Federal prosecutors on Tuesday brought criminal charges against manufacturers of popular dietary supplements promoted to athletes as workout and diet aids.
The Justice Department unsealed a criminal indictment against USPlabs of Dallas and a number of the company’s executives and employees. It charges, among other things, that they conspired to import a synthetic stimulant made in a Chinese chemical factory and then used it in products they advertised as containing all-natural plant extracts.
The indictment also alleges that USPlabs knew some of their products could cause liver damage, yet sold them anyway — in particular, a product called OxyElite Pro.
USPlabs could not be reached for comment on Tuesday afternoon.
The case against USPlabs is part of a year-long investigation by a half-dozen federal agencies, including the Food and Drug Administration, the Federal Trade Commission, and the Internal Revenue Service. The Pentagon and the US Anti-Doping Agency also participated; both have expressed concern in recent months about the high prevalence of military personnel and athletes using dietary supplements.
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Unlike pharmaceuticals, supplements are not heavily regulated. Manufacturers do not have to prove their safety or efficacy before putting them on the market. Federal officials can step in to yank the products off shelves, but only after receiving complaints that the supplements are mislabeled or are causing consumers harm.
In the case of OxyElite Pro, federal officials said they were told that USPlabs would stop distributing it because of concerns about liver damage — yet the company instead “engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible,” according to a Justice Department press release.
The sweeping federal action announced Tuesday includes federal court cases in 18 states, many of them filed in recent months. More than 100 individuals and companies were targeted, some with criminal and others with civil cases. The IRS and FDA have seized assets including investment accounts, real estate, and luxury cars, the Justice Department said.
The Council for Responsible Nutrition, a trade group representing the dietary supplement industry, applauded the legal actions as necessary to protect consumers.
“These actions should serve as a strong warning to any company selling products in the dietary supplement space that if you’re going to engage in illegal activity, you’re going to pay the price,” said Steve Mister, the group’s president and chief executive.
The trade group has resisted calls by some public health experts to toughen federal law to allow more aggressive premarket inspection and regulation of dietary supplements. The industry has been booming as global food and drug companies and individual entrepreneurs have raced to create new supplements, often called nutraceuticals, to capitalize on loose federal regulation and strong interest from consumers.
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The civil cases outlined on Tuesday target companies that allegedly illegally marketed supplements as treatments for various diseases, including herpes, cancer, arthritis, and Alzheimer’s.
Under federal law, supplement manufacturers are not allowed to claim that their products can diagnose, cure, treat, or prevent a disease. But they still have plenty of leeway. Instead of touting a product as a cure for osteoporosis, for instance, the company could say that it “promotes healthy bones.”
Other civil cases allege that companies use unsafe food additives or active pharmaceutical drugs that are not listed on the products’ labels. Still others charge manufacturers with using “bogus weight-loss experts” and fake clinical trial data to promote their products.
“People looking for a dietary supplement to improve their health have to wade through a swamp of misleading ads,” Jessica Rich, director of the FTC’s Bureau of Consumer Protection, said in a statement.
At least 23,000 emergency room visits in the US each year are attributed to dietary supplements, according to a recent study in the New England Journal of Medicine. Supplement users going to the ER often complained of chest pain and heart palpitations.
