Warning on Body Building Products Marketed as Containing Steroids or Steroid-Like Substances

 

On July 28, 2009, the U.S. Food and Drug Administration (FDA) issued a public health advisory warning consumers to stop using any body building products that are represented to contain steroids or steroid-like substances. Many of these products are marketed as dietary supplements.
This advisory was issued along with a warning letter sent to American Cellular Laboratories Inc. for marketing and distributing body building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved and misbranded drugs.

Q. What types of products are affected by this public health advisory?

A. FDA is warning consumers about products that are being marketed for body building and that claim to contain steroids or steroid-like substances. These products are sold online and in retail stores and are promoted as hormone products and/or as alternatives to anabolic steroids for increasing muscle mass and strength. Many of these products are labeled as dietary supplements and make claims about the ability of the active ingredients to enhance or diminish androgen, estrogen, or progestin-like effects in the body. Consumers should be aware that these products are potentially harmful and that FDA has not approved them nor reviewed their safety before marketing.

Q. What are some examples of these types of products?

A. These body building products are often marketed as being anabolic (promoting muscle building) and/or being similar to anabolic steroids (such as testosterone). The products included in the warning letter to American Cellular Laboratories Inc. provide a few examples of the body building products about which FDA has safety concerns. The product names and ingredients listed in the warning letter are:

• TREN-Xtreme: 19-Norandrosta-4,9-diene-3,17 dione, marketed as “similar to Trenbolone”
• MASS Xtreme: 17α-methyl-etioallocholan-2-ene-17b-ol, marketed as “similar to Methyl Testosterone”
• ESTRO Xtreme: 4-hydroxyandrostenedione (4-OHA)
• AH-89-Xtreme: 5α-androstano[3,2-c]pyrazole-3-one-17β-ol-THP-ether, marketed as “similar to Stanozolol”
• HMG Xtreme: 2α,3α-epithio-17α-methyl-17β-hydroxy-5α-etioallocholane
• MMA-3 Xtreme: Androsta-1,4-dien-3,17-dione, marketed as “similar to Boldenone (Equipoise)”
• VNS-9 Xtreme: 17α-methyl-4-chloro-androsta-1,4-diene-3β,17β-diol, marketed as “similar to Turinabol”
• TT-40-Xtreme: 1-androsterone, marketed as “very similar to 1-Testosterone” and “converts to 1-Testosterone”

Q. What are the health risks of these types of products?

A. Adverse event reports received by FDA for body building products that are labeled to contain steroids or steroid alternatives involve men (ages 22-55) and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). Acute liver injury is known to be a possible harmful effect of using anabolic steroid-containing products. In addition, anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and increased risk of heart attack and stroke.

Q. Why does FDA say these products are illegally marketed?

A. These products are NOT dietary supplements because they contain synthetic steroid or steroid-like active ingredients. These products are unapproved new drugs because they are not generally recognized as safe and effective. In fact, they are potentially har

Steroids are synthetic hormones designed to treat medical ailments…

Steroids were developed as medical treatments and they come in two varieties. Anabolic steroids are the kind you hear about the most. They behave like male sex hormones, and doctors prescribe them for treating problems like late puberty as well as significant muscle loss in patients with cancer and AIDS. But they’re often used illicitly by athletes who are addicted to winning.

Corticosteroids are less controversial and treat things like allergic reactions and autoimmune diseases. Cortisone is one common example, which doctors use to treat the pain and swelling that comes with skin conditions like bad insect bites and poison oak. Prednisone is another corticosteroid, which treats autoimmune diseases including lupus and arthritis.

Both types can be taken orally, injected muscularly, or rubbed on the skin.

…that work by speeding up muscle growth…

There are lots of different types of anabolic steroids, but most of them beefify similarly. When we work out, we create tiny micro-tears in muscle fibers. When the muscle regrows and heals, it grows back a little bit larger, and repeating that process over time is how we get hard and massive (that’s the idea anyway). The male sex hormone testosterone facilitates that muscle growth. Anabolic steroids do the same thing but better and faster. They also speed the muscle-healing process by blocking the stress hormone cortisol, which breaks down muscle tissue. That can mean less down time for athletes who go into overtime.

…but are often abused and used illegally…

Because anabolic steroids are so good at growing muscle, athletes sometimes use them to enhance their performance or improve their physical appearance—even though it’s almost always verboten. From baseball players to boxers to body builders, steroids have scandalised the world of amateur and professional sports for decades.

Abusers might take up to 100 times more drug than you’d find in a medical dose. That spells danger. So to try to take a shit ton of drugs with fewer side effects, some folks use a cocktail of steroid types—like oral plus injectable—which is called stacking. Pyramiding, i.e. administering doses in 6 to 12 week cycles, is another method for trying to make steroids work better but decrease the incredibly nasty side effects (see below). There’s no scientific evidence, however, that stacking or pyramiding works.

… which can lead to exceedingly unpleasant and dangerous side effects …

The potential side-effects of anabolic steroid abuse include: liver tumors, jaundice, high blood pressure, increased cholesterol, kidney tumors, fluid retention, severe acne, testicle shrinkage, reduced sperm count, infertility, baldness, breast development, prostate cancer and (my favourite!) an enlarged head. Women experience increased facial hair, male-pattern baldness, changes or cessation in menstrual cycle, and deepening of the voice. Adolescents could halt their growth because the drugs can cause early skeletal maturation and acceleration of puberty.

And that’s not all! Steroids can cause emotional problems, including dramatic mood swings that have been known to lead to violence, i.e. “roid rage,” depression, paranoid jealousy, extreme irritability, delusions, and impaired judgment.

And then there’s the possibility of needle-born diseases including HIV and hepatitis B and C.

In it to win it!

… but some folks decide the risks are worth it because the drugs make you harder, faster, stronger…

Despite the nasty side effects and the increasingly strict rules against using steroids in sports, the list of athletes who have been caught or strongly suspected of doing using steroids anyway is long. Barry Bonds is one the most famous cases—he was convicted in 2011 of obstruction of justice for lying about this steroid use.a