Nov. 18, 2015 -- Seven federal agencies, including the Department of Justice and the FDA, held an extraordinary joint press conference Tuesday to announce the civil and criminal indictments of more than 100 makers and marketers of dietary supplements.
Promises that signal iffy products, according to federal agencies, include:
If a product makes those claims, ask your health care provider:
Seals that certify supplement safety include United States Pharmacopeia (USP) or a symbol from NSF International or ConsumerLab.com.
At the center of the action, called the Dietary Supplement Sweep, was an 11-count criminal indictment against Dallas-based USPlabs. The company made weight loss and bodybuilding supplements blamed for dozens of liver injuries -- some which required transplants -- and several fatal heart attacks in young, apparently healthy adults, authorities say.
“The USPlabs case and others brought as part of this sweep illustrate alarming practices the department found -- practices that must be brought to the public’s attention so consumers know the serious health risks of untested products,” says the DOJ’s Principal Deputy Assistant Attorney General Benjamin Mizer in a press release.
The indictment offers a rare glimpse into the dangerous sell first, test later business practices embraced by the supplements industry and codified by a 1994 law called the Dietary Supplement Health and Education Act, or DSHEA. The law allows supplement manufacturers to self-certify that their products are safe and effective. The FDA can only step in once a problem comes to light.
Critics of the supplement industry applauded the indictments, but said they wouldn’t be enough to keep consumers safe in the long run until laws are changed.
“I’m glad to see enforcement actions taking place against companies that knowingly endanger or mislead American consumers. But, the bottom line is that a lack of consistent oversight makes the dietary supplement industry resemble the Wild West -- and until the government makes this a real priority, we will continue to see shelves stocked with products that could potentially harm American families,” U.S. Senator Claire McCaskill said in a press statement.
If the government wins its case against USPlabs, the company could face hundreds of millions of dollars in fines. Four company executives and a consultant face between 1 and 100 years in prison, depending on the individual charges against them.
“What worries me tremendously is that USPlabs is not alone in this practice,” says Pieter Cohen, MD, an assistant professor of medicine at Harvard who has published numerous studies questioning the safety of dietary supplements. “There are dozens of other companies doing the same thing today -- so consumers should understand that this is typical for the industry and reflects products sold at mainstream retailers.”
Fraud, Deception, and a Cover-Up
The indictment, which offers details from the criminal investigation launched in 2013, reveals how company executives made millions off of weight loss and bodybuilding supplements that they claimed contained natural plant extracts like geranium and green coffee bean, when the ingredients were really synthetic stimulants shipped from China. They directed their Chinese supplier to hide the real ingredients behind false “Certificates of Analysis” so they could escape notice by federal authorities.
“Lol,” company executives joked in a 2009 email exchange referenced in the indictment, “stuff is completely synthetic.”
The “stuff” they were joking about was DMAA, one of the active ingredients in the product OxyElite Pro. The supplement, which was reformulated several times with different problematic ingredients, may have sickened nearly 100 people, according to the CDC. Many of those cases were military service members stationed in Hawaii who were taking OxyElite products to drop weight to meet required standards, Cohen says.
“It ended up making one woman so ill that she required a new liver, and of course now with a new liver and the 10 different anti-rejection medications she has to take every day, she’s no longer able to serve the country,” Cohen says.
Perhaps the most damning details in the complaint concern how the company was testing its products.
“Defendants sometimes tested the products on themselves and sold the ones that made them feel good,” Mizer said, in a news conference.
Executives also knew that at least one of the ingredients they used could be toxic to the liver, according to the indictment, but they reasoned that since they were just using ground-up tree roots instead of a more concentrated plant extract, there wouldn’t be enough material in the product to harm people.
“The defendants promised the FDA and the public that they would stop distributing the product at issue, but they did not,” Mizer said.
Internal company emails show that instead of taking actions to get their products off the market, they ramped up distribution, making at least $400 million off their illegal products, according to the indictment.
Peter Barton Hutt, a Washington, D.C.-based attorney representing USPlabs, declined to comment for this story.
Trade groups that represent dietary supplement manufacturers were quick to commend the federal crackdown, which they said demonstrated that there are ample laws in place to protect the public from a few rogue companies in the industry.
“This afternoon’s press conference was welcome and overdue, and we were gratified to see the breadth of agencies represented. UNPA and responsible industry have long urged regulators to take decisive action against noncompliant products, as were highlighted today,” wrote Loren Israelsen, president of the United Natural Products Alliance, in a statement released to the media.
“Today’s press conference was a good demonstration of regulators taking action. We say, ‘Carry on,’” Israelsen wrote.
U.S. Senators Dick Durbin and Richard Blumenthal praised the “unprecedented cooperation” among federal agencies, but said the news “further supports the need for comprehensive federal regulation to protect consumers from both intentional, serious harm, and misleading health claims from dietary supplement manufacturers.”
They have promised to reintroduce a bill that would require supplement manufacturers to register their products with the FDA and would require warning labels for ingredients that could cause serious adverse events or drug interactions.