Federal authorities filed court papers last month alleging that two over-the-counter dietary supplements commonly used by high school football players contain steroids. Tren Extreme and Mass Extreme, manufactured by American Cellular Labs, are marketed as a potent legal alternative to steroids. However, search warrants were executed alleging that the supplements contain illegal designer steroids including Madol, a substance first identified six years ago during the investigation into the Bay Area Laboratory Co-operative.
Authorities say that Max Muscle, a supplement store with approximately 100 locations across the country, paid American Cellular Labs to be the exclusive retailer of these products, which are also available online.
An individual at Max Muscle’s corporate office said that no one was available to comment on how many of the company’s stores carried American Cellular products. A Max Muscle outlet in Iowa was offering an online promotion of Tren Xtreme for free, but a salesman reported that the store no longer sold the brand.
Travis Tygart, head of the United States Anti-Doping Agency, said that the substance helps athletes quickly gain strength and muscle mass and is popular amount high school football players because it works. He did not offer an estimate regarding how many high school athletes have used the product.
The investigation into American Cellular Labs is led by Jeff Novitzky of the FDA and prosecutors from the U.S. attorney’s office for the Northern District of California. Novitzky has been the face of the government’s investigation into the distribution of performance-enhancing drugs since 2002.
The FDA has jurisdiction over dietary supplements, which are defined as products that offer general health benefits but do not claim to treat specific conditions. Manufacturers of dietary supplements are responsible for recording and ensuring the accuracy of the claims that they make regarding the safety and efficacy of their products. The FDA is only empowered to act in cases when it identifies a harmful or adulterated product on the market. If authorities find that a supplement contains an undeclared pharmaceutical ingredient like a steroid, the product is considered to be an illegal drug.
Steroids are naturally produced organic compounds that can be used legally to treat conditions like testosterone deficiency. Athletes have also used illegal forms of steroids for performance enhancement. Such usage is particularly concerning in preteen and teenage boys, because artificially high levels of testosterone can stop bone growth.
Investigators first became concerned about products made by American Cellular Labs after reports of severe liver and kidney problems in people who had used the two products. In one case, a liver transplant doctor reported that a 38-year-old male patient who had used the products had to be hospitalized with severe liver dysfunction and acute kidney failure which required dialysis.
While legal steroids entail risks, unknowingly taking supplements that contain illegal compounds is even riskier because the drugs come with unknown risks, according to Dr. Pieter Cohen of the Harvard Medical School. When prescribing similar drugs for men who have a deficiency, doctors closely monitor patients to avoid higher-than-normal hormone levels, but designer steroids have not been studied for safety. Cohen added that while there is no research showing that the new compounds are safe in humans, there is evidence that analogs of pharmaceutical compounds have let to life-threatening diseases that required transplantation in the past.