro. If you have prostate cancer, Andro can fuel the cancer and cause it to proliferate more aggressively. Because Andro can also elevate estrogen levels, men and women with breast cancer should avoid the use of these pro-hormones. Furthermore, any type of cancer would warrant that you stop using it since these are, in fact, hormone disrupters.

Is there ever a reason to use Androstenedione?

If you work with a longevity doctor and the appropriate tests are administered to determine that you are low in Androstenedione, then you may be a candidate for using it. While this hormone, like many others, can decline with age, it does play a role in enhanced immune function and bone density. When women reach menopause, the levels of this hormone drop dramatically. And in certain diseases like lupus, the levels for this hormone are generally found to be lower.

Androstenedione sounds more like a drug then a supplement, so how did this end up being sold through health food stores?

Like many laws that are enacted, there will always be people or companies that look for and find potential loopholes. In a loophole, the wording can be interpreted in such a way that it opens the door for a company to test the boundaries of the law. In this case, the supplement laws state that if a substance is derived from natural sources, it falls under the Supplement Act (DSHEA) and not the Drug Act, and if a substance falls under the Supplement Act, because supplements are not regulated by the FDA, it can enter the marketplace escaping the attention of the FDA. In nature there are many natural sources that have identical chemical structures to various human hormones. Keep in mind that most drugs are originally found in nature. For example, aspirin is derived from the herb known as white willow bark. Valium was originally derived from valerian root. And soybeans contain estrogens that are structurally similar to the human hormone.

What should I do if I purchased this product?

Because these pro-hormones are so expensive, rather than throwing them in the trash, return them to the store where you purchased them and ask for a full refund. If the store clerk tries to tell you they don't give refunds, let them know that you heard about the FDA's warning letter and, because they sold you a potentially dangerous product, by law, they must provide you a refund. Regardless of whether it's a full bottle or there are only a few tablets left, you are entitled to a full refund.

When you go into a health food store, if you're like most people, you expect to find products that are good for you. After all, they're not called "unhealthy food stores." If you are interested in maintaining a healthy body, be aware that so long as there are companies out to make a profit, there will always be unscrupulous vendors out to take your money at the expense of your health. LipoKenetix killed eight people and caused hundreds of liver complications. GHB, a powerful narcotic derived from household cleaners, was originally distributed through health food stores. Renutrient, White Lighting and similar pro-GHB products skirted the law and flooded the health food store shelves in the late 90's. Now Ephedrine has been removed because of the potential for abuse and harm. My point is that it is up to you to be educated about the benefits and potential side effects of everything you put into your body. One final question:

How do I find out if a supplement is bad for me?

Go to the FDA web site at www.fda.com and click on "Warnings" under the Dietary Supplement section. All warning letters and discussions with regard to suspicious supplements are listed there. Another way to stay informed is to tune into my radio show every Friday on 700 AM KSEV from 12-1 PM. Whenever a warning is issued, you can bet that I'll be discussing the topic