Anabolic Steroids -The consumer, the FDA and the Manufacturer
Even If the most conscientious consumer sifted through the mountains of available information and then carefully weighed each source of the information prior to making a determination if a product was safe, it would take hundreds of hours for some products. Even after completing the research, the consumer is at a distinct disadvantage in trying to determine safe from unsafe and good from bad.
An “overly broad warning” and Public Health Advisory (PHA) from the FDA on the dangers of anabolic steroids has served only to confuse the public more. In their advisory, the FDA set forth only a few unlisted ingredients in Body Building type products: containing androgen-, estrogen-, and progestin-related active ingredients. But, public information like this does as much to confuse or fail to engage with a confused, non-scientific public. Mistrust of the Government is an epidemic and is as much caused by a failure to inform the consumer about dangers in a way that any consumer will understand.
Anabolic Steroids are synthetically produced variations of testosterone a naturally occurring male hormone. The two major effects of these steroids are an “anabolic effect”; an often unnatural building of tissues, mainly muscle, accomplished by the promotion of protein synthesis.
People abusing steroids may take up to 100 times a normal dosage and more than one at a time (called stacking); alternate with high dose, then low dose (called cycling); or slowly escalate the dosage amount (called pyramiding). Anabolic Steroids are so widespread now that users include school-age children, athletes, business professionals, and a growing trend of woman striving to have the perfect physique.
The progression of steroid use caused the FDA, DEA and Federal law to place anabolic steroids in Schedule III of the Controlled Substances Act (CSA). The Anabolic Steroid Control Act of 2004, placed 32 additional steroids in Schedule III and expanded the DEA’s regulatory and enforcement authority relating to steroids. Unfortunately, this has resulted in manufacturers becoming cleverer in the delivery of their product to the market and they have found a loophole through the unregulated Dietary Supplement Industry.
Many consumers are under the impression that all “steroids” have been banned and are off the shelf. The scary fact is that only the ones that have been identified by the FDA are safely out of consumer products. New formulations are being developed that do not require FDA approval because the ingredients are “listed” as Dietary Supplements” and have successfully flown under the radar of the FDA.
The belief that these products are safe is a dangerous one. In some respects, these “dietary supplement” products are more dangerous because they either contain actual banned steroids or compounds in the products can have the same medical consequences.
In recent years, mostly as a result of failed drug testing in athletes, it has it been discovered that synthetic pro hormones or anabolic steroids are being used as Dietary Supplements. Although the marketed product may not contain actually banned steroids, it may contain substances that have not yet been approved by the FDA or properly evaluated by the manufacturer. As was seen in 2003 when U.S. track and field athletes tested positive for THG, they were caused by legally obtained products derived from synthetic steroids, trenbolone and gestrinone, and they were ultimately banned.
According to the DEA, the following three steroids meet the criteria for “anabolic steroids” under the Anabolic Steroid Control Act of 2004 (”Classification of Three Steroids as Schedule III Anabolic Steroids Under the Controlled Substances Act,” April 25).”
- Boldione (aka androsta-1,4-diene-3,17-dione)
- Desoxymethyltestosterone (aka DMT and 17a-methyl-5a-androst-2-en-17b-ol)
- 19-nor-4,9(10)-androstadienedione (aka 19-norandrosta-4,9(10)-diene-3,17-dione and esta-4,9(10)-diene-3,17-dione)
A recent study revealed contamination of approximately 25% of popular dietary supplements in the U.S. with low levels of steroids that were not declared on the product label. The International Olympic Committee (IOC) conducted a study between 2000 and 2002 that revealed “15% of dietary supplements, purchased in various countries, contained undeclared steroid and/or prohormone ingredients.”
Some explanations for the high incidence of steroids and stimulants found in sports supplements according to the DEA are:
- Intentional contamination. There have been allegations that some supplement companies may have added undeclared ingredients, usually by the addition of a stimulant, so that the consumer actually “feels” that the product is working. For example, the overall success of the sports nutrition supplement industry is largely due to the “placebo effect” - if the consumer “feels” something from the supplement, they think it is working. Consumers are convinced that if it “feels” like it is working, it may actually have benefit (placebo) and they will continue to buy the product.
- Cross-contamination. Many factories manufacturer varieties of different categories of supplements in the same facility. For example, ephedrine products may be processed on the same equipment as vitamin and mineral products; hormonal products may be processed on same line as protein powders. If the equipment is not cleaned properly, contamination can result.
- Contaminated raw material. Supplement manufacturers often import raw materials from Asia, India and Eastern Europe. This could be contaminated with impurities.
The dietary supplement industry is a “buyer beware”; consumer educate thyself industry. Although responsible, careful manufacturers exist, the ingredients are largely unregulated and the quality is not consistently verified.
The purchase of dietary supplements is one of those areas in which the consumer must educate themselves; ask questions, research, and carefully consider. The FDA simply does not have the resources to gain control over drugs and medical devices. Although remarks delivered on 8/9/09, by newly installed FDA Chief Margaret Hamburg gives new hope, the public should still not rely on the FDA to manage the dietary supplement industry at this point:
“Last week, we took action against companies selling anabolic steroids under the guise of dietary supplements.
One manufacturer, American Cellular Labs, sells eight of these products on its website. The site promotes the products with claims like, “MASS Xtreme is perfect if you are focused on adding muscle mass, power and strength to your physique,” and “ESTRO Xtreme… You get two estrogen blocking effects in one fantastic product!”
In fact, these over-the-counter body-building products have been associated with serious and life-threatening adverse events, including liver injury, stroke, kidney failure, and pulmonary embolism.
These are unproven and unapproved drugs, not dietary supplements.”
Posted: August 10th, 2009 under Other Steroid News.
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