Two Dietary Supplements Said to Contain Steroids By MICHAEL S. SCHMIDT and NATASHA SINGER
Two over-the-counter dietary supplements that anti-doping officials say are popular among high school football players contain steroids, according to court papers filed by federal authorities on Thursday.
The supplements, Tren Xtreme and Mass Xtreme, are manufactured by American Cellular Labs and marketed as a “potent legal alternative to” steroids. But authorities alleged in search warrants executed on Thursday that the supplements contain illegal man-made steroids, also known as designer steroids. One of the substances is Madol, which was first identified six years ago during the investigation into the Bay Area Laboratory Co-operative.
The authorities said that Max Muscle, a walk-in supplement store with about 100 locations nation-wide, paid American Cellular Labs to be the exclusive retailer of these products, which could also be purchased on the Internet.
Maurice Sandoval, identified in the court documents as American Cellular’s chief executive, said in a telephone interview that he never personally sold steroids but declined to comment on whether the company had sold steroids. He said he sold the company last year but that a paperwork error kept his name on the company.
Someone who answered the phone Thursday at Max Muscle’s corporate office in Anaheim, Calif., said no one was available to comment on how many Max Muscle stores carried the American Cellular products. “This is not our product,” said the man, who would not give his name and hung up.
On Thursday, the Web site of a Max Muscle outlet in Des Moines was offering a promotion of Tren Xtreme for free, but a salesman who answered the phone there said the store no longer sold the brand.
Travis Tygart, the head of the United States Anti-Doping Agency, said the substance helped athletes quickly gain muscle mass and strength.
“This is the supplement of choice for high school football players, and we have heard that from more than one source,” Tygart said. “It’s one of the more popular dietary supplements for these athletes because it works.”
Tygart declined to estimate how many high school athletes had used the product.
The investigation into American Cellular Labs is led by Jeff Novitzky, an agent for the Food and Drug Administration, and prosecutors from the United States attorney’s office for the Northern District of California. Since 2002, Novitzky has become the face of the government’s investigations into the distribution of performance-enhancing drugs.
The F.D.A. did not return calls seeking comment on the investigation.
The search warrants were executed at a Muscle Max store in the Castro section of San Francisco and at Sandoval’s residence in Pacifica, Calif. Another search warrant was executed on the office of WVM Global Incorporated, in Lake Forest, Calif., which authorities believe is an associated business to American Cellular.
The F.D.A. has jurisdiction over dietary supplements, defined as products that can offer general health benefits but cannot claim to treat specific diseases or symptoms.
Manufacturers of dietary supplements are responsible for ensuring and documenting the safety and efficacy claims of their products. According to the law governing dietary supplements, the F.D.A. is empowered to act only in cases when it identifies a harmful or adulterated product that is already on sale.
But if federal authorities find a supplement to contain an undeclared active pharmaceutical ingredient like a steroid, the agency considers the product to be an illegal, unapproved drug.
Illegal steroids are of particular concern in preteen and teenage boys, doctors said, because artificially high levels of testosterone can stop their bones from growing.
Steroids are organic compounds, like hormones, naturally produced by the body. They are also used as legal drugs to treat conditions like testosterone deficiency. Athletes have also used illegal forms of steroids for performance enhancement.
Investigators grew concerned over sports products made by American Cellular Labs after the F.D.A. received reports of severe liver and kidney problems in people who had used the two products, according to court documents.
In one case, a liver transplant doctor reported that a 38-year-old male patient who had used these products was later hospitalized with severe liver dysfunction and acute kidney failure which needed to be treated with dialysis, the documents said.
Legal steroid drugs come with health risks. But unknowingly taking supplements that contain illegal compounded steroids is even riskier because such drugs entail unknown risks, said Dr. Pieter Cohen, an instructor at the Harvard Medical School who is studying the dangers of adulterated dietary supplements.
For example, when doctors prescribe testosterone for men who have a testosterone deficiency, physicians monitor the patients closely because such steroids can lead to higher-than-normal hormone levels, potentially putting patients at risk for prostate cancer.
But taking designer steroids in a sports supplement is even more dangerous for people, he said, because these compounds have not been studied for safety.
“It’s placing the consumer at very serious risk of harm because there is absolutely no research showing that this new compound is safe in humans,” said Cohen, a general internist at the Cambridge Health Alliance, a network of public hospitals in Massachusetts. “We do have evidence that, in the past, analogs of pharmaceutical compounds have led to unexpected life-threatening disease such as liver failure that required transplantation.”