At issue is whether OxyElite Pro is in compliance with FDA regulations in the wake of a growing liver-injury outbreak linked to the dietary supplement.
A U.S. senator is asking a leading sports supplement firm to answer questions about the safety of its products in the wake of a growing number of liver injury cases under investigation by health officials.
"I am concerned about the mounting evidence that products manufactured by USPlabs endanger consumer health and contain adulterated ingredients," said Sen. Dick Durbin, D-Ill. "The recent cases of adverse events — including liver injury and even death — surrounding yet another USPlabs product raise serious questions about the company's practices and commitment to consumer safety."
On Tuesday, Durbin sent a letter to USPlabs CEO Jacob Geissler, citing a USA TODAY article published last week about the company's repeated run-ins with the FDA, Geissler's criminal history and the growing number of liver-injury cases in an outbreak that health officials have linked to the company's OxyElite Pro supplement.
USPlabs markets OxyElite Pro as an all-natural supplement it says will give users energy and focus in workouts and help with appetite suppression.
Durbin's letter asks Geissler to answer several questions by Nov. 18 about the company's compliance with federal regulations and the safety of its products. Durbin is seeking details about adverse events involving USPlabs products and all new dietary ingredient notifications submitted by the firm to the Food and Drug Administration. Durbin also has asked the company to list all of its products that contain an ingredient called aegeline.
Officials at USPlabs said in a statement: "We look forward to co-operating with Senator Durbin and providing the scientific information which clearly establishes the safety of our products."
The company has disputed that OxyElite Pro is at fault in the outbreak and have said that aegeline, which comes from the Bael tree, is a safe ingredient long consumed by people around the world.
The FDA issued a warning letter to USPlabs on Oct. 11, alleging that aegeline is a new ingredient that the company should have notified the agency about. The FDA has noted that aegeline is an ingredient in OxyElite Pro — which is suspected in the current outbreak — as well as another of the company's supplements: VERSA-1.
USPlabs told USA TODAY last week that the company will be sending a formal response to the FDA's warning letter.
Durbin said reports by USA TODAY and other news organizations have exposed the lack of information available to consumers about dietary supplements. In August, Durbin and Sen. Richard Blumenthal, D-Conn., introduced a bill that among other things would give the FDA more authority to require manufacturers to register their products and ingredients with the agency and provide proof of any health benefit claims.
As of last week, the number of confirmed liver injury cases in the outbreak linked to OxyElite Pro had grown to 48, with all but seven of them in Hawaii, according to federal and state health officials.
The outbreak emerged in the wake of USPlabs high-profile fight with the FDA over the company's previous use of the controversial stimulant DMAA in some of its products.
Geissler, who is on the board of the American Herbal Products Association, was indicted on a controlled substance charge involving possessing thousands of pills containing anabolic steroids in 2003, USA TODAY reported last week.
To read all articles in USA TODAY's Supplement Shell Game series, go to: supplements.usatoday.com.
Follow USA TODAY investigative reporter Alison Young on Twitter: @alisonannyoung