The U.S. Food and Drug Administration (FDA) is warning that Tri-Methyl Xtreme, a muscle-building supplement sold by Las Vegas company Extreme Products Group, has been linked to liver damage. According to Associated Press, the supplement was linked to three reported injuries in California, New Jersey and Utah. The FDA began investigating the product following these reports.
Tri-Methyl Xtreme claims to contain anabolic steroids, although it is sold as a dietary supplement. Dr. Charles Lee of the FDA drug center’s office of compliance said that anabolic steroids “may have a range of serious adverse effects on many organ systems, and the damage may be irreversible,” according to Wall Street Journal. The FDA warned that these chemicals can also negatively impact cholesterol levels, increase the risk of heart attack and stroke, cause masculinity in women and lead to testicle shrinkage.
Individuals who used Tri-Methyl Xtreme should seek medical attention if they experience symptoms such as unexplained fatigue, abdominal or back pain, discolored urine or other unexplained changed in their health.
The dietary supplement industry has been under increased scrutiny in light of safety concerns. A recent study led by Harvard Medical School professor Pieter A. Cohen found that many supplements listing acacia rigidula as an ingredient actually contain BMPEA, a substance similar to amphetamine. Dr. Cohen took issue with the fact that the FDA studied this issue in 2013, but would not identify products.
The FDA stated that it “prioritizes enforcement actions based on available resources and the level of safety concern identified, but the agency faces the challenge of having limited resources to monitor the marketplace for potentially harmful dietary supplements.”
The supplement industry has also been criticized for another issue. The office of the New York Attorney General Eric Schneider looked at herbal supplements from certain major retailers and found that only 21 percent contained plants that were advertised.
Dietary and herbal supplements are regulated differently than drugs. Supplement makers do not need to undergo testing to show that they are safe or effective, they are only responsible for their safety. As a result, the industry is largely self-policed. Supplements are not allowed to contain prescription drug ingredients.