Federal officials in the US have announced a crackdown on the dietary supplements industry, targeting firms that falsely claimed their pills could help people lose weight, build muscle or even kick drugs.
The Justice Department said it had filed criminal charges against Dallas-based USPlabs, known for workout and weight-loss supplements such as Jack3d and OxyElite Pro.
USPlabs allegedly told some retailers that its products contained natural plant extracts, but the company actually used a synthetic stimulant manufactured in a Chinese chemical factory, according to the department's complaint.
Four unnamed people related to the USPlabs case were arrested on Tuesday, and two more are expected to self surrender, according to the Justice Department.
"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," said Principal Deputy Assistant Attorney General Benjamin C. Mizer in the announcement.
A USPlabs spokesman could not be immediately reached for comment.
Justice officials said the department had worked with other federal officials, including at the Food and Drug Administration, Federal Trade Commission and the US Anti-Doping Agency, over the past year to bring civil and criminal cases against more than 100 makers and marketers of dietary supplements.
Sunrise Nutraceuticals admits no wrongdoing, but at this time is co-operating with the FTC and has chosen to discontinue its claims regarding symptoms of opiate withdrawal.
As part of those efforts, the FTC said it had filed a federal lawsuit against Florida-based Sunrise Nutraceuticals, accusing it of falsely claiming that its dietary supplement Elimidrol could help someone with opiate withdrawals. The company allegedly said Elimidrol was the No 1 opiate withdrawal supplement and was the only opiate withdrawal product "guaranteed to work", according to the FTC.
"Sunrise Nutraceuticals admits no wrongdoing, but at this time is co-operating with the FTC and has chosen to discontinue its claims regarding symptoms of opiate withdrawal," the company said in a statement.
"Sunrise Nutraceuticals will continue to focus on providing high-quality products that exceed its customer's expectations."
The industry has been criticised for some time. In April, more than a dozen state attorneys general asked Congress to launch an investigation into herbal supplements. A recent study in the British Journal of Cancer found a potential connection between men who took muscle-building supplements and the risk of developing testicular cancer. The New York attorney general's office ordered four retailers - GNC, Target, Walgreens and Wal-Mart - to halt sales of some supplements after DNA tests apparently showed that they did not always contain the herbs advertised.
Supplement-makers also have a legal responsibility to ensure the safety of their products. But unlike with traditional drugs, which must undergo a series of clinical trials to prove they are safe and effective, the FDA has little means of flagging suspect supplements before they hit the market.
GNC was not named in Tuesday's announcement, but the mere speculation that a federal probe would touch on supplements sent its stock plummeting 20 per cent before recovering most, though not all, of its losses, finishing the day down 6.4 percent.
Health experts have long complained that supplements, which are not considered a food or a drug, are too loosely regulated and pose a safety hazard to consumers. Companies are required to ensure that products are safe and accurately labeled, experts say, but there is little federal oversight. The industry has countered that problems are contained among a few bad actors and do reflect an industry-wide problem.
The FDA does have some authority to oversee dietary supplements but not nearly the strict regulatory power that it has over pharmaceutical drugs.
One critical difference is that dietary supplements do not need FDA approval hitting the market. Except in rare cases, firms do not need to provide the agency with evidence showing that supplement ingredients are safe or actually work.
Manufacturers have to adhere to certain labeling requirements, such as including the name of the manufacturer, a list of ingredients and identifying the product as a "supplement".
Supplement-makers also have a legal responsibility to ensure the safety of their products. But unlike with traditional drugs, which must undergo a series of clinical trials to prove they are safe and effective, the FDA has little means of flagging suspect supplements before they hit the market. In fact, when problems arise, the FDA is responsible for showing that a dietary supplement is unsafe before it can pull it from store shelves.
Dietary supplements are used by an estimated 150 million Americans, or more than half of US adults, according to the Council for Responsible Nutrition, which represents the US$35 billion industry.